Carmell Therapeutics Receives IND Clearance for CT-101, Bone Healing Accelerant

Carmell Therapeutics获得CT-101骨愈合促进剂的IND临床实验许可

2020-01-09 10:00:03 BioSpace

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“Receiving IND clearance to begin clinical trials is a key milestone in the development of our groundbreaking regenerative medicine platform technology,” said Randy Hubbell, Carmell Therapeutics’ President and CEO. “Carmell Therapeutics is now on a path to be the first company in the bone healing space with a BLA supported by two prospective, randomized, multicenter clinical studies demonstrating superiority to the current standard of care.” “Our IND clearance for our Bone Healing Accelerant, a combination biologic and device product, indicates Carmell has made significant progress in our level of biologic product knowledge, quality system implementation, and manufacturing process validation,” continued Hubbell. “Pursuing a BLA approval for our Bone Healing Accelerant demonstrates Carmell’s commitment to the most robust - and ultimately most commercially valuable - regulatory pathway currently in the orthopedic/wound healing space,” said Hubbell. Carmell’s Bone Healing Accelerant is regulated under the U.S. FDA’s Center for Biologics Evaluation and Research. The FDA accepted the data and the overall study design from the company’s double-arm, multicenter, Phase II clinical trial of Bone Healing Accelerant in open tibia fractures. In this study, BHA demonstrated a significant reduction of infections compared to controls, no adverse reactions, a clear trend towards accelerated wound healing at 30 days, and accelerated bone healing compared to controls. The bone healing acceleration was especially evident for the most severe type IIIA and IIIB open tibia fractures with extensive soft tissue injury. “This IND clearance is significant for us as the rigorous chemistry, controls and product manufacturing (CMC) requirements of the IND submission provide the framework for what will be submitted in the BLA application upon completion of the pivotal studies,” said Stephanie Kladakis, Ph.D., