Category Archives: Stem Cell Medicine

Therapeutic Solutions International Files Patent on Ability of QuadraMune Ingredient Pterostilbene to Reduce Inflammation while Stimulating Brain…

OCEANSIDE, Calif., July 28, 2020 /PRNewswire/ --Therapeutics Solution International, Inc., (OTC Markets: TSOI), reported new data demonstrating that the blueberry derived compound pterostilbene possesses numerous brain protective and potentially brain regenerative activities. Pterostilbene is one of four ingredients which comprise QuadraMune, a nutraceutical being developed by the Company which is currently in a clinical trial for prevention of COVID-19. Information on the clinical trial can be found on the Government Clinical Trials website https://clinicaltrials.gov/ct2/show/NCT04421391.

"These new data confirm previous findings published on pterostilbene and also reveal novel therapeutic properties of this naturally occurring nutrient," said Dr. James Veltmeyer, Chief Medical Officer of the Company and Voted Top Doctor of San Diego. "By continually investigating mechanisms of action of our products, our ambition is to ensure we have support of the top medical and scientific leaders. In my opinion, many times, it does not matter how good your product is, what matters is that you have scientific basis for why it works. This is especially important in the current age of molecular medicine."

The data disclosed by the Company indicates:

a) pterostilbene suppresses inflammatory cytokines TNF-alpha, IL-1 beta and IL-6;

b) pterostilbene inhibits death of neurons caused by inflammatory mediators;

c) pterostilbene stimulates production of regenerative factors from cells in the brain such as BDNF, NGF, FGF-1, and FGF-2; and

d) pterostilbene allows/enhances proliferation of endogenous brain stem cells.

"The importance of possessing a deep scientific understanding of your product can be seen in the example of nutraceuticals which ended up obtaining regulatory clearance as drugs," said Timothy Dixon, President and CEO of Therapeutic Solutions International. "For example, Lovaza and Vascepa are both fish oil based products which have been developed scientifically and FDA approved through clinical trials. Lovaza, which is sold by GSK, had sales of approximately 1 billion per year and is used for reduction of triglycerides.1 Vascepa, sold by Amarin, had sales in 2019 of 410 million and is used to prevent heart attacks.2 We believe that similar developmental pathways may be possible with several of our existing products."

The Company is currently pursuing FDA clearance for its cell therapy produce StemVacs, for which an IND number was previously granted. The Company's in-licensed stem cell, the JadiCell has FDA clearance for other indications.

About Therapeutic Solutions International, Inc.Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is http://www.therapeuticsolutionsint.com, our public forum is https://board.therapeuticsolutionsint.com/.

1http://www.pmlive.com/pharma_news/teva_launches_first_generic_of_gsks_lovaza_in_us_559273 2https://www.fool.com/investing/2020/01/07/amarin-reports-preliminary-vascepa-sales-projects.aspx

Therapeutic Solutions International, Inc. [emailprotected]

SOURCE Therapeutic Solutions International

therapeuticsolutionsint.com

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Therapeutic Solutions International Files Patent on Ability of QuadraMune Ingredient Pterostilbene to Reduce Inflammation while Stimulating Brain...

Duvelisib May Reduce Lung Inflammation in Severe COVID-19 Cases – OncLive

An Emory University-led phase 2 study will evaluate whether the the PI3K-gamma/delta inhibitor duvelisib (Copiktra) is effective at reducing lung inflammation in patients with severe novel coronavirus 2019 (COVID-19), thereby decreasing incidences of mechanical ventilation and death in these patients.1,2

Investigators theorize that the agent will not only work to reduce inflammation and pulmonary edema, but could also potentially decrease duration of viremia and prompt a response from immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies that could in turn respond to SARS-Cov-2 spike proteins.

The increase in proteins can lead to a cytokine storm, resulting in severe pneumonitis and acute respiratory distress syndrome (ARDS), and can be fatal.1 Investigators hope to reduce the incidence rate of death or mechanical ventilation intervention, which is 40%, to 15% with the use of duvelisib.

Duvelisibs use in COVID-19 comes not from its anti-cancer properties, but its activity in the immune system. Particularly, we found that it can enhance the growth and expansion of T-cells that retain anti-cancer activity, principal study investigator Edmund K. Waller, MD, PhD, a professor in the Departments of Medicine, Pathology, and Hematology and Medical Oncology at Emory University School of Medicine, as well as the medical director of the Center for Stem Cell Processing and Apheresis Emory University Hospital, said in an interview with OncLive. Results from clinical trials in patients with lymphoma show that these patients had lower levels of cytokinesthe inflammatory proteins we believe are a part of COVID-19 pathologywhen theyve been treated with duvelisib compared with other anticancer therapies.

