BioRestorative Therapies Partners with Galen Patient Recruitment to Accelerate Completion of Enrollment in Phase 2 Trial of BRTX-100 in Chronic Lumbar Disc Disease
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The announcement of BioRestorative Therapies' collaboration with Galen Patient Recruitment, Inc. signifies a strategic move to mitigate one of the biggest bottlenecks in clinical trials: patient enrollment. The tripling of monthly trial capacity from 10 to 30 participants is a substantial increase, which could potentially shorten the timeline to market for BRTX-100. For investors, this operational enhancement may translate into a more efficient allocation of capital, reducing the cash burn rate often associated with prolonged clinical studies. Furthermore, the focus on a cell-based therapy for chronic lumbar disc disease taps into a specialized segment of the regenerative medicine market, which is poised for growth given the aging population and the increasing demand for non-surgical treatment options.
Streamlining the clinical trial process is a critical factor in drug development. The partnership with Galen, a company specializing in patient recruitment, could address a common industry hurdle and improve the likelihood of meeting enrollment targets. This is particularly relevant as the referenced industry statistics highlight the prevalence of under-enrollment issues. For BioRestorative, the ability to conduct a Phase 2 study efficiently may lead to quicker data readouts, enabling faster progression to subsequent trial phases or regulatory interactions. It's important to note that the Phase 2 study's design, being prospective, randomized, double-blinded and controlled, aligns with the gold standard for evaluating therapeutic efficacy and safety, which should provide robust data to inform future development stages.
Investors should note that the market for chronic lumbar disc disease treatments is competitive, with several players working on innovative solutions. The success of BRTX-100 hinges not only on clinical outcomes but also on its ability to capture market share upon approval. The current progress and strategic collaboration may enhance investor confidence, but it's essential to remain aware of the competitive landscape and reimbursement challenges in the healthcare sector. The long-term market potential for BRTX-100 will depend on its clinical differentiation from existing therapies and the overall cost-effectiveness it offers to the healthcare system.
— Collaboration follows recent manufacturing/clinical process enhancements that have tripled monthly trial capacity —
— Patient enrollment expected to be completed in 2024 —
MELVILLE, N.Y., April 08, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced a collaboration with Galen Patient Recruitment, Inc. (“Galen”) which, combined with the recent expansion of clinical trial capacity from approximately 10 to 30 participants per month, is expected to help accelerate the completion of patient enrollment in the ongoing Phase 2 study of BioRestorative’s lead clinical candidate, BRTX-100, in chronic lumbar disc disease (“cLDD”).
BRTX-100 is a novel cell-based therapeutic engineered to target areas of the body that have little blood flow. The safety and efficacy of BRTX-100 in treating cLDD is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study. A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States. Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or placebo.
“The industry statistics can be sobering; around
Reference
1 Brøgger-Mikkelsen M, Ali Z, Zibert JR, Andersen AD, Thomsen SF. Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis. J Med Internet Res. 2020 Nov 4;22(11):e22179. doi: 10.2196/22179. PMID: 33146627; PMCID: PMC7673977.
About Galen Patient Recruitment
Since 2006, Galen (www.galenrecruitment.com) has helped its clients bring new medical innovations to market through cost-effective patient recruitment solutions. Galen doesn’t believe in one-size fits all. It approaches each study with a fresh perspective, and considers all of the variables in the study enrollment equation – the research sites, study coordinators and, most importantly, the patients. This leads to comprehensive yet flexible recruitment programs that take the guesswork out of achieving enrollment goals.
About BioRestorative Therapies
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 commenced 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:
Email: ir@biorestorative.com
