BioRestorative Therapies to Present Preliminary BRTX-100 Clinical Data at the Orthopaedic Research Society (ORS) 2024 Annual Meeting
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Insights
The preliminary data from the Phase 2 clinical trial of BRTX-100 is a critical milestone for BioRestorative Therapies, Inc. as it evaluates the safety and efficacy of this stem cell-based therapy for chronic lumbar disc disease (cLDD). The randomized, double-blinded and controlled study design is a gold standard in clinical research, aiming to eliminate bias and provide reliable data. The potential of BRTX-100 to target areas with poor blood flow could represent a significant advancement in treating cLDD, which is a common cause of lower back pain and disability.
The 26–52 week blinded data will provide insights into the short-term safety and possible efficacy trends of the treatment. However, long-term data will be crucial to fully assess the therapeutic's potential benefits and risks. It's important to note that the results are still preliminary and the trial is ongoing. Positive outcomes could lead to an increase in the company's stock value due to the anticipation of a new effective treatment option in the market. Conversely, if the results raise concerns, it could negatively impact investor sentiment.
It is also noteworthy that the trial includes up to 99 subjects across multiple sites, which enhances the diversity of the patient population and may contribute to the robustness of the findings. The ratio of 2:1 for treatment versus placebo is a common practice that ensures a larger data set for the active treatment while maintaining a control group for comparison.
Investors will be closely monitoring the outcomes of the Phase 2 trial data presentation for BRTX-100, as positive preliminary data can lead to increased investor confidence and a potential uptick in BioRestorative's stock price. The company's decision to host a webcasted conference call indicates a strategic move to engage with investors and analysts, providing an in-depth look at the data and the opportunity for direct questions.
The stock market reaction to such data can be immediate and significant, especially for clinical stage biotech companies where much of the valuation is based on potential future earnings from pipeline products. The fact that BioRestorative is presenting at the Orthopaedic Research Society (ORS) meeting is also of interest to investors, as it shows the company's commitment to scientific communication and may help in building credibility within the medical community.
However, the inherent risk of investing in clinical stage biotech firms should not be underestimated. Delays, negative results, or regulatory hurdles can lead to volatility in the company's stock. Thus, the financial implications of this data release are contingent upon the outcomes and subsequent regulatory pathways.
The market for treatments of chronic lumbar disc disease is substantial, given the prevalence of the condition and the limited efficacy of current non-surgical options. A successful introduction of BRTX-100 could disrupt the current market, offering a novel solution for a condition that affects millions worldwide. From a market perspective, the differentiation of BRTX-100 lies in its targeted approach for areas with limited blood flow, which is a unique angle in the competitive landscape of cLDD therapies.
Furthermore, the market's response to the clinical trial data will depend not only on the safety and efficacy results but also on the potential cost-effectiveness of the therapy. If BRTX-100 proves to be a more effective and safer alternative to existing treatments, it could command a premium price point and secure a significant market share. However, it is essential to consider the reimbursement landscape and how insurance companies will view this new therapy.
Understanding the patient and clinician perspectives on stem cell therapies is also vital. Market acceptance will hinge on the perceived benefits versus existing treatments, the ease of the treatment process and the long-term outcomes. Patient advocacy groups and clinician endorsements can play a pivotal role in the adoption of BRTX-100, should it reach the market.
— Blinded data from the ongoing Phase 2 clinical trial of BRTX-100 to be described in poster presentation —
— Company to host webcasted conference call to review data on February 5, 2024 at 8:30am EST —
MELVILLE, N.Y., Feb. 01, 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 that preliminary 26–52 week blinded data from the ongoing Phase 2 clinical trial of BRTX-100 in subjects with chronic lumbar disc disease (“cLDD”) will be presented by Francisco Silva, Vice President of Research and Development, at the Orthopaedic Research Society (ORS) 2024 Annual Meeting, taking place February 2-6, 2024 in Long Beach, California.
BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is the Company’s lead clinical candidate. 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 presentation, titled “Autologous Stem Cell Therapy for Chronic Lumbar Disc Disease, Initial Phase 2 Clinical Safety and Feasibility Data of Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells,” is scheduled for Sunday, February 4, 2024 between 10:15am-11:15am PST.
“We are excited by this opportunity to share, for the very first time, preliminary data from the ongoing Phase 2 clinical trial of BRTX-100 in the treatment of cLDD,” said Lance Alstodt, Chief Executive Officer of BioRestorative. “As interest in the potential clinical benefits of BRTX-100 grows, it is important that we continue to drive awareness of this novel therapeutic candidate amongst researchers, regulators and clinicians through clinical presentations at important meetings like ORS.”
Conference Call & Webcast Details
BioRestorative management will host a webcasted conference call with an associated slide presentation at 8:30am EST on Monday, February 5, 2024 to review the BRTX-100 poster. To join the conference call via phone and participate in the live Q&A session, please dial 888-506-0062 (United States) or 973-528-0011 (International), participant access code 234972. The live webcast and audio archive of the presentation may be accessed on the investor section of the BioRestorative website at https://www.biorestorative.com/investor-relations/. An archived replay will be available for approximately 90 days following the event.
About BioRestorative Therapies, Inc.
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
FAQ
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