In September 2018, the FDA has approved duvelisib for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or relapsed/refractory follicular lymphoma.

Waller added that duvelisib may help T cells grow and potentially fight COVID-19, while simultaneously modulating the inflammation that could lead to fluid accumulation in patients lungs.

In the study, duvelisib will be administered to patients with COVID-19 over the course of 2 weeks, and investigators will evaluate the agents efficacy in not only reducing the need for mechanical ventilation and the risk of death within 30 days of treatment.

Additional end points include the need for high-flow oxygen devices, supplemental oxygen, and hospitalization with or without ongoing medical care. The targeted enrollment is 80 adults whose ages are 18 years and older who have been confirmed to have severe COVID-19 symptoms, such as pneumonia and difficulty breathing. Patients will then be randomized to either duvelisib (n = 40) or placebo (n = 40). Waller said he hopes to determine whether or not the agent will be effective in managing the virus to prevent patients from being admitted to the intensive care unit. Duvelisib, he added, could provide a valuable third line of defense after the infection has been established.

In a preclinical pharmacology setting, duvelisib was shown to be highly potent, with investigators noting a whole blood IC50 of 0.36 nM for delta subunit inhibition and whole blood IC50 of 19.6nM for gamma subunit inhibition. The agent was shown to double T cells in both patients with CLL, as well as healthy volunteers from 40 nM to 0.4 mM over 9 to 14 days.

Should the study results be positive, Waller said that the data warrant a need for a larger, multicenter study to further confirm the findings. Even in the event of a smaller, but still significant reduction by one-third or more of patients, the research could be expanded to include hundreds of patients with severe COVID-19, he said.

This is a challenging time, concluded Waller. There are more [factors about this virus] that we dont know than we do know. We have to be cautious as new data become available [to ensure] that its rigorously looked at in order to change medical practices based on solid clinical data. Our study is small, and I wont say that it will change clinical practice, but hopefully its a step towards finding better ways to treat these patients.

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Duvelisib May Reduce Lung Inflammation in Severe COVID-19 Cases - OncLive

A breakthrough: Stem cell therapy cures Covid-19 The Manila Times – The Manila Times

SIX patients who were suffering from the acute coronavirus disease 2019 (Covid-19) were cured through the stem cell technology using blood from preserved umbilical cords.

The revolutionary method of curing the dreaded virus, which originated in China and has spread worldwide, was announced by The Medical City (TMC) hospital in Pasig City.

Health Secretary Francisco Duque 3rd was informed of the breakthrough in treating the pandemic illness through a letter sent by Dr. Eugenio F. Ramos, TMC president and chief executive officer, on Thursday, July 23.

Our government, particularly the Department of Health, can take pride in the fact that the Philippines is not behind at all in innovative practice in medicine, said Ramos in his letter to Duque.

The TMC has been experimenting with stem cell therapy since 2015 through its Institute of Personalized Molecular Medicines stem cell program.

The stem cell experiment was made on seven Covid-19 patients who were so ill they were about to be intubated.

Intubation means inserting a tube into the patients mouth that reaches the trachea to allow him/her to breathe through a lung machine.

Six of the seven patients had recovered, the TMC said; one was so ill he died during the procedure.

As I told you this morning, we would have wanted to complete at least 10 Covid-19 cases before informing you, but it might be taken against us if we kept this knowledge from the public too long while patients are dying and no single drug seems to work, Dr. Ramos told Duque.

Ramos simplified for the public how the stem cell therapy works:

Stem cells are very young cells from the body that can be differentiated into whatever cell lines (lung, heart, kidney, liver, skin, etc.) that the body needs when it needs them, e.g., when an organ is injured or deteriorates. Stem cells can be triggered or infused to do [repair] work.

In severe Covid-19 cases, what triggers a cascade of inflammatory cells (called cytokines) is the injury caused by the virus. The lungs, in particular, become inflamed and the respiratory function rapidly deteriorates leading to death.

Before the cascade happens in which case the patient is in a severe condition probably requiring intubation the infusion of mesenchymal stem cells collected [from] the umbilical cord and grown in [the regenerative medicine laboratory of TMC into the patients veins, takes place.

