BioRestorative Therapies Partners with Galen Patient Recruitment to Accelerate Completion of Enrollment in Phase 2 Trial of BRTX-100 in Chronic Lumbar Disc Disease

— Collaboration follows recent manufacturing/clinical process enhancements that have tripled monthly trial capacity —

— Patient enrollment expected to be completed in 2024 —

MELVILLE, N.Y., April 08, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced a collaboration with Galen Patient Recruitment, Inc. (“Galen”) which, combined with the recent expansion of clinical trial capacity from approximately 10 to 30 participants per month, is expected to help accelerate the completion of patient enrollment in the ongoing Phase 2 study of BioRestorative’s lead clinical candidate, BRTX-100, in chronic lumbar disc disease (“cLDD”).

BRTX-100 is a novel cell-based therapeutic engineered to target areas of the body that have little blood flow. The safety and efficacy of BRTX-100 in treating cLDD is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study. A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States. Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or placebo.

“The industry statistics can be sobering; around 80% of clinical trials fail to meet their initial enrollment targets and timelines, with patient recruitment being the single biggest cause of trial delays,”¹ said Lance Alstodt, Chief Executive Officer of BioRestorative. “With that in mind, we are confident that our partnership with an industry leader like Galen will help us achieve our 2024 enrollment goals by closing any gaps that may exist in our current recruitment process.”

Reference

¹ Brøgger-Mikkelsen M, Ali Z, Zibert JR, Andersen AD, Thomsen SF. Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis. J Med Internet Res. 2020 Nov 4;22(11):e22179. doi: 10.2196/22179. PMID: 33146627; PMCID: PMC7673977.

About Galen Patient Recruitment

Since 2006, Galen (www.galenrecruitment.com) has helped its clients bring new medical innovations to market through cost-effective patient recruitment solutions. Galen doesn’t believe in one-size fits all. It approaches each study with a fresh perspective, and considers all of the variables in the study enrollment equation – the research sites, study coordinators and, most importantly, the patients. This leads to comprehensive yet flexible recruitment programs that take the guesswork out of achieving enrollment goals.