Presenting Encouraging Data, Acquiring Licenses, Issuing Patents And More – BioRestorative's Inroads Bringing Its Stem Cell Therapies To Market

From alleviating lower back pain to treating obesity, stem cells can play a central role in healing some of the world's most prevalent conditions. For good reason: stem cells are regenerative and can turbocharge the body’s natural healing process. BioRestorative Therapies, Inc. BRTX, a regenerative medicine company focused on stem cell-based therapies and products, has been inkling deals and securing patents to treat back pain and obesity as well as other hard-to-cure ailments and diseases. 

Take BRTX-100 for example. It's BioRestorative's autologous stem cell product for chronic lower back pain. It uses a patient's stem cells, which are harvested, cultured and then injected directly into the affected disc to start the repair process. BRTX-100 is designed to treat the 25 million people in the U.S. who suffer from chronic lower back pain each year, half of whom have or will be diagnosed with disc degeneration, reports the company, and current treatments on the market are less than ideal. Opioid pain relievers, steroid injections and physical therapy help manage pain but don't cure it. Surgery is another option, but clinical outcomes can be limited.  

Phase 2 Trial Results Coming 

The company is currently engaged in a phase 2 clinical trial using BRTX-100 to treat persistent lower back pain caused by painful degenerative discs. This week (Nov. 10-14), BioRestorative presented new preliminary 26–52-week blinded data from the ongoing phase 2 clinical trial at the Orthopaedic Research Society (ORS) Philadelphia Spine Research Society (PSRS) 7th International Spine Research Symposium in Skytop, Pennsylvania. BioRestorative will also make the data available through a public announcement.

 "In February 2024, we were strongly encouraged that the Visual Analog Scale, Oswestry Disability Index, Roland Morris Disability Questionnaire, and Functional Rating Index collected at 26 and 52 weeks after injection indicated a positive trend compared to the baseline with the first four patients enrolled in the study," said BioRestorative's CEO Lance Alstodt. "Now, at ORS PSRS 2024, we have revealed data on 10 patients. Blinded preliminary clinical data of safety and efficacy endpoints are very encouraging, with patient reported pain and function outcomes demonstrating a positive trend," said Mr. Alstodt. "Most importantly, at 26 weeks, 70% of the patients are reporting a significantly greater than 30% increase in function and a more than 30% decrease in pain. If data continues with this trend, we are confident that we will hit our efficacy end points for the phase 2 trial," he continued

Fighting Obesity With Stem Cells With A Focus On Growing IP Portfolio

Then there is BioRestorative's ThermoStem, which uses brown adipose-derived (brown fat) stem cells to generate new brown fat tissue to target obesity and metabolic disorders. This type of fat is known to burn rather than store energy. Elevated levels of brown fat have been shown to increase metabolism and facilitate weight loss, reports BioRestorative. It's a big market for BioRestorative to go after. After all, 40% of Americans are obese; 30% have type 2 diabetes or pre-diabetes and half of Americans have at least one major risk factor for heart disease, according to data compiled by the company. 

ThermoStem is also making news with BioRestorative recently announcing that the Israel Patent Office has issued the company a Notice of Allowance for a new patent application (Israeli Patent Appl. No. 287557) covering several fundamental aspects of its allogeneic, off-the-shelf ThermoStem platform. It’s the 14th international patent and covers non-naturally occurring three-dimensional brown adipose-derived stem cell (BADSC) aggregates, encapsulation, a method for making them and a method for treating a patient with a disorder.

"We believe that our ThermoStem-based BADSCs hold tremendous promise to deliver a superior efficacy and tolerability profile over GLP-1 drugs," said Alstodt. "This latest patent issuance demonstrates our strong commitment to protecting the innovation of our ThermoStem program and the significant potential commercial opportunity that it represents for ourselves and any current and/or future potential licensing partners. And, given Israel's global prominence in stem cell research, we are particularly excited by this latest patent issuance."

Expanding Via Licensing 

In addition to securing patents and gearing up to present clinical data, BioRestorative recently obtained a license from the New York State Department of Health (NYSDOH) to process, isolate, expand and preserve allogeneic (non-autologous) donor tissue, including stem cells, for medical research. In New York, companies are required to have a license to engage in tissue and stem cell activities. Previously BioRestorative was licensed by the NYSDOH to act as a tissue bank for the processing of mesenchymal stem cells derived from autologous donors only.

BioRestorative says the expanded license enables it to leverage its state-of-the-art cGMP manufacturing to process, bank and distribute clinical-grade allogeneic (off-the-shelf) biologics. "It will significantly enhance our ability to develop an unrivaled clinical pipeline of off-the-shelf cell-based biologic products," says Alstodt.

Stem cells play an important role in treating several prevalent diseases. The remedies of today aren't cutting it. BioRestorative aims to change that with BRTX-100 and ThermoStem – and it's working hard to get the licenses and patents to make that happen. 

Other companies competing in the cell-based biologics or chronic pain treatment space include Mesoblast MESO, Brainstorm Cell Therapeutic BCLI and Longeveron LGVN.

To learn more about BioRestorative's stem cell therapies, click here. 

Featured photo by Sasun Bughdaryan on Unsplash.

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