Therapeutics Company Announces Notice of Allowance For Major Patent Over Metabolic Disease Program
BioRestorative Therapies Announces Notice of Allowance for Patent Covering Fundamental Aspect of ThermoStem® Metabolic Disease Program.
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BioRestorative Therapies, Inc. (BioRestorative or BRTX), a company specializing in stem cell-based therapies, has announced that it received a notice of allowance from the Japanese Patent Office for patent application No. 2021-564135. This patent pertains to the company's allogeneic, off-the-shelf ThermoStem® platform, a crucial aspect of its metabolic disease program.
The ThermoStem® Platform
The ThermoStem® platform is designed to utilize brown adipose tissue (BAT) stem cells for therapeutic purposes. BAT, often referred to as "brown fat," is known for its ability to burn energy and generate heat. This function makes brown fat a promising target for treating metabolic disorders such as obesity and diabetes.
Published preclinical data from a collaborative study with the University of Utah School of Medicine (UUSOM) provided vital insights into the potential of BAT stem cells in metabolic therapies. The study revealed that metabolically active BAT stem cells are present in adult humans. These cells can be expanded in vitro and exhibit multilineage differentiation potential, including osteogenetic, chondrogenic, and adipogenic differentiation. Crucially, these BAT stem cells can differentiate into metabolically active brown adipocytes, which demonstrate mature functional properties such as increased mitochondrial activity.
The UUSOM study utilized high-fat fed NOD-SCID mice to evaluate the effects of differentiated BAT-derived stem cells (BADSCs). These mice were transplanted with BADSCs supported by a BioRestorative-developed 3D Porous Extracellular Matrix-Derived Scaffold. The results indicated substantial reductions in weight, triglyceride, and blood glucose levels compared to control mice injected with saline. Additionally, the 3D scaffold retained viable transplanted cells for at least five weeks post-implantation, highlighting its effectiveness in supporting cell survival.
This new patent is the fifth Japanese patent issued for BioRestorative’s ThermoStem® technology platform. The patent covers a method of creating three-dimensional brown adipose derived stem cell aggregates without using a differentiation medium. This advancement offers a feasible approach to developing BAT-based therapies.
CEO's Statement
Lance Alstodt, BioRestorative’s Chief Executive Officer, emphasized the importance of protecting the intellectual property associated with ThermoStem®. As awareness grows around the potential of ThermoStem®-based BADSCs for treating obesity and other metabolic disorders, securing robust patent protection is vital for the company and its potential licensing partners. Alstodt highlighted the proactive steps taken to expand the ThermoStem® intellectual property estate to ensure long-term market exclusivity.
BioRestorative Therapies is engaged in ongoing discussions with an undisclosed commercial-stage regenerative medicine company regarding a potential license of ThermoStem® metabolic intellectual property. While no assurances can be made about reaching a license agreement or the terms of such an agreement, these discussions indicate interest in the commercial application of BioRestorative’s technology. BioRestorative Therapies develops therapeutic products utilizing cell and tissue protocols, primarily involving adult stem cells. The company focuses on two core clinical development programs:
Disc/Spine Program (brtxDISC™):
This program targets chronic lumbar disc disease. Using a proprietary stem cell population, the therapy is delivered via injection into patients' degenerated discs. The goal is to restore disc structure and function, alleviate pain, and improve mobility.
Metabolic Program (ThermoStem®):
This program leverages brown adipose (fat) derived stem cells to treat metabolic disorders, including obesity and diabetes. The therapy involves differentiating stem cells into brown adipocytes, which can enhance metabolic activity and energy expenditure.
Additionally, BioRestorative has ventured into the cosmetic sector with its BioCosmeceutical product line, which integrates stem cell-based ingredients to promote skin health and rejuvenation.
Potential Impact of ThermoStem® Technology
The ThermoStem® platform holds promise for addressing prevalent health issues related to metabolic disorders. By utilizing BAT stem cells, the technology aims to harness the natural energy-burning capabilities of brown fat to facilitate weight loss and improve metabolic health. If successful, this approach could provide an innovative solution for individuals struggling with obesity and related conditions. With the approval of the Japanese patent, BioRestorative Therapies has fortified its intellectual property portfolio, paving the way for potential advancements in metabolic disease treatment. Continued research and clinical trials will be critical to translating preclinical findings into viable therapies for human patients.
BioRestorative Therapies’ recent patent allowance marks a significant milestone for the company’s ThermoStem® metabolic disease program. As the company continues to advance its research and engage in licensing discussions, the future looks promising for the development of innovative stem cell-based treatments for metabolic disorders. BioRestorative’s commitment to expanding its intellectual property estate shows its dedication to pioneering new therapies that could positively impact global health.
Disclaimer: This article is intended for informational purposes only. It should not be construed as professional advice. Readers are encouraged to conduct their research and consult with qualified professionals before making any investment or medical decisions.
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