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Exclusive Report on Stem Cell Therapy in Cancer Market | Analysis and Opportunity Assessment from 2021-2028 |Aelan Cell Technologies, Baylx, Benitec…

The Stem Cell Therapy in Cancer Market 2021-2028 exploration report by Infinity Business Insights offers an inside and out assessment dependent on Leading Players, Development, Project Economics, Future Growth, Market Estimate, Pricing Analysis, and Revenue.

Rising interests in the structure of a proficient medication dealing with the anchor are projected to give the global Stem Cell Therapy in Cancer market a significant lift in the coming years. Another factor projected to upgrade the global Stem Cell Therapy in Cancer market over the gauge time frame is an expansion in the use of different medication wellbeing programs related to other designing controls.

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PRIME 30+ players of the Stem Cell Therapy in Cancer Industry:

Aelan Cell Technologies, Baylx, Benitec Biopharma, Bluerock Therapeutics, Calidi Biotherapeutics, Cellular Dynamics International, Center For Ips Cell Research And Application, Century Therapeutics, Khloris Biosciences, Reneuron, & Others.

The pandemic has impacted the worldwide medical services in the Stem Cell Therapy in Cancer market, and nations, for example, Germany and the United States have encountered huge issues. To close the hole in the inventory network, the public authority is putting resources into medical services innovation to satisfy the rising need.

Stem Cell Therapy in Cancer industry -By Application:Hospitals, Specialized Clinics, Academic & Research Institutes, Others,

Stem Cell Therapy in Cancer industry By Product:

Stem Cell And Non-Stem Cell

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Exclusive Report on Stem Cell Therapy in Cancer Market | Analysis and Opportunity Assessment from 2021-2028 |Aelan Cell Technologies, Baylx, Benitec...

Global Cell Therapy Bioprocessing Market Scope and Forecast By 2021-2027 I Top key players- Fresenius Kabi SA, Asahi Kasei Corporation, The Manomet…

The global Cell Therapy Bioprocessing Market is segmented on the basis of type, Application, End-User, and Region. The Cell Therapy Bioprocessing Market accounted for xx% in 2020 and is forecasted to account for a CAGR of xx% in the forecast period of 2021-27.

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The COVID-19 crisis has expanded its horizons. Cell Therapy Bioprocessing Market already perform an important, if underappreciated, role in the healthcare system around the world. It has made healthcare available to those who are relocated or isolated. During the ongoing COVID-19 outbreak, mobile hospitals were a lifesaver for those who didnt have easy access to hospitals. The utilization of mobile hospitals and associated applications, according to healthcare specialists and health IT developers, might considerably aid in monitoring and regulating the COVID-19 outbreak.

The global Cell Therapy Bioprocessing Market industry is being driven by an increase in the prevalence of infectious and chronic diseases. In times of pandemic, mobile hospitals have proven their importance, from cost-cutting benefits for the healthcare system to efficient patient treatment in less time. Furthermore, new medical gadgets and imaging technology are increasingly being used to diagnose patients as early as feasible.

Top key players: Fresenius Kabi SA, Asahi Kasei Corporation, Sartorius SA, MERCK KGaA, THERMO FISHER SCIENTIFIQUE INC., Corning incorporated, Cytiva, Lonza, Repligen, and Catalent Inc

Segmentation: Biotreatments market by technology by cell therapy: Bioreactor Freeze Electrospinning Control flow centrifugation Ultrasonic Lysis genome editing technology cellular immortalization technology Technology viral vectors

Cell therapy bioprocessing market by cell type: Stem cell Immune cell Human embryonic stem cell Pluripotent stem cell Hematopoietic stem cell

Cell therapy biotreatment market by indication: Cardiovascular disease (CVD) Oncology Wound healing Orthopedic Others

Cell therapy bioprocessing market by end user: Hospitals and clinics Diagnostic centers Regenerative medicine centers University and research institute

Our industry experts are working determinedly to comprehend, amass and opportune convey appraisal on effect of COVID-19 debacle on numerous organizations and their customers to help them in taking brilliant business choices.

The main goal for the dissemination of this information is to give a descriptive analysis of how the trends could potentially affect the upcoming future of Cell Therapy Bioprocessing Market during the forecast period. This markets competitive manufactures and the upcoming manufactures are studied with their detailed research. Revenue, production, price, market share of these players is mentioned with precise information.

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Geographically, global Cell Therapy Bioprocessing Market has been scrutinized across global regions to study about various successful strategies carried out by industries. It includes major regions such as North America, Latin America, Middle East, Asia-Pacific, Africa, and Europe on the basis of different parameters. Different top-level industries have been profiled to get better insights into the global Cell Therapy Bioprocessing Market. Additionally, it offers detailed elaboration on different policies, rules and regulations initiated by governments to set standards for global market businesses.

All the research report is made by using two techniques that are Primary and secondary research. There are various dynamic features of the business, like client need and feedback from the customers. Before Infinity Business Insights curate any report, it has studied in-depth from all dynamic aspects such as industrial structure, application, classification, and definition.

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The Oncology Institute of Hope and Innovation (TOI) Expands to San Diego County – Yahoo Finance

Two state-of-the-art clinics opening in Vista and Chula Vista with a third in Hillcrest slated for later this year

SAN DIEGO, August 04, 2021--(BUSINESS WIRE)--The Oncology Institute of Hope and Innovation (TOI) began seeing patients this week at two new locations in Vista and Chula Vista, marking the community-based oncology providers entry into San Diego County. A third location in Hillcrest is slated to open in the fall.

Founded in 2007, TOI is a multi-state cancer care practice dedicated to healing and empowering patients through compassion, innovation, and state-of-the-art medical care. TOI is the largest value-based oncology practice in the U.S., taking accountability for both the quality outcomes as well as the medical costs associated with a population of more than 1 million patients. TOI recently announced its intent to become a publicly traded company via a business combination with DFP Healthcare (NASDAQ: DFPH, DFPHW).

"At TOI, we believe every patient should have access to specialized care including clinical trials and transfusions, in their own community," shared Brad Hively, CEO. "We are thrilled to bring our cutting-edge cancer care to San Diego County."

As the nations leading value-based oncology provider, TOI offers a diverse set of cutting-edge resources including:

A leading clinical research program offering patients access to more than 130 clinical trials.

Comprehensive dispensary services to offer convenience and savings to patients receiving oral chemotherapeutics.

A care management program which helps patients navigate a complex healthcare system.

A state-of-the-art website with educational resources, scheduling capabilities, and a convenient patient portal.

Patients can now book appointments with three highly rated physicians: Drs. Jeffrey Andrey, Babak Baseri, and Anwer Shaikh.

About The Oncology Institute of Hope and Innovation

Founded in 2007, The Oncology Institute of Hope and Innovation (TOI) is one of the largest community oncology practices in the US as well as our nations leading value-based oncology services platform. TOI employs 70+ physicians and advanced practice providers in 45+ clinic locations, with more than 500 total employees helping to offer leading-edge, evidence-based cancer care to a population of more than 1 million patients. TOI brings comprehensive, integrated cancer care into community settings, including clinical trials, stem cell transplants, transfusions, and other care delivery models traditionally associated with the most advanced tertiary care settings. For more information visit http://www.theoncologyinstitute.com.

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Contacts

Julie Korinke Director, Marketing and Communications 562.735.3226 x.88806 juliekorinke@theoncologyinstitute.com

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The Oncology Institute of Hope and Innovation (TOI) Expands to San Diego County - Yahoo Finance

Covid-19 and the blood – Trinidad & Tobago Express Newspapers

PERSONS with haematological (blood) diseases are among those most at risk of severe illness and complications from Covid-19, says Trinidad-born, UK-based consultant haematologist and clinical senior lecturer Dr Keith Wilson.

Blood diseases are conditions that impact the bloods ability to function correctly. They can affect any of the three main components of blood.

Our bodies naturally respond to any infection by raising an immune response however people with haematological conditions have an impaired immune system either due to the condition itself or the treatment of the condition.

Most patients with haematological malignancies are immunosuppressed as a result of their baseline condition, treating such ones with chemo or radiotherapy will cause immunosuppression so you have immunosuppression upon immunosuppression. That would explain why those patients are at high risk of infection,says Wilson who is the Director of the South Wales Blood and Marrow Transplant Programme.

In a zoom interview with the Express, the haematologist also referred to preliminary results from recent studies in the UK which have revealed that people with haematological malignancies respond poorly to the vaccine. The studies show that even if such ones have been vaccinated their bodies may not mount an adequate response should they come into contact with the virus. Nevertheless, Wilson stresses that such highly vulnerable persons should take the vaccine.

Our advice to our patients is that they should be vaccinated. But that advice comes with a caveatwe cannot guarantee that they would respond adequately to the vaccine. So the advice is a double barrel oneget the vaccine but continue the protective measures that we have instituted over the years,he says.

Since the start of the pandemic, Wilson has been working longer hours. He and his colleagues had to change the way they work in a variety of settings. Their patients are vulnerable at the best of times so in order to protect them, Wilson and his department had to institute different zones in the hospital. Maintaining the zonal arrangement meant spacing out appointments and spacing patients out physically.

To get through the workload meant working for much longer periods than we were accustomed to and that has continued until now. The UK is experiencing its third wave and therefore the protective measures have to remain in place, those requirements havent been modified since we adopted them in March/April 2020, says Wilson.

