— Amendment replaces saline injections with sham injections in the control group —
MELVILLE, N.Y., April 16, 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 the U.S. Food and Drug Administration ("FDA") has cleared an important amendment to the protocol of the ongoing Phase 2 study investigating the use of BRTX-100, the Company's lead cell therapy candidate, in treating chronic lumbar disc disease ("cLDD"). The protocol amendment removes saline injection in the control arm of the study and replaces it with a sham injection.
"The FDA clearance of this important amendment highlights our positive relationship with the agency, brings additional safety to our subject participants, and helps preclude the possibility of transient clinical outcomes in the control group, which can impact end of study readouts," said Lance Alstodt, BioRestorative's Chief Executive Officer. "To further clarify, control patients in our Phase 2 clinical trial will now have a needle placed in close proximity to the target disc, but the disc will not be pierced, nor will it have saline injected into it. This positive change in our protocol will not have any impact from a timing perspective, affirming our already established 2024 enrollment completion target."
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.
About BioRestorative Therapies, Inc.
BioRestorative Therapies, Inc. () 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.
— 修正案在對照組中用假注射代替鹽水注射 —
紐約州梅爾維爾,2024年4月16日(GLOBE NEWSWIRE)——專注於幹細胞療法的臨床階段公司BioRestorative Therapies, Inc. (“BioRestorative”、“BRTX” 或 “公司”)(納斯達克股票代碼:BRTX)今天宣佈,美國食品藥品監督管理局(“FDA”)已批准對正在進行的調查該用途的2期研究協議的重要修正案該公司治療慢性腰椎間盤疾病(“cldD”)的主要候選細胞療法 BRTX-100。該方案修正案取消了研究對照組中的鹽水注射,取而代之的是假注射。
BioRestorative首席執行官蘭斯·阿爾斯托特表示:“美國食品藥品管理局對這項重要修正案的批准凸顯了我們與該機構的積極關係,爲我們的受試者帶來了額外的安全性,並有助於排除對照組出現短暫臨床結果的可能性,這可能會影響研究的結束結果。”“爲了進一步澄清,在我們的2期臨床試驗中,對照患者現在將在靶椎間盤附近放置一根針頭,但椎間盤不會被刺穿,也不會向其注射鹽水。從時間角度來看,我們協議的這一積極變化不會產生任何影響,這肯定了我們已經確定的2024年入學完成目標。”
BRTX-100 是一種基於細胞的新型治療藥物,旨在靶向血流較少的身體部位,是該公司的主要臨床候選藥物。一項前瞻性、隨機、雙盲和對照研究正在評估 BRTX-100 治療 cLDD 的安全性和有效性。共有99名符合條件的受試者將在美國多達16個臨床場所入組。該試驗中包括的受試者將以 2:1 的比例隨機分配,接受 BRTX-100 或安慰劑。
關於BioRestorative Therapies, Inc.
BioRestorative Therapies, Inc. () 使用細胞和組織方案開發治療產品,主要涉及成體幹細胞。如下所述,我們的兩個核心項目與椎間盤/脊柱疾病和代謝障礙的治療有關:
• 椎間盤/脊柱計劃(BRTxDisc):我們的主要候選細胞療法 BRTX-100 是由從患者骨髓中收集的自體(或個人自身)培養的間充質幹細胞配製而成的產品。我們打算將該產品用於非手術治療腰骶椎間盤疼痛性疾病或作爲外科手術的補充療法。BRTX-100 生產過程採用專有技術,包括收集患者的骨髓、從骨髓中分離和培養幹細胞以及對細胞進行冷凍保存。在門診手術中,醫生應將 BRTX-100 注射到患者受損的椎間盤中。該治療適用於未通過非侵入性手術緩解疼痛且可能面臨手術前景的患者。我們已經開始一項使用 BRTX-100 治療由椎間盤退行性疾病引起的慢性下背部疼痛的 2 期臨床試驗。
• 代謝計劃(ThermoStem):我們正在開發一種基於細胞的候選療法,使用棕色脂肪(脂肪)衍生幹細胞生成棕色脂肪組織(“BAT”),針對肥胖和代謝障礙。BAT 旨在模仿天然存在的調節人類代謝動態平衡的棕色脂肪庫。初步的臨床前研究表明,動物體內棕色脂肪含量的增加可能是卡路里燃燒量增加以及葡萄糖和脂質水平降低的原因。研究人員發現,棕色脂肪含量較高的人患肥胖和糖尿病的風險可能會降低。