BioRestorative Therapies Receives Unanimous Recommendation from Data Safety Monitoring Board (DSMB) to Continue its Phase 2 Clinical Trial without any Changes

• No Dose Limiting Toxicity (DLT) was Observed in the Patients in the Safety Run-In Segment of Study
  
• DSMB Recommendation Allows for Open Enrollment
  

MELVILLE, N.Y., June 27, 2023 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced that the independent Data Safety Monitoring Board (“DSMB”), which is overseeing the Company’s ongoing Phase 2 clinical trial to treat chronic lumbar disc disease (“cLDD”), unanimously recommended the continuation of BioRestorative’s study in accordance with 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. Three patients in the safety run-in group received an intradiscal injection of 40,000,000 hypoxic cultured mesenchymal stem cells and one patient received an injection of saline placebo. This safety run-in was used to evaluate the safety and dose limiting toxicity of BRTX-100. There were no DLTs observed in the patients within the safety run segment of the study. Based on the clinical results of the safety run-in segment of the Phase 2 trial, the DSMB recommended that the Company be permitted to commence open enrollment of the 99 patient study. Each of 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.

"This unanimous recommendation of the DSMB to allow BioRestorative to proceed without any changes to the protocol represents a significant binary outcome and major milestone for the continuation of our clinical program. With the safety profile of BRTX-100 now established through the DSMB process, we intend to accelerate the enrollment of the balance of our 99 patient study. In addition and more importantly, we intend to leverage the product technology platform across multiple indications further extending our pipeline opportunities," said Lance Alstodt, CEO of BioRestorative Therapies.