A total of four infusions are given over a short period of a few days. These messenchymal stem cells rally the cells in the lungs to fight the cytokines.

In short, the stem cells from the umbilical cord produce new cells to replace those damaged by the virus in the lungs, leading to the patients recovery.

The umbilical cord is rich in nutrients to rebuild destroyed tissues, according to Ramos.

TMCs stem cell program also makes use of bone marrow taken from a patients spine to cure cancer.

But the bone marrow stem cell is also used to delay the aging process in elderly patients.

TMC had the most number of bone marrow transplantation for blood cancers, with more than 90 percent survival rate, said Dr. Ramos.

Since 2015, a total of 112 patients have enrolled in TMCs regenerative medicine program.

Of the total, 57 percent were cancer patients and 43 percent were non-cancer patients, said TMCs Dr. Michelle Joy Baldorado-de Vera.

Oncologists (doctors who specialize in cancer) are part of the regenerative medicine program Alan Olavere, Marina Chua-Tan and Josephine Tolentino.

Other members are hematologists (blood doctors) Norma Ona and Alma Calavera, neurologists John Tiongson and Marc Joseph Buensalido, and immunologist Michelle de Vera.

Dr. Sam Bernal, a Filipino American who grew up in the United States, is a consultant to the program.

Bernal is a molecular scientist and an oncologist who has been into stem cell technology for decades.

He was part of the foreign group that was tapped by the government for technology transfer.

Former Health secretary Alfredo Bengzon, who is a part owner of TMC, engaged Bernal to pioneer stem cell therapy in the country.

TMC has had foreign patients who underwent stem cell therapy, but refuses to disclose their number.

As is the norm among Filipinos who have the crab mentality, TMCs stem cell program has been criticized by fellow doctors.

Weve been defending the program from the outset, said Dr. Ramos.

But its not only TMC that has been into stem cell therapy; the other hospitals are the Makati Medical Center and the governments National Kidney and Transplant Institute.

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A breakthrough: Stem cell therapy cures Covid-19 The Manila Times - The Manila Times

UAE hails success of first bone marrow transplant – The National

The UAE is celebrating the success of its first bone marrow transplant.

Typically used to treat patients with blood and cancer disorders , the landmark procedure was carried out on a patient with multiple myeloma, a form of blood cancer.

While cancer is the third-highest cause of death across the Emirates, many Emirati citizens and residents have sought treatment abroad for cell therapy and regenerative medicine.

News of the successful transplant, which was the result of collaboration between Abu Dhabi Stem Cells Centre and Sheikh Khalifa Medical City, represents a major breakthrough for cancer patients living in the UAE who can now seek treatment closer to home to remain with family.

Researchers work to develop medication that can be used to treat Covid-19 patients, at Abu Dhabi Stem Cell Centre. Wam Twitter

Researchers work to develop medication that can be used to treat Covid-19 patients, at Abu Dhabi Stem Cell Centre. Wam Twitter

Researchers work to develop medication that can be used to treat Covid-19 patients, at Abu Dhabi Stem Cell Centre. Wam Twitter

Researchers work to develop medication that can be used to treat Covid-19 patients, at Abu Dhabi Stem Cell Centre. Wam Twitter

The doctors and researchers at Abu Dhabi Stem Cell Centre who were involved in the development of a potential Covid-19 treatment. CourtesyAbu Dhabi Stem Cell Centre

The milestone announcement comes as the centre launched the Abu Dhabi Bone Marrow Transplant programme on Monday.

"It fills us with great pride to be part of a first for the country and to make such a life-saving treatment available and accessible to those who need it here," said Dr Fatima Alkaabi, executive Director of the Abu Dhabi Bone Marrow Transplant programme.

"We are very grateful for the support and collaboration of SKMC in making this opportunity possible."

Bone marrow transplants are one of the most established stem cell-based therapies in the treatment of cancer, particularly blood cancers.

The unique procedure developed by the centre involved harvesting peripheral blood stem cells from the patient, who then underwent high-dose chemotherapy to eradicate all cancerous cells and most of the bone marrow.

The harvested stem cells were then infused back into the bloodstream, where they restore the destroyed cells and over the course of two weeks restart the production of healthy non-malignant blood cells.

"The patient is basically without an immune system while waiting for the transfused cells to take effect and must remain in isolation under the strictest infection control guidelines," said Dr Yendry Ventura, general manager of the stem cell centre and Abu Dhabi bone marrow transplant programme director.

