Clinical Trial News

Silo Pharma completes pre-IND meeting with FDA for SPC-15, an intranasal treatment for PTSD and stress-induced anxiety, aligning on the 505(b)(2) regulatory pathway. The company plans to advance SPC-15 into human trials, aiming for FDA approval and commercialization.

KalVista Pharmaceuticals to participate in a fireside chat at the 2024 Cantor Global Healthcare Conference on September 19th. The company announced positive phase 3 data for its oral therapy, sebetralstat, in February 2024, with an FDA PDUFA goal date of June 17, 2025. KalVista received EMA MAA validation in August 2024 and plans to file for approval in the UK, Japan, and other countries later in 2024.

Dupixent showed a 31% reduction in COPD exacerbations and improved lung function in a pooled analysis of BOREAS and NOTUS phase 3 studies, reinforcing its clinical benefit for uncontrolled COPD patients with type 2 inflammation.

Serac Healthcare and University of Exeter start Phase II study on 99mTc-maraciclatide, a SPECT imaging agent for ILD prognostication. PREDICT-ILD aims to assess CT effectiveness in ILD progression detection, with a sub-study evaluating 99mTc-maraciclatide. Recruitment ongoing at three NHS sites, led by Professors Scotton and Dixon, funded by Wellcome Trust. Sub-study to compare 99mTc-maraciclatide uptake between IPF, non-IPF fibrosing-ILD, and healthy controls, aiming to predict disease progression.

AstraZeneca shares dropped 5% after disappointing lung cancer drug trial results, with its experimental drug datopotamab deruxtecan not significantly improving overall survival for patients.

TC BioPharm plans pre-clinical studies for Monkey Pox treatment with TCB 008, an unmodified cell therapy using gamma delta T cells. The company also progresses ACHIEVE Phase 2b trial for AML/MDS-AML with TCB008, and secures a European patent for modified delta cells in cancer and viral treatments.

Updated Phase II INTELLECT study results presented at WCLC 2024 show iruplinalkib (Qixinke®) efficacy in ALK-positive crizotinib-resistant NSCLC, with median OS of 41.79 months and DCR of 94.5%. No new safety signals identified.

MAIA Biotechnology reports favorable interim survival benefit for THIO in advanced NSCLC, with 16 patients surpassing 12-month follow-up, including 9 in third-line treatment achieving a median survival of 10.6 months, surpassing standard-of-care overall survival of 5.8 months. THIO followed by Libtayo® has been well-tolerated.

The Global Exosome Market: Size, Forecast, Trials, and Trends, 2024 report details the growing exosome market, highlighting advancements in diagnostics, therapeutics, and cosmetics. Exosomes, extracellular vesicles, are valuable for disease detection, diagnosis, and treatment. The market is expanding with 388 clinical trials underway, and first exosome therapeutics expected by 2029. Key players and technologies are profiled, along with market forecasts through 2030.

Cognitive behavioral therapy significantly improved sexual desire and satisfaction in middle-aged and older women experiencing menopause-related sexual concerns, according to a study by McMaster University's Sheryl Green.