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BioRestorative Therapies Announces Key Milestone of Dosing Completion in Safety Cohort of Phase 2 Trial Targeting Chronic Lumbar Disc Disease
--Clinical data expected to be reviewed by independent data safety monitoring board (DSMB) as to initial safety dosing profile of BRTX-100-- MELVILLE, N.Y.,
About this update from Biorestorative Therapies, Inc.
[{"type":"text","content":"--Clinical data expected to be reviewed by independent data safety monitoring board (DSMB) as to initial safety dosing profile of BRTX-100-- MELVILLE, N.Y., June 12, 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 final subject in its BRTX-100 Phase 2 clinical trial safety cohort has been dosed. Four study participants were dosed at a 3:1 ratio with either 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 that have little blood flow. BRTX-100 is currently being evaluated in a Phase 2 clinical trial to treat chronic lumbar disc disease (“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, with 40 million cells intradiscally injected into the nucleus of the lumbar disc. 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. 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 (“DLT”) 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. “We are excited to announce this important clinical milestone as we continue to drive the development of BRTX-100 as a potential treatment for patients suffering from lower back pain,” said Lance Alstodt, CEO of BioRestorative. \"I am extremely impressed with the effort of our clinical and operational teams, working collectively throughout the early stages of the trial to coordinate and successfully complete dosing our safety cohort. Open enrollment will enable us to rapidly increase patient recruitment and allow us to work toward the completion of our Phase 2 trial.” About BioRestorative Therapies, Inc. BioRest...