tacrolimus (LYT-510) / PureTech - LARVOL DELTA

GvHD prophylaxis: novel strategies and future directions (YouTube) - "During the GvHD Hub Steering Committee Meeting in October 2023, key opinion leaders met to discuss GvHD prophylaxis, including novel strategies and future directions. The recorded discussion was chaired by Professor...Yi-Bin Chen, Amin Alousi....The steering committee discussed how there is a need for the results from comparative trials in order to inform prophylaxis choices in clinical practice. The experts considered regimens involving combinations of post-transplant cyclophosphamide, tacrolimus, ruxolitinib, and mycophenolate mofetil, and how combinations could be optimized in immunosuppressed patients."

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Inside the Clinic: A Team-Based Approach to Management of GVHD : Episode 11 Chronic GVHD Incidence and Risk Factors (OncLive)

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Three-Drug Regimen Improves Protection against GVHD after Stem Cell Transplant (National Cancer Institute) - "Excitement about the cyclophosphamide-based regimen in people receiving well-matched transplants began when the results from the smaller trial were reported in 2019, said the trial’s lead investigator, Shernan Holtan, M.D....'I am hearing from colleagues around the globe that practice patterns are changing' based on the trial's findings, Dr. Holtan continued. 'This cyclophosphamide-based regimen could indeed become the new standard of care for [allogeneic stem cell transplants], especially considering the reduction in both severe acute and chronic GVHD.'"

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Study Sets New Standard for Graft-Versus-Host Disease Prevention After Stem Cell Transplant (Newswise) - "Clinicians have a new standard for graft-versus-host disease (GVHD) prevention after allogeneic hematopoietic stem cell transplantation, according to results from a phase III study published June 22 in the New England Journal of Medicine. The new standard is more effective at preventing GVHD and came with less side effects, compared with the current gold standard....Other researchers who contributed to the study are...Mehdi Hamadani, MD....Miguel-Angel Perales, MD...Ran Reshef, MD...Shernan G. Holtan...Amin Alousi, M.D...Mahasweta Gooptu, MD...Aric Hall, M.D..."

Faculty Interview & Free CME/NCPD Activity: Graft-Versus-Host Disease (YouTube) - "First, listen along as Dr. Shernan Holtan shares the latest data from the BTM CTN 1703 trial of posttransplant cyclophosphamide, tacrolimus, and mycophenolate mofetil as GVHD prophylaxis after allogeneic hematopoietic cell transplantation, then stay tuned after the interview to listen along to the full activity....In this podcast activity, Shernan Holtan, MD...will explore new biomarkers used for diagnosis and therapy selection, discuss the latest clinical trial findings, and advise practitioners on how to individualize treatment to patients' needs."

Audio • Biomarker • Interview

Tacrolimus and Reduced-Dose Methotrexate Combined With Mycophenolate Mofetil to Prevent Graft-Versus-Host Disease Open-label, phase 3, prospective randomized trial (Oncology Learning Network) - "'The use of a calcineurin inhibitor, most commonly tacrolimus, in combination with methotrexate, has been a standard practice over the past 3 decades for GVHD prevention,' explains Betty K Hamilton, MD...'This approach, however, is associated with several toxicities; although several alternative approaches to GVHD prevention have been investigated, they have all failed to significantly improve transplant outcomes.'"

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Research Reveals Novel Insights into Transplant Rejection and New Drug Development Targets (PRNewswire) - "The study results reflect eight years of teamwork led by experts at Cincinnati Children's and the University of Cincinnati College of Medicine with contributions from researchers at the University of Notre Dame and Novartis....In addition to...contributors included Rita Alloway, PharmD..."

Faculty Interview & Free CME/NCPD Activity: Graft-Versus-Host Disease (YouTube) - "First, listen along as Dr. Shernan Holtan shares the latest data from the BTM CTN 1703 trial of posttransplant cyclophosphamide, tacrolimus, and mycophenolate mofetil as GVHD prophylaxis after allogeneic hematopoietic cell transplantation, then stay tuned after the interview to listen along to the full activity....In this podcast activity, Shernan Holtan...will explore new biomarkers used for diagnosis and therapy selection, discuss the latest clinical trial findings, and advise practitioners on how to individualize treatment to patients' needs."

Audio • Biomarker • Interview

PTCy/Tac/MMF as the new standard for graft-versus-host disease (GVHD) prophylaxis in reduced int… (YouTube) - "Dr Holtan reports that PTCy/Tac/MMF was shown to be superior to Tac/MTX in graft-versus-host disease-free, relapse-free survival."

