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$BRTX BioRestorative Therapies Presents Preliminary Clinical Data from Phase 2 Study of BRTX-100 in Chronic Lumbar Disc Disease
BioRestorative Therapies, Inc. (“BioRestorative”, “$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 년 전
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.”
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1 년 전
BioRestorative Therapies Announces Activation of Northwell Health in the Companys Phase 2 Clinical Trial Targeting Chronic Lumbar Disc Disease
8:30 AM ET 9/8/23 | GlobeNewswire
BioRestorative Therapies Announces Activation of Northwell Health in the Company's Phase 2 Clinical Trial Targeting Chronic Lumbar Disc Disease
--Site activation allows for patients in the State of New York to participate in the BRTX-100 trial--
--15 Clinical Sites Identified, 12 of the 15 Activated and Recruiting Subjects
MELVILLE, N.Y., Sept. 08, 2023 (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 Northwell Health, New York State's largest health care provider, has been activated and can now start recruitment in the State of New York for BioRestorative's ongoing Phase 2 clinical trial targeting chronic lumbar disc disease ("cLDD"). BioRestorative and Northwell Health entered into a clinical trial agreement in May with regard to the Phase 2 trial. Much effort and collaboration have taken place and, now that site specific training is complete, the site can initiate patient recruitment and enrollment.
BRTX-100, the Company's lead clinical candidate, is a novel cell-based therapeutic engineered to target areas of the body that have little blood flow and limited oxygen supply. It is currently being evaluated in connection with the Company's ongoing Phase 2 clinical trial targeting cLDD. The trial is prospective, randomized, double-blinded and controlled. The trial will evaluate the safety and preliminary efficacy of a single dose of BRTX-100, with 40 million cells injected into the lumbar disc that is causing pain. A total of up to 99 eligible patients will be randomized at up to 15 clinical sites in the United States to receive either the investigational drug (BRTX-100) or control in a 2:1 fashion. BioRestorative recently completed its safety run-in phase of the Phase 2 trial and is now openly enrolling patients across all its clinical sites located throughout the United States.
"I'm pleased to report that, after several months of a deliberate and thoughtful collaboration with Northwell Health, the largest healthcare provider and employer in New York State, we have reached the point of initiating the patient enrollment process. Given the size of Northwell Health and its relative proximity to our facilities in Melville, New York, we look forward to significant benefits from working with Northwell Health in connection with our Phase 2 clinical trial. We hope that our partnership will result in a highly efficient recruitment / enrollment process among other significant benefits," stated Lance Alstodt, Chief Executive Officer of BioRestorative.
Dr. Sohrab Virk of Northwell Health stated, "Everyone at Northwell is laser focused on improving clinical outcomes related to the spine. The technology of BRTX-100 represents a new hope for improving pain/functionality for our patients dealing with discogenic pain. We are eager to begin our investigation and hope to bring the extensive clinical volume and outstanding physician talent at Northwell to help with this trial."
Dr. Virk is an orthopedic surgeon who specializes in the treatment of spine-related issues, specifically using minimally invasive surgical techniques and motion sparing technology. He is also an assistant professor of Orthopedic Surgery at the Donald and Barbara Zucker School of Medicine at Hofstra University.
Northwell Health is New York State's largest health care provider and private employer, with 21 hospitals, 850 outpatient facilities and more than 12,000 affiliated physicians. The partnership will enable Northwell Health to begin active recruitment and enrollment in BioRestorative's clinical trial targeting patients suffering from chronic lumbar disc disease.
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(TM) ): 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 chronic lumbar disc disease.
-- Metabolic Program (ThermoStem(R) ): 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.
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