BioRestorative Therapies and Northwell Health Enter into Agreement to Participate in the Company’s Phase 2 Clinical Trial
- New York State’s largest health care provider will participate in BRTX’s clinical trial
- Expansive universe of patients and clinical sites from which to recruit high quality subjects
- Leverage Northwell’s “Center for Regenerative Orthopedic Medicine”
- Potential future collaborations to be explored in connection with basic science research
MELVILLE, N.Y., May 08, 2023 (GLOBE NEWSWIRE) -- . (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ: ) , a clinical stage company focused on stem cell-based therapies, today announced that it has signed a clinical trial agreement with Northwell Health, New York State's largest health care provider and private employer, and Northwell’s Feinstein Institutes for Medical Research. The signing of the agreement will allow Northwell Health to participate in BioRestorative Therapies ongoing Phase 2 clinical trial targeting chronic lumber disc disease (cLDD).
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 connection with a Phase 2 clinical trial to treat cLDD. The BRTX-100 approach involves an office based injection procedure which introduces the patient’s own cells which have been uniquely expanded and conditioned to result in therapeutic impact within the harsh environment of the intervertebral disc and for an all too common pain which is otherwise not reliably treated. 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. BioRestorative recently completed enrollment for the safety run-in phase of its Phase 2 trial.
Lance Alstodt, Chief Executive Officer of BioRestorative, stated, “Partnering with Northwell Health and Northwell’s Feinstein Institutes for Medical Research, the largest hospital system and health provider in New York State, is a testament to the strength of our corporate profile, our technology and the prospects for our product candidate, BRTX 100. We are delighted to enter into such an agreement with Northwell and their world class team of non-surgical and surgical spine clinicians and researchers across the disciplines. We hope to identify other areas where our two organizations can work closely with one another. Research is a very obvious area of focus for both of us and we look forward to exploring strategic possibilities to enhance and strengthen our relationship with Northwell.”
Dr. Jeffry Beer, of Northwell, stated “Chronic low back pain remains one of the most common and difficult clinical conditions we encounter as spine specialists. We don’t currently have highly effective treatment options. The current phase 2 FDA trial is meticulously designed to provide us greater insight into the role of this unique and autologous stem cell therapy.” Dr. Jeffry R. Beer is a Voluntary Staff Physician at Long Island Jewish Medical Center, Northwell Health; Clinical Assistant Professor, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell; and Partner, Long Island Spine Rehabilitation Medicine, PC, East Meadow, NY.
Northwell Health is New York State's largest health care provider and private employer, with 21 hospitals, 850 outpatient facilities and more than 12,000 affiliated physicians. The partnership will enable Northwell to participate in BioRestorative’s clinical trial targeting patients suffering from chronic lumbar disc disease.
About BioRestorative Therapies, Inc.
BioRestorative Therapies, Inc. () 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 commenced 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.
Forward-Looking Statements
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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