"Since we are still in the midst of a global pandemic, we took additional precautions to ensure the best outcome possible for all involved."

Abu Dhabi Stem Cells Centre has been a driving force behind medical research in the country, including playing a key role in the ongoing fight against Covid-19.

Earlier last month, the team announced the results of the trial of its treatment for Covid-19 patients, branded UAECell19.

After opening in December, the centre has already received international press coverage over to its research into a treatment for the virus.

Their groundbreaking work has involved taking stem cells from a patients blood and returning them, via a nebuliser, as a fine mist to the lungs.

There they help regenerate lung cells and improve the body's immune response by preventing an overreaction to the infection that can damage healthy cells.

Updated: July 27, 2020 05:14 PM

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UAE hails success of first bone marrow transplant - The National

Drug target for aggressive breast cancer found by team of UK and US scientists – iNews

The scientists said they were excited by their findings (Photo: ERIC PIERMONT/AFP/Getty)

A team of British and American scientists have discovered a way to slow the growth of breast cancer stem cells in the lab, which could eventually lead to combination drug therapies on previously untreatable forms of the disease.

Around three quarters of women who have breast cancer have what are known as oestrogen receptor positive tumours. Some breast cancer cells have receptors that bind to the hormone oestrogen and depend on it to grow. Though anti-oestrogen drugs such as tamoxifen and fulvestrant are able to prevent reoccurrence in most of these breast cancers, tumours reoccur in 1 out of 4 cases.

Many of the women relapse after several years, because some of the cancer cells remain after treatment. The cells, called cancer stem cells, lay dormant in the body and cannot be targeted by anti-oestrogen therapies.

Scientists have now found that cancer stem cells resistant to anti-oestrogen drugs express an immune system-related receptor, called interleukin 1 receptor. They also found that Anakinra, a drug used to treat rheumatoid arthritis, was able to reduce the ability of the cancer stem cells to grow.

However, the team said further research in animals and humans is needed before they can confirm if drugs targeting interleukin 1 receptor could be used as an effective treatment.

Scientists from the Universities of Michigan, Liverpool and Edinburgh were closely involved in the study led by Dr Bruno Simes and Professor Rob Clarke from The University of Manchester

Dr Simes said: Resistance to anti-oestrogen therapies in breast cancer patients is a major problem and one which cancer scientists have been trying to address for many years. Many drugs have been investigated by scientists as a possible combination therapy taken with anti-oestrogen therapies and we are still searching for a solution for these patients.

However, most of these drugs target actively dividing cells whereas we are trying to also target cells that are in a dormant state. So we hope that these women who have increased numbers of cancer stem cells and do not respond to currents treatment could one day benefit from combination therapy.

Theres a very long way to go before we can say if this approach will help these women but we are excited by our findings.

The study is published in the journal Stem Cell Reports.

Justin Stebbing, professor of cancer medicine and medical oncology at Imperial College London, said: Stem cells represent a very important target to understand better and eradicate, because they are responsible for some of the most worrying aspects of cancer, such as its ability to regrow, or be resistant to treatment. They are also a rare population but this laboratory research shows that cancer stem cells have on their surface a protein that we have a drug for interestingly one that is being trialled in Covid-19 too.

Hopefully, we can in the future link this laboratory work to research in women in the clinic, helping to reduce recurrence rates by eradicating rare stem cell populations that contribute to recurrence.

Baroness Delyth Morgan, chief executive at Breast Cancer Now, which helped fund the study, said: Its promising that targeting this protein [interleukin-1 receptor] may help reduce the growth of breast cancer stem cells, which are thought to be central to the disease spreading around the body, where it becomes incurable.

The development of resistance to hormone therapies remains a major challenge in the clinic. With around 11,500 women still dying from breast cancer each year in the UK, we urgently need to find new ways to prevent the disease spreading and to treat it more effectively when it does.

This exciting discovery highlights the importance of research to understand the molecular detail of how breast cancer spreads, and of investigating the potential of existing drugs to try to stop it. In particular, these findings offer further evidence that arthritis drugs such as Anakinra may be useful additions in treating breast cancer, and we hope further research can now help us fully understand their potential and whether and how they might work as a cancer treatment.

