Interim Results of Phase I Study Confirms Safety with Early Signs of Efficacy for TRPH-222 in NHL – OncoZine

The investigational drug TRPH-222 (previously known as CAT-02-106), a next-generation antibody-drug conjugate (ADC), is demonstrating early signs of efficacy in the interim results of a multi-center, open-label, monotherapy phase I clinical trial (NCT03682796) in heavily pre-treated patients with relapsed and/or refractory (R/R) B-cell lymphoma (non-Hodgkins lymphoma or NHL), cancer that originates in the lymphatic system. [1]

To date, the majority of antibody-drug conjugates or ADCs in the pipeline are targeted biopharmaceutical drugs that combine monoclonal antibodies specific to surface antigens present on particular tumor cells with highly potent anti-cancer agents linked via a chemical linker.

Furthermore, with eight approved drugs on the market, ADCs are emerging as a powerful class of therapeutic agents in oncology and hematology

In the ongoing two-stage phase I study of TRPH-222, which started in February 2019, the drug has been safely administered intravenously to patients at dosages of up to 7.5 mg/kg every three weeks (q3w). The trial is currently ongoing with a 10 mg/kg q3w dose cohort.

Study designDuring the first stage of the study, which was designed to determine the maximum tolerated dose of TRPH-222 as well as assessing the safety, anti-tumor activity, and pharmacokinetics of the drug, investigators observed tumor area reductions in patients with both indolent and aggressive NHL subtypes, and durable responses in follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and mantle cell lymphoma (MCL) patients.

Early signs of potential therapeutic benefit were seen in the dose-escalation stage of the trial. These observations were based on evaluated data from 19 heavily pre-treated NHL patients, which included five (5) patients confirmed to have had a complete response (CR) at doses of 0.6 to 4.2 mg/kg q3w.

DevelopmentTRPH-222 was originally developed by Catalent Biologics subsidiary Redwood Bioscience.

In 2016 Catalent and Triphase Accelerator signed a collaboration that gave worldwide licensing of TRPH-222 to Triphase, a private drug development company with a primary focus on oncology and with operations in Toronto and San Diego.Triphase has a strategic relationship with Celgene (now Bristol Myers Squibb) for oncology-focused drug development opportunities, including TRPH-222.

Well toleratedThroughout the trial, TRPH-222 has been well-tolerated, with an overall benign safety profile.

For example, the investigators have not observed frequent side effects typically seen with other ADCs containing microtubule-interfering payloads. Events such as elevations in liver enzymes, alterations in blood cell parameters, and peripheral neuropathies, commonly observed with ADCs, have been infrequent and have reversed in all patients.

The feedback from our investigators regarding the overall safety profile of TRPH-222 is very encouraging, noted Nancy Levin, Ph.D., Vice President of Development, Triphase Accelerator, and TRPH-222 program lead.

We find that the current and emerging clinical data provide additional support for our preclinical observations of an excellent safety profile for this molecule, she added.

These interim results indicate that TRPH-222 is a very well-tolerated novel antibody-drug conjugate in this clinical study. The unique molecular design allows a higher delivery of the cytotoxic agent in the tumor bed, and, at the current doses tested, side effects have been mild and manageable, observed Francisco Hernandez-Ilizaliturri, M.D., Chief of the Lymphoma Section at Roswell Park, and lead investigator for the TRPH-222-100 study.

Of interest, clinical activity has been observed even at the lowest dose tested, and five complete remissions have been achieved in previously treated lymphoma patients. Together, our preliminary findings support our hypothesis that TRPH-222 is an active and safe novel targeted agent in B-cell malignancies, Hernandez-Ilizaliturri concluded.

Targeting CD22TRPH-222 is composed of an anti-CD22 antibody, modified to allow site-specific conjugation of a maytansine payload via a non-cleavable linker.The molecular target of the drug, CD22, is a B cell-restricted transmembrane sialoglycoprotein expressed on more than 90% of the surface of B cells in patients with B-cell malignancies and thought to be involved in signal transduction, B cell activation, and regulation.

Because CD22 is expressed on nearly all B-cell malignancies but is essentially absent in other tissues, it is considered a good target for the treatment with targeted therapeutics, including ADCs. Furthermore, with the approval, in 2017, of inotuzumab ozogamicin (CMC-544, Besponsa; Pfizer), for the treatment of R/R CD22-positive B cell ALL and trials including pinatuzumab vedotin (Genentech/Roche) and Epratuzumab (Immunomedics and Bayer), CD22 is a clinically validated target with potential in NHL and acute lymphocytic leukemia (also known as acute lymphoblastic leukemia or ALL). [2][3]

Hematologic cancers are a complex group of diseases, with more than 60 different (sub) types of lymphomas, leukemias, or myelomas that require unique treatment options. Hence, attempts to target CD22 for the treatment of B-cell malignancies by ADCs have not always been successful. One reason for this is that these drugs have demonstrated a limited therapeutic index caused in part by dose-limiting side effects triggered by unacceptably high levels of released cytotoxic payload. As a result, a number of investigational agents could not be dosed high enough to be efficacious in B-cell lymphomas.

TRPH-222, which combines a humanized antibody optimized for site-specific protein-modification conjugation to a cytotoxic payload using Hydrazino-Pictet-Spengler (HIPS) chemistry and a proprietary linker, is based on Catalents proprietary aldehyde tag SMARTag technology. [4][5]

This technology employs natural co-translational modifications found in human cells to create one or more attachment sites at designated positions on protein molecules. These chemical handles are then stably conjugated to payloads (e.g., cytotoxic or effector) to prevent their systemic release.

The SMARTag platform provides precise payload positioning, stable, site-specific conjugation, and defined stoichiometry of drugto-antibody ratios. The control afforded by the technology enables the identification of superior drugs from libraries of differentially designed conjugates.

Preclinical data have suggested that this optimization of payload placement and linker composition, combined with the stability afforded by HIPS chemistry, may lead to better tolerability, efficacy, and expanded therapeutic index as compared to standard maytansine-based ADCs. [1][6][7]

MilestoneAlthough advances in combination chemotherapy, stem cell transplantation, and the advent of rituximab have, over the last 20 years, improved the cure rates for patients with indolent and aggressive NHL, nearly 50% to 60% of patients diagnosed will ultimately fail therapy. As a result, there is a major unmet medical need.

TRPH-222 may offer a potential therapeutic alternative in these heavily pretreated patients if the interim results are confirmed in subsequent clinical studies.

Given the fact that heavily pretreated patients are not usually treated with monotherapy, the observed responses together with the demonstrated safety profile make us feel very excited about the molecule and the SMARTag technology, added Mathias Schmidt, Ph.D., Executive Vice President and Head of Research & Development of Triphase Accelerator.

This is an important interim milestone for the program, and the data are important not only in the context of TRPH-222 but also because they signal broader opportunities for the general application of SMARTag technology to improve ADC tolerability and expand its therapeutic index, said Penelope Drake, Ph.D., Director, Research & Development at Catalent Biologics.Webinar

Experts from Triphase Accelerator and Catalent Biologics plan to present further details in a webinar on Tuesday, May 26, 2020, at 2:00 p.m. EDT (11.00 a.m. PDT) in the ongoing investigational trial and underlying SMARTag technology platform.

Clinical trialsStudy of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma NCT03682796.

Reference[1] TRPH-222 / CD22-4AP. Drug Description ADC Review, Journal of Antibody-drug Conjugates. Online. Last accessed on May 17, 2020[2] Lanza F, Maffini E, Rondoni M, Massari E, Faini AC, Malavasi F. CD22 Expression in B-Cell Acute Lymphoblastic Leukemia: Biological Significance and Implications for Inotuzumab Therapy in Adults. Cancers (Basel). 2020;12(2):303. Published 2020 Jan 28. doi:10.3390/cancers12020303[3] Advani RH, Lebovic D, Chen A, et al. Phase I Study of the Anti-CD22 Antibody-Drug Conjugate Pinatuzumab Vedotin with/without Rituximab in Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma. Clin Cancer Res. 2017;23(5):11671176. doi:10.1158/1078-0432.CCR-16-0772[4] Agarwal P, Kudirka R, Albers AE, et al. Hydrazino-Pictet-Spengler ligation as a biocompatible method for the generation of stable protein conjugates. Bioconjug Chem. 2013;24(6):846851. doi:10.1021/bc400042a[5] Rabuka D, Rush JS, deHart GW, Wu P, Bertozzi CR. Site-specific chemical protein conjugation using genetically encoded aldehyde tags. Nat Protoc. 2012;7(6):10521067. Published 2012 May 10. doi:10.1038/nprot.2012.045[6] Maclaren AP, Levin N, Lowman H. TRPH-222, a novel anti-CD22 antibody-drug conjugate (ADC), has significant anti-tumor activity in NHL xenografts and reduces B cells in monkeys [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl): Abstract nr# 835.[7] Drake PM, Carlson A, McFarland JM, et al. CAT-02-106, a Site-Specifically Conjugated Anti-CD22 Antibody Bearing an MDR1-Resistant Maytansine Payload Yields Excellent Efficacy and Safety in Preclinical Models. Mol Cancer Ther. 2018;17(1):161168. doi:10.1158/1535-7163.MCT-17-0776

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Interim Results of Phase I Study Confirms Safety with Early Signs of Efficacy for TRPH-222 in NHL - OncoZine

Stem Cell Treatments Market Report, History and Forecast 2015-2025, Breakdown Data by Manufacturers, Key Regions, Types and Application – Express…

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R3 Stem Cell International Now Offering Enhanced Autism Stem Cell Program in Mexico – PR Web

Top Stem Cell Treatment for Autism in Mexico (888) 988-0515

SCOTTSDALE, Ariz. (PRWEB) May 18, 2020

R3 Stem Cell International is now offering an enhanced autism stem cell therapy program at its Tijuana regenerative clinic. There are two program options for patients and their families, which are all inclusive and represent extremely effective and safe cell counts.

While it is unclear exactly what causes Autism Spectrum Disorder (ASD), there are several recent clinical studies which have shown exciting outcomes for patients. Also, those studies have shown mesenchymal stem cell therapy for autism to be very safe as well.

R3 Stem Cell International's enhanced program provides umbilical cord derived stem cell therapy for patients, with total cell counts for the treatment ranging between 90 million up to 200 million live stem cells. The actual total administered depends on patient weight.

According to R3 International Medical Director Ramon De La Puerta, "We have seen exceptional outcomes for autism patients, which typically include increased cognitive abilities, interpersonal skills, less aggression and more. The biologics undergo quality assurance standards that exceed FDA regulations in the US, and no preservatives are used so cell viability is over 95%!"

The two all inclusive treatment options include either a five day stay, or several trips over a span of of a year. The all inclusive fee starts at $8975, and involves several IV therapies. Sedation is available with a highly qualified anesthesiologist if necessary, and parents are welcome to attend all treatment sessions.

As with all R3 Stem Cell International procedures, R3 takes care of concierge escort transportation from San Diego to the clinic, which is only 20 minutes from the SD International Airport. R3 will also help with travel logistics.

According to R3 CEO David Greene, MD, MBA, "Our enhanced Autism program offers an incredible opportunity for families desiring a safe, cost effective and clinically effective option for those who have not responded desirably with conventional treatments. Over 8 years of therapies, R3 has not seen any significant adverse events, and the patient satisfaction rate has been amazing!"

In order to find out if a person is a good candidate for stem cell therapy for Autism, R3 offers a free phone consultation for families simply by calling (888) 988-0515.

About R3 Stem Cell International: After 14,000 stem cell procedures in the US, R3 opened R3 Stem Cell International. With the first location in Tijuana, https://stemcelltreatmentclinic.com has been an incredible option for patients suffering from all types of chronic conditions such as kidney, liver, lung and heart issues. Additionally, neurologic issues respond well such as stroke, Alzheimer's, stem cells for diabetes and more.

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Saad Z. Usmani, on the Approval of Daratumumab and Hyaluronidase-fihj – Cancer Network

In an interview with CancerNetwork, Saad Z. Usmani, MD, FACP, hematologist and medical oncologist at Levine Cancer Institute, spoke about the recent approval of daratumumab and hyaluronidase-fihj (Darzalex Faspro) for use in adult patients with newly diagnosed or relapsed/refractory multiple myeloma.

The addition of this product now allows for subcutaneous dosing of daratumumab.

One of the concerns that medical oncologists have had is the long infusion time [of daratumumab], especially in the first cycle of treatment, said Usmani. The subcutaneous formulation of daratumumab brings a lot of convenience to the patients.

The combination of daratumumab and hyaluronidase-fihj is now approved for the following indications, of which intravenous daratumumab had already received approval:

[This] is going to be very important moving forward in the new COVID-19 pandemic environment where were trying to find innovative ways in which we can streamline the operations in the clinic, as well as make things more convenient for our patients and do it in a safe environment, Usmani said.

References:

FDA. FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma. FDA website. Published May 1, 2020. fda.gov/drugs/drug-approvals-and-databases/fda-approves-daratumumab-and-hyaluronidase-fihj-multiple-myeloma. Accessed May 1, 2020.

This segment comes from the CancerNetworkportion of the MJH Life Sciences National Broadcast, airing daily on all MJH Life Sciences channels.

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Saad Z. Usmani, on the Approval of Daratumumab and Hyaluronidase-fihj - Cancer Network

Stem Cell Concentration System Market Report 2020: Rising Impressive Business – News by aeresearch

The recent report on Stem Cell Concentration System market provides an end-to-end assessment of this business sphere and comprises of important data regarding the pivotal parameters such as prevailing market trends, current revenue, market share, industry size, periodic deliverables, and profit estimates over the forecast duration.

New latest Growth Report on Stem Cell Concentration System Market Size, Share | Industry Segment by Applications (Hospital, Clinic and Diagnostic Laboratories), by Type (Syringes, Bone Marrow Collection Needles, Anticoagulant and Concentrating Devices and Others), Regional Outlook, Market Demand, Latest Trends, Industry Growth & Revenue by Manufacturers, Company Profiles & Forecasts to 2025. Analyzes current market size and upcoming 5 years growth of this industry.

A thorough examination of the behavior patterns of the Stem Cell Concentration System market over the projected timeframe has been laid out in the report. Insights about various aspects that shape the market dynamics, alongside the growth rate projections of the industry over the forecast period in enclosed in the report. The report further elaborates challenges encountered by this industry vertical, in conjunction with the growth prospects that could propel the industry growth over the forecast timeline.

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COVID-19, the disease it causes, surfaced in late 2019, and now had become a full-blown crisis worldwide. Over fifty key countries had declared a national emergency to combat coronavirus. With cases spreading, and the epicentre of the outbreak shifting to Europe, North America, India and Latin America, life in these regions has been upended the way it had been in Asia earlier in the developing crisis. As the coronavirus pandemic has worsened, the entertainment industry has been upended along with most every other facet of life. As experts work toward a better understanding, the world shudders in fear of the unknown, a worry that has rocked global financial markets, leading to daily volatility in the U.S. stock markets.

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Stem Cell Concentration System Market Report 2020: Rising Impressive Business - News by aeresearch

Precision therapy approach secures small biotech $42M haul to combat disease that inspired the Ice Bucket Challenge – Endpoints News

Akin to cystic fibrosis (CF), scientists understand that certain mutations contribute to the development of the fatal neurological disorder amyotrophic lateral sclerosis (ALS). And much like CF drugmaker Vertex, a small Cambridge, Massachusetts-based biotech is forging a path to engineering precision therapies to treat the disease that killed visionary physicist Stephen Hawking.

The company, christened QurAlis, now has $42 million in its coffers with three preclinical programs and 5 employees (including senior management) to combat an illness that has long flummoxed researchers, resulting in a couple of approved therapies over the course of decades, neither of which attacks the underlying cause of the rare progressive condition that attacks nerve cells located in the brain and spinal cord responsible for controlling voluntary muscles.

ALS garnered international attention when New York Yankees player Lou Gehrig abruptly retired from baseball in 1939, after being diagnosed with the disease. In 2014, ALS returned to the spotlight with the Ice Bucket Challenge, which involved people pouring ice-cold water over their heads, posting a video on social media, and donating funds for research on the condition.

QurAlis chief Kasper Roet, whose interest in ALS was piqued while he was working on his PhD at the Netherlands Institute for Neuroscience focusing on a treatment for spinal cord paralysis and moonlighting at the Netherlands Brain Bank as an ad-hoc autopsy team coordinator, saw an opportunity to combat ALS when Harvard scientists Kevin Eggan and Clifford Woolf pioneered some new stem cell technology.

Essentially, they found a way to take skin cells from a patient, turn them into stem cells, and turn those into the nerve cells that are degenerating. Thats the missing link, Roet said. So now we can finally use patients own cells to both do target discovery and develop potential therapeutics.

So Roet packed up his things and shifted base to Boston to learn more, with plans to head back to Europe to start a company. He never left. QurAlis was born in 2016, working out of a co-working space called LabCentral after winning a spot via an Amgen-sponsored innovation competition. The company was carved out of a collaboration with Eggans startup Q-State Biosciences, which developed laser technology to examine cell behavior examining how a neuron fires was imperative in the drug discovery process for ALS.

QurAlis, which counts Vertexs founding scientist Manuel Navia as an advisor, now has three preclinical programs. The furthest along is a therapy designed to target a specific potassium channel that is implicated in certain ALS patients the plan is to take that small molecule into the clinic next year, Roet said.

It has become really clear that if you understand why a specific tumor is developing you can develop very specific targeted therapies, he explained in an interview drawing a parallel between ALS and oncology. Thats exactly the same strategy that we are following for ALS. The genetics have shown that over 25 genes are causing the (ALS) mutations. Some of them work together, some of them are very dominant and work alone what we are doing is trying to get those specific proteins that are tied to very specific ALS populations, where we know that that specific target plays a very important and crucial role in the development of the disease.

In 2018, QurAlis scored seed funding from Amgen, Alexandria, and MP Healthcare Venture Management. The Series A injection was led by LS Polaris Innovation Fund, lead seed investor Mission BioCapital, INKEF Capital and the Dementia Discovery Fund, and co-led by Droia Ventures. Additional new investors include Mitsui Global Investment and Dolby Family Ventures, and existing investors Amgen Ventures, MP Healthcare Venture Management, and Sanford Biosciences also chipped in.

Roet is not sure how long these funds will last, particularly given the uncertainty of the coronavirus pandemic. But some of the capital will be used in hiring, given that the QurAlis team is comprised of a mere five people, including Roet.

Weve been very productive, he said. But we can definitely use some extra hands.

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Precision therapy approach secures small biotech $42M haul to combat disease that inspired the Ice Bucket Challenge - Endpoints News

Mike Tyson reveals doctors gave him translucent blood injection that left him feeling weird during stem cel – The Sun

MIKE TYSON has revealed he was injected with nearly-translucent blood in his bid to make a comeback... and the former heavyweight champ said it made him feel "weird".

The 53-year-old - who retired from boxing in 2005 - has announced his intention to dust off the gloves and return to compete in exhibition bouts.

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His return to action has been aided by stem-cell research therapy, that has left him feeling like a "different person".

He said: "You know what I had done? I had stem-cell research therapy.

"I feel like a different person but I can't comprehend why I feel this way. It's really wild what scientists can do."

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition that usually takes the form of a bone marrow transplantation.

In a recent interview with rapper LL Cool J on the Rock the Bells Radio show on SiriusXM, Tyson opened up on the effects the treatment has had on him.

Commenting on the mental aspect of training for a fight for the first time in 15 years, he said: "My mind wouldnt belong to me.

"My mind would belong to somebody that disliked me enough to break my soul, and I would give them my mind for that period of time.

"Six weeks of this and Id be in the best shape Ive ever dreamed of being in. As a matter of fact, Im going through that process right now. And you know what else I did, I did stem-cell research."

Tyson was then asked whether that meant if his white blood had been spun and then put back in, to which he replied: "Yes. As they took the blood it was red and when it came back it was almost transfluid (sic).

"I could almost see through the blood, and then they injected it in me.

"And Ive been weird ever since, Ive got to get balanced now."

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FIGHT FOR THE AGESHow heavyweights Tyson and Briggs compare with combined age of 101

THE REAL DEALHolyfield warns Tyson he won't settle for any nonsense in exhibition fight

EVERY LIDDELL HELPSTyson urged to return at 53 as he 'still has it', says UFC icon Liddell

MIKE DROPTyson return 'not something' Hearn wants to promote but 'intrigued' by comeback

LOW BLOWHolyfield snubs Mike Tyson as hardest hitter and instead picks George Foreman

MIKE DROPMike Tyson recalls prison visit from Tupac and hitting a fellow inmate

WHAT IS STEM CELL TREATMENT USED FOR?

Stem cell transplants are carried out when bone marrow is damaged or isnt able to produce healthy blood cells.

It can also be used to replace damaged blood cells as the result of intensive cancer treatment.

Here are conditions that stem cell transplants can be used to treat:

Iron Mike has been called out by former rival Evander Holyfield to complete their trilogy following their two meetings in 1990s.

And his unusual methods for getting back in shape seem to be working.

Tyson is looking in incredible condition as he uploaded a clip of himself that showed off his ferocious power and speed.

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Mike Tyson reveals doctors gave him translucent blood injection that left him feeling weird during stem cel - The Sun

Who Believe? Chad Coulter’s spirit lives on through his son on and off the field – Dave Campbell’s Texas Football

Chad Coulter embodied everything good about Orangefield, Texas. His work ethic, his selfless motivation, his love for his family and neighbor. He passed away from cancer in 2019, but his spirit lives on in his son, Coby Coulter.

If you have a chance to look up toward the heavens today, give it a second and you might hear the faint whispers of a man yelling Who Believe? as he did so often around Orangefield, Texas.

Go ahead and shout back We Believe if youre able. It would mean a lot to the Coulters.

Chad Coulter is no longer with us; he succumbed to his battle with Non-Hodgkin Lymphoma shortly after the 2019 football season. But his memory most definitely lives on in the tight-knit community 25 minutes east of Beaumont.

Coulter bled orange and white. He grew up a Bobcat and proudly wore the No. 72 as he became an all-state offensive lineman before going off to play at Kilgore College.

He was known around town as the man that would yell the first part of Orangefields school motto, Who Believe?

Someone that most definitely does is his son Coby, a junior-to-be who wears the same number and plays the same position in honor of his pops.

He was a nice guy who cared for everyone in Orangefield, Coby said. He really loved the people around here. He loved being around people. He loved all of us, the whole family.

Chad did a bit of everything in the Orangefield school system. He coached track, was the junior high boys athletic coordinator, was an offensive line coach at the high school, taught science.

Hell, at one point he was the assistant softball coach, said Josh Smalley, Orangefields head football coach.

He didnt stop coaching football until he had a couple of heart attacks.

When he got done with stem cell therapy the doctor told him he needed to take two to three months off. But he loved going to work, said his wife, Heggie Coulter. He loved being with those kids. He was in everything.

Added Smalley: He never complained. Im sure there were days when he would go and get chemo in the morning and then come to practice after school, and Im sure he didnt feel like doing it but did it because he loves the kids. Never heard the guy complain. He was a happy-go-lucky guy.

He battled cancer for over three years until it reached his brain. The doctors told his family they could try to treat it, but werent sure if it would do any good. He got more treatments, but by September, it had returned strong enough to paralyze half of his face.

Then in October it paralyzed the other half of his face, Heggie said. We knew in November that he didnt have much time left.

