Hole shot King
1年前
$BRTX BioRestorative Therapies Presents Preliminary Clinical Data from Phase 2 Study of BRTX-100 in Chronic Lumbar Disc Disease
BioRestorative Therapies, Inc. (“BioRestorative”, “$BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced the public availability of a poster, presented yesterday at the Orthopaedic Research Society (ORS) 2024 Annual Meeting, which describes preliminary 26 and 52 week blinded data from the ongoing Phase 2 clinical trial of the Company’s lead clinical candidate, BRTX-100, in subjects with chronic lumbar disc disease (“cLDD”).
The presented poster, 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” can be accessed on the Company’s website at www.biorestorative.com under “Scientific Publications” in the Product Candidate section. During a webcasted conference call scheduled for 8:30am EST today, BioRestorative management will be available to discuss data from the presentation as well as provide a clinical update.
Previous clinical studies have demonstrated that the harsh microenvironment of the disc could impact cell dose viability and result in a non-efficacious or the worsening of clinical outcomes. Although this is blinded and early clinical data, it is important to note that the Visual Analog Scale, Oswestry Disability Index, Roland Morris Disability Questionnaire, and Functional Rating Index collected at weeks 26 and 52 post-injection demonstrated a positive trend compared to baseline. In addition to safety outcomes, changes to these pain and function scales compared to baseline are used by the U.S. Food and Drug Administration (FDA) to determine whether the trial will be allowed to proceed and ultimately gain Biologics License Application (BLA) approval.
“We are thrilled with the progress of our ongoing clinical development programs. With regard to the Phase 2 study investigating the use of BRTX-100 in the treatment of cLDD, we are strongly encouraged by the preliminary data presented at ORS 2024. The preliminary clinical data shows meaningful signals in patients enrolled in the study and, importantly, no notable safety signals,” said Lance Alstodt, Chief Executive Officer of BioRestorative.
Hole shot King
1年前
BioRestorative Therapies Receives a Notice of Allowance by the United States Patent and Trademark Office for a Patent Application Related to its Obesity Program
BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced that the United States Patent and Trademark Office has issued a notice of allowance for a patent application related to the Company’s metabolic ThermoStem® program. The notice of allowance was issued on October 26, 2023. The application is scheduled to issue as U.S. Patent No. 11,851,682 on December 26, 2023.
This will be the fourth U.S. patent granted under this particular patent family. Claims granted under the new patent cover methods of using differentiated human brown fat adipocytes as a platform to screen and identify compounds that can activate and regulate metabolic activity. These compounds, if discovered to provide metabolic benefits, can then be further developed into drugs targeting weight loss. Therapeutic benefits of using activated brown adipose have been demonstrated in various models and may provide a valuable therapeutic tool for treating a range of metabolic disorders. For example, studies have shown that GLP-based therapeutics interact with brown adipose tissue.
“This notice of allowance is an important milestone as it provides us with tools that can be used as a platform to screen large libraries of compounds targeting metabolic disorders such as obesity,” said Lance Alstodt, the Company’s CEO. “The prevalence of developmental pipelines targeting obesity has increased substantially over the past year. As a result there is a need for more advanced targeted and precise tools and methods for identifying such compounds. This notice of allowance will afford us the protections necessary to allocate resources to develop these extremely valuable tools.”