BioRestorative Therapies Presents Preliminary Clinical Data from Phase 2 Study of BRTX-100 in Chronic Lumbar Disc Disease

— Preliminary data includes 26 and 52-week follow-up end points as part of ongoing Phase 2 trial —

— Company to host webcasted conference call today at 8:30am EST —

MELVILLE, N.Y., Feb. 05, 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 the public availability of a poster, presented yesterday at the Orthopaedic Research Society (ORS) 2024 Annual Meeting, which describes preliminary 26 and 52 week blinded data from the ongoing Phase 2 clinical trial of the Company’s lead clinical candidate, BRTX-100, in subjects with chronic lumbar disc disease (“cLDD”).

The presented poster, titled “Autologous Stem Cell Therapy for Chronic Lumbar Disc Disease; Initial Phase 2 Clinical Safety and Feasibility Data of Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells” can be accessed on the Company’s website at www.biorestorative.com under “Scientific Publications” in the Product Candidate section. During a webcasted conference call scheduled for 8:30am EST today, BioRestorative management will be available to discuss data from the presentation as well as provide a clinical update.

Previous clinical studies have demonstrated that the harsh microenvironment of the disc could impact cell dose viability and result in a non-efficacious or the worsening of clinical outcomes. Although this is blinded and early clinical data, it is important to note that the Visual Analog Scale, Oswestry Disability Index, Roland Morris Disability Questionnaire, and Functional Rating Index collected at weeks 26 and 52 post-injection demonstrated a positive trend compared to baseline. In addition to safety outcomes, changes to these pain and function scales compared to baseline are used by the U.S. Food and Drug Administration (FDA) to determine whether the trial will be allowed to proceed and ultimately gain Biologics License Application (BLA) approval.

“We are thrilled with the progress of our ongoing clinical development programs. With regard to the Phase 2 study investigating the use of BRTX-100 in the treatment of cLDD, we are strongly encouraged by the preliminary data presented at ORS 2024. The preliminary clinical data shows meaningful signals in patients enrolled in the study and, importantly, no notable safety signals,” said Lance Alstodt, Chief Executive Officer of BioRestorative.