Despite all of this, Chad was there to watch his son at every Orangefield game except the Bobcats bi-district playoff loss to Franklin.

He would always show with his actions, Coby said. Hed always lend a helping hand to anyone in need. He was always there to help.

As you could imagine, the perseverance that Coby showed through all of this was as inspirational as any motivational speech Smalley could have ever conjured up for his team.

To be a sophomore in high school and deal with the death of his father, I cant imagine what he had to go through daily, Smalley said. To have your dad battle cancer and you still have to be a kid and go to school, go to football practice and play in a game, he is a special young man.

The impact that Chad had on the community was nowhere more apparent than at his funeral. Over 500 people showed up. Athletes stood for the entire 2-hour service with their finger in the air. Coaches, trainers, co-workers, high school and college teammates shared memories instead of the traditional eulogy.

What Chad Coulter means to this school district and this community you cant put into words, Smalley said. Everybody that has taught, coached here or played here reached out and loved the family.

His word for the school year was Live.

This meant more to him than staying alive, Heggie said. He wanted to inspire others to live each day to the fullest no matter what obstacles they faced.

Thats a message that Coby lives by every day.

It made me want to be a better person and to always put others before yourself, he said.

After Chads passing, students started a petition to name the stadium after Coach Coulter. It had about 2,000 signatures before COVID-19 put things on pause.

He was the epitome of what it means to be a Bobcat; toughness, hard-worker, no fear, Smalley said. He definitely put that into his kids and family.

Boy, did he.

He would always tell me that I couldnt guard him, laughed Coby, who could squat 425 as an incoming freshman and can now squat 600 pounds. I would have taken him easy.

Who believe?

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Who Believe? Chad Coulter's spirit lives on through his son on and off the field - Dave Campbell's Texas Football

Doctor, Heal Thyself: Physician Burnout In The Wake Of Covid-19 – Forbes

Physician burnout and suicide were epidemics before the current pandemic.

Nationwide, our doctors are jumping from rooftops, overdosing in call rooms and hanging themselves in hospital chapels. Its medicines dirty secret.

This unnerving account by Pamela Wible, MD during her 2015 TEDMED talk sent chills down my spine. Dr. Wible described the death of one physician by bullying, hazing and sleep deprivation a torture technique adding that each year, more than one million Americans lose their doctor due to suicide. Her cell phone has become an unofficial suicide hotline. The founder of Ideal Medical Care, Dr. Wible is also featured in the groundbreaking documentary, Do No Harm, which has been virtually screened every Sunday in May at 8pm EST. Suicide is an occupational hazard of our profession.

Physician burnout was an epidemic BEFORE the Covid-19 pandemic. According to a 2018 study, 400 physicians die by suicide each year double that of the general population. In addition, doctors have the highest suicide rate of any profession in the U.S including combat veterans. From an economic standpoint, studies estimate that physician burnout is costing the health care system approximately $4.6 billion per year. So, how do we stop this dreadful reality? Read on (HINT: its NOT through resilience and wellness trainings).

Many doctors view medicine as a calling, entering the field with immense altruism paired with a passion for science and healing the sick. The erosion of these intrinsic motivators leads to burnout which psychologist Christina Maslach defines as a syndrome of emotional and physical exhaustion, depersonalization and diminished personal accomplishment.

The stress of long hours, no sleep, poor eating, inadequate protection, the fear of contaminating loved ones, the fear of dying and seeing patients die no matter what you do, the disrespect by hospital administrators and the fear of being fired, all remain the reality for those who are in the thick of things, denounced Lynette Charity, MD, an anesthesiologist who speaks nationwide about physician burnout.

Studies also show that burnout is associated with negative clinical outcomes: decreased quality of patient care; increased number of medical errors; and higher rates of addiction, depression and suicide among physicians.

Dr. Lynette Charity, an anesthesiologist and physician advocate, speaks nationwide about burnout ... [+] among doctors.

Burnout has nothing to do with weakness, laziness or incompetence. The prevailing attitude, report Pamela Hartzband, MD and Jerome Groopman, MD in a recent NEJM article, was that burnout is a physician problem and those who cant adapt need to get with the program or leave. Turns out that structural and systemic issues are heavy culprits. Despite lip service to patient-centered care, many physicians believe the current healthcare system is propelled by money and metrics, according to Hartzband and Groopman. Doctors are well-meaning and willing to work long hours, and hospital executives know this and exploit it, as Danielle Ofri, MD aptly asserts in The Business of Health Care Depends on Exploiting Doctors and Nurses.

Medical workers in protective clothing move the body of a deceased patient to a refrigerated ... [+] overflow morgue outside the Wyckoff Heights Medical Center in the Brooklyn borough of New York City, the epicenter of the Covid-19 pandemic.

