EXCLUSIVE: Data Monitoring Committee Allows BioRestorative's Chronic Lumbar Disc Disease Study To Continue Unchanged

BioRestorative Therapies Inc BRTX has announced that the independent Data Safety Monitoring Board (DSMB), overseeing the company's ongoing Phase 2 trial to treat chronic lumbar disc disease, unanimously recommended the continuation of the study under the current version of the protocol with no changes.

The treated patients will receive BRTX-100, a product formulated from autologous (or a person's own) hypoxic cultured mesenchymal stem cells collected from the patient's bone marrow and autologous platelet lysate.

Earlier this month, BioRestorative announced that the final subject in its BRTX-100 Phase 2 trial safety cohort had been dosed. Four participants were dosed at a 3:1 ratio with BRTX-100 or control. 

What Happened: Three patients in the safety run-in group received an intradiscal injection of 40,000,000 hypoxic cultured mesenchymal stem cells, and one received an injection of saline placebo.

This safety run-in was used to evaluate the safety and dose-limiting toxicity of BRTX-100.

No DLTs were observed within the safety run segment of the study. 

The DSMB recommended that the company be permitted to commence open enrollment of the 99-patient study.  

These additional patients (other than those receiving a placebo) will be treated with BRTX-100, which includes 40,000,000 hypoxic cultured mesenchymal stem cells.

In March, BioRestorative entered into an agreement with Bruder Consulting & Venture Group, a full-service strategic advisory, to assist the company in seeking FDA approval for the expanded clinical application of BRTX-100.

Price Action: BRTX shares are trading 5.86% higher at $6.87 during the premarket session on the last check Tuesday.