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Drug target for aggressive breast cancer found by team of UK and US scientists - iNews

Rethinking the Science of Skin – The New Yorker

When my sister and I were young, we liked to come home from school and turn on Guiding Light, a soap opera on CBS. We only ever caught the last fifteen minutes of the hour-long show, but, because it wasnt particularly subtle, this was plenty of time to follow even its most involved plotlinessuch as when Reva Shayne, a nine-times-married character who had arcs as a talk-show host, a psychic, the princess of a fictional island, and a time traveller to the Civil War and Nazi Germany, had to fight Dolly, a devious clone that her most recent husband had made of her in order to spare her children from grief during the most recent of her presumed deaths.

Guiding Light began, in 1937, as a radio show to promote a soap called Duz. (Duz does everything.) When it went off the air, in 2009, it was the longest-running show in broadcast history. It was owned, until the end, not by CBS but by Procter & Gamble, which began as a soap company and has been credited with inventing modern advertising in America. In addition to promoting its brands with paintings on trolley cars and billboards, the company developed more than twenty radio and television dramas. The first, Oxydols Own Ma Perkins, premired in 1933; the last, As The World Turns, left the airwaves in 2010, by which time the term soap opera had become freestanding. You could even watch them, as I did, without ever knowing they had anything to do with a soap company.

It was easy, until the COVID-19 outbreak, not to think very often or very deeply about soap. Early in the pandemic, this began to change. We learned which pop songs had choruses that we could sing to keep us scrubbing for a full twenty seconds; we learned that, at least during the pre-lockdown period, the lines outside mens rooms grew suddenly longerlikely because (according to one study) only thirty-one per cent of men had previously been in the habit of washing their hands after using the bathroom. As distilleries and breweries pivoted to producing hand sanitizer, the Times ran a piece explaining why old-fashioned soap was actually better at destroying the coronavirus: the hydrophobic tails of soap molecules bond with the lipid membrane that protects the virus, literally ripping it apart, while their hydrophilic heads bond with the water that washes the dead virus away. Like many people, I developed a new appreciation for soap, imagining with grim satisfaction a scene of microscopic destruction each time I scrubbed my hands.

So this has been a strange time to be reading a book by a medical doctor which takes a critical view of the soap industry and begins with the sentence Five years ago, I stopped showering.

Let me clarify at once that James Hamblin, a staff writer at The Atlantic and the author of Clean: The New Science of Skin (Riverhead), is still an advocate of regular handwashing, indisputably a world-changing innovation in public health, and of especially crucial importance at this moment in history. (Hamblin also writes that he would never wear a white coat two days in a row without cleaning it.) But hes doubtful about all the scrubbing and soapingnot to mention moisturizing and deodorizing and serum-and-acid applicationto which we subject the rest of our bodys largest organ, and about the companies that spend a lot of money to convince us that we must do so to be clean.

Soap is an ancient invention, so old that we can only assume it was the lucky result of animal fat spilling into fire ash and some people being alert enough to notice the cleaning power of the resulting lather. Still, early versions, made with lye, could burn skin, and were used more often for laundry than for people. Bathing more commonly involved water, sand, pumice, scrapers, and oils or perfumesthough in certain places the whole notion was seen as dangerous. Some historical records suggest that washing was comparatively rare in the Western world: Marco Polo wrote of his surprise at how frequently people in India and China bathed, and Ahmad ibn Fadlan, who travelled from the court of Baghdad to the Volga River in the early tenth century, wrote that the people he met on his journey did not wash after eating, shitting, peeing, or having sex, and were the filthiest of Allahs creatures. The French historian Jules Michelet described the European Middle Ages as a thousand years without a bath.

In America, soap made for skin became commonly sold only in the nineteenth century, largely as a way to make money from the leftovers of the meatpacking industry, which produced large quantities of unused animal fat. Entrepreneurs added potash and made soap, for which they then needed to create public demand. These early soapers included William Procter and James Gamble, who began working together after marrying a pair of sisters; another familial pair, whose company name eventually changed from Lever Brothers to Unilever; and a man named William Wrigley, Jr., who gave away chewinggum as a promotion for his soap, but found that the gum was in higher demand.

Last year, the beauty-and-personal-care market in the U.S. was valued at nearly a hundred billion dollars, which makes it hard to imagine a time when people had to be persuaded to use soap. But the soap industry, Hamblin argues, serves as an effective introduction to the history of American marketing. Early soap companies pioneered many techniques that we still see today: a single company owning lots of competing brands with nearly identical products, in order to foster feelings of consumer choice and loyalty; the use of sponsored content, such as the soap operas or Procter & Gambles How to Bring Up a Baby, which was part health pamphlet and part advertisement. The ad campaigns created a sense of lurking danger in the competition by claiming that their own products were safer and purer, or they promoted, as product virtues, obscure, jargony terms (triple milled) that consumers assumed to be important simply because they were touted on a package. The companies leaned, not at all subtly, on racism and classism to sell their products. They even used people who would now be called influencers, such as the film stars who appeared in 9 out of 10 screen stars use Lux Toilet Soap ads. Lever never even paid them, Hamblin writes, and the practice being so new, the stars apparently didnt think to ask.

The other innovation was to create, and then meet, needs that people didnt know they had. Hamblin notes that B.O. began as a marketing term, and that many soaps advertised as antimicrobial and antibacterial were less safethan standard soap, leaving behind dangerous compounds. (Many products that we now think of as soaps are actually detergents, made from synthetic compounds.)

Meanwhile, soap companies, in order to expand their product lines, had to sell the idea that soap was insufficient on its ownor that its effects had to be undone by yet more products, Hamblin writes. You needed separate soaps for your hair, your body, your face, and even for different members of a family. (Albert Einstein, asked why he didnt use shaving cream, then newly invented, is reported to have replied, Two soaps? That is too complicated!) To offset the drying effects of soap, you then needed other productsconditioners, moisturizers, toners. Hamblin identifies the 1957 introduction of Dove, whose cleaning power is reduced because its mixed with moisturizer, as the moment when the industry started moving toward selling a product that would do nothing at all.

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Rethinking the Science of Skin - The New Yorker

Boehringer Ingelheim acquires GST to strengthen its stem cell capabilities in Animal Health – Business Wire

INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim, a market leader in animal health, has acquired Global Stem cell Technology (GST), a Belgian veterinary biotech company. GST is dedicated to the research, development and production of evidence-based, regenerative medicines (stem cell therapies) used to treat orthopedic and metabolic diseases in animals. Boehringer Ingelheim already entered into a partnership with GST in 2018; in 2019, the companies launched Arti-Cell Forte in Europe.

Arti-Cell Forte is testimony to the innovation strength that lies within both companies. It is the first-ever stem cell product in the veterinary world granted marketing authorization by the European Commission. The acquisition and integration of GST will accelerate the development pipeline of Boehringer Ingelheim while maintaining its focus on setting new standards of care for animals.

Collaboration with external partners plays an essential role in helping us expand our portfolio. After two years of a very successful partnership, we have decided to acquire GST. We are convinced that its expertise in the field of state-of-the art stem cell products will help us bring even more innovative solutions to our customers, shares Jean-Luc Michel, Head of Global Strategic Marketing, Boehringer Ingelheim Animal Health.

Boehringer Ingelheim wants to lead a new wave of innovation in the veterinary field. This ambition is a natural fit with GSTs management, staff and vision. From the very beginning we aimed to change the veterinary field, a role we will continue to play as a new R&D division within Boehringer Ingelheim, says Jan Spaas, CEO of GST.

This decision is fully aligned with our recently refocused strategic direction. Stem cell research areas and regenerative medicine offer an exciting potential for the next wave of innovation we are actively pursuing. In addition, strengthening external partnerships to accelerate our innovative efforts and growth is one of the key elements of our strategy, adds Eric Haaksma, Head of Global Innovation at Boehringer Ingelheim Animal Health.

The companies did not disclose the financial terms of the deal.

For references and notes to editors, please visit:

http://www.boehringer-ingelheim.com/press-release/boehringer-ingelheim-acquires-global-stem-cell-technology

Intended audiences:

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

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Boehringer Ingelheim acquires GST to strengthen its stem cell capabilities in Animal Health - Business Wire

Why I Walk To End Alzheimer’s – TAPinto.net

The Alzheimer's Association Greater New Jersey Chapter is spotlighting people who make a difference in the fight to end Alzheimer's and all other dementia, by participating in the upcoming 2020 Walk To End Alzheimers (WTEA)the worlds largest event to raise awareness and funds for Alzheimers care, support and research. Today we say "thank you" toAnnie Butt.

Annie, a student at New Jersey Institute of Technology where she is studying biomedical engineering and stem cell research, is the Chair of the Essex-Hudson-Union Walk Committee. In addition to conducting outreach to local colleges and community-based organizations encouraging them to volunteer and participate in the Walk, she also creates promotional graphics used on the Chapters social media platforms designed to engage participants and show appreciation.

Joining the Walk to End Alzheimer's has been such an exciting opportunity for me! said Annie. As someone who has a passion for medicine, I want to participate in the Walk to End Alzheimer's, especially since there is no cure for the disease. I am constantly lookingforward to meeting new people through the Association and hearing the stories ofindividualswith loved ones affected by Alzheimer's and helping in any way that I can.

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More than 5 million Americans are living with Alzheimer's disease, the sixth-leading cause of death in the U.S. and the only disease among the top 10 causes that cannot be cured, prevented or even slowed. Additionally, more than 16 million family and friends provide care to people with Alzheimers and other dementias in the U.S. In New Jersey alone, there are more than 190,000 people living with the disease and 448,000 caregivers.

Register your team today. Sign up as a Team Captain or register to walk as an individual. Learn more at alz.org/njwalk. To donate, text 2ENDALZ to 51555, or contact us at gnjwalks@alz.org for more information.

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Why I Walk To End Alzheimer's - TAPinto.net

Stem Cell Market Status by Upcoming Trends 2020 Growth Drivers | Competitive Strategy, Regional Outlook with SWOT Analysis till 2024 – Owned

Stem cells banking is gaining importance with the support of government initiatives. The number of stem cell banks is increasing in developing countries, which is aiding the growth of the market. Also, increasing awareness about stem cell storage among the people has positively affected the market. Currently, the market is not well established in many therapeutic areas and has shown nascent success in history. However, it holds great potential in both the diagnosis and therapeutic fields.

Scope of the Report:

The scope of this market is limited to tracking the stem cell market. As per the scope of this report, stem cells are biological cells that can differentiate into other types of cells. Also, various types of stem cells are used for therapeutic purposes.

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Key Market Trends:

Oncology Disorders Segment is Expected to Exhibit Fastest Growth Rate Over the Forecast Period

Cancer has a major impact on society in the United States and across the world. As per the estimation of National Cancer Institute, in 2018, 1,735,350 new cases of cancer were anticipated to get diagnosed in the United States, and 609,640 deaths were expected from the disease. This increasing medical burden is due to population growth. Bone marrow transplant or stem cell transplant is a treatment for some types of cancers, like leukemia, multiple myeloma, multiple myeloma, neuroblastoma, or some types of lymphoma.

Embryonic stem cells (ESC) are the major source of stem cells for therapeutic purposes, due to their higher totipotency and indefinite lifespan, as compared to adult stem cells with lower totipotency and restricted lifespan. However, the use of ESCs for research and therapeutic purposes is restricted and prohibited in many countries throughout the world, due to some ethical constraints. Scientists from the University of California, Irvine, created the stem cell-based approach to kill cancerous tissue while preventing some toxic side effects of chemotherapy by treating the disease in a more localized way.

Although the market shows positive growth, due to the growing focus of stem cell-based research that can further strengthen the clinical application, its expensive nature for stem cell therapy may still hamper its growth.

North America Captured The Largest Market Share and is Expected to Retain its Dominance

North America dominated the overall stem cell market with the United States contributing to the largest share in the market. In 2014, the Sanford Stem Cell Clinical Center at the University of California, San Diego (UCSD) Health System, announced the launch of a clinical trial, in order to assess the safety of neural stem cell-based therapy in patients with chronic spinal cord injury. Researchers hoped that the transplanted stem cells may develop into new neurons that could replace severed or lost nerve connections, and restore at least some motor and sensory functions. Such numerous stem cell studies across the United States have helped in the growth of the stem cell market.

The report provides key statistics on the market status of the Stem Cell Market manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the Stem Cell .

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Key Insights of Stem Cell Market:

Stem Cell Market Report Covers Following Points in TOC:

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Sobi will file for a re-examination of emapalumab in Europe following negative opinion by CHMP | Antibodies | News Channels – PipelineReview.com

Details Category: Antibodies Published on Friday, 24 July 2020 14:39 Hits: 93

STOCKHOLM, Sweden I July 24, 2020 I Swedish Orphan Biovitrum AB (publ) (Sobi) (STO:SOBI) today announced that the Committee for Medicinal Products for Human use (CHMP) has adopted a negative opinion recommending a refusal of the marketing authorisation for emapalumab for the treatment of primary haemophagocytic lymphohistiocytosis (HLH) in children under 18 years of age in Europe. Given the significant unmet medical need that emapalumab addresses in patients with primary HLH with no approved treatments in Europe, Sobi will be requesting a re-examination by the CHMP with an expected opinion by end of year 2020.

Primary HLH is a rare syndrome that typically presents in infancy but can also be seen in adults and is associated with high morbidity and mortality. In spite of some treatment advances, there continues to be a very high unmet medical need in particular in patients that have failed conventional therapy as there are no approved treatment options outside the US. In the US, emapalumab is the first therapy approved by the US Food & Drug Administration (FDA) for primary HLH. Over 100 patients have been treated in the US and the benefit/risk profile continues to be favourable.

Emapalumab has demonstrated a positive benefit/risk profile in primary HLH in a post-approval real life setting in the US since the FDA approval in 2018. The product has been able to make a substantial difference for a very vulnerable group of patients in the US. We are proud of having made a significant contribution with our product in the primary HLH indication and we are gratified by the recent academic validation of our work via publication in the New England Journal of Medicine. During the last years our team has gained a lot of experience in this rather complex disease area. We will do our utmost to share these insights and address the open questions by CHMP during the re-examination with a view to secure access for primary HLH in children to this treatment in Europe, says Guido Oelkers, CEO and President of Sobi.

HLH is a rare disease but with a large unmet medical need globally. The most important markets based on number of patients for both primary and secondary HLH are China followed by the US, Europe and Japan. In addition to HLH, Sobi will initiate clinical studies with emapalumab for potential indications such as pre-emptive treatment of patients with risk factors of HSCT acute graft failure which will further expand the patient population and market potential for emapalumab. Sobis earlier communicated estimated peak sales target for emapalumab beyond USD 500 million remains unchanged regardless of an approval in Europe.

Professor Franco Locatelli, Principal Investigator in the EU says In my role as Principal Investigator of the NI-0501-04/05 studies in Europe I was significantly surprised about the EMA decision not to approve emapalumab for children with primary HLH who failed or are intolerant to front-line therapy. I had the privilege to observe that this monoclonal antibody, targeting the main cytokine involved in the disease pathophysiology, was well tolerated and effective in a large proportion of the patients, representing a model of precision medicine. While US children have since almost 2 years the possibility to be treated with this novel, safe, highly effective and targeted therapy, the EMA decision paves the way for migratory health flows towards non-European Centers that can grant this treatment.

Professor Michael Jordan, Principal Investigator in the US confirms The NI-0501-04/05 studies have demonstrated that emapalumab has clear therapeutic activity in primary HLH and have validated interferon gamma as a key target in these patients. These studies have also demonstrated that this unique and targeted approach to therapy has a very favorable safety profile. I am grateful for the opportunity to help lead these trials which were conducted with the greatest rigor and transparency, far exceeding that of any trial to date in this very challenging patient population. The worldwide team of collaborators, including physicians at many centers in the US and Europe, as well as individuals at Sobi, should be proud of this ground-breaking achievement. I believe that emapalumab will benefit patients around the world with HLH, especially as we continue to learn how to best apply this unique drug in patients with HLH.

Recently, the results from the pivotal study evaluating the efficacy and safety of emapalumab in patients with primary HLH were published in one of the highest-ranking medical journals, New England Journal of Medicine.

About emapalumab Emapalumab is a monoclonal antibody that binds to and neutralises interferon gamma (IFN). In the US, emapalumab is indicated for paediatric (newborn and older) and adult primary haemophagocytic lymphohistiocytosis (HLH) patients with refractory, recurrent or progressive disease, or intolerance to conventional HLH therapy. Emapalumab is the first and only medicine approved in the US for primary HLH, a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval is based on data from the phase 2/3 studies (NCT01818492 and NCT02069899). Emapalumab is indicated for administration through intravenous infusion over one hour twice per week until haematopoietic stem cell transplantation (HSCT). For more information please see http://www.gamifant.com including the full US Prescribing Information.

About SobiTM Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Sobi is providing sustainable access to innovative therapies in the areas of haematology, immunology and specialty indications. Today, Sobi employs approximately 1,400 people across Europe, North America, the Middle East, Russia and North Africa. In 2019, Sobis revenues amounted to SEK 14.2 billion. Sobis share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at http://www.sobi.com.

SOURCE: Sobi

Link:
Sobi will file for a re-examination of emapalumab in Europe following negative opinion by CHMP | Antibodies | News Channels - PipelineReview.com