EXCLUSIVE: BioRestorative Completes Dosing In Safety Cohort Of Chronic Lower Back Pain Trial

BioRestorative Therapies Inc BRTX announced that the final subject in its BRTX-100 Phase 2 trial safety cohort has been dosed. Four participants were dosed at a 3:1 ratio with BRTX-100 or control. 

BRTX-100, the company’s lead clinical candidate, is a novel cell-based therapeutic engineered to target areas of the body with little blood flow.

BRTX-100 is currently being evaluated in a Phase 2 trial to treat chronic lumbar disc disease.

Chairman & CEO Lance Alstodt tells Benzinga, “Dosing all four sentinel subjects is important as the key safety data, organized through our third-party medical monitor, will be evaluated by the Data Safety Monitoring Board (DSMB). With approval from the DSMB, we may accelerate the balance of our enrollment, establish the initial safety profile of the product and, most importantly, leverage this platform technology across other indications within the body.”

The trial will evaluate the safety and preliminary efficacy of a single dose of BRTX-100, with 40 million cells intradiscally injected into the nucleus of the lumbar disc.

The initial safety run-in part of the study is intended to assess the initial safety of a dose of BRTX-100.

If no dose-limiting toxicity occurs among the four BRTX-100 treated subjects, enrollment will transition and expand to the 2:1 randomization scheme planned for the main component of the study.

Establishing the safety profile and DLT of patients dosed with BRTX-100 will allow for open enrollment across all activated clinical sites participating in the clinical trial and accelerate patient recruitment.

“I believe we are very well positioned and prepared to prosecute the balance of our enrollment of our 99 subject Phase 2 study...This is a very exciting time for BioRestorative Therapies and its shareholders. A positive review by the DSMB has the potential to unlock the strategic and fundamental value inherent within this product platform, “Alstodt added.

Price Action: BRTX shares closed at $5.25 on Friday.