BioRestorative Therapies Reports Positive Findings from Independent Review of its BRTX-100 Program
BioRestorative Therapies, Inc.
Jun. 11, 2018
MELVILLE, N.Y., June 11, 2018 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. ("BioRestorative" or the “Company") (OTC:BRTX), a life sciences company focused on stem cell-based therapies, today reported the findings from Defined Health, which was engaged by the Company to conduct an independent review of BRTX-100, the Company’s lead cell therapy candidate designed to treat chronic Lumbar Disc Disease (cLDD). Defined Health is a business development and strategy consulting firm that has worked with many of the leading companies in the pharmaceutical, biotech and healthcare industries for over 25 years.
The review was intended to collect informed, independent opinions regarding BRTX-100 among key opinion leaders (KOLs) (orthopedic surgeons specializing in back and spine surgery with experience in stem cell therapy), who, upon studying applicable clinical material, could offer opinions regarding the future therapeutic potential of BRTX-100.
As noted in the report, the KOLs reacted positively to the value proposition of BRTX-100 and were optimistic that the clinical data presented to date is likely to be mirrored in future clinical investigations. Given the opportunity, KOLs indicated that they would likely participate in a clinical trial should it be offered at their center and that they would recommend the study to appropriately eligible patients. If BRTX-100 were to be granted FDA approval, KOLs anticipate that it would be integrated into the standard of care for eligible cLDD patients.
The Company plans to use the results of the review to further refine its planned activities around BRTX-100, including potential licensing, co-development and commercialization activities.
Adam Bergstein, Sr. Vice President, Planning and Development, commented, “This study strongly validates the potential opportunity for BRTX-100. Commissioning Defined Health to talk with KOLs in an objective and unbiased format provides third-party support for the program, which we believe will be valuable as we advance discussions with potential co-development and commercialization partners.”
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 protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease. The BRTX-100 production process 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 due to degenerative disc disease related to protruding/bulging discs.
• Metabolic Program (ThermoStem®): We are developing a cell-based therapy 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 the body 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 those set forth in the Company's 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.