The haematology unit also introduced telephone clinics for patients who do not need to be seen face to face.

Over the years, Wilsons hard work and dedication to his profession has won him recognition. In 2017 he was awarded Health Care Professional of the Year and was praised for being an extremely hard working individual with extremely high standards. He was also commended for supporting patients throughout their journey and being open and honest about their treatment options.

His commitment to improving treatment for patients came to the fore in the late 90s when Wilson and his colleagues at the South Wales Blood and Marrow Transplant Programme conducted a collaborative study on a method of transplantation called reduced intensity allogeneic stem cell transplantation. Stem cell transplantation has been around for decades however in the beginning the results were uniformly poor. Generally people received high doses of chemotherapy with radiation therapy, which meant that patients had to be young enough to tolerate the treatment, however patients who bore the greatest burden of the diseasepatients 60 years and olderwere excluded from these therapies, explained Wilson. During the collaborative study Wilson and his colleagues observed that the stem cells used in allogeneic or donor transplants actually have anti-leukaemic potential, much the same way the immune system can detect a cancer cell as foreign and attack it the same way it fights infection. That opened up the possibility of reducing the dose of chemotherapy and radiotherapy given as part of the stem cell transplant process. This method is not only available to younger patients who were too sick to have the full blown version but more importantly the reduced intensity approach has made it possible for Wilson and his team to treat older patients who were once largely excluded.

Today three quarters of all allogeneic or donor transplants are now done with this new method called reduced intensity conditioning. If we didnt have this method at our disposal it means that the vast majority of patients with haematological malignancies would not have this treatment optionwhichfor many cancers, is the only means of cure,explains Wilson.

Long before he began his journey to become a doctor and specialist, Wilson held several leadership positions as a pupil at Presentation College. He was head college prefect and sang in the school choir and was also platoon sergeant (Cadets). He learned to play the steelpan and was also actively involved in many sports organisations. He went on to study medicine at the University of the West Indies St Augustine and at UWI Mona, Jamaica. Wilson practised internal medicine at the San Fernando General Hospital before migrating to the UK in 1991.

There was one particular patient who motivated Wilson to specialise in haematology. At that time there was only one trained haematologist - the late Dr Waveney Charles serving T&T. The patient presented with a rare condition aplastic anaemia where the bone marrow shuts down. Wilson communicated with Charles about possible treatment options. But the patient wasnt suitable for any of the options which were available, instead he was given supportive care.

He did survive for about five years which was a feat in itself given that without proper treatment someone with severe aplastic anaemia would have a life expectancy of six to 18 months. He was young, mischievous, playful. Not being able to offer him what he needed best stirred in me a desire to do haematology, I remember saying to myself I must learn how to treat this condition and I must be able to do transplantation, so I credit my decision to do haematology and transplantation in particular to this young man who entered my life so many years ago,he says.

Wilson once had a dream of starting a stem cell transplant unit in the Caribbean but those plans never materialised for a number of reasons. There would need to be a combination of qualified physicians, infrastructural adjustments and support services to make it possible to do it safely but it is within reach if there is sufficient appetite to do it, he says.

The consultant haematologist has not forgotten his roots, over the years he has visited Trinidad at different intervals. He would embrace the opportunity to repay some of the investment that was made in him many years ago when he began his career in medicine.

Im always open to the possibility of helping the haematology community particularly with regards to haematological malignancy where I would be most equipped to make a contribution, he says.

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Covid-19 and the blood - Trinidad & Tobago Express Newspapers

Vampire Facial 2021: My Before and After Pics of PRP Microneedling – Cosmopolitan

Listen, I'm not one to be ~easily influenced~ into trying something just because a celebrity or influencer posts about it. ...Well, okay, except for that one time I tried the viral Hanacure face mask. Or, fine, that other time I ordered Curology (but it really works! Sue me!). Or, ugh, that time I triedand surprisingly lovedsoap brows. But! I can say that I did hold out on trying one incredibly popular trend for years: PRP microneedlingaka the vampire facial. Yup, despite the fact that Kim Kardashian posted a viral selfie of her own vampire facial in 2013, I saw that bloodied towel next to her and decided I'd sit that trend out.

But it's been eight years, and the popularity of vampire facials has yet to die downand for good reason: They're said to help boost collagen production (for tighter, smoother, newer-looking skin) and improve everything from hyperpigmentation to acne scars, so I decided it might be one worth finally trying it for myself and paid a visit to board-certified dermatologist Jordan Carqueville, MD. Never say never, kids. Below, a breakdown of the bloody beauty treatment and a review of my experience trying it for the first time.

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To put it simply, a vampire facial stimulates collagen production in your skin through a combination of microneedling with platelet-rich plasma (PRP). Stay with me. Microneedling, as you probably already know, is a treatment that involves poking your skin with itty-bitty needles to create "micro-injuries." Sounds barbaric, but these little injuries actually trigger your body's wound-healing process to encourage new collagen production (aka the essence of good skin).

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The only difference with a vampire facial is instead of puncturing your skin with bare needles (like with microneedling), it's punctured with your own blood platelets. Yup. Basically, some blood is drawn from your arm, then spun with a centrifuge to separate the plasma and platelets that contain your own growth factorsi.e., platelet-rich plasma (PRP). That PRP is then "microneedled" into the skin and applied on top of the micro-wounds to help stimulate your collagen even more.

It all sounds incredibly ~extra~, but vampire facials (or PRP microneedling, if we're being specific) can help boost collagen production, brighten your overall skin tone, get rid of minor acne scars, fade hyperpigmentation, and tighten your skin.

A vampire facial is microneedlingbut better. Microneedling works great to stimulate collagen on its own, but Dr. Carqueville says that PRP serves as one of the best ways to really boost your collagen by using those concentrated platelets and growth factors in addition to the basic microneedling.

After you heal (which can take up to a week), your skin will look and feel brighter, dewier, more supple, and refreshedbut don't expect those results overnight. Immediately after my treatment, my face was comically red and flushed, and it only softened to a bright-pink (!) for the rest of the day. It also felt tight, tender, and dry, like I'd been swimming in the salty ocean aaaand also got a sunburn. By the next morning, I felt totally normal again, and the redness had significantly improved, but I still had lil red splotches all over my face that took a few days to fade.

According to Dr. Carqueville, how long a vampire facial takes to heal depends on the needle length and the amount of pressure applied. With the stronger treatments, the healing period could last five to seven days, and for a light refresher, two to three days. Since I was in the hands of a physician I trusted, I felt comfortable with a stronger, more aggressive treatment in hopes that I would see some serious results even faster. So needless to say, my face needed the maximum amount of time to heal: one full week.

After your skin heals, you can expect to have a nice, dewy glow for a few weeks, but know that your results will just get better with time. Basically, a vampire facial is an investment toward your future skinit's not an immediate fix. "Collagen stimulation, that tightening and remodeling of your collagen, happens over the course of six months to a year after a procedure like this," Dr. Carqueville explains. I mean, you're quite literally tricking your body into speeding up its natural regenerative process, and that's gonna take some time.

With vampire facials or PRP microneedling, a light refresher once a quarter or even once a year might be enough for someone younger without major acne scarring. But if you're trying to treat deeper acne scars, you might need a series of three sessions spaced four to six weeks apart. "Theres no right or wrong answer, but generally, the cumulative results will be more noticeable with the more treatments you get," Dr. Carqueville says. Your dermatologist will be able to tell you during your consultation how many treatments they think you'll need, so don't stress.

The first few days after your treatment, keep it simple. You've just created wounds that need to heal, so any harsh ingredients like exfoliating acids are a definite no. For the first 48 hours, Dr. Carqueville recommends sticking with just a hyaluronic acid serum and a thin layer of Vaseline on top if your skin feels a little dry. Or, try a bland, basic, fragrance-free moisturizer, and keep your skin makeup free.

If improving pigment (like melasma) is the goal, Dr. Carqueville likes incorporating a dark-spot-correcting cream after a couple of days of initial healing (around 48 to 72 hours after) while it still can penetrate really well. "When you do microneedling, you open up your skin channels to better absorb topical medications," says Dr. Carqueville. "It does help the skin become more amenable to absorbing those active ingredients."

The number-one thing you should not do? Go out in the sun. Dr. Carqueville explains that because vampire facials compromise the top layer of your skin, you dont have as much protection from the sun, so you need to be really cautious. Avoid exposure the best you can during the initial healing period, then use lots of sunscreen and wear all the sun protection gear to keep your skin safe.

The price depends largely upon where you're receiving the treatment, but microneedling alone costs at least $200, on the very low end, and once you throw in the PRP (e.g., the blood draw, centrifuge, etc.), that price will increase to the $1,000-$2,000 range. It's not cheap, but do you really want to bargain shop when you're getting blood drawn and needles stuck in your face? No, no you do not.

On a scale from one to Brazilian bikini wax, Id rate the pain a five. I was numbed up, both with a topical numbing cream and lidocaine injections (honestly, the shots were the worst part), but I still felt the whole treatment and can't imagine going through it if I had full sensation of my face. Basically, numbing is mandatory. All in all, after waiting 45 minutes for the numbing cream to set in, the process was quick, so any pain or discomfort was temporary.

I wish I could look at you in your eyes when saying this because it's *that* important: No, you should not try to DIY a vampire facial at home. Considering all the numbing beforehand and, ya know, the whole drawing and spinning of your blood, this treatment can only be performed by a trained, experienced provider, or ideally, a physician.

Dermarolling, on the other hand, is a treatment much milder than a vampire facial that can be accomplished at home (sans blood) with a needle-covered roller. It doesn't penetrate as deeply (or involve any PRP for that matter), so it isn't nearly as effective as a vampire facial or even in-office microneedling, but as long as you adjust your expectations (and as long as your dermatologist gives you the OK), dermarolling is a much more affordable and accessible treatment.

Ora Microneedle Face Roller System

StackedSkincare Micro-Roller .2mm

BeautyBio GloPRO Microneedling Regeneration Tool

Jenny Patinkin Rose on Rose Derma Roller

Despite the gory nickname and photos, a vampire facial is actually great for your skin. Dr. Carqueville says the side effects of a vampire facial are usually low, as long as it's performed by a physician or experienced provider who's knowledgeable in PRP treatments. Still, as with anything that disrupts the skin barrier, theres always a risk of infection, bruising, redness, swelling, and tenderness, she says. Scarring, hyperpigmentation, and hypo-pigmentation are also risks and can be exacerbated with sun exposure, so here is your second reminder to slather on that sunscreen.

Expensive? Yes. Painful? If you weren't numbed up, probably. Worth it? Absolutely, IMO. Unlike other pricey skin treatments, like chemical peels, you actually get long-term benefits out of a vampire facial by stimulating that collagen in your dermis. It's only been a handful of days since my treatment, so I'm still waiting on my long-term results (and for my face to heal completely, TBH), but I already see improvements and would definitely recommend it to friends.

As long as you've got a week where no one's going to see your face (and you don't have a fear of needles, because there are a lot of those involved), I'd say it's worth all the blood, sweat, and internal tears over my bank account.

I Got a Microcurrent Facial, Now My Skin Is Amaze

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Treatment of Keloids Using PSR Combined with Radiation. | CCID – Dove Medical Press

Introduction

Keloids, a type of histologically localized dermal inflammation, are the result of an aberrant healing process featuring abnormal proliferation of fibrous tissue and chronic inflammation after skin injuries reach the reticular dermis.1 Due to the excessive amounts of collagen and glycoprotein accumulating in the dermis, keloids progress and enlarge by growing beyond the boundaries of the original wounds, which distinguishes them from hypertrophic scars. The affected skin usually stiffens and gets pruritic, with various color ranges from pink to dark brown.

The current mainstays of treating hypertrophic scars and keloids remain nonstandard with multiple modalities involved, including surgical excision, intralesional steroids, silicone gel, pressure therapy and laser therapy. Surgical excision alone has been proved to result in high recurrence rate because of post-traumatic collagen synthesis stimulation, while subtotal excision with lateral undermining might possibly improve outcome.2 In recent years, several studies reported low recurrence rate by following surgical excision with other modalities, usually radiation therapy or intralesional steroids injection.3,4 Silicone gel, often used as adjuvant treatment after surgery or laser, has also been reported by some studies to be effective in reducing recurrence rate.5 Laser therapy includes a series of treatment modalities including neodymium-doped yttrium aluminium garnet (Nd:YAG) laser, carbon dioxide laser and diode laser.68 Though laser treatment alone had less effectiveness on keloid than hypertrophic scar with high recurrence rate, a combination of laser and other single-application treatments such as silicone gel, and intralesional steroid injections were proven to be an effective and safe therapeutic approach.8

In recent years, a novel device, plasma skin regeneration system (PSR) is applied to treat mesh skin-grafted scars and traumatic scars.9 Unlike laser therapy which directly applies radio frequency to skin, PSR uses radio frequency to convert nitrogen to plasma, a high-energy state of matter that is emitted at 515 millisecond pulses to deliver 14 J of energy.9 Plasma then conveys energy to the wounded skin and causes a thermal effect that gasifies proliferative fibrous tissue in the dermis. The effect on skin rejuvenation depends on the amount of plasma energy delivered. Thus, it enables operators to adopt various energy levels and different number of treatments to different wound types and locations.

In this study, the authors innovatively removed keloids with PSR. Given that single treatment may result in high recurrence rate, the authors administrated adjuvant radiotherapy. Radiation therapy has been illustrated to be effective in the control of keloid recurrence by inducing keloid fibroblast apoptosis and destroying collagen structure.2,10 The aim of this study is to evaluate the effectiveness and safety of PSR combined with radiation therapy in the treatment of keloids on different body parts.

This study was conducted in accordance with the Declaration of Helsinki. Ethical approval was obtained from the ethics committee of Peking Union Medical College Hospital. Patient data confidentiality was maintained in accordance with the regulations. Written informed consent was waived in light of the retrospective nature of this study. A total of 71 consecutive patients (aged 1569) with 98 dermal lesions clinically diagnosed as keloids were enrolled in this uncontrolled prospective study, with stipulated selection criteria. The skin types of enrolled patients were type III or IV. The over-extensive growth pattern unconfined to the original wound edges was required as a clinical distinction of keloids from hypertrophic scars.

Patients were excluded from this study if they had previously undergone at least one of the following treatments within the last six months: surgical excision, free-flap grafting, carbon dioxide resurfacing, triamcinolone intralesional injection, silicone gel sheeting, and pressure therapy. Pregnant and lactating patients and those with systemic comorbidities including cardiovascular diseases, diabetes mellitus, and chronic renal failure were also excluded to avoid unnecessary potential risks.

A clinical evaluation process was developed primarily based on the number, thickness, and texture of the lesions (Figure 1). Each patient admitted for the treatment of keloids underwent this evaluation process. PSR was mainly applied for progressive keloids with multiple lesions. Ideal lesions were no thicker than 4 mm. Patients whose keloids were thicker than 10 mm were recommended not to receive this treatment, because thick lesions needed high level of energy and too much energy would cause severe side effects. For lesions 4 to 10mm thick or those much stiffer than usual, we administered intralesional injections of betamethasone (Diprospan) to soften the lesions before PSR.

Figure 1 Clinical evaluation and treatment process for keloids.

Plasma was administrated to qualified keloid lesions right after subdermal injection of 0.5% lidocaine (540mL, depending on the size of lesion), which spared patients from pain when receiving PSR treatment. Doctors resurfaced the lesions using PSR, making them as flat as the surrounding skin. The patients were asked to cover the lesion with topical antibacterial spray to prevent potential topical infection. External beam irradiation was administered with a total dose of 18 Gy in two fractions, one week apart. Specifically, the first radiation therapy was performed within 24 hours after treatment, and the second was performed 1 week later. The minimum follow-up period was 12 months.

Digital photographs were taken to record the morphological characteristics of the keloids before treatment, immediately after treatment and at the end of follow-up. The patient and observer scar assessment scale (POSAS) was used to evaluate the effect of PSR.11 Both patients and observers were asked to fill in the numeric scale before treatment and 12 months posttreatment. To avoid bias, the POSAS observer study was performed independently by an experienced plastic surgeon who was not involved in the treatment.

Means and standard deviations were calculated for each variable. The Students t-test was performed using SPSS 23.0 (IBM, New York, USA) to analyze and summarize all the original data. P values of <0.05 were considered statistically significant.

A total of 71 patients (32 males and 39 females) were enrolled in our study. The demographics are summarized in Table 1. Twenty-nine patients were self-reported to have clear incentive such as acne, trauma, and surgical incision. Moreover, 33 patients reported familial inheritance. The 98 lesions were distributed as follows: 23 lesions (23.5%) on face and neck, 26 (26.5%) on chest, 16 (16.3%) on shoulders, 16 (16.3%) on the back and 17 (17.3%) on limbs. The average lesion size was 5.030.72 cm. The average re-epithelization duration was 33.7810.46 days.

Table 1 Patient Demographics

According to the patients (Table 2), POSAS scoring showed a significant improvement in the 98 keloids, with the mean score decreasing from 35.059.94 before treatment to 21.847.04 (p value <0.05). The mean score of keloids on the face and neck dropped significantly from 36.4310.60 to 20.006.62 (p value <0.05), with an improvement over 40%. The mean score of keloids on chest and back also decreased from 41.0810.29 and 29.564.16 to 24.157.82 (p value <0.05) and 18.195.31 (p value <0.05), respectively. However, improvement of keloids on shoulders and limbs was limited though still statistically significant. Table 3 demonstrates the six items that were evaluated by each patient. Comprehensive improvements were made on all items. Amelioration on pain and itchiness was over 50%.

Table 2 Total Patient-Reported Scores of Keloids on Different Body Parts Before and After Treatment

Table 3 Results of POSAS According to Patients

The results from the independent observer (Table 4) and the patients were consistent. The mean score of all 98 keloids dropped from 37.598.17 to 23.477.53 (p value <0.05). Keloids on face and neck, chest and back responded better to the treatment than those on shoulders and limbs. The observer score of six items is shown in Table 5. All items were significantly improved. Pigmentation (the extent of improvement in color) and relief (the extent of improvement in irregularities) were not improved remarkably as compared to the other four items, which corresponded with the results from the patient score. Figures 2Figures 3Figures 4Figures 5 showed keloids on different locations before and after treatment.

Table 4 Total Observer-Reported Scores of Keloids on Different Body Parts Before and After Treatment

Table 5 Results of POSAS According to Observer

Figure 2 A patient with multiple lesions of keloids on his face prior to treatment (A) and 1 year after PSR treatment with 2 radiation therapy thereafter (B). No recurrence was found.

Figure 3 A patient with multiple lesions of keloids on his chest prior to treatment (A) and 1 year after PSR treatment with 2 radiation therapy thereafter (B). No recurrence was found.

Figure 4 A patient with multiple lesions of keloids on her shoulder prior to treatment (A) and 1 year after PSR treatment with 2 radiation therapy thereafter (B). No recurrence was found.

Figure 5 A patient with multiple lesions of keloids on her arm prior to treatment (A) and 1 year after PSR treatment with 2 radiation therapy thereafter (B). No recurrence was found.

Adverse effects after radiation therapy are summarized in Table 6. Erythema and edema were common complications that occurred to almost all patients, but soon disappeared without special treatment. Local infection was reported by eight patients, and the type of infection was acne folliculitis. It was the main reason for which patients revisited our center in weeks after treatment. Late adverse effects included hyperpigmentation, hypopigmentation and radiation dermatitis. No case of carcinogenesis was reported. Complications of PSR were mild. Hyperpigmentation and hypopigmentation were complaints made by seven and five patients, respectively. During follow-up, 15 keloids (15.3%) were observed or reported to relapse. Recurrent lesions were further treated with dye laser or steroid injection.

Table 6 Summary of Adverse Effects

Keloid has long bothered clinicians and patients as there is no standard therapy that gains universally approval. Single treatment, either surgical excision or laser therapy, has been repeatedly proven to result in high recurrence rate.12 In the light of this, combination of keloid removal and adjuvant therapy has received much attention and increasingly more studies have shown its effectiveness with low recurrence rate.35 Adjuvant therapy includes a series of treatments that are administrated after surgical excision or laser therapy. Radiation therapy, steroid injection and silicone gel have all been reported to be effective adjuvant therapies. Park and Rah treated helical rim keloids with surgical excision plus silicone gel pressure therapy.13 The therapy protocol resulted in improvement on most items in the POSAS with recurrence-free rate of 95%. Garg et al evaluated the effect of CO2 laser ablation followed by steroid injection.14 Their study illustrated that CO2 laser alone was not efficient enough while adding steroid injection as adjuvant therapy could significantly reduce recurrence rate. Hersant et al reported a pilot study using platelet-rich plasma injection as adjuvant therapy to surgical excision.15 Vancouver Scar Scale score was reduced by more than 50% after 2-year follow-up though 29% of keloids relapsed. Considering that the keloids of interest did not respond to conventional therapies, it was a satisfactory result.

Multiple treatments of PSR have been proven to be clinically effective for traumatic scars, mesh skin-grafted scars, and wrinkles at an interval of 3 weeks to 1 month.9,16 In this study, we reported single-dose PSR treatment combined with radiotherapy as an effective management for keloids. The endpoint of PSR therapy was when the lesions were almost as flat as the surrounding normal skin although red in color. More energy was applied for thicker lesions. An intralesional injection of the compound betamethasone was administered before PSR for thick lesions (thickness >4 mm) to avoid excessive plasma irradiation that could cause serious side effects and longer recovery time. However, for keloids less thick than 4 mm, PSR was administered without the steroid injection.17 After PSR, a total of 18 Gy of radiation were administrated in two fractions, 24 hours posttreatment and again 1 week later. We regard adjuvant radiotherapy important in the prevention of recurrence. Numerous studies have shown surgery excision alone was followed by high recurrence rate, and that radiation therapy after keloid removal could significantly reduce recurrence rate to a desirable level.2,3 The mechanism of radiotherapeutic prevention remains unclear. One possible explanation is suggested to be the elimination of abnormally activated fibroblasts and stimulation of normal ones.18 Kal et al recommended biologically effective dose for keloid prevention should be 3040 Gy, which could be achieved by either a single fraction of 1315 Gy or 1720 Gy in 2 fractions.19 Furthermore, radiotherapy was advocated to be administrated immediately after keloid removal or within 2 days.20 We strictly complied with these suggestions in this study.

Plasma combined with radiation therapy results in good clinical outcome, though improvement varies on different body parts. Keloids on face and neck, chest and back were significantly improved after treatment according to both patients and observers. However, improvement of keloids on shoulders and limbs was limited. The frequent movement of these body parts results in high stretch tension that impedes collagen renewal and dermal remodeling. Though excessive proliferative fibrous tissue is removed, the rebuilding process of dermal architecture is relatively slower than that of lesions with less stretch tension.

In this study, complications are categorized by treatment area and duration. Complications after radiation therapy are considered adverse effects that occur within the radiation field beyond the lesion. Complications that limit to the lesion area are PSR-related. Acute adverse effects are defined as complications that disappeared within 4 weeks, while long-term adverse effects usually last longer than 1 month.

In terms of complications after radiation therapy, erythema and edema were reported by almost all patients in the first few days, but usually disappeared in 2 weeks without medication. In our follow-up, no patients resorted to medical treatment for long-lasting erythema or edema. Speranza et al confirmed that erythema was the most frequent acute side effect, but it had no association with patient satisfaction.21 Late complications reported by our patients include skin color change and chronic radiodermatitis. Permanent pigmentation and depigmentation are commonly reported to be a major late complication with incidence rate varying from 30% to 60% according to other studies.21,22 In this study, no case of necrosis or carcinogenesis was reported. Risk of radiation-induced tumor has been repeatedly proven to be very low.22 However, clinicians should always be cautious about the radiation energy in total when applying adjuvant radiotherapy. Sakamoto et al illustrated that relapse rate and adverse-effect were both dose-related.23 They recommended an optimal dose of 20 Gy in five fractions. We agreed that 18 Gy in 2 fractions is a nice balance between adverse effects and recurrence rate.

A few lesions developed hyperpigmentation or hypopigmentation limited to the area that received PSR treatment. These complications were considered PSR-related and had nothing to do with radiation therapy. Lesions with PSR-related complications were all thicker than 4mm before treatment. However, it should be mentioned that not every thick lesion developed these complications. We speculate that this is because intralesional injection of steroid is insufficient for some thick lesions. Thick lesions with insufficient steroid are not completely soften and thus require more energy to be flatten. The high energy level leads to adverse effects that do not develop at lower level of energy. In general, PSR should be considered a safe therapy with mild complications. An in vivo study showed that PSR could consistently achieve thermal injury into the papillary dermis resulting in collagen remodeling without permanent pigmentary or textural irregularities.24 Other studies also confirmed that PSR treatment caused less complications. According to Fosters study, no patient developed permanent hypopigmentation, a complication that is generally observed in 820% of CO2 resurfacing patients, although a very small proportion (4%) of patients reported transient hyperpigmentation, which should be treated with hydroquinone creams or combination creams containing a mild topical corticosteroid, retinoid, and hydroquinone.25 Fitzpatrick et al reported that the thermal damage by PSR for any energy level was at most equivalent to medium fluence of the carbon dioxide laser and that the damage was confined within 15 m depth, in contrast to 33.4 m thermal damage created by high fluence of the carbon dioxide laser.26

In fact, not many risk factors other than ancestry, early age and skin injuries are known about keloid. But even less is known about factors that could possibly affect long-term curative effect. For example, sexuality, age, familial inheritance, and lesion size are all possible to influence clinical improvement. This study indicates keloids on different body parts may respond differently to the combination therapy. In the future, other factors that affect clinical outcome should be further studied with keloid location as a control factor.

This study has some limitations. Firstly, this is an observational study that evaluates the effectiveness and safety of PSR with adjuvant radiation therapy, while it does not compare PSR with other common treatment modalities. Randomized controlled studies are necessary for further evaluation of PSR. Secondly, the observation period of this study is relatively short to evaluate long-term curative effect, as previous studies reported that the control rate of keloid decreased 5 or 10 years or more after treatment.27,28 Thirdly, this study used a standardized scale for the evaluation of therapeutic effects. It has been mentioned that scale evaluation is subjected to a number of human factors and that objective assessment tools should be advocated.29 Application of objective assessment tools such as laser speckle contrast imaging and three-dimensional imaging could yield quantitative and more robust results.30,31

Plasma Skin Regeneration combined with adjuvant radiation therapy should be regarded as a safe, low-risk, effective treatment for keloids. Steroid could be administrated for thick lesions before PSR to avoid excessive thermal effect that increases the rate of side effects.

The authors declare no conflicts of interest for this work.

1. Ogawa R. Keloid and hypertrophic scars are the result of chronic inflammation in the reticular dermis. Int J Mol Sci. 2017;18(3):606.

2. Al-Attar A, Mess S, Thomassen JM, Kauffman CL, Davison SP. Keloid pathogenesis and treatment. Plast Reconstr Surg. 2006;117(1):286300. doi:10.1097/01.prs.0000195073.73580.46

3. Jones ME, Ganzer CA, Bennett D, Finizio A. Surgical excision of keloids followed by in-office superficial radiation therapy: prospective study examining clinical outcomes. Plast Reconstr Surg Glob Open. 2019;7(5):e2212. doi:10.1097/GOX.0000000000002212

4. Chua SC, Gidaszewski B, Khajehei M. Efficacy of surgical excision and sub-dermal injection of triamcinolone acetonide for treatment of keloid scars after caesarean section: a single blind randomised controlled trial protocol. Trials. 2019;20(1):363. doi:10.1186/s13063-019-3465-6

5. Stromps JP, Dunda S, Eppstein RJ, Babic D, Har-Shai Y, Pallua N. Intralesional cryosurgery combined with topical silicone gel sheeting for the treatment of refractory keloids. Dermatol Surg. 2014;40(9):9961003. doi:10.1097/01.DSS.0000452627.91586.cc

6. Koike S, Akaishi S, Nagashima Y, Dohi T, Hyakusoku H, Ogawa R. Nd:YAG laser treatment for keloids and hypertrophic scars: an analysis of 102 cases. Plast Reconstr Surg Glob Open. 2014;2(12):e272. doi:10.1097/GOX.0000000000000231

7. Henderson DL, Cromwell TA, Mes LG. Argon and carbon dioxide laser treatment of hypertrophic and keloid scars. Lasers Surg Med. 1984;3(4):271277. doi:10.1002/lsm.1900030402

8. Li K, Nicoli F, Xi WJ, et al. The 1470 nm diode laser with an intralesional fiber device: a proposed solution for the treatment of inflamed and infected keloids. Burns Trauma. 2019;7:5. doi:10.1186/s41038-019-0143-6

9. Kono T, Groff WF, Sakurai H, Yamaki T, Soejima K, Nozaki M. Treatment of traumatic scars using plasma skin regeneration (PSR) system. Lasers Surg Med. 2009;41(2):128130. doi:10.1002/lsm.20723

10. Berman B, Maderal A, Raphael B. Keloids and hypertrophic scars: pathophysiology, classification, and treatment. Dermatol Surg. 2017;43(Suppl 1):S3S18. doi:10.1097/DSS.0000000000000819

11. Draaijers LJ, Tempelman FRH, Botman YAM, et al. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004;113(7):19601965. doi:10.1097/01.PRS.0000122207.28773.56

12. Arno AI, Gauglitz GG, Barret JP, Jeschke MG. Up-to-date approach to manage keloids and hypertrophic scars: a useful guide. Burns. 2014;40(7):12551266. doi:10.1016/j.burns.2014.02.011

13. Park TH, Rah DK. Successful eradication of helical rim keloids with surgical excision followed by pressure therapy using a combination of magnets and silicone gel sheeting. Int Wound J. 2017;14(2):302306. doi:10.1111/iwj.12547

14. Garg GA, Sao PP, Khopkar US. Effect of carbon dioxide laser ablation followed by intralesional steroids on keloids. J Cutan Aesthet Surg. 2011;4(1):26. doi:10.4103/0974-2077.79176

15. Hersant B, SidAhmed-Mezi M, Picard F, et al. Efficacy of autologous platelet concentrates as adjuvant therapy to surgical excision in the treatment of keloid scars refractory to conventional treatments: a Pilot Prospective Study. Ann Plast Surg. 2018;81(2):170175. doi:10.1097/SAP.0000000000001448

16. Theppornpitak N, Udompataikul M, Chalermchai T, Ophaswongse S, Limtanyakul P. Nitrogen plasma skin regeneration for the treatment of mild-to-moderate periorbital wrinkles: a prospective, randomized, controlled evaluator-blinded trial. J Cosmet Dermatol. 2019;18(1):163168. doi:10.1111/jocd.12767

17. Park KY, Lee Y, Hong JY, Chung WS, Kim MN, Kim BJ. Vibration anesthesia for pain reduction during intralesional steroid injection for keloid treatment. Dermatol Surg. 2017;43(5):724727. doi:10.1097/DSS.0000000000001040

18. Stadelmann WK, Digenis AG, Tobin GR. Physiology and healing dynamics of chronic cutaneous wounds. Am J Surg. 1998;176:28S38S. doi:10.1016/S0002-9610(98)00183-4

19. Kal HB, Veen RE, Jurgenliemk-Schulz IM. Dose-effect relationships for recurrence of keloid and pterygium after surgery and radiotherapy. Int J Radiat Oncol Biol Phys. 2009;74(1):245251. doi:10.1016/j.ijrobp.2008.12.066

20. Bischof M, Krempien R, Debus J, Treiber M. Postoperative electron beam radiotherapy for keloids: objective findings and patient satisfaction in self-assessment. Int J Dermatol. 2007;46:971975. doi:10.1111/j.1365-4632.2007.03326.x

21. Speranza G, Sultanem K, Muanza T. Descriptive study of patients receiving excision and radiotherapy for keloids. Int J Radiat Oncol Biol Phys. 2008;71(5):14651469. doi:10.1016/j.ijrobp.2007.12.015

22. Ogawa R, Yoshitatsu S, Yoshida K, Miyashita T. Is radiation therapy for keloids acceptable? The risk of radiation-induced carcinogenesis. Plast Reconstr Surg. 2009;124(4):11961201. doi:10.1097/PRS.0b013e3181b5a3ae

23. Sakamoto T, Oya N, Shibuya K, Nagata Y, Hiraoka M. Dose-response relationship and dose optimization in radiotherapy of postoperative keloids. Radiother Oncol. 2009;91(2):271276. doi:10.1016/j.radonc.2008.12.018

24. Tremblay JF, Moy RL. Treatment of post-auricular skin using a novel plasma resurfacing system: an in vivo clinical and histologic study. Lasers Surg Med. 2004;34:25.

25. Foster KW, Moy RL, Fincher EF. Advances in plasma skin regeneration. J Cosmet Dermatol. 2008;7:169179. doi:10.1111/j.1473-2165.2008.00385.x

26. Fitzpatrick R, Bernstein E, Iyer S, Brown D, Andrews P, Penny K. A histopathologic evaluation of the Plasma Skin Regeneration System (PSR) versus a standard carbon dioxide resurfacing laser in an animal model. Lasers Surg Med. 2008;40(2):9399. doi:10.1002/lsm.20547

27. Shen J, Lian X, Sun Y, et al. Hypofractionated electron-beam radiation therapy for keloids: retrospective study of 568 cases with 834 lesions. J Radiat Res. 2015;56(5):811817. doi:10.1093/jrr/rrv031

28. Maemoto H, Iraha S, Arashiro K, Ishigami K, Ganaha F, Murayama S. Risk factors of recurrence after postoperative electron beam radiation therapy for keloid: comparison of long-term local control rate. Rep Pract Oncol Radiother. 2020;25(4):606611. doi:10.1016/j.rpor.2020.05.001

29. Chong Y, Long X, Ho YS. Scientific landscape and trend analysis of keloid research: a 30-year bibliometric review. Ann Transl Med. 2021;9(11):945. doi:10.21037/atm-21-508

30. Xu C, Ting W, Teng Y, Long X, Wang X. Laser speckle contrast imaging for the objective assessment of blood perfusion in keloids treated with dual-wavelength laser therapy. Dermatol Surg. 2021;47(4):e117e121. doi:10.1097/DSS.0000000000002836

31. Ruccia F, Zoccali G, Cooper L, Rosten C, Nduka C. A three-dimensional scar assessment tool for keloid scars: volume, erythema and melanin quantified. Skin Res Technol. 2021; Epub. doi:10.1111/srt.13050

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Treatment of Keloids Using PSR Combined with Radiation. | CCID - Dove Medical Press

Asia-Pacific Cell Therapy Market 2021-2028 – Opportunities in the Approval of Kymriah and Yescarta – PRNewswire

DUBLIN, Aug. 4, 2021 /PRNewswire/ -- The "Asia Pacific Cell Therapy Market Size, Share & Trends Analysis Report by Use-type (Clinical-use, Research-use), by Therapy Type (Autologous, Allogeneic) and Segment Forecasts, 2021-2028" report has been added to ResearchAndMarkets.com's offering.

The Asia Pacific cell therapy market size is expected to reach USD 2.9 billion by 2028. The market is expected to expand at a CAGR of 14.9% from 2021 to 2028.

Rapid advancements in regenerative medicine are anticipated to provide effective solutions for chronic conditions. A substantial number of companies in the growing markets, such as India and South Korea, are striving to capitalize on the untapped opportunities in the market, thereby driving the market.

The growth is greatly benefitted by the fund and regulatory support from government bodies and regulatory agencies. For instance, in August 2020, the government of South Korea passed an Act on the Safety and Support of Advanced Regenerative Medical Treatment and Medicine to establish a regulatory system for patient safety during quality control and clinical trials and to strengthen the regulatory support for regenerative medicine development.

The implementation of the act is expected to enhance clinical studies and approvals of regenerative medicine in South Korea. Furthermore, CAR-T and TCR T-cell therapies have already revolutionized hematologic cancer treatment. With the onset of the COVID-19 pandemic, scientists are deciphering its potential against the novel coronavirus. The concept of using T cells against chronic viral infections, such as HIV and hepatitis B, has already been proposed.

Based on the previous research insights, Singapore-based Duke-NUS medical school's emerging infectious diseases research program demonstrated the utility of these immunotherapies in treating patients with COVID-19 infection.

Thus, an increase in research for use of cell therapies for COVID-19 treatment is expected to drive the market in Asian countries. In April 2021, a team of researchers from Japan used induced pluripotent stem cells (iPS) to find drugs that can effectively inhibit the coronavirus and other RNA viruses.

Key Topics Covered:

Chapter 1 Methodology and Scope

Chapter 2 Executive Summary 2.1 Market Snapshot

Chapter 3 Cell Therapy Market Variables, Trends, and Scope 3.1 Market Trends and Outlook 3.2 Market Segmentation and Scope 3.3 Market Dynamics 3.3.1 Market driver analysis 3.3.1.1 Rise in number of clinical studies for cellular therapies in Asia Pacific 3.3.1.2 Expanding regenerative medicine landscape in Asian countries 3.3.1.3 Introduction of novel platforms and technologies 3.3.2 Market restraint analysis 3.3.2.1 Ethical concerns 3.3.2.2 Clinical issues pertaining to development & implementation of cell therapy 3.3.2.2.1 Manufacturing issues 3.3.2.2.2 Genetic instability 3.3.2.2.3 Condition of stem cell culture 3.3.2.2.4 Stem cell distribution after transplant 3.3.2.2.5 Immunological rejection 3.3.2.2.6 Challenges associated with allogeneic mode of transplantation 3.3.3 Market opportunity analysis 3.3.3.1 Approval of Kymriah and Yescarta across various Asian countries 3.3.3.2 Developments in CAR T-cell therapy for solid tumors 3.3.4 Market challenge analysis 3.3.4.1 Operational challenges associated with cell therapy development & usage 3.3.4.1.1 Volume of clinical trials for cell and gene therapy vs accessible qualified centers 3.3.4.1.2 Complex patient referral pathway 3.3.4.1.3 Patient treatment, selection, and evaluation 3.3.4.1.4 Availability of staff vs volume of cell therapy treatments 3.4 Penetration and Growth Prospect Mapping for Therapy Type, 2020 3.5 Business Environment Analysis 3.5.1 SWOT Analysis; By factor (Political & Legal, Economic and Technological) 3.5.2 Porter's Five Forces Analysis 3.6 Regulatory Framework 3.6.1 China 3.6.1.1 Regulatory challenges & risk of selling unapproved cell therapies 3.6.2 Japan

Chapter 4 Cell Therapy Market: COVID-19 Impact analysis 4.1 Challenge's analysis 4.1.1 Manufacturing & supply challenges 4.1.2 Troubleshooting the manufacturing & supply challenges associated to COVID-19 4.2 Opportunities analysis 4.2.1 Need for development of new therapies against SARS-CoV-2 4.2.1.1 Role of T-cell based therapeutics in COVID-19 management 4.2.1.2 Role of mesenchymal cell-based therapeutics in COVID-19 management 4.2.2 Rise in demand for supply chain management solutions 4.3 Challenges in manufacturing cell therapies against COVID-19 4.4 Clinical Trial Analysis 4.5 Key Market Initiatives

Chapter 5 Asia Pacific Cell Therapy CDMOs/CMOs Landscape 5.1 Role of Cell Therapy CDMOs 5.2 Key Trends Impacting Asia Cell Therapy CDMO Market 5.2.1 Regulatory reforms 5.2.2 Expansion strategies 5.2.3 Rising investments 5.3 Manufacturing Volume Analysis 5.3.1 Wuxi Biologics 5.3.2 Samsung Biologics 5.3.3 GenScript 5.3.4 Boehringer Ingelheim 5.3.5 Seneca Biopharma, Inc. 5.3.6 Wuxi AppTech 5.4 Competitive Milieu 5.4.1 Regional network map for major players

Chapter 6 Asia Pacific Cell Therapy Market: Use Type Business Analysis 6.1 Market (Stem & non-stem cells): Use type movement analysis 6.2 Clinical Use 6.2.1 Market (stem & non-stem cells) for clinical use, 2017 - 2028 (USD Million) 6.2.2 Market (stem & non-stem cells) for clinical use, by therapeutic area 6.2.2.1 Malignancies 6.2.2.1.1 Market (stem & non-stem cells) for malignancies, 2017 - 2028 (USD Million) 6.2.2.2 Musculoskeletal disorders 6.2.2.3 Autoimmune disorders 6.2.2.4 Dermatology 6.2.3 Market (stem & non-stem cells) for clinical use, by cell type 6.2.3.1 Stem cell therapies 6.2.3.1.1 Market, 2017 - 2028 (USD Million) 6.2.3.1.2 BM, blood, & umbilical cord-derived stem cells/mesenchymal stem cells 6.2.3.1.3 Adipose-derived stem cell therapies 6.2.3.1.4 Other stem cell therapies 6.2.3.2 Non-stem cell therapies 6.3 Research Use

Chapter 7 Asia Pacific Cell Therapy Market: Therapy Type Business Analysis 7.1 Market (Stem & Non-stem Cells): Therapy type movement analysis 7.2 Allogeneic Therapies 7.3 Autologous Therapies

Chapter 8 Asia Pacific Cell Therapy Market: Country Business Analysis 8.1 Market (Stem & Non-stem Cells) Share by Country, 2020 & 2028

Chapter 9 Asia Pacific Cell Therapy Market: Competitive Landscape

For more information about this report visit https://www.researchandmarkets.com/r/3hdt1c

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Asia-Pacific Cell Therapy Market 2021-2028 - Opportunities in the Approval of Kymriah and Yescarta - PRNewswire

Fate Therapeutics Announces Treatment of First Patient in Landmark Phase 1 Clinical Trial of … – The Bakersfield Californian

Off-the-Shelf CAR T-cell Product Candidate Derived from Clonal Master iPSC Line with Novel CD19-specific 1XX CAR Integrated into TRAC Locus

Phase 1 Clinical Study will Evaluate Three Dosing Regimens of FT819 for Patients with Advanced B-cell Leukemias and Lymphomas

SAN DIEGO, Aug. 02, 2021 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, announced today that the first patient has been treated with FT819, an off-the-shelf chimeric antigen receptor (CAR) T-cell therapy targeting CD19+ malignancies. FT819 is the first-ever CAR T-cell therapy derived from a clonal master induced pluripotent stem cell (iPSC) line, a renewable cell source that enables mass production of high quality, allogeneic CAR T cells with greater product consistency, off-the-shelf availability, and broader patient accessibility. FT819 is engineered with several first-of-kind features designed to improve the safety and efficacy of CAR T-cell therapy.

Remarkable clinical outcomes have been achieved through treatment with patient-derived CAR T-cell therapy, however, next-generation approaches are necessary to reach more patients who are in need of these highly-effective therapies, said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. Treatment of the first-ever patient with FT819 ushers in a new era for off-the-shelf CAR T-cell therapy, with the potential to overcome the real-world limitations of existing patient- and donor-derived therapeutic approaches and unlock the full potential of CAR T-cell therapy. We would like to thank our collaborators at Memorial Sloan Kettering Cancer Center, whose partnership over the past five years has profoundly contributed to this landmark achievement.

FT819 was designed to specifically address several limitations associated with the current generation of patient- and donor-derived CAR T-cell therapies. Under a collaboration with Memorial Sloan Kettering Cancer Center (MSK) led by Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering and Head, Gene Expression and Gene Transfer Laboratory, the Company incorporated several first-of-kind features into FT819 including:

Use of a clonal master engineered iPSC line as the starting cell source, which enables CAR T cells to be mass produced and delivered off-the-shelf for broad patient access;Incorporation of a novel 1XX CAR signaling domain, which has been shown to extend T-cell effector function without eliciting exhaustion as described in the journal Nature Medicine (

);Insertion of the CAR transgene directly into the T-cell receptor alpha constant (TRAC) locus, which has been shown to promote uniform CAR expression and enhanced T-cell potency as described in the journal Nature (https://

); andComplete bi-allelic disruption of T-cell receptor (TCR) expression for the prevention of graft-versus-host disease (GvHD), a potentially life-threatening complication associated with allogeneic T-cell therapy.

The multi-center Phase 1 clinical trial of FT819 is designed to determine the recommended Phase 2 dose and schedule of FT819 and assess its safety and clinical activity in adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and B-cell lymphomas (BCL). Three treatment regimens will be independently evaluated for each type of malignancy in dose escalation: Regimen A as a single dose of FT819; Regimen B as a single dose of FT819 with IL-2 cytokine support; and Regimen C as three fractionated doses of FT819. For each indication and regimen, dose-expansion cohorts may be enrolled to further evaluate the clinical activity of FT819. The first patient with relapsed / refractory ALL was enrolled in Regimen A and received a dose of 90 million cells.

At the 24th American Society of Gene & Cell Therapy Annual Meeting held in May 2021, the Company presented preclinical data demonstrating that FT819 exhibits uniform 1XX CAR expression with complete elimination of endogenous TCR expression. The product candidate was shown to contain a stem- and central-memory T-cell phenotype, and had high-level expression of the activation marker CD25 and the trafficking marker CXCR4 and very low-level expression of the checkpoint proteins PD1, TIM3, CTLA4 and LAG3. Additionally, data from functional assessments showed that FT819 had potent antigen-specific cytolytic activity in vitro against CD19-expressing leukemia and lymphoma cell lines comparable to that of healthy donor-derived CAR T cells, and persisted and maintained tumor clearance in the bone marrow in an in vivo disseminated xenograft model of lymphoblastic leukemia.

