Clinical-stage Therapeutics Company Announces Potential License Agreement
Clinical-stage Therapeutics Company Announces Potential License Agreement
BioRestorative Therapies in Substantive Discussions for Potential License Agreement for ThermoStem® Metabolic Disease Program.
Disclaimer: The following article includes forward-looking statements and potential outcomes that are subject to uncertainties and risks. Readers are advised to consider these when interpreting the information provided. BioRestorative Therapies does not guarantee that any license agreement will be finalized, nor can it assure commercially favorable terms.
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BioRestorative Therapies, Inc. (NASDAQ:BRTX), a clinical-stage company focused on stem cell-based therapies, has announced that it is currently engaged in substantive discussions with an undisclosed commercial-stage regenerative medicine company. These discussions concern a potential licensing agreement for BioRestorative’s allogeneic, off-the-shelf ThermoStem® metabolic disease intellectual property. This development marks a significant step for BioRestorative as it aims to bring its innovative therapeutic solutions closer to commercialization.
ThermoStem®
ThermoStem® is a groundbreaking program developed by BioRestorative Therapies, targeting obesity and related metabolic disorders through stem cell technology. At the core of this program is the utilization of brown adipose tissue (BAT) stem cells. BAT is known for its role in thermogenesis and energy expenditure, making it a promising target for metabolic interventions. Previous peer-reviewed preclinical data, published in collaboration with the University of Utah School of Medicine, highlighted the potential of ThermoStem®. The study identified a clonogenic population of metabolically active brown adipose tissue stem cells in adult humans. These cells demonstrated the ability to:
Expand in vitro.
Exhibit multilineage differentiation potential (osteogenetic, chondrogenic, and adipogenic).
Functionally differentiate into metabolically active brown adipocytes.
The significance of these findings lies in the mature functional properties exhibited by the differentiated brown adipose-derived stem cells (BADSCs), including increased mitochondrial activity—an essential characteristic of BAT. Such properties underline the potential of BADSCs in addressing metabolic disorders. To further explore the therapeutic potential of BADSCs, BioRestorative developed a 3D Porous Extracellular Matrix-Derived Scaffold. This scaffold is designed to enhance cell delivery efficacy.
Animal Studies and Results
In a pivotal study involving high-fat fed NOD-SCID mice, differentiated BADSCs supported by the 3D scaffold were transplanted. The results were compelling:
Significant reductions in weight.
Lower triglyceride levels.
Decreased blood glucose levels compared to control groups that received saline-only injections.
These results suggest that BADSCs, when delivered using the 3D scaffold, could potentially offer a novel treatment modality for obesity and related metabolic disorders. BioRestorative Therapies has reported that it is in substantive discussions with a commercial-stage regenerative medicine company regarding the licensing of ThermoStem® intellectual property. Lance Alstodt, Chief Executive Officer of BioRestorative Therapies, expressed optimism about the growing interest in the ThermoStem® platform from potential license partners. He emphasized the importance of the animal studies, which demonstrated the efficacy of BADSCs and 3D scaffolds, in attracting high-caliber commercial partners.
Despite the promising discussions, BioRestorative has cautioned that no assurances can be given that a license agreement will be finalized, whether on commercially reasonable terms or otherwise. The company has stated that it does not intend to make any further announcements regarding the license unless an agreement is reached. BioRestorative Therapies is at the forefront of developing therapeutic products utilizing cell and tissue protocols, primarily involving adult stem cells. The company's core clinical development programs focus on:
Disc/spine disease.
Metabolic disorders.
Additionally, BioRestorative has recently ventured into the BioCosmeceutical market.
Disc/Spine Program (brtxDISC™)
The lead cell therapy candidate in this program is BRTX-100. This product is formulated from autologous, cultured mesenchymal stem cells collected from the patient’s bone marrow. BRTX-100 is intended for non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to surgical procedures. During an outpatient procedure, a physician injects BRTX-100 into the patient’s damaged disc, offering a potential solution for chronic disc-related pain. The ThermoStem® program represents the company’s significant effort in addressing metabolic diseases through innovative stem cell-based approaches. By focusing on brown adipose tissue stem cells, BioRestorative aims to develop treatments that can effectively combat obesity and its related complications.
Recently, BioRestorative has expanded its portfolio to include BioCosmeceutical products. These offerings leverage the company’s expertise in stem cell technology to provide advanced skincare solutions that promote skin health and rejuvenation. BioRestorative Therapies is making substantial progress in developing and potentially commercializing its innovative stem cell-based therapies. The ongoing discussions for a potential ThermoStem® licensing agreement reflect the broader interest in the company’s proprietary technologies. While there are no guarantees that an agreement will be reached, the engagement with a commercial-stage regenerative medicine company underscores the potential and promise of BioRestorative’s therapeutic platforms.
As BioRestorative continues to advance its clinical development programs and explore new market opportunities, it remains poised to make significant contributions to the fields of regenerative medicine and metabolic disease treatment.
Disclaimer: The content of this article includes forward-looking statements and potential outcomes that are inherently uncertain and subject to risks. No guarantee is provided that any license agreement will be finalized. Readers should interpret the information herein with caution and consult relevant professionals where necessary.
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