The medical field is at a crisis. This pandemic has exposed many cracks in the U.S. healthcare system. From inadequate testing and personal protective equipment (PPE) to overcrowded emergency departments, frontline health staff are putting their lives at risk to care for highly infectious patients debilitated by Covid-19. And yet medical professionals are responding to this crisis with unprecedented selflessness, resilience and compassion.

For many physicians, Covid-19 may be the proverbial straw that breaks the camels back as they isolate themselves physically from their family and friends while encountering a surge of sickness and death, said Nisha Mehta, MD, radiologist, physician advocate and keynote speaker.

Here are a few real-world examples. About a month into the pandemic, at the end of a difficult shift, an infectious disease physician with 20 years of experience, texted me the following: Just admitted a 28yo pregnant woman in 2nd trimester w COVID. About to get intubated. I hate these days. Two weeks later, this same physician texted: I just started sobbing. I mean, bawling. But in the bathroom so my 6yo wouldnt see.

A doctor checks on a Covid-19-infected patient connected to a ventilator.

Some hospitals have created the position, Chief Wellness Officer. Others have offered resilience and meditation workshops, social hours and tips for maximizing productivity. But, according to Hartzman and Groopman, none of these solutions address the underlying problem: a profound lack of alignment between caregivers values and the reconfigured health care system. Here are some strategies that may actually curtail the wave of physician burnout and suicide:

1. Reduce administrative burden This includes prior authorizations, disability paperwork and the electronic medical record (EMR) which has simply become a burdensome billing tool. Let the bean counters and the C-Suite collect the data and enter it into the EMRs, suggested Dr. Charity, adding: Provide scribes for the doctors.

2. Flexibility over schedules A 2017 study showed that physician input in scheduling was one of the few systems solutions that reduced burnout as it allowed for individual practice styles and patient interactions.

3. Mental health support Because burnout can lead to depression, anxiety, PTSD and secondary trauma, appropriate and timely mental health treatment is critical and can include counseling and medications. In NY state, text NYFRONTLINE to 741741 to access 24/7 emotional support services.

Access to timely mental health support is critical in reducing burnout.

4. Reduce gender bias The National Academy of Medicine reported that burnout may be 20-60% higher among female vs male physicians. Over 70% of women doctors experienced gender discrimination; they are consistently paid less than their male counterparts, less likely to be referred by their professional titles and less likely to be promoted. Female physicians also spend 8.5 additional hours per week on childcare and other domestic duties, while men reported spending an extra 40 minutes on domestic work.

6. Diversify Doctor Voices We need more women and women of color to be in decision-making positions. Minority voices are not being heard, and they are being disproportionately harmed.

7. Speak Out - If youre a physician whos going through a hard time, I promise you youre not alone. Please talk to somebody. And if you see a colleague suffering, please get her/him help. You may just be saving a life. Call National Suicide Prevention Lifeline 1-800-273-TALK (8255).

In addition to the above recommendations, a group of New York doctors (myself included) created a petition to advocate for physician protection and compensation which is being sent to legislators. It can be signed by non-healthcare workers.

Dr. Nisha Mehta, a physician advocate: "So many physicians contact me with fears, frustrations and ... [+] sadness as they experience unprecedented challenges emotionally, physically and financially."

*****

Medicine is a calling for many. But is it really worth dying for? I dont think so. Doctors are people, too. And thats not being trite. In order to stem the tide of physician burnout and suicide, we all have a role to play. If we want our doctors to be whole and full of joy, we must reaffirm their humanity and their value in society. Medical culture and health care systems must change but this will only happen when theyre forced to change. Physicians must first acknowledge and heal their own pain and suffering - for their sake and that of their patients and communities.

Read more:
Doctor, Heal Thyself: Physician Burnout In The Wake Of Covid-19 - Forbes

Outbreak on edge of Navajo Nation overwhelms rural hospital – Yahoo Lifestyle

GALLUP, N.M. (AP) On the eve of New Mexico's shutdown of bars and restaurants to stem the spread of the coronavirus, the city of Gallup came alive for one last night of revelry.

Before the night was out in the desert oasis on the fringes of the Navajo Nation, 98 people were detained for public intoxication and sent to sober up at a detox center. Several homeless people also sought refuge in the same cinder block building, which doubles as a shelter. Somewhere in the mix, lurked the virus.

The outbreak seeded at the NaNizhoozhi Center would combine with the small, local hospitals ill-fated staffing decisions and its well-intentioned but potentially overambitious treatment plans to create a perfect storm that has overwhelmed doctors and nurses and paralyzed this community in the states hard-hit northwest.

In all, 22 people infected with the coronavirus were transferred from the detox center to Rehoboth McKinley Christian Hospital, the only acute care medical center for the general public within 110 miles (180 kilometers) of Gallup.

They were putting multiple cots in one room to accommodate them, said pulmonologist Rajiv Patel, who helped lead the hospitals initial response.

To care for that influx, any available doctor was pressed into service, including those who normally don't handle critically ill patients, Patel said.

Thats right when we overloaded, said hospital CEO David Conejo. Now weve got too many patients, and too few (staff) to help.

Rehoboths eight intensive care beds are full, and now it has to transfer all coronavirus patients with severe breathing problems away from the facility and the adjacent Gallup Indian Medical Center, which attends exclusively to the Native American community.

Of about 500 medical and support staff, at least 32 hospital workers have become infected, and doctors and nurses say that they all live with the fear of spreading the virus to their colleagues and relatives.

Conejo blames Patel for the fact that the hospital became overwhelmed, saying the doctor took on more COVID-19 patients than the staff could handle because of his ambition but also good intentions.

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But Patel who arrived at Rehoboth in March from an Army reserve stint in Kuwait said the hospital simply didn't have enough staff with the experience to provide the right care and struggled to train more quickly. Patel has since left to work at Flagstaff Medical Center in Arizona.

Twice, the doctor said, alarms went off during the night on breathing machines only to be misinterpreted by overnight staff. Within two days of those missteps, he and colleagues decided that severely ill coronavirus patients would have to go elsewhere a heart-wrenching decision that meant sick people would be treated far from family and one that underscored the consequences of not having adequate care in the region.

It was an easy decision because it was the right thing to do for patients, said Patel, whose wife is Navajo. It was very saddening for me personally because my heart and soul are completely invested in the health situation on the reservation."

Many nurses and doctors, meanwhile, say staffing at the hospital was inadequate because of Conejo's move to cut back on nurses in the first week of March to offset declining hospital revenues after elective surgeries were suspended. They voiced their discontent at a recent protest calling for his resignation.

We knew it was coming to McKinley County, there wasnt any ifs, ands or buts. I was directed that I had to let go of 17 agency nurses, said Felicia Adams, chief nursing officer who has recovered from COVID-19. We want to take care of our patients, we dont want to have to send them away.

Conejo defended his oversight, noting that he deferred to the hospitals board of trustees and a team of nurses and physicians on final decisions. He also said the hospital couldnt afford not to cut staff in March and that the facility wanted to reduce overall employment to qualify for small-business assistance. But Adams and others believe Conejo put profits ahead of care.

Physician Caleb Lauber said that, as experienced contract nurses were let go in March, unfamiliar responsibilities were thrust upon other nurses given only on-the-fly training.

New Mexicos state auditor is seeking more information about the county-owned hospital's finances from its private operators. State health officials and philanthropists, meanwhile, are recruiting more than a dozen volunteer medical professionals and have hired a new critical care physician for the hospital.

While much of New Mexico is showing signs of emerging from the initial wave of the pandemic, stubbornly high rates of infection and death persist in the states northwest corner including in the Navajo Nation that extends into Arizona and Utah. More than half of New Mexicos roughly 6,100 confirmed infections are in Native Americans.

For most people, the coronavirus causes mild or moderate symptoms. For some, especially older adults and people with existing health problems, it can cause more severe illness and lead to death.

As the Navajo have suffered in this pandemic, so, too has Gallup, whose fate has long been tied to the neighboring Navajo Nation. In normal times, the citys population of 22,000 can quickly quadruple in size since it is a crucial source of supplies and water for faraway Navajo households, many of which lack full plumbing.

The city is also a destination for many of the most marginalized Navajo, those who have left home and ended up on Gallup's streets, often as they grapple with alcohol addiction. Officials suspect that the coronavirus whipped through the homeless population, and some passed through the NaNizhoozhi Center, putting the liquor-tax funded shelter and detox center at the heart of the city's outbreak.

The city and its rural outskirts account for about 30% of COVID-19 infections statewide, with 78 related deaths as of Monday.

To stem the spread, Gallup was subject to an extreme 10-day lockdown this month cutting the city off from many of those who depend on it for supplies. Authorities have now set up free water stations and deliveries to avoid the risk of transmission posed by coin-operated water stations, where hand after hand scooped out returned change.

Now, the NaNizhoozhi Center is also part of the response as it steers destitute people infected by the coronavirus toward isolation in rooms at four otherwise unoccupied motel buildings. Some 140 people are currently participating in the impromptu system, and officials hope it will interrupt a treadmill of infections among Gallups homeless population.

But the virus has also taken its toll on the center. In addition to the 22 residents who became infected, several staff have been sickened by the virus and some simply stopped showing up, said Kevin Foley, executive director of the center. Six jobs now are open at a rate of $10 and hour, with just one application, he said.

He yearns for a Hollywood ending.

I wish that all those people would come over in those space suits and just clean the place for good," he said, "but its not like that.

___

Associated Press writer Felicia Fonseca contributed to this report from Flagstaff, Arizona.

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Outbreak on edge of Navajo Nation overwhelms rural hospital - Yahoo Lifestyle