Opinion | This Could Be One of the Most Brazen Attacks on … – The New York Times

In their zeal to continue upending abortion access after the overturning of Roe v. Wade, legislators, activists and litigants have pushed increasingly extreme measures that disregard medical science, insert government into the exam room and increase the odds of maternal deaths. Not satisfied with banning abortion in their home states, some lawmakers are trying to restrict access in other states as well a chilling attempt to intimidate patients and physicians alike.

Against this backdrop, the Supreme Court faces a decision that lays bare the threat to facts, evidence and the health of Americas patients. The case, Alliance for Hippocratic Medicine v. F.D.A. in which anti-abortion organizations and doctors who have never prescribed the pill mifepristone argue, absurdly, that 23 years ago the F.D.A. did not follow proper protocol in approving it as part of a two-drug regimen for abortion is one of the most brazen attacks yet against reproductive health. If the lower courts rulings on mifepristone are not reversed entirely, it could also upend the Food and Drug Administrations drug regulatory process. This would throw our health care system into chaos in ways that extend far beyond the specific fight over mifepristone, a highly effective drug that has been used safely by millions of patients for medication abortions and for miscarriage care for more than two decades.

In seeking to restrict access to abortion across the United States, the plaintiffs in this case have, intentionally or not, seriously jeopardized our nations 85-year-old drug regulatory system. We must be cleareyed; upholding any parts of the district courts dangerous ruling would in all likelihood almost immediately prompt challenges to other longstanding safe and effective F.D.A.-approved drugs that doctors and patients rely on every day.

After three years of politicization fueled by disinformation, this would surely include challenges to many vaccines, including those that reduce the risks of serious illness from Covid-19. We should expect lawsuits against common types of safe and highly effective hormonal birth control, including emergency contraception. Also at risk: drugs used to treat cancer and arthritis that can incidentally affect unexpected pregnancies, drugs to prevent or treat H.I.V., and medications aimed at providing gender-affirming care.

The threat may ultimately include promising drugs and treatments built around stem cell technology to treat Parkinsons, Alzheimers, multiple sclerosis or even more common types of chronic disease, such as diabetes. With ever-growing anti-science aggression, disinformation campaigns and vitriol about all types of medical advancements, there is no telling where the court challenges may lead perhaps even to widely used drugs now sold over the counter to treat pain, allergies or heartburn that happen to have been studied with fetal stem cells.

This would represent a dangerous and reckless step backward for our country. More people would live sicker, suffer more and die younger while the scientifically proven safe and effective drugs they need remain locked away.

We simply cannot be a country where your access to the care you need is determined by the whims of ideologically driven judges and lawmakers without medical or scientific training. Thats why a dozen of the nations leading medical organizations, including the one I head, the American Medical Association, strongly oppose this politically motivated assault on patient and physician autonomy and have filed amicus briefs to make our case.

We cannot allow pseudoscience and speculation to override the substantial weight of scientific evidence from more than 100 studies and millions of patients that confirm the safety and efficacy of a drug or course of treatment.

The legal challenge to mifepristone threatens grave harm to our patients, public health and the shared decision-making at the core of the physician-patient relationship. But there are even broader implications of this case: the integrity of the long-established F.D.A.-approval process and whether we want science or ideologues informing decisions about our individual and collective health.

Jack Resneck Jr. (@JackResneckMD), a physician at the University of California, San Francisco, is president of the American Medical Association.

Source photograph by James Worrell/Time & Life Pictures, via Shutterstock.

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Opinion | This Could Be One of the Most Brazen Attacks on ... - The New York Times

Reinforcement learning: from board games to protein design – UW Medicine Newsroom

Scientists have successfully applied reinforcement learning to a challenge in molecular biology.

A team led by UW Medicine researchersdeveloped powerful new protein design software adapted from a strategy proven adept at board games like chess and Go. In one experiment, proteins made with the new approach were found to be effective at generating useful antibodies in mice.

Reinforcement learning is a type of machine learning in which a computer program learns to make decisions by trying different actions and receiving feedback. Such an algorithm can learn to play chess, for example, by testing millions of different moves that lead to victory or defeat on the board. Theprogram isdesigned to learn from these experiences and become better at making decisions over time.

To make a reinforcement learning program for protein design, the scientists gave the computer millions of simple starting molecules. The software then made ten thousand attempts at randomly improving each toward a predefined goal. The computer lengthened the proteins or bent them in specific ways until it learned how to contort them into desired shapes.

The findings, reported April 21 in Science, suggest that this breakthrough may soon lead to more potent vaccines. More broadly, the approach could lead to a new era in protein design.

"Our results show that reinforcement learning can do more than master board games. When trained to solve long-standing puzzles in protein science, the software excelled at creating useful molecules," said senior authorDavid Baker, professor of biochemistry at the UW School of Medicine in Seattle and a recipient of the 2021 Breakthrough Prize in Life Sciences.

"If this method is applied to the right research problems, he said, it could accelerate progress in a variety of scientific fields."

The research is a milestone in tapping artificial intelligence to conduct protein science research. The potential applications are vast, from developing more effective cancer treatments to creating new biodegradable textiles.

Isaac D. Lutz, Shunzhi Wang, and ChristofferNorn, all members ofthe Baker Lab, led the research. Their teams Science manuscript is titled "Top-down design of protein architectures with reinforcement learning."

"Our approach is unique because we use reinforcement learning to solve the problem of creating protein shapes that fit together like pieces of a puzzle," explained co-lead author Lutz, a doctoral student at theUW Medicine Institute for Protein Design."This simply was not possible using prior approaches and has the potential to transform the types of molecules we can build."

As part of this study, the scientists manufactured hundreds of AI-designed proteins in the lab. Using electron microscopes and other instruments, they confirmed that many of the protein shapes created by the computer were indeed realized in the lab.

This approach proved not only accurate but also highly customizable. For example, we asked the software to make spherical structures with no holes, small holes, or large holes. Its potential to make all kinds of architectures has yet to be fully explored, said co-lead author Shunzhi Wang, a postdoctoral scholar at the UW Medicine Institute for Protein Design.

The team concentrated on designing new nano-scale structures composed of many protein molecules. This required designing both the protein components themselves and the chemical interfaces that allow the nano-structures to self-assemble.

Electron microscopy confirmed that numerous AI-designed nano-structures were able to form in the lab. As a measure of how accurate the design software had become, the scientists observed many unique nano-structures in which every atom was found to be in the intended place. In other words, the deviation between the intended and realized nano-structure was on average less than the width of a single atom. This is called atomically accurate design.

The authors foresee a future in which this approach could enable them and others to create therapeutic proteins, vaccines, and other molecules that could not have been made using prior methods.

Researchers from the UW Medicine Institute for Stem Cell and Regenerative Medicine used primary cell models of blood vessel cells to show that the designed protein scaffolds outperformed previous versions of the technology. For example, because the receptors that help cells receive and interpret signals were clustered more densely on the more compact scaffolds, they were more effective at promoting blood vessel stability.

Hannele Ruohola-Baker, a UW School of Medicine professor of biochemistry and one of the studys authors, spoke to the implications of the investigation for regenerative medicine: The more accurate the technology becomes, the more it opens up potential applications, including vascular treatments for diabetes, brain injuries, strokes, and other cases where blood vessels are at risk. We can also imagine more precise delivery of factors that we use to differentiate stem cells into various cell types, giving us new ways to regulate the processes of cell development and aging.

This work was funded by the National Institutes of Health (P30 GM124169, S10OD018483, 1U19AG065156-01, T90 DE021984, 1P01AI167966); Open Philanthropy Project and The Audacious Project at the Institute for Protein Design; Novo Nordisk Foundation (NNF170C0030446); Microsoft; and Amgen. Research was in part conducted at the Advanced Light Source, a national user facility operated by Lawrence Berkeley National Laboratory on behalf of the Department of Energy

Written by Ian Haydon, UW Medicine Institute for Protein Design

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Adult stem cell therapy validated as alternative to total hip replacement – Guardian Nigeria

A new study has validated adult stem cell therapy as alternative to total hip replacement in patients with severe hip osteoarthritis.

The study published in the April edition of the Journal of International Case Reports (ICARE) is titled Adult Stem Cell Therapy as an Alternative to Total Hip Arthroplasty in Severe Hip Osteoarthritis.

Medical Director of Glory Wellness and Regenerative Centre, Lekki, Lagos, Dr. David Ikudayisi, led the study.

Hip osteoarthritis is one of the leading causes of chronic hip joint pain and disability worldwide. According to research, the global incidence of hip osteoarthritis from 1990 to 2019 increased from 0.74 million to 1.58 million.

The aim of the study was to evaluate the importance of adult stem cell therapy as an alternative to total hip arthroplasty in severe hip osteoarthritis.

Arthroplasty is a surgical procedure to restore the function of a joint. Resurfacing the bones can restore a joint. An artificial joint (called a prosthesis) may also be used. Various types of arthritis may affect the joints.

A case study of a patient that had adult stem cell therapy on account of severe right hip osteoarthritis was used. Right hip severity was assessed using the Harris Hip Score (HHS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale. Radiologic studies (X-ray and MRI) were done. The patient had a session of adult stem cell therapy (autologous mesenchymal cells) and was observed for six months, then had allogenic exosomes and plasma rich platelet therapy. At 10 months, the patient had another session of ADSC Therapy and PRP Therapy and was observed with a follow up for 24 months.

The WOMAC and HHS assessed on the (zero, six, 12 and 24 months) showed quality improvement from an initial score of 96/96 to a score of 0/96 and from 31 per cent to 97 per cent at 24 months respectively. Post procedure radiologic studies of the hip done at the same months showed marked progressive changes.

The researchers concluded: Adult stem cell therapy is a promising alternative method of treatment in people with severe hip osteoarthritis. Results showed a positive outcome according to all the grading systems used in this study and this patient was followed up for 24 months and, he is still being followed up, which is proving its advantage in long-term outcome.

Commenting on the study, Ikudayisi said: Osteoarthritis is a chronic joint disease that has evidence-based conservative treatment options like exercise, weight management, patient education and some medications for pain. Definitive therapy known for stage 4 is usually total hip replacement, which is a surgical procedure, which is where adult stem cell therapy has it advantage as it is minimally invasive, safe, and with no reported treatment related adverse effect.

Recent literature has revealed the anti-inflammatory and healing properties of stem cells. The use of autologous SVF and BMAC in conjunction with PRP could be a novel therapy. Future studies could help to establish appropriate clinical protocols including repeat dosing, quantity/volume of MSCs (BMAC and SVF) or concentration of PRP for specific indications. Also, future studies need to compare cases with and without intravenous transplantation of SVF to determine the extent of the role of systemic transplantation of autologous SVF in localised regeneration of the hip joints.

Proposed mechanisms of action in this patient could be a paracrine effect or engraftment of the injected cells. The injection of the MSCs (ADSCs and BMSCs) most probably stimulated a reduction of inflammation followed by the formation of new, healthy tissue.

Direct injection of MSCs (SVF and BMAC) plus PRP in severe hip osteoarthritis can be effectively and safely completed in an outpatient setting according to this case study. The patient tolerated the procedure with no reported adverse events. Radiographic imaging depicted the stages of healing after a single injection of the cellular mixture. Anticipated outcomes for healing processes and detailed protocols could be determined with larger clinical studies.

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LVMH’s head of research: ‘What matters for Dior is to invent and be a … – Glossy

Reverse aging research is all the rage, with medical companies and now beauty brands exploring how to tap into a newer and more advanced concept than anti-aging.

Most recently, Dior Beauty stepped into the spotlight with its late-March announcement at the 21st Aesthetic and Anti-Aging Medicine World Congress in Monaco that it had established an International Reverse Aging Scientific Advisory Board. Comprising the board are 600 researchers and 18 experts, including Dr. Nicola Neretti, a biologist at the Institute for Brain & Neural Systems at Brown University, and Dr. David Furman, the director of the 1000 Immunomes Project at Stanford University. Diors own research will add to the knowledge base on aging science around stem cells, inflammation and cell communication. The idea is to better understand the 12 signs of aging, including genomic instability, epigenetic changes, stem cell fatigue and chronic inflammation. It will then weave that knowledge into skin-care product innovations to reverse these signs, according to Bruno Bavouzet, evp of R&D at LMVH, who oversees all beauty brands including Dior, Givenchy, Fresh and Benefit Cosmetics.

Our No. 1 goal is understanding the different path [around aging], from a biological standpoint. With time, we will make discoveries on the real mechanisms that accelerate aging, he said. No. 2 is to identify the potential actions that we can have through cosmetic [products] and how can we can [reverse] the biological age.

Bavouzet spoke with Glossy further about the concept of reverse aging, including why Dior is exploring the topic, what can be gained with the new advisory board and what a collective intelligence approach means. This interview has been lightly edited and condensed for clarity.

What does reverse aging mean?When we talk about reverse aging, basically what we know is that chronological age is different from biological age. That means that if you are 40- or 50-years-old, that definitely is your chronological age, but your biological age and the age of your cells can be different. We know in medicine that you can reverse your biological age by adding good health practices. What we dont always understand is the mechanisms of these aging processes and how they are connected to each other. The first stage [of our research] is to better understand the underlying mechanisms, with all their biological complexity, and why we are aging differently.

Reverse aging starts with the 12 hallmarks of aging. Historically, anti-aging people used to work on one approach, perhaps it was stem cells or polymers, et cetera. But we believe the best approach [to reverse aging or anti-aging] is a holistic approach. But that can be complex. Because there has been progress in biological discoveries and big data, we are able to [process] complex information.

What is the boards purpose and what does it do?We believe [the field of] reverse aging is impacted by very different biological mechanisms. And we believe that we need to have all the people in different fields work together, exchange information and build bridges between topics. We are working on reverse aging internally, obviously, but we want to accelerate that [research], meaning that we need more insights, from a scientific standpoint, on discoveries, [as well as] more data, and more experience. The board is advising us on our research. It will regroup several times a year. But throughout the year, we might also have continuous exchanges on specific topics with around four people. Its about building what I would call a collective intelligence approach, meaning that we are grouping all these people who are experts on the human body, while we [Dior] work on the skin. Not all of them are skin experts, but they can help us translate some research on different [scientific] topics to the skin, as well.

Why is Dior Beauty the right LVMH brand for this research?Dior has always been science-focused. Dior was the first brand back in the 1980s to launch liposomes in the skin-care industry. Thats really something that was important at the time with big effects. Its true that when you think about Dior, you obviously think about fashion and makeup. But Dior has always been thinking about and integrating the idea of how to make women happier. At an early stage [in the brands history] it started to launch skin-care products that were acting on the transformation of the skin. What matters for Dior is to invent and be a pioneer in beauty, as it has in the fashion industry.

What has spurred this reverse aging focus?There is a continuity from what has historically been the focus of anti-aging. The topic is also led by medicine. There has been a lot of progress in medicine and many therapies, like stem cells which are considered the mother cell, and trying to apply the same science to cosmetics. Obviously, we cannot do exactly the same thing. But when we started to work about 10-15 years ago on the microbiome of the skin, we got inspiration from work that was focused on [gastrointestinal science]. It is a pretty similar approach we are conducting here with reverse aging.

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Live Event for April 21: Sleeping pill reduces levels of Alzheimers proteins – Newswise

What:Researcher at Washington University School of Medicine in St. Louis will discuss the studywhich involved a sleeping aid known as suvorexant that is already approved by the Food and Drug Administration (FDA) for insomnia, hints at the potential of sleep medications to slow or stop the progression of Alzheimers disease.

When:April 21st, 2PM EST

Where:Live Events Zoom Room (link will be given once you register)

Who: Dr. Brendan P. Lucey, MD -Associate Professor of Neurology, Section Head, Sleep Medicine

Researcher's info:

Brendan Lucey is associate professor of neurology and Sleep Medicine Section head. Born and raised in Burlington, Vermont, he received his undergraduate degree at the University of Vermont and his medical degree from the Johns Hopkins University School of Medicine. Following medical school, Lucey completed his neurology residency at Washington University and a clinical neurophysiology fellowship at Brigham and Womens Hospital. From 2008-2012, Lucey was on active duty in the U.S. Air Force and then joined the Department of Neurology at Washington University.

Luceys current research interests are in sleep, aging and Alzheimers disease. His lab focuses on studying the potential of sleep interventions to prevent or delay the onset of Alzheimers disease. Using lumbar catheters, he investigates how sleep affects different markers of Alzheimers disease changes in the brain such as amyloid-beta and tau. Lucey is also interested in whether or not sleep changes may be non-invasive markers for Alzheimers disease progression.

Media Register to Attend Here

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Live Event for April 21: Sleeping pill reduces levels of Alzheimers proteins - Newswise

Exosome Therapy For Skin Care & Hair Loss Is A Promising … – The Zoe Report

Our skin is designed to heal itself, but like the need to down a shot of espresso to get going into the morning, sometimes the organ needs an extra kick. Thats where exosome therapy comes into play, the latest trend in the aesthetics space. Falling under the regenerative therapy umbrella, a category of treatments that use stem cells or platelets (like in PRP) to replace or regenerate the skin in order to improve texture and tone, exosomes are poised to become the next It girl in skin care. And like PRP, this treatment can also be used to treat hair loss by stimulating the hair follicles.

Until recently, exosomes were dismissed as mere byproducts of cellular activity, but recent research has revealed their incredible potential to transform how we approach skin care and hair care a modern-day Cinderella story, if you will. Especially because the science behind the treatment has a long-lasting, holistic effect rather than arguably functioning like a Bandaid for skin concerns like Botox and many fillers do. Exosomes are usually derived from stem cells and contain signaling molecules and growth factors designed to stimulate regeneration and healing, explains Dr. Julie Russak, M.D., board-certified dermatologist and founder of Russak Dermatology Clinic in New York City.

But, as with any trendy new beauty treatment, its important to get the facts before touting it as a game-changing innovation. Ahead, TZR gets the lowdown on exosome therapy with the help of a few dermatologists, including its benefits and whether or not it lives up to its promises of healthy skin and hair.

To put it simply, exosomes are tiny vesicles (bubbles) that help cells communicate with each other. When they are injected into tissue, they can reprogram surrounding cells to start growing and regenerating. These vesicles contain amino acids, proteins, lipids, peptides, and growth factors, which are all beneficial to the skin and hair. This manifests aesthetically as improved skin texture, increased hydration, reduced fine lines and wrinkles, and improved overall skin tone and brightness. They can also promote hair growth by stimulating and strengthening hair follicles, and promotes thicker strands.

It's important to note that exosomes need a little help to work their magic. When applied topically, they are unable to penetrate the skin's surface and end up just hanging out on the outermost layer. To be effective, they must be infused deep into the epidermis, which is why they are typically used in conjunction with other treatments that create disruptions in the skin like resurfacing lasers or microneedling (a technique that creates tiny channels on the skin's surface). The therapy can also be combined with other regenerative therapies, like PRP or stem cell therapy, to further enhance their effectiveness.

Another reason why you wont see the vesicles on the inkey lists of skin care products at Sephora? Exosomes are highly fragile and need to be refrigerated at cold temperatures; they cannot survive for long outside of these conditions. So, for example, a cream touting exosome technology could possibly possess [similar] benefits, but the end product is non-living, and more testing needs to be done to determine the biological effect, explains Dr. Sanjay Batra, Ph.D., a regenerative medicine expert.

Exosomes are an excellent solution for tackling wrinkles as these tiny vesicles can effectively stimulate cell growth and repair. Due to their unique ability to transport to directed sources, they are far more efficacious than simply applying peptides or growth factors directly on the skin, explains board-certified dermatologist and founder of Ocean Skin & Vein Institute, Dr. Divya Shokeen, M.D. Anyone looking to bring a bit of vibrancy back to their face can benefit from the therapy, as it increases collagen and elastin production and the dermatologist says, has been shown to have a significant visible reduction in fine lines, aging, and sunspots. What's more, exosomes have anti-inflammatory properties that can help calm skin. Research also shows they can minimize the symptoms of psoriasis and atopic dermatitis.

Within just one week of treatment, you may notice an improvement in texture, tone, firmness, the appearance of pore size, and the look of fine lines. Continued use of exosome therapy can lead to long-term improvements, resulting in healthier, stronger, and more youthful-looking skin over time, adds Dr. Russak.

Exosomes not only trigger healing and tissue regeneration on your face, but also in the cells of hair follicles on the scalp, which results in a stronger potential for regrowth in those experiencing hair loss. Russak explains, By delivering these molecules to the skin on the scalp and directly to the hair follicles, we can provide intensive hair rejuvenation benefits and signal the hair follicles to grow healthy hair. When hair follicles quit, we deliver both exosomes into the scalp to awaken the follicle and stimulate hair growth.

While many people turn to PRP injections for hair growth, Dr. Russak notes, exosomes are the superior option compared to PRP due to their increased potency and reliability. Unlike PRP, which is derived from platelets in our blood, the vesicles are extracted from stem cells found in sources such as fat, umbilical cords, or bone marrow. "The growth factors in our PRP may be weaker depending on our age and health status," she explains. "Exosomes contain growth factors and signaling molecules for regeneration and healing, which are extracted from inside the fresh cell. Many are also from embryonic stem cells, which are brand-new cells that have the most regenerative potential possible." Research also shows that they can help cells grow and heal wounds better than PRP can without having to use a patient's own blood.

Exosome therapy is paving the way for a new era in beauty treatments that prioritize skin and hair regeneration over simply masking common concerns like visible signs of aging. With the ability to promote natural healing and rejuvenation, this therapy offers a promising solution for those looking to keep their skin and hair in tip top shape for the long term.

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Novel PSMA Targeted Therapy Induces Preliminary Responses … – Targeted Oncology

Jones T. Nauseef, MD, PhD

Since prostate-specific membrane antigen (PSMA) became a standard-of-care therapy for patients with metastatic castration-resistant prostate cancer (mCRPC) in 2022, multiple agents showing potential to offer higher potency have entered the pipeline.

225Ac-J591, an alpha-emitter antibody-drug conjugate is 1 PSMA targeted therapy making headway, according to Jones T. Nauseef, MD, PhD. A phase 1 dose-escalation study investigating the agent in patients with mCRPC recently completed and is advancing to phase 2.1

There are a couple different ways to target PSMA. One is with a small molecule ligand, and the other one would be with a monoclonal antibody. J591 is our monoclonal antibody that has terrific targeting on cells that are expressing PSMA, and it helps with internalization into the cell. This monoclonal antibody is going to go throughout the body and with it carry actinium 225, and that is a potent radionuclide. With the antibody going to the sites where you want it to go, it will bring with its payload, which is radionuclide, explained Nauseef, assistant professor of medicine, Division of Hematology and Medical Oncology, Weill Cornell Medicine, and assistant attending physician at NewYork-Presbyterian Hospital, in an interview with Targeted Oncology.

Results from the 24 patients with mCRPC included in the phase 1 study of 225Ac-J591 showed that the administration of a single fractionated cycle of 225Ac-J59l led to few high-grade adverse events. Moreover, preliminary efficacy was demonstrated with the drug in terms of prostate-specific antigen decline and changes in circulating-tumor (ct)DNA.

In the interview, Nauseef discussed how 225Ac-J591 achieves apoptosis, and findings from the phase 1 study, which he presented during the American Association (AACR) for Cancer Research Annual Meeting 2023.

TARGETED ONCOLOGY: Can you talk about the introduction of PSMA-targeted therapy in the prostate cancer space and the impact it has had?

Nauseef: The treatment of prostate cancers, specifically metastatic castrate-resistant prostate cancer, has changed so much in 25 years. [There has been] approval of drugs in many sectors, [including] AR pathway inhibitors, taxanes, targeted therapies, you name it. Most recently, with the approval of 177 Lu- PSAM-617, targeted radiotherapy is now reality in prostate cancer. This has come about because PSMA is just such a terrific target. Almost all of it is on prostate cells or prostate cancer cells. There are some in physiologic spaces, but otherwise, it makes for a nice target. The drugs that are now approved have had some real successes.

What can say about the agent 225Ac-J591 and the rationale for using it to treat patients with mCRPC?

There are a couple different ways to target PSMA. One is with a small molecule ligand, and the other one would be with a monoclonal antibody. J591 is our monoclonal antibody that has terrific targeting on cells that are expressing PSMA, and it helps with internalization into the cell. This monoclonal antibody is going to go throughout the body and with it carry actinium 225, and that is a potent radionuclide. With the antibody going to the sites where you want it to go, it will bring with its payload, which is radionuclide.

