Clinical Trial News

The article explores the resurgence of interest in psychedelics as a treatment for mental health disorders, highlighting a clinical trial at UC San Francisco involving long-term AIDS survivors. It discusses the historical context of psychedelic research, the therapeutic potential of substances like psilocybin and MDMA, and the challenges and future directions of psychedelic medicine.

A systematic review and meta-analysis of 10 studies involving over 50,000 patients demonstrates that artificial intelligence (AI) significantly improves the efficiency and accuracy of cancer clinical trial enrollment. AI algorithms, utilizing both structured and unstructured data, have shown to be highly accurate, with a summary sensitivity of 90.5% and specificity of 99.3%, offering substantial time savings and potential for increased inclusivity in clinical trials.

The combination of SEA-CD40, gemcitabine, nab-paclitaxel, and pembrolizumab showed a 44% ORR in metastatic PDAC patients, with tolerable AEs and evidence of immune activation, suggesting potential for immunotherapy in pancreas cancer treatment.

Ropeginterferon alfa-2b, approved for polycythemia vera (PV) treatment, shows safety and efficacy in clinical trials. Emerging studies suggest higher initial doses and rapid titration may enhance tolerability and efficacy. Ongoing research explores its application in myeloproliferative neoplasms, aiming to optimize dosing for improved patient outcomes.

LOY-001, a drug aimed at extending the lifespan of large dogs, has cleared key FDA hurdles, potentially available by 2026. It targets the IGF-1 hormone, higher in large breeds, to match levels in smaller breeds. Pending further FDA approval, it could significantly impact service dogs' longevity and quality of life.

Ensysce Biosciences, Inc. reflects on its 2022 milestones, including advancements in its opioid abuse deterrent and overdose protection programs, and outlines future goals in a letter to shareholders from CEO Dr. Lynn Kirkpatrick.

In April 2022, FDA approved axi-cel for adults with refractory or early relapsed LBCL, based on ZUMA-7 trial showing longer event-free survival vs standard therapy. Axi-cel had higher rates of cytokine release syndrome and neurologic toxicity but marks a paradigm shift in LBCL treatment.

The FDA has granted fast track designation to CFI-402257, a novel therapy for treating adult patients with ER-positive/HER2-negative advanced breast cancer, especially after disease progression on prior CDK4/6 inhibitors and endocrine therapy. This designation is based on early signs of durable activity and a manageable safety profile of CFI-402257, both as a monotherapy and in combination with fulvestrant.

STK-001, Stoke Therapeutics' treatment for Dravet syndrome, shows promise in reducing seizures in children and adolescents, with Phase 1/2a trials indicating safety and efficacy. Interim results suggest a shift towards syndrome management, with further data expected to inform Phase 3 trials. STK-001 aims to restore NaV1.1 levels, potentially improving quality of life.

A phase II clinical trial, FIRE-4.5, compared the efficacy of FOLFOXIRI combined with cetuximab versus bevacizumab as first-line treatment for BRAFV600E-mutant metastatic colorectal cancer, finding bevacizumab-based chemotherapy preferable.