BioRestorative Therapies Expanding its Cell Therapy Manufacturing Facility
BioRestorative Therapies, Inc. (OTC: BRTX) announced the expansion of its Melville, NY research labs for clinical production of cell therapies.
The new cGMP facility will support the Phase 2 clinical trial for BRTX-100 and the ThermoStem® program, enhancing internal manufacturing capabilities.
As part of this initiative, the company plans to hire more employees, aligning operations with FDA and EMA regulations for clinical-grade cell production.
- Initiation of expansion to include clinical manufacturing capabilities.
- Supporting Phase 2 clinical trial for BRTX-100.
- Development of state-of-the-art cGMP facility compliant with FDA and EMA standards.
- Anticipated hiring of additional full-time employees.
- None.
MELVILLE, N.Y., May 10, 2021 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the “Company” or “BioRestorative”) (OTC: BRTX), a life sciences company focused on stem cell-based therapies, today announced that it is initiating expansion of its Melville, New York based research laboratories to include capabilities for the clinical production of the Company’s pipeline of clinical and investigational cell therapy candidates.
“We look forward to expanding our current research and development operations to include clinical manufacturing, a necessary step to initiate our Phase 2 clinical trial for our novel Disc/Spine program,” said Lance Alstodt, CEO of BioRestorative. “The ability to control internal clinical grade cell manufacturing capacity is critical in order to support multiple product manufacturing for our two programs: BRTX -100 and our allogeneic ThermoStem® metabolic program. Additionally, this capability will allow us to advance our proprietary technologies and begin first in man clinical studies with our collaborative clinical partners.”
The cGMP facility is anticipated to include process development space, ISO 7 cleanrooms, and state-of-the-art scientific equipment. As the manufacturing facility becomes fully operational, the Company expects to hire additional full-time employees. The new facility is being designed to provide cGMP manufacturing according to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations and guidelines to support clinical grade cell production.
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.
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.
CONTACT:
Lance Alstodt
(631) 760-8406
Email: ir@biorestorative.com
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