Image Credit: heitipaves [stock.adobe.com]

This is important. Patients with mCRPC can have cancer anywhere in their body, and you want to be able to target this. You can do that effectively with an antibody like J591 and bring with it a potent radionuclide. Thats one of the things that's so nice about the potency of this drug is that it has a short path length. Though you're delivering a high energy that even a single hit on a cell can result in double stranded DNA breaks and cell death, the path length is short, so your toxicity may be lower because the drug isn't going to get away from where you want it to be. This will be true anywhere that a patient has cancer. That is commonly in the bones and the lymph nodes, but also visceral sites of disease, such as the liver and lungs.

Can you explain about the study design and methods used in this study?

The data we presented was our phase 1 study of patients who did not have prior exposure to Lutetium-177-PSMA-617 in all patients with mCRPC. These patients were all the men had prior exposure to taxane-based chemotherapies, and half of them had received 2 or more prior androgen receptor signaling inhibitors, but everyone needed to have at least 1. This study design was modified 3 + 3 dose-escalation.

A key point to note about this study, in contrast to the VISION study [NCT03511664] that led to the approval of PSMA 617 is that PSMA PET imaging was done at baseline and was part of the screening criteria. But avidity or positivity on the scan was not required to be enrolled in the study. This is important because you could essentially take almost any patient with mCRPC and put them in this study and be able to generalize the results that we observed. In the dose-escalation, we had 3 cohorts, and after seeing what the toxicity was, we added a fourth cohort. That was how we established our recommended phase 2 dose.

What results did you present during AACR 2023?

Anytime we do a phase 1 study, everyone is interested in any evidence for preliminary efficacy. But the primary objective of these studies is to determine the dose-limiting toxicity, and the recommended phase 2 dose, and those things were established in our study.

Regarding the dose-limiting toxicity [DLT] period, we defined this period as the 8 weeks following the first dose of the drug, and the drug is given twice, once on day 1, once on day 15 in a dose intense fractionated regimen, during a single cycle. We looked specifically for DLTs related to neutropenia, thrombocytopenia, and then any-grade toxicity that would have delayed receipt of the second dose by greater than 2 weeks. In the dose-escalation, we observed at the highest dose, 2 DLTs. One patient had grade 4 thrombocytopenia, and that patient had prior exposure to PSMA 617 radioligand therapy. Then, a second DLT was in a patient with grade 2 thrombocytopenia that resulted in delay of the second dose by greater than 2 weeks. Following that, we did revise the protocol as mentioned and made an intermediate dose, a cohort 2.5 at 120 kg, delivered in 2 doses. In this group, 6 patients were treated and only 1 DLT was observed, which was grade 4 thrombocytopenia.

The grade 4 thrombocytopenia that I mentioned was transient and reversible. I saw this patient last month. His platelets are now back to normal, there were no high-grade non-hematologic toxicities, and fatigue and pain flare were common, but were all grade 1 or grade 2.

As far as efficacy goes, we observed very good efficacy regarding PSA change. Of the patients treated who were evaluable, we saw PSA declined in almost every patient with commonly PSA declines of 50% or 90%. Of those patients who had a PSA decline of 50%, 12 of the 16 were confirmed as PSA50, and 1 of those patients is still pending as confirmatory PSA.

We also saw good efficacy regarding circulating tumor cells. There were 14 patients that had CTCs at baseline, and at 12 weeks were available for change. Across the board we saw good responses.

Breaking that down into greater detail, most of the patients did have a CTC response. Almost 80% of patients had any CTC response of the patients who had variable CTCs at baseline. At 12 weeks, more than 50% had a 50% or greater decline in CTC count. There were also 5 patients who were unfavorable at baseline, and 2 of them converted to favorable. I think most excitingly, of the 11 patients who had detectable CTC as baseline, 6 of them became undetectable at 12 weeks, consistent with a good response.

What are the next steps with this research?

We've identified as the recommended phase 2 dose 120 KBq/kg given into fractions. We are proceeding with the phase 2 study with that dose.

There are important changes to highlight that will be occurring in the phase 2. One is the addition of a radioligand-specific patient-reported outcome. This is nice because we can observe whether the adverse event profile is different than it might be from chemotherapy or targeted agent or something on the AR signaling pathway. This patient-reported outcome was tailored specifically to radionuclide therapies. I think that's important to highlight and it makes us better able to take care of these patients as this becomes a more common modality. The second change is the introduction of dosimetry for alpha emitters. This will be done using multi-timepoint specification for Francium and Bismuth. Using dosimetry will allow us to measure and calculate the radioactivity dose received rather than just delivered, which I think is important as we move into using alpha emitters more commonly.

REFERENCE:

Nauseef JT, Sun M, Thomas C, et al. CT014 - Phase I dose-escalation study of fractionated dose 225Ac J591 for metastatic castration resistant prostate cancer. resented at: 2023 AACR Annual Meeting; April 14-19, 2023; Orlando, FL. Abstract CT-014.

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Novel PSMA Targeted Therapy Induces Preliminary Responses ... - Targeted Oncology

TIBI Director and CEO Ali Khademhosseini receives Technology … – EurekAlert

(LOS ANGELES) April 20, 2023 - Dr. Ali Khademhosseini has been awarded the 2023 Technology Innovation and Development Award from the Society of Biomaterials (SFB). The award honors those whose research, scientific innovations, and leadership are used to develop novel products or technologies to benefit patients.

Dr. Khademhosseini is the founding Director and CEO of the Terasaki Institute for Biomedical Innovation (TIBI), which incorporates a variety of interdisciplinary research platforms and uses patient-derived cells for micro- and nanoscale technologies to achieve 'personalized' approaches to medical problems.

Prior to coming to TIBI, he was the Founding Director of the Center for Minimally Invasive Therapeutics and the Levi Knight Professor of Bioengineering, Chemical Engineering, and Radiology at the University of California-Los Angeles (UCLA). Before UCLA, he was at Harvard University, a Professor at Harvard Medical School and faculty at the Harvard-MIT's Division of Health Sciences and Technology, Brigham and Women's Hospital, and associate faculty at the Wyss Institute for Biologically Inspired Engineering.

Over the course of his career, Dr. Khademhosseini has pioneered high-performance, personally tailored biomaterials and has been a leader in tissue engineering, vascular tissue biofabrication, cell-based therapies, and stem cell regulation.

His extensive work has produced several novel products and innovative technologies to benefit medical patients, which have come about through multi-national research collaborations, the generation of 700+ papers and 50+ patents, and the founding of three start-up companies.

Among these innovations, the engineering of shear-thinning materials termed Gel Embolic Materials (GEM) developed for the embolization of blood vessels is of particular significance. The GEM technology is an up-and-coming technology for replacing the current gold standard in embolization using metallic coils. Based on this technology, Dr. Khademhosseini co-founded Obsidio Medical (http://obsidiomed.com/) to pursue clinical applications of this invention. Due to its semi-solid nature, the GEM can be placed locally and customized for each person. Different than other embolic materials that can require time to form an obstruction to blood flow, the GEM technology quickly fills the targeted vasculature and instantly creates a barrier. The GEM technology was cleared by the U.S. Food and Drug Administration, and the Boston Scientific Corporation acquired Obsidio to enhance its interventional oncology and embolization portfolio.

Dr. Khademhosseini has a long history of achievements, starting with his early years as the recipient of the Presidential Early Career Award for Scientists and Engineers, the highest honor given by the US government for early-career investigators. Since then, he has received over 70 major national and international awards. This award is Khademhosseini's third from the Society, following his 2017 Clemson Award and the 2011 Young Investigator Award. It was formally presented to him during the Society for Biomaterials Annual Meeting and Exposition 2023.

The SFB is a multidisciplinary society of academic, healthcare, governmental, and business professionals dedicated to promoting advancements in all aspects of biomaterial science, education, and professional standards to enhance human health and quality of life.

About the Terasaki Institute for Biomedical Innovation

The Terasaki Institute for Biomedical Innovation is accelerating the pace of translational research by supporting the worlds leading scientists with an open, entrepreneurial environment for bioengineering new materials, biological models, and advanced technologies to address critical challenges to the health of the planet and its people. The Institutes worldwide collaborations with academic, clinical, and entrepreneurial partners provide a rich foundation for translating innovations to the real world.

Contact:Stewart HanPresidentTerasaki Institute for Biomedical Innovationshan@terasaki.org

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Growing Prevalence and Recurrence of Rheumatoid Arthritis to … – Digital Journal

PRESS RELEASE

Published April 20, 2023

The global rheumatoid arthritis stem cell therapy market account for a share of USD 23.42 Billion in 2022. The market is anticipated to surpass the valuation of USD 33.30 Billion by end of the forecast period i.e. 2032. The rheumatoid arthritis stem cell market is expected to grow with a CAGR of 4.5 %.

Rheumatoid arthritis is a chronic inflammatory disorder in which the bodys immune system attacks its own joints. It is a progressive and disabling disease, which can cause a lot of pain and deformity of the joints if not managed properly. The symptoms of rheumatoid arthritis include joint stiffness, swelling, fatigue, and joint pain. Stem cell therapy is one of the most promising treatments for rheumatoid arthritis as it has the potential to repair and regenerate damaged tissue.

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Market Trends

Eminent Players

Regional Insights

Geographically, the global rheumatoid arthritis stem cell therapy market can be segmented into viz. North America, Latin America, Europe, Asia-Pacific excluding Japan (APEJ), Japan, and the Middle East and Africa (MEA). North America is expected to be the dominant region in the global rheumatoid arthritis stem cell therapy market, owing to the presence of various key players.

The rheumatoid arthritis stem cell therapy market in Asia Pacific excluding Japan is expected to grow at a significant CAGR due to the expansion of product offerings by key players. Europe is expected to have the second large share in the global rheumatoid arthritis stem cell therapy market throughout the forecast period.

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In-Depth Assessment on Key Segments

Tentatively, the global rheumatoid arthritis stem cell therapy market can be segmented on the basis of treatment type, application, end-user, and geography.

Key Questions Covered in the Rheumatoid arthritis stem cell therapy Report

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Cancer survivor gives $10 million to speed translational research … – EurekAlert

image:Dr. Marie and Vijay Goradia view more

Credit: Courtesy of Vijay Goradia

HOUSTON Vijay Goradia, a Houston-based businessman, philanthropist, and cancer survivor, has donated $10 million to The University of Texas MD Anderson Cancer Center to speed translational research and clinical trials. An initial allocation of $3.5 million will fund the institutions clinical trial of a CD70-targeted chimeric antigen receptor (CAR) natural killer (NK) cell therapy for patients with renal cell carcinoma (RCC), developed by Katy Rezvani, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy.

We are focused on supporting the innovation and commercialization of groundbreaking research, said Goradia, who also serves as a member of the MD Anderson Cancer Center Board of Visitors Executive Committee. There is so much impactful work happening at MD Anderson. Our first step was to fund Dr. Rezvanis incredible work in CAR NK cells. She has had some success in treating blood cancers, but now she is working on finding treatments for solid tumors, including renal cancer. We felt this was something worth supporting and we are very excited. We are very hopeful.

Goradia, a kidney cancer survivor, and his wife, Marie, established the Vijay and Marie Goradia Cancer Fund at MD Anderson through this transformational gift. Their hope is to not only expedite innovation coming from MD Anderson but to invest in the continued success of such research. The remainder of the gift will support additional therapeutics across the research enterprise.

The generosity of the Goradia family will be felt by cancer patients and their families for decades to come, said Peter WT Pisters, M.D., president of MD Anderson. Future translational and therapeutic discoveries that will be supported by this fund, including the CD70 CAR NK trial, will not only expand our efforts in targeting the disease, but also may generate financial benefits to support promising research in the years ahead.

A true game changerRenal cell carcinoma is the most common form of kidney cancer. Each year, RCC accounts for approximately 79,000 new cancer cases and 14,000 deaths in the U.S, according to the National Institutes of Health (NIH). While initial treatment with surgery for localized tumors can be curative, about 30% of patients develop metastatic disease, which currently is considered incurable because most of these tumors resist available chemotherapies.

Rezvani has led extensive translational research at MD Anderson to develop and expand the power of NK cells. These tumor-destroying immune cells serve as a first defense against malignancy, but cancer cells can make themselves invisible. By genetically modifying the NK cells with CARs, which are special receptors designed to bind to specific proteins on the surface of cancer cells, the NK cells can better find and eliminate target cancer cells. Rezvanis laboratory then multiplies the number of CAR NK cells, growing them in large numbers before infusing them into patients.

This research has the potential to become a viable treatment in a fairly short period of time, said Rezvani. I am grateful to Vijay and the entire Goradia family for their support and generosity as well as their belief in the science. This is the right place, the right time, and the right opportunity for such a transformational investment that may have such a grand impact in so many patients lives.

The clinical trial will be a Phase I/II study that will test the safety, feasibility, persistence, and antitumor activity of off-the-shelf cord blood-derived CAR NK cells targeting CD70 and armored with IL-15 for patients with RCC. While this study is directed specifically at RCC, CD70 also is present in other malignancies, including mesothelioma, lung, and bladder cancers, suggesting there may be potential applications in other cancer types.

MD Anderson has long been a leader in cancer research, diagnosis and treatment and we are inspired by the institutions efforts to bring cutting-edge research and innovation to patients in need, said Sapphira Goradia, executive director of the Vijay and Marie Goradia Charitable Foundation. The Marie and Vijay Goradia Charitable Foundation is dedicated to expanding access to quality health care and we hope this investment will support the acceleration of more effective and affordable cancer treatments.

Inspiring innovationPhilanthropy has been ingrained in Goradias DNA. From his humble beginnings in Mumbai, India, Goradia has made a concerted effort to help others. And he is not stopping anytime soon.

We are all hoping for the same end result, Making Cancer History, he said. And that cannot happen without meaningful research being done by very smart, talented, committed people. Our hope is that MD Anderson remains at the forefront by attracting very capable and talented people to come and join its already very capable research faculty.

Goradia said this cannot be accomplished by one, 10 or even 100 philanthropists. It is going to take more.

We have the format. My hope is that other donors who are interested in funding groundbreaking research and innovation may want to replicate this whole idea, he said. We can do this over and over again. Together, lets end cancer.

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About MD AndersonThe University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. The institutions sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 53 comprehensive cancer centers designated by the National Cancer Institute (NCI). MDAnderson is No. 1 for cancer in U.S. News & World Reports Best Hospitals rankings and has been named one of the nations top two hospitals for cancer since the rankings began in 1990. MDAnderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

2023 The University of Texas MD Anderson Cancer Center

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