Pursuant to a license agreement with MSK, Fate Therapeutics has an exclusive license for all human therapeutic use to U.S. Patent No. 10,370,452, which covers compositions and uses of effector T cells expressing a CAR, where such T cells are derived from a pluripotent stem cell including an iPSC. In addition to the patent rights licensed from MSK, the Company owns an extensive intellectual property portfolio that broadly covers compositions and methods for the genome editing of iPSCs using CRISPR and other nucleases, including the use of CRISPR to insert a CAR in the TRAC locus for endogenous transcriptional control.

Fate Therapeutics haslicensedintellectual propertyfrom MSK on which Dr. Sadelain is aninventor.As a result of the licensing arrangement, MSK has financial interests related to Fate Therapeutics.

About Fate Therapeutics iPSC Product Platform The Companys proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Companys platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

About FT819 FT819 is an investigational, universal, off-the-shelf, T-cell receptor (TCR)-less CD19 chimeric antigen receptor (CAR) T-cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line, which is engineered with the following features designed to improve the safety and efficacy of CAR19 T-cell therapy: a novel 1XX CAR signaling domain, which has been shown to extend T-cell effector function without eliciting exhaustion; integration of the CAR19 transgene directly into the T-cell receptor alpha constant (TRAC) locus, which has been shown to promote uniform CAR19 expression and enhanced T-cell potency; and complete bi-allelic disruption of TCR expression for the prevention of graft-versus-host disease (GvHD). FT819 demonstrated antigen-specific cytolytic activity in vitro against CD19-expressing leukemia and lymphoma cell lines comparable to that of primary CAR T cells, and persisted and maintained tumor clearance in the bone marrow in an in vivo disseminated xenograft model of lymphoblastic leukemia (Valamehr et al. 2020). FT819 is being investigated in a multi-center Phase 1 clinical trial for the treatment of relapsed / refractory B-cell malignancies, including B-cell lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia (NCT04629729).

About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Companys immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.fatetherapeutics.com.

Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the advancement of, plans related to, and the therapeutic potential of the Company's product candidates, the Companys clinical development and manufacturing strategies, and the Companys plans for the clinical investigation and manufacture of its product candidates, including FT819. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that results observed in studies of its product candidates, including preclinical studies and clinical trials of any of its product candidates, will not be observed in ongoing or future studies involving these product candidates, the risk that the Company may cease or delay clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, the amount and type of data to be generated, or otherwise to support regulatory approval, difficulties or delays in subject enrollment and continuation in current and planned clinical trials, difficulties in manufacturing or supplying the Companys product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Companys actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Companys periodic filings with the Securities and Exchange Commission, including but not limited to the Companys most recently filed periodic report, and from time to time in the Companys press releases and other investor communications.Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Contact: Christina Tartaglia Stern Investor Relations, Inc. 212.362.1200 christina@sternir.com

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Fate Therapeutics Announces Treatment of First Patient in Landmark Phase 1 Clinical Trial of ... - The Bakersfield Californian

IDH1 Inhibitors, CAR T-Cell Therapy, and Third-Generation TKIs Refresh Relapsed/Refractory Leukemia Landscape – OncLive

Acute Myeloid Leukemia

Historical complete response (CR)/CR with incomplete hematologic recovery rates with approved IDH inhibitors, enasidenib (Idhifa) and ivosidenib (Tibsovo), hover around 30% and have a median overall survival (OS) of approximately 9 months in the relapsed/refractory setting, said Shammo, a professor of medicine and pathology at Rush University Medical Center, in a virtual presentation during the2021 ASCO Direct HighlightsTMwebcast in Chicago, a program developed by Physicians Education Resource LLC.

Olutasidenib, a highly potent, orally active, selective IDH1 inhibitor, was developed to improve outcomes in the 7% to 14% of patients with AML who harbor IDH1 mutations.

In the phase 1/2 2102-HEM-101 trial (NCT02719574), 150 mg of oral olutasidenib was evaluated as a single agent and in combination with azacitidine across 8 cohorts of patients with acute myeloid leukemia (AML) and myelodysplastic syndromes. Findings from the planned interim analysis, which were presented during the 2021 ASCO Annual Meeting, focused on cohort 1, which enrolled 153 patients with relapsed/refractory, IDH1-mutant AML.1

In the efficacy-evaluable population (n = 123), 37% of patients had secondary AML, 73% of patients had intermediate cytogenetic risk, 44% of patients were refractory to their last line of therapy, and 11% had failed allogeneic stem cell transplant, reflecting a difficult population to treat, said Shammo.

The primary end point, CR/CR with partial hematologic recovery (CRh), was 33% (95% CI, 25.1%-42.4%), and most CR/CRh responders had a CR (30%; 95% CI, 22.1%-39.0%).

Transfusion independence was achieved in all response groups, particularly those achieving a CR, said Shammo.

The agent also demonstrated durable CR/CRh benefit, with a median duration of CR/CRh that was not reached and a median duration of response (DOR) of 11.7 months. In a sensitivity analysis with transplant considered as the end of a response, the median duration of CR/CRh response was 13.8 months.

Those who responded well had a much longer DOR, and a fraction of those patients managed to go onto stem cell transplant, which is what you would like to do in relapsed/refractory AML, said Shammo.

Better response was strongly associated with longer survival as well. At a median follow-up of 9.7 months, the median OS was not reached in patients who had achieved a CR/CRh, with an estimated 18-month OS rate of 87%. In the safety population (n = 153), the median OS was 10.5 months (95% CI, 7.7-15.5). Among nonCR/CRh responders and non-responders, the median OS was 15.0 months (95% CI, 5.0not evaluable) and 4.1 months (95% CI, 3.2-5.8), respectively.

Clinical benefit, as evidenced by DOR and OS, extended to patients who responded but did not achieve CR/CRh, said Shammo.

The primary treatment-emergent adverse effects (AEs) included leukocytosis (all-grade, 25%; grade 3/4, 9%) and febrile neutropenia (all-grade, 22%; grade 3/4, 20%), said Shammo. AEs of special interest reflected reports of differentiation syndrome (all-grade, 14%; grade 3/4, 7%), QTc prolongation (all-grade, 8%; grade 3/4, <1%), and liver abnormalities (all-grade, 21%; grade 3/4, 10%).

Olutasidenib was well tolerated with a safety profile largely consistent with that of other IDH inhibitors, but patients should be monitored for differentiation syndrome and liver abnormalities, said Shammo.

These results are very promising and very impressive, and, hopefully, we will see more results not only with the single agent but also with the combination with azacitidine in other myeloid malignancies, added Shammo.

Turning to acute lymphoblastic leukemia (AML), Shammo discussed the results of the phase 1/2 ZUMA-3 trial (NCT02614066), which evaluated the CD19-directed chimeric antigen receptor (CAR) T-cell therapy brexucabtagene autoleucel in patients with relapsed/refractory ALL.2

Approximately 40% to 50% of adults with B-ALL experience relapse after initial treatment, with a 1-year OS rate of 26% after first salvage therapy, said Shammo in explaining the rationale for the study.

In the phase 1 portion of the study, brexucabtagene autoleucel demonstrated a CR/CRi rate of 83% and manageable safety profile. In the phase 2 portion, 71 patients were enrolled, and 55 patients received brexucabtagene autoleucel.

Patients could have received prior treatment with blinatumomab (Blincyto) and underwent conditioning chemotherapy with fludarabine and cyclophosphamide prior to treatment with the recommended phase 2 dose of brexucabtagene autoleucel: 1 x 106 CAR T cells/kg.

Brexucabtagene autoleucel was successfully manufactured in 92% of patients, and the median time from leukapheresis to manufacturing release was 13 days for patients in the United States, which Shammo called remarkable.

Regarding baseline demographics, 27% of patients had Philadelphia chromosomepositive disease, 100% of which had central nervous system disease at baseline, and 47% of patients had received at least 3 lines of prior therapy.

Additionally, 45% of patients received prior blinatumomab, 42% underwent prior allogeneic transplant, and the median blast count was 65.0 and 59.0 at screening and preconditioning after bridging chemotherapy, respectively.

At a median follow-up of 16.4 months, the primary end point of CR/CRi rate by central assessment, was 70.9% (CR, 56.4%; CRi, 14.5%); 31% of responders were in ongoing remission at the data cutoff.

[We saw] a high and durable response rate in heavily pretreated adults with relapsed/refractory B-ALL, most of whom had high disease burden, said Shammo.

The median time to initial CR/CRi was 1.1 months. The minimal residual disease (MRD)negativity rate was 97% in responders, and 10 patients, including 9 with CR/CRi and 1 with blast-free hypoplastic or aplastic bone marrow underwent allogeneic transplant a median of 98 days (range, 60-207) following CAR T-cell infusion.

This is exactly what you would like to do: induce patients into remission to take them to allogeneic transplant, said Shammo. Whats remarkable is that MRD negativity in patients who had this treatment approximated 100%.

Among patients with CR/CRi (n = 39), the median OS was not reached (95% CI, 16.2-NE) and the median relapse-free survival (RFS) was 14.2 months (95% CI, 11.6-NE). All-treated patients (n = 39) had a median OS and RFS of 18.2 months (95% CI, 15.9-NE) and 11.6 months (95% CI, 2.7-15.5) respectively. Non-CR/CRi responders (n = 16) had a median OS and RFS of 2.4 months (95% CI, 0.7-NE) and 0.0 months (95% CI, NE-NE), respectively.

Regarding safety, any-grade cytokine release syndrome (CRS) occurred in 89% of patients, and grade 3 or higher CRS occurred in 24% of patients, with a median onset of 5 days and manifestation of pyrexia and hypotension.

Thats relatively favorable compared with what you might expect with [CAR T-cell therapy], said Shammo.

No cases of grade 5 CRS were reported, although 1 patient had grade brain herniation related to study treatment.

Any-grade neurologic events were reported in 60% of patients, and grade 3 or greater events occurred in 25% of patients, with a median onset of 9 days and manifestation of tremor and confused state.

Tocilizumab (Actemra), steroids, and vasopressors were given to 80%, 75%, and 40% of patients, respectively.

The safety profile was manageable, and AEs were largely reversible, said Shammo. The efficacy, rapid manufacturing, and manageable safety support the promising potential of brexucabtagene autoleucel to provide long-term clinical benefit in adults with relapsed/refractory B-ALL.

On April 2, 2021, a supplemental biologics license application was submitted to the FDA for brexucabtagene autoleucel as a treatment for adult patients with relapsed/refractory B-cell precursor ALL.3

If approved, brexucabtagene autoleucel would become the first and only CAR T-cell therapy approved for adults aged at least 18 years old with relapsed/refractory ALL.

The final study Shammo highlighted was the phase 2 OPTIC trial (NCT02467270), which evaluated 3 daily starting doses of ponatinib45 mg (n = 93), 30 mg (n = 93), and 15 mg (n = 91)in patients with chronic-phase chronic myeloid leukemia (CP-CML) resistant to a prior second-generation BCR-ABL1 TKI inhibitor or with a T315I mutation.4

Patients in the 45-mg and 35-mg arms were dose reduced to 15 mg daily upon achievement of 1% or less BCR-ABL1 and across arms were dose reduced to 10 mg daily in the presence of AEs.

Ponatinib, the only pan-BCR-ABL1 inhibitor, is a third-generation TKI designed to inhibit BCR-ABL1 with or without any single resistance mutation, including T315I.

In the pivotal, phase 2 PACE trial (NCT01207440), ponatinib demonstrated deep and durable responses to 45 mg of ponatinib in patients with resistant and intolerant CP-CML. However, a high incidence of arterial occlusive events (AOEs) was reported in the study, thought to be dose dependent, which ultimately compromised the utility of the drug, said Shammo.

[OPTIC] asked what dose is needed to be sure that the patients disease is under control and that perhaps we had mitigated the AOEs, said Shammo.

Notably, more than half of patients across dose cohorts had received at least 3 prior TKIs, and approximately a quarter of patients had a T315I mutation, said Shammo.

At a median follow-up of 32 months, the percentage of patients with 1% or less BCR-ABL1 at 12 months was 44.1% (95% CI, 31.7%-57.0%), 29.0% (95% CI, 18.4%-41.6%), and 23.1% (95% CI, 13.4%-35.3%) in the 45-mg, 30-mg, and 15-mg cohorts, respectively.

In the 30-mg and 15-mg cohorts, patients with less-resistant disease and without a T315I mutation at baseline had greater benefit than those with [a] T315I [mutation], said Shammo.

The 3-year OS probabilities were very reasonable, said Shammo, at 89.29%, 88.58%, and 91.71%, respectively. Notably, robust survival outcomes were reported in patients with and without BCR-ABL1 mutations, said Shammo.

What was interesting is that if you had the T315I mutation at baseline, you do need the 45-mg dose, because the response rates [with that dose] seem to be so much better than [those] patients who received a lower dose of ponatinib, said Shammo.

In terms of safety, any-grade treatment-emergent AOEs occurred in 9.6% of patients in the 45-mg arm, 5.3% in the 30-mg arm, and 3.2% in the 15-mg arm; grade 3 or greater rates occurred in 5.3%, 5.3%, and 3.2% of patients, respectively.

At this primary analysis, novel response-based ponatinib dosing regimens had clinically manageable safety and AOE profiles, with an optimal benefit-risk profile achieved with a 45-mg starting dose reduced to 15 mg upon response, concluded Shammo.

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IDH1 Inhibitors, CAR T-Cell Therapy, and Third-Generation TKIs Refresh Relapsed/Refractory Leukemia Landscape - OncLive

Lenzilumab Treatment May Provide Enhanced Likelihood of Survival Without Ventilation in Hospitalized Black and African-American COVID-19 Patients -…

BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm, announced analysis of results from its Phase 3 LIVE-AIR study of lenzilumab in hospitalized patients with COVID-19 suggesting Black and African-American patients having a CRP<150 mg/L may be the highest responders to treatment, with a nearly 9-fold increase in likelihood of survival without ventilation (SWOV) [n=51, p-value=0.0412]. In the overall population with CRP<150 mg/L, LIVE-AIR Phase 3 results show patients treated with lenzilumab demonstrated a 2.5-fold increased likelihood of SWOV [mITT, n=351, p-value=0.0009].

Humanigen believes this analysis is an important finding because Black and African-American patients are hyper-vulnerable to COVID-19, said Cameron Durrant, MD, Chief Executive Officer, Humanigen. In light of the rapid ongoing spread of the Delta variant, data suggesting that Black and African-American patients, who are hyper-vulnerable to COVID-19, and may be hyper-responsive to lenzilumab is important in the broader context of the potential benefits that may result if the FDA were to grant emergency use authorization.

The Centers for Disease Control and Prevention (CDC) has found that race and ethnicity are risk markers for other conditions that affect health, including socioeconomic status, access to health care, and exposure to SARS-CoV-2 related to occupation, such as frontline, essential, and critical infrastructure workers.1 The American Heart Associations COVID-19 Cardiovascular Disease Registry found that Black patients had the highest prevalence of obesity, hypertension, and diabetes, all of which are medical conditions the CDC identifies as making adults of any age more likely to get severely ill from COVID-19.3,4

In the interest of public health and safety, it is our priority to share data with stakeholders to improve our understanding of the disease and potential treatments, said Adrian Kilcoyne, MD, Chief Medical Officer, Humanigen. While there may be some limitations to subset analyses, we believe the ongoing public health crisis caused by SARS-CoV-2 warrants consideration of these important data by regulatory authorities.

Humanigen intends to submit data from this analysis for publication in a peer-reviewed journal and present the findings at a medical meeting. These new data from the LIVE-AIR study will also be shared with regulatory authorities in the US, UK, European Union, and other geographies.

About the LIVE-AIR, Phase 3 Study of Lenzilumab

LIVE-AIR Phase 3 study met its primary endpoint of survival without ventilation demonstrating a 1.54-fold improvement overall and trended to a 2.68-fold improvement in Black and African-American patients. This study was a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial for the treatment and prevention of serious and potentially fatal outcomes in patients hospitalized with COVID-19 pneumonia. The primary objective was to assess whether lenzilumab, in addition to other treatments, which included dexamethasone (or other steroids) and/or remdesivir, could alleviate the immune-mediated cytokine storm and improve survival without ventilation, or SWOV (sometimes referred to as ventilator-free survival). SWOV is a composite endpoint of time to death and time to invasive mechanical ventilation (IMV), which is a robust measure that is less prone to favor a treatment with discordant effects on survival or days free of ventilation.5

The LIVE-AIR study enrolled 520 patients in 29 sites in the US and Brazil who were at least 18 years of age; experienced blood oxygen saturation (SpO2) of less than or equal to 94%; or required low-flow supplemental oxygen, or high-flow oxygen support, or non-invasive positive pressure ventilation; and were hospitalized but did not require IMV. Following enrollment, subjects were randomized to receive three infusions of either lenzilumab or placebo, each infusion separated by eight hours over a 24-hour period. The primary endpoint was the difference between lenzilumab treatment and placebo treatment in SWOV through day 28 following treatment. Key secondary endpoints, also measured through day 28, included ventilator-free days, duration of ICU stay, incidence of IMV, extracorporeal membrane oxygenation (ECMO), and/or death, time to death, all-cause mortality, and time to recovery. Results of the trial have been submitted for publication in a peer-reviewed journal.

About Humanigen, Inc.

Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm. Lenzilumab is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm. Early in the COVID-19 pandemic, investigation showed high levels of GM-CSF secreting T cells were associated with disease severity and intensive care unit admission. Humanigens Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19. Humanigen is developing lenzilumab as a treatment for cytokine storm associated with CD19-targeted CAR-T cell therapies and exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease (aGvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT), eosinophilic asthma, and rheumatoid arthritis. Humanigen is also developing a portfolio of clinical and pre-clinical therapies for the treatment of inflammation and immuno-oncology. For more information, visit http://www.humanigen.com and follow Humanigen on LinkedIn, Twitter, and Facebook.

Humanigen Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding the effectiveness of lenzilumab in Black and African-American patients; the review of our submission for emergency use authorization by the FDA; and our other plans to explore the effectiveness of lenzilumab and other candidates in our development portfolio as therapies for other inflammation and immune-oncology indications.

Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections of our latest annual and quarterly reports and other filings with the SEC.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. The Company undertakes no obligation to revise or update any forward-looking statements made in this filing to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.

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Lenzilumab Treatment May Provide Enhanced Likelihood of Survival Without Ventilation in Hospitalized Black and African-American COVID-19 Patients -...