– Blinded preliminary knowledge display a constructive pattern and clear sign in Major and Secondary endpoints –
– Affected person reported efficacy outcomes present a cloth lower in ache and improve in perform –
– If constructive developments proceed, Firm assured that the Section 2 trial will meet its Major and Secondary finish factors –
– The blinded preliminary BRTX-100 knowledge to be described in a podium presentation this morning on the ORS PSRS seventh Worldwide Backbone Analysis Symposium
– Webcasted convention name additionally scheduled for at the moment at 4:30pm EST –
MELVILLE, N.Y., Nov. 13, 2024 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Firm”) (NASDAQ:BRTX), a medical stage regenerative drugs innovator targeted on stem cell-based therapies and merchandise, at the moment introduced new preliminary 26–52 week blinded knowledge from the primary 10 sufferers with power lumbar disc illness (“cLDD”) enrolled within the ongoing Section 2 medical trial of BRTX-100.
BRTX-100, a novel cell-based therapeutic engineered to focus on areas of the physique which have little blood circulate, is the Firm’s lead medical candidate. The security and efficacy of BRTX-100 in treating cLDD is being evaluated in a Section 2, potential, randomized, double-blinded and managed examine. A complete of as much as 99 eligible topics might be enrolled at as much as 16 medical websites in the US. Topics included within the trial might be randomized 2:1 to obtain both BRTX-100 or placebo.
No critical hostile occasions (SAEs) had been reported in any of the ten security run-in topics. Notably, there was additionally no dose (40X106 cells) limiting toxicity at 26-52 weeks.
Along with the aforementioned preliminary major security endpoint knowledge, the Firm reported blinded medical knowledge on the secondary efficacy endpoint of at the very least a 30% lower in ache as measured on the Visible Analog Scale (“VAS”) and at the very least a 30% improve in perform based mostly on the Oswestry Incapacity Index (“ODI”) at week 52. The blinded preliminary efficacy endpoint knowledge demonstrated:
- At 26 weeks, 70% of topics (n=10) reported a >30% enchancment in VAS versus baseline;
- At 52 weeks, 100% of topics (n=4) reported a >30% enchancment in VAS versus baseline (n=4);
- At 12 and 26 weeks, 70% of topics (n=10) had a >30% enchancment in ODI versus baseline;
- At 52 weeks, 100% of topics (n=4) had a >30% enchancment in ODI versus baseline; and
- At 26 weeks, 70% of topics (n=10) reported a >30% lower in ache (VAS) and a >30% improve in perform (ODI).
“Blinded preliminary medical knowledge of security and efficacy endpoints from the continued Section 2 medical trial of BRTX-100 within the therapy of cLDD are very encouraging, with affected person reported ache and performance outcomes demonstrating a constructive pattern,” mentioned Lance Alstodt, Chief Govt Officer of BioRestorative. “Most significantly, at 26 weeks 70% of the sufferers are reporting a higher than 30% improve in perform and a greater than 30% lower in ache. If knowledge continues with this pattern, we’re assured that we’ll hit our efficacy finish factors for the Section 2 trial.”
This new blinded preliminary security and efficacy knowledge from the continued Section 2 medical trial of BRTX-100 might be described in podium presentation later at the moment on the Orthopaedic Analysis Society (ORS) Philadelphia Backbone Analysis Society (PSRS) 7th Worldwide Backbone Analysis Symposium, happening in Skytop, Pennsylvania. BioRestorative administration may even host a webcasted convention name with an related slide presentation at the moment at 4:30pm EST to evaluation the BRTX-100 knowledge, in addition to evaluation its third quarter 2024 monetary outcomes and supply a enterprise replace.
Convention Name & Webcast Particulars
To affix the convention name through telephone and take part within the stay Q&A session, please dial 877-545-0320 (United States) or 973-528-0002 (Worldwide), participant entry code 823128. The stay webcast (with slides) and audio archive of the presentation could also be accessed on the investor part of the BioRestorative web site at https://www.biorestorative.com/investor-relations/. An archived replay might be accessible for roughly 90 days following the occasion.
About BioRestorative Therapies, Inc.
BioRestorative (www.biorestorative.com) develops therapeutic merchandise utilizing cell and tissue protocols, primarily involving grownup stem cells. As described beneath, our two core medical improvement packages relate to the therapy of disc/spine illness and metabolic problems, and we’ve additionally lately begun providing BioCosmeceutical merchandise:
• Disc/Backbone Program (brtxDISC™): Our lead cell remedy candidate, BRTX-100, is a product formulated from autologous (or an individual’s personal) cultured mesenchymal stem cells collected from the affected person’s bone marrow. We intend that the product might be used for the non-surgical therapy of painful lumbosacral disc problems or as a complementary therapeutic to a surgical process. The BRTX-100 manufacturing course of makes use of proprietary expertise and includes gathering a affected person’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient process, BRTX-100 is to be injected by a doctor into the affected person’s broken disc. The therapy is meant for sufferers whose ache has not been alleviated by non-invasive procedures and who probably face the prospect of surgical procedure. We’ve commenced a Section 2 medical trial utilizing BRTX-100 to deal with power decrease again ache arising from degenerative disc illness.
• Metabolic Program (ThermoStem®): We’re creating cell-based remedy candidates to focus on weight problems and metabolic problems utilizing brown adipose (fats) derived stem cells (“BADSC”) to generate brown adipose tissue (“BAT”), in addition to exosomes secreted by BADSC. BAT is meant to imitate naturally occurring brown adipose depots that regulate metabolic homeostasis in people. Preliminary preclinical analysis signifies that elevated quantities of brown fats in animals could also be accountable for extra caloric burning in addition to lowered glucose and lipid ranges. Researchers have discovered that individuals with larger ranges of brown fats could have a lowered danger for weight problems and diabetes. BADSC secreted exosomes may influence weight reduction.
• BioCosmeceuticals: We function a business BioCosmeceutical platform. Our present business product, formulated and manufactured utilizing our cGMP ISO-7 licensed clear room, is a cell-based secretome containing exosomes, proteins and development components. This proprietary biologic serum has been particularly engineered by us to scale back the looks of superb traces and wrinkles and produce forth different areas of beauty effectiveness. Shifting ahead, we additionally intend to discover the potential of increasing our business providing to incorporate a broader household of cell-based biologic aesthetic merchandise and therapeutics through Investigational New Drug (IND)-enabling research, with the intention of pioneering U.S. Food and Drug Administration (FDA) approvals within the rising BioCosmeceuticals area.
Ahead-Trying Statements
This press launch incorporates “forward-looking statements” inside the which means of Part 27A of the Securities Act of 1933, as amended, and Part 21E of the Securities Change Act of 1934, as amended, and such forward-looking statements are made pursuant to the secure harbor provisions of the Personal Securities Litigation Reform Act of 1995. You’re cautioned that such statements are topic to a mess of dangers and uncertainties that would trigger future circumstances, occasions or outcomes to vary materially from these projected within the forward-looking statements on account of varied components and different dangers, together with, with out limitation, these set forth within the Firm’s newest Type 10-Okay, as amended, and Type 10-Q filed with the Securities and Change Fee. It is best to take into account these components in evaluating the forward-looking statements included herein, and never place undue reliance on such statements. The forward-looking statements on this launch are made as of the date hereof and the Firm undertakes no obligation to replace such statements.
CONTACT:
Stephen Kilmer
Investor Relations
Direct: (646) 274-3580
Electronic mail: skilmer@biorestorative.com
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