CytoDyn Appoints Dr. Melissa Palmer, M.D., as Lead Consultant in Hepatology; Announces Follow-Up Inflammation Studies with SMC Laboratories
CytoDyn (OTCQB: CYDY) has appointed Dr. Melissa Palmer as Lead Consultant in Hepatology to drive the company's research and development strategy for liver conditions. Following promising initial results, CytoDyn has commissioned two follow-up studies with SMC Laboratories to confirm fibrosis reversal observations, with results expected in early 2025. The studies will compare leronlimab alone and in combination with other therapies, including resmetirom and a GLP-1 agonist. Dr. Palmer, an internationally renowned hepatologist with over three decades of experience and previous interim CMO role at CytoDyn, will oversee these studies focusing on MASH and liver fibrosis treatments.
CytoDyn (OTCQB: CYDY) ha nominato la Dr.ssa Melissa Palmer come Consulente Principale in Epatologia per guidare la strategia di ricerca e sviluppo dell'azienda per le condizioni epatiche. Dopo risultati iniziali promettenti, CytoDyn ha commissionato due studi di follow-up con i Laboratori SMC per confermare le osservazioni sulla reversibilità della fibrosi, con risultati attesi all'inizio del 2025. Gli studi confronteranno leronlimab sia da solo che in combinazione con altre terapie, inclusi resmetirom e un agonista GLP-1. La Dr.ssa Palmer, un'epatologa di fama internazionale con oltre tre decenni di esperienza e precedente ruolo di CMO ad interim presso CytoDyn, supervisionerà questi studi focalizzandosi su MASH e trattamenti per la fibrosi epatica.
CytoDyn (OTCQB: CYDY) ha designado a la Dra. Melissa Palmer como Consultora Principal en Hepatología para impulsar la estrategia de investigación y desarrollo de la empresa en condiciones hepáticas. Tras resultados iniciales prometedores, CytoDyn ha encargado dos estudios de seguimiento con los Laboratorios SMC para confirmar las observaciones sobre la reversibilidad de la fibrosis, con resultados esperados a principios de 2025. Los estudios compararán leronlimab solo y en combinación con otras terapias, incluidos resmetirom y un agonista GLP-1. La Dra. Palmer, una hepatóloga de renombre internacional con más de tres décadas de experiencia y un anterior papel como CMO interina en CytoDyn, supervisará estos estudios centrándose en MASH y tratamientos para la fibrosis hepática.
CytoDyn (OTCQB: CYDY)은 간 질환에 대한 연구 및 개발 전략을 주도할 간 질환 강사로 Melissa Palmer 박사를 임명했습니다. 유망한 초기 결과를 바탕으로, CytoDyn은 섬유증 역전 관찰을 확인하기 위해 SMC 연구소와 두 개의 후속 연구를 의뢰했으며, 결과는 2025년 초에 나올 것으로 예상됩니다. 연구는 leronlimab 단독 요법과 함께 resmetirom 및 GLP-1 작용제 포함한 다른 요법과의 조합을 비교할 것입니다. Palmer 박사는 30년 이상의 경험을 지닌 국제적으로 유명한 간 전문가로, CytoDyn에서의 이전 CMO 역할을 맡았으며, MASH 및 간 섬유증 치료에 중점을 두고 이 연구를 감독할 것입니다.
CytoDyn (OTCQB: CYDY) a nommé la Dr Melissa Palmer en tant que Consultante Principale en Hépatologie pour diriger la stratégie de recherche et développement de l'entreprise sur les maladies du foie. Suite à des résultats initiaux prometteurs, CytoDyn a commandé deux études de suivi avec les laboratoires SMC pour confirmer les observations concernant l'inversion de la fibrose, avec des résultats attendus début 2025. Les études compareront leronlimab seul et en combinaison avec d'autres thérapies, notamment le resmetirom et un agoniste GLP-1. La Dr Palmer, une hépatologue de renommée internationale ayant plus de trente ans d'expérience et un précédent rôle de CMO par intérim chez CytoDyn, supervisera ces études axées sur le MASH et les traitements de la fibrose hépatique.
CytoDyn (OTCQB: CYDY) hat Dr. Melissa Palmer zur leitenden Beraterin für Hepatologie ernannt, um die Forschungs- und Entwicklungsstrategie des Unternehmens für Lebererkrankungen voranzutreiben. Nach vielversprechenden ersten Ergebnissen hat CytoDyn zwei Nachfolgestudien mit den SMC-Laboren in Auftrag gegeben, um die Beobachtungen zur Rückbildung von Fibrose zu bestätigen, wobei die Ergebnisse Anfang 2025 erwartet werden. Die Studien werden leronlimab allein sowie in Kombination mit anderen Therapien, einschließlich Resmetirom und einem GLP-1 Agonisten, vergleichen. Dr. Palmer, eine international renommierte Hepatologin mit über drei Jahrzehnten Erfahrung und einer vorherigen interimistischen CMO-Rolle bei CytoDyn, wird diese Studien überwachen, die sich auf MASH und Behandlungen von Leberfibrose konzentrieren.
- Appointment of experienced hepatologist Dr. Palmer strengthens the company's liver disease research capabilities
- Promising initial results in fibrosis reversal from preclinical studies
- Two follow-up studies commissioned to validate initial findings
- Strategic evaluation of leronlimab in combination with approved MASH treatment (resmetirom)
- Results from follow-up studies not expected until early 2025
- Still in preclinical stage for liver disease indications
VANCOUVER, Wash., Oct. 30, 2024 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that Dr. Melissa Palmer, M.D., has been engaged as Lead Consultant in Hepatology. In this role, Dr. Palmer will drive the Company’s strategy for research and development in Hepatology, leveraging her expertise to further CytoDyn’s clinical evaluation of leronlimab in treating liver conditions, including MASH and liver fibrosis. This engagement follows the recent breakthroughs with SMC Laboratories (“SMC”).
In addition, the Company announced that following promising initial results from its preclinical study with SMC, it has commissioned the lab to conduct two follow-up studies to confirm and extend the observation of fibrosis reversal observed in the study concluded in September 2024. Both follow-up studies are underway, with results expected in early 2025.
An internationally renowned hepatologist, Dr. Palmer brings more than three decades of deep research experience to the CytoDyn team. She has held leadership positions at several biotech and pharmaceutical companies, including serving as Chief Medical Officer of Gannex/Ascletis and Head of Liver Disease at Takeda Pharmaceutical Company. She has also worked as a hepatology consultant with over 60 biotech and pharmaceutical companies since 1991 and previously served as interim Chief Medical Officer of CytoDyn.
In addition to consulting, Dr. Palmer has been the primary investigator for numerous clinical trials in MASH and other liver diseases. Her work has been published in over 100 publications, abstracts, manuscripts, books and book chapters, including several guidelines she co-authored with colleagues from the FDA and EMA concerning drug-induced liver injury among patients in clinical trials evaluating potential drugs to treat MASH and other liver diseases. She also maintained a solo medical practice treating patients with liver disease for over 20 years.
Dr. Palmer will work with the CytoDyn team to oversee the two follow-up studies with SMC. These studies will again compare leronlimab alone and in combination with other therapies, including both resmetirom, the only approved treatment for MASH, and a GLP-1 agonist in an increased number of mice evaluated in both a proprietary STAM model of MASH which includes T2DM (previously studied), as well as a second model of liver fibrosis driven by CCL4 toxicity that is independent of fat deposition.
“As we continue to capitalize on our momentum and push forward the path of scientific discovery here at CytoDyn, we are pleased to welcome Dr. Palmer to the team,” said Dr. Jacob Lalezari, CEO. “Dr. Palmer’s robust research and consulting background, and past familiarity with CytoDyn, will provide the tailored expertise we need to maximize opportunities to pursue breakthroughs in new treatment paths for MASH and liver fibrosis.”
Dr. Palmer added, “This is an exciting time in liver health research, as scientific innovation paves the way for improved treatments for conditions like MASH and liver fibrosis. I look forward to collaborating with the CytoDyn team to advance clinical evaluations of leronlimab, including the studies in motion, and explore new treatments that have the potential to truly transform patient outcomes.”
Dr. Palmer trained in Hepatology at Mount Sinai School of Medicine, where she also received her M.D. degree. She also holds a B.S. from Columbia University and is a Fellow of the American Association for the Study of Liver Diseases.
About CytoDyn
CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. Leronlimab is being studied for oncology and inflammation, as well as other potential indications, including but not limited to HIV and MASH.
About SMC Laboratories
SMC Laboratories, Inc. is a CRO, with a focus on conducting the non-clinical research necessary for the drug development process. As a global consulting company that designs studies according to customer requests, it supports cutting-edge non-clinical pharmacological studies. The company owns a variety of mouse models for inflammation and fibrosis in various organs, centered on the innovative STAM™ mouse' animal model of liver cancer derived from MASLD (metabolic dysfunction-associated steatotic liver disease). This patented mouse model was developed by SMC Laboratories as a worldwide-first model based on MASLD. We offer non-clinical pharmacological studies using the model mouse. Please check the company's website for further details.
Note Regarding Forward-Looking Statements
This news release contains forward-looking statements relating to, among other things, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2024, including the section captioned “Forward-Looking Statements” and in Item 1A. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments.
Media Contacts
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FAQ
What are the new studies CytoDyn (CYDY) is conducting with SMC Laboratories?
Who is Dr. Melissa Palmer and what is her role at CytoDyn (CYDY)?
When will CytoDyn (CYDY) receive results from their new liver fibrosis studies?