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Comparison of Anti-Mold Prophylaxis and Pharmacist Impact on Tacrolimus Drug Monitoring in Heart Recipients (ISHLT 2023) - "Vori and isa provided similar efficacy in preventing infections. Vori may be more challenging to manage due to more potent DDI, requiring more dose adjustments, while isa requires more resources to obtain insurance approval. Pharmacist management of DDIs, with proactive dose changes could explain the lack of difference in percentage of low levels post ppx discontinuation."

Emerging Liver Literature Club (AASLD) - "Article #3 - 'Three-Year Results of Renal Function in Liver Transplant Recipients on Low-dose Sirolimus and Tacrolimus: A Multicenter, Randomized, Controlled Trial'..."

Live event

Post-transplant cyclophosphamide, tacrolimus, and MMF for GvHD in the myeloablative setting (YouTube) - "Shernan Holtan, MD...briefly discusses the results of a Phase II study evaluating post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil (MMF) for graft-versus-host disease (GvHD) in the myeloablative transplant setting. This interview took place at the 64th ASH Annual Meeting and Exposition congress in New Orleans, LA."

Interview • Video

Quick Takes on Important Cancer Research From ASH 2022 (THE ASCO POST) - '"Based on these results, we believe that posttransplant cyclophosphamide, tacrolimus, and mycophenolate mofetil should be the standard graft-vs-host-disease prophylaxis in well-matched adult, reduced-intensity transplantation,' said lead study author Shernan G. Holtan, MD...According to Dr. Holtan, further research is needed to confirm these findings and determine the long-term effects of this treatment regimen. The researchers are planning patient-reported outcome analyses and microbiota studies from their companion protocol, BMT CTN 1801."

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Psoriasis vs. Eczema: Differences, Images, Treatment - "Eczema and psoriasis, while two distinct conditions, have something key in common. Both these diseases, says Dr. Amy Paller...Dr. Paller explained that eczema is usually 'characterized by poorly demarcated red, dry areas with fine scale,' while psoriasis appears as 'red, well-circumscribed lesions (called plaques) with heaped-up, white scaling.'"

Media quote • Psoriasis

ASH 2022 LBA: post-transplant cyclophosphamide, tacrolimus & MMF for GvHD prophylaxis in RIC (YouTube) - "Shernan Holtan, MD...discusses the late-breaking abstract she presented at the 2022 ASH Annual Meeting on post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil (MMF) as the new standard for graft-versus-host disease (GvHD) prophylaxis in reduced intensity conditioning (RIC).This interview took place at the 64th ASH Annual Meeting and Exposition congress in New Orleans, LA."

Interview • Video

Graft Versus Host Disease Treatment Advances - Episode 12: Recap: Identifying Chronic Graft-Vs-Host Disease and Discussing Treatment Options (Cancer Network) - "SAFAH: The easiest way to speak of it is [in terms of] where the stem cells are coming from, the peripheral blood vs the bone marrow. There is also cord [blood], and although adult stem cell transplants [SCT] use it in very few instances, it is more common when it comes to using SCT in the pediatric state."

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Bishop Reviews Risk Assessment and Treatment for GVHD (Targeted Oncology) - "Michael R. Bishop, MD, discussed a patient with graft-versus-host disease who first underwent a myeloablative conditioning regimen and peripheral blood stem-cell matched hematopoietic cell transplant as treatment....GVHD develops in 3 phases as was described by the work of James L. Ferrara, MD, who has been a leader in our understanding of the biology of acute GVHD....A paper published by John E. Levine, MD, and his colleagues from the University of Michigan looked at a combination of different molecular markers and cytokines, and were able to demonstrate that, based upon this, they could stratify patients into high-risk and low-risk GVHD."

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PureTech Announces Annual Results for Year Ended December 31, 2021 (Businesswire) - "In the 2022 post-period, we nominated a new therapeutic candidate, LYT-510...We intend to file for regulatory approval to initiate first-in-human studies at year end 2022 and initiate a clinical study evaluating LYT-510 as a single agent for the potential treatment of IBD and chronic pouchitis in early 2023. LYT-500 is an orally administered combination of therapeutic agents in development for IBD. We expect preclinical proof-of-concept data for LYT-500 in the first half of 2022."

New trial • Preclinical • Immunology • Inflammatory Bowel Disease

Alivio Therapeutics Awarded $3.3 Million from U.S. Department of Defense (Businesswire) - "Alivio Therapeutics...Today announced a $3.3 million U.S. Department of Defense (DoD) Technology/Therapeutic Development Award to advance its product candidate, ALV-304, for the treatment of inflammatory bowel disease (IBD). The funds will support Alivio’s preclinical research and development activities to potentially enable the filing of an investigational new drug (IND) application for ALV-304."

Preclinical • Reimbursement • Inflammatory Bowel Disease