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BioRestorative Therapies Announces Completion of Patient Enrollment for Safety Run-In Component of its Phase 2 Clinical Study of BRTX-100
--Clinical data from safety run-in scheduled to be released in second half of 2023.— MELVILLE, N.Y., April 24, 2023 (GLOBE NEWSWIRE) -- BioRestorative
About this update from Biorestorative Therapies, Inc.
[{"type":"text","content":"--Clinical data from safety run-in scheduled to be released in second half of 2023.— MELVILLE, N.Y., April 24, 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 it has completed enrollment for the safety run-in component of its Phase 2 clinical study of BRTX-100 targeting patients suffering from chronic lumbar disc disease (cLDD). BRTX-100 is the Company’s lead clinical candidate, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow. BRTX-100 is currently being evaluated in connection with a Phase 2 clinical trial to treat cLDD. The trial is prospective, randomized, double-blinded and controlled. The trial will evaluate the safety and preliminary efficacy of a single dose of BRTX-100. A total of up to 99 eligible patients will be randomized at up to 15 clinical sites in the United States to receive either the investigational drug (BRTX-100) or control in a 2:1 fashion. Lance Alstodt, Chief Executive Officer of BioRestorative Therapies, stated “The completion of patient recruitment and enrollment for the safety run-in component of our Phase 2 study of BRTX-100 is a very significant milestone for our company. Positive safety data would enable us to initiate unrestricted enrollment across all of our clinical sites and, of course, establish a strong safety profile for BRTX-100. In addition, we would be able to leverage the BRTX-100 platform across other indications within the body on an investigational basis with potentially a shorter timeline from a regulatory pathway perspective.” About BioRestorative Therapies, Inc. BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders: • Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgi...