Clinical Trial News

Epsolay cream, approved by the FDA, offers a new treatment for rosacea with a 5% benzoyl peroxide formula. It showed a 70% reduction in lesions in trials, with nearly half of participants achieving clear or almost clear skin. Galderma plans to commercialize it in the US, while its availability in Australia remains uncertain.

Axicabtagene ciloleucel (axi-cel) shows durable response in real-world settings for relapsed or refractory large B-cell lymphoma, including ZUMA-1 ineligible patients. Elderly patients had favorable outcomes despite higher CRS and ICANS rates. Patient selection should consider comorbidities and risk-to-benefit ratio.

Study criteria for patients ≥18 with advanced mesothelioma or solid tumors, requiring informed consent, specific genetic alterations, and measurable lesions. Excludes recent anti-cancer therapies, insufficient organ function, and active COVID-19. Includes willingness for tumor biopsies.

Ultragenyx acquires global rights to ABO-102, a gene therapy for Sanfilippo Syndrome Type A, from Abeona Therapeutics. Interim data from the Transpher A trial shows potential in preserving neurocognitive development in treated children. Ultragenyx to lead the program, with Abeona eligible for royalties and milestone payments.

A case report highlights the use of dual immune checkpoint inhibitors (nivolumab and ipilimumab) in treating a large, locally advanced metastatic colon cancer with deficient mismatch repair, achieving a pathological complete response. This suggests potential benefits of immunotherapy before colorectal surgery, especially for dMMR/MSI-H tumors.

4SC AG announced the Data Safety Monitoring Board recommends continuing the RESMAIN study without changes. This study evaluates resminostat for advanced-stage cutaneous T-cell lymphoma maintenance treatment. Recruitment is closed, with unblinding and top-line data expected in Q1 2023. Resminostat aims to prolong progression-free survival and improve quality of life.

A comprehensive review of clinical trials for traumatic brain injury (TBI) highlights the ongoing search for effective treatments, focusing on drugs like amantadine, botulinum toxin A, and tranexamic acid. Despite numerous trials, the variability in study outcomes underscores the need for careful trial design and patient stratification.

Regeneron announced the FDA extended its review of REGEN-COV for COVID-19 treatment and prophylaxis, setting a new target action date of July 13, 2022. REGEN-COV, not currently authorized in the U.S., is part of Regeneron's efforts to combat COVID-19 with next-generation antibodies, including a first-in-human trial.

Scott T. Tagawa discusses a phase 1/2 trial (NCT04886986) investigating 225Ac-J591 and 177Lu-PSMA-I&T in metastatic castration-resistant prostate cancer. Initial findings show 225Ac-J591 is tolerable, with no dose-limiting toxicities in early cohorts, though one patient experienced grade 3 thrombocytopenia.

A recent open-label, single-centre, randomised controlled trial conducted in Australia has shown that drug treatment can be effective for Crohn's disease strictures, traditionally treated with surgery or endoscopic balloon dilation. The study compared intensive high-dose adalimumab plus thiopurine treatment with standard adalimumab monotherapy, finding that most patients experienced improved symptoms and stricture morphology with the intensive treatment.