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By Faith Ashmore, Benzinga
BioRestorative Therapies Inc. (NASDAQ: BRTX) (“BioRestorative”) may have had a successful year of novel drug development. The company is engaged in developing therapeutic products using cell and tissue protocols, primarily with adult stem cells, for large multi-billion dollar markets that are underserved and affect millions of Americans, like chronic lower back pain and metabolic disorders.
BioRestorative currently has two major programs that are being evaluated for a variety of chronic diseases and pain. Their novel drug BRTX-100 is an autologous stem cell product; the cells are harvested, cultured and then injected directly into the patient’s body. BioRestorative’s other product — ThermoStem® — has shown promising results in preclinical models for the treatment of obesity and related metabolic diseases.
In December, BioRestorative was awarded a Small Business Innovation Research (SBIR) grant. This grant was given for the development and evaluation of the company’s ThermoStem program for developing a therapeutic to treat polycystic ovary syndrome (PCOS). Previously, the company was granted a Small Business Technology Transfer (STTR) grant for Phase 1 development of BRTX-100 to explore the therapeutic effects of PEG-peptide hydrogel-encapsulated hypoxic bone marrow stem cells. It’s rare that a company of its size has received two government grants, validating its technology and potential application.
The company entered into an agreement with Regenexx, LLC, providing BioRestorative with the exclusive worldwide commercial rights of the intellectual property that is underlying some key principles of BRTX-100. Currently, BRTX-100 is in a Phase 2 trial with approximately 15 sites in the U.S. This exclusive arrangement should provide value to BRTX and or a commercial partner in potential later-stage development transactions.
BRTX-100 began Phase 2 trials in February, defined as a prospective, randomized, double-blinded controlled study to evaluate the efficacy and safety of BRTX from a single injected dose.
One of the company’s significant developments in 2022 was the completion of a cGMP manufacturing facility with an ISO 7-certified clean room. This facility was completed in April and was instrumental in progressing the company forward to meet the needs of Phase 2 clinical trials for chronic lumbar disc disease.
Throughout the year, BioRestorative participated in several high-profile conferences. The company presented at H.C. Wainwright Bioconnect, Roth Inaugural Healthcare Conference and Dawson James Securities Conference, to name a few.
BioRestorative was also granted a patent application for their ThermoStem program in Japan, which demonstrates the company’s potential for global application of their therapeutic products.
BioRestorative and other companies like Lineage Cell Therapeutics Inc (NYSE: LCTX), Brainstorm Cell Therapeutics Inc (NASDAQ: BCLI), Vericel Corp (NASDAQ: VCEL) and large cap pharma as well such as Novo Nordisk (NYSE: NVO) and Pfizer Inc. (NYSE: PFE) are leading the charge towards a new era of medical advancement. As biotech companies become increasingly successful at providing therapeutic solutions, it will be interesting to see how technology and innovation leads to higher quality of life for patients who have previously been left with little or no solutions.
To learn more about BioRestorative, visit its website.
This article was originally published on Benzinga here.
BioRestorative Therapies was founded by scientists and researchers committed to developing stem cell therapies to address unmet needs in patients with highly prevalent conditions.Our advances in stem cell biology and delivery protocols harbor great promise in conditioning our bodies’ own regenerative potential to treat major diseases more effectively than current interventions.Today, BioRestorative is actively developing programs that aim to dramatically increase quality of care for both (i) chronic back pain caused by disc degeneration, as well as (ii) metabolic disorders including obesity and diabetes.
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