Clinical Trial News

I-Mab announced financial results and pipeline progress, including IND clearance for uliledlimab, a collaboration with Bristol Myers Squibb for givastomig, and promising early data for ragistomig. With $207.5 million in cash, the company is well-positioned for pipeline advancement, expecting cash runway into 2027.

CereVasc, Inc. received FDA Breakthrough Device Designation for its eShunt System, aimed at treating Normal Pressure Hydrocephalus (NPH). This designation facilitates priority review and enhanced FDA communication. The eShunt System offers a minimally invasive treatment option for NPH, addressing a significant unmet need with over 700,000 affected individuals in the US.

European Commission grants Marketing Authorization for PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for first-line treatment of adult patients with unresectable or metastatic urothelial cancer eligible for platinum-containing chemotherapy. Approval based on Phase 3 EV-302 trial results showing nearly doubled median overall survival and significantly extended progression-free survival compared to platinum-containing chemotherapy.

Heparin, a sulphated polysaccharide, shows potential antiviral action against SARS-CoV-2, binding to the virus's spike protein to inhibit infection. A study evaluated inhaled enriched heparin's safety and efficacy in COVID-19 patients, revealing a significant decrease in viral load without cytotoxicity, suggesting dual antiviral and antithrombotic effects.

Pamidronate for pain in adult chronic nonbacterial osteitis (PAM-CNO): protocol of a randomized, double-blind, placebo-controlled trial.

ProJenX, Inc. forms Clinical Advisory Board (ClAB) with experts in ALS and neurodegenerative diseases to guide clinical development of prosetin, a novel brain-penetrant MAP4K inhibitor. Prosetin is being evaluated in Study PRO-101, a Phase 1 trial assessing safety and tolerability in healthy volunteers and ALS participants, with positive early results.

VTP-1000, an investigational immunotherapy, aims to help the immune system tolerate gluten in the AVALON celiac disease clinical trial. The phase 1 trial assesses VTP-1000's safety and tolerability in adults with celiac disease on a gluten-free diet. Potential participants must be 18-65 years old, diagnosed with celiac disease within the past 10 years, and live in the US. The study, conducted across several US locations, offers compensation for time and travel. Learn more at avalon.celiac.org.

Professor Fatima Merchant leads a team developing patient-specific molds for breast cancer patients, funded by a $2.7 million NIH grant. The project aims to improve reconstruction efficiency and psychosocial adjustment, featuring a randomized controlled clinical trial to evaluate impact.

A double-blind, randomized, controlled trial found limited impact of cannabidiol on health-related quality of life for people with long-term controlled HIV.

AiViva Biopharma completed enrollment and dosing in a phase 1 trial of AIV007, a tyrosine kinase inhibitor for wet AMD and DME, administered via periocular injection. The trial, involving 18 participants, aims to evaluate safety over 6 months, with full results expected in Q1 2025.