PRC Clinical to Provide Start-up CRO Services for BRTX-100 Phase 2 Clinical Trial
MELVILLE, N.Y., Nov. 19, 2021 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (the “Company” or “BioRestorative”) (NASDAQ:BRTX), a life sciences company focused on adult stem cell-based therapies, today announced that it has entered into a letter of intent with PRC Clinical, a CRO specializing in clinical trial management, with regard to PRC Clinical providing startup clinical project management activities for the Company’s BRTX-100 Phase 2 clinical trial to treat chronic lumbar disc disease.
“We are pleased to announce that we have entered into a letter of intent for PRC Clinical to provide startup activities for our Phase 2 study. PRC has extensive experience and expertise in managing clinical studies in the stem cell and regenerative medicine space. They also have the experienced and professional network of clinicians and study sites streamlining patient enrollment, site monitoring and management. Additionally, we have been working with and familiarizing ourselves with PRC’s team and capabilities since 2019. We are thrilled to finally be in a position to begin the process of validating our technology through the FDA process, while keeping shareholders updated along the regulatory pathway,” said Lance Alstodt, CEO of BioRestorative.
PRC Clinical has provided specialty CRO services for nearly 20 years. Their innovative approach to executing studies for biotech and pharmaceutical companies combines high-touch human elements and cutting-edge technology with extensive experience and deep therapeutic knowledge. PRC Clinical is an all inclusive CRO and has specialized expertise across regenerative medicine, CNS, ophthalmology, pulmonary and COVID-19, rare and orphan disease and more complex indications.
“PRC Clinical is pleased to begin start-up CRO activities for BRTX-100. We look forward to being able to bring our stem cell experience to this trial. We are committed to supporting BioRestorative’s development of BRTX-100 and its clinical application,” said Curtis Head, CEO of PRC Clinical.
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 surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.
• Metabolic Program (ThermoStem®): We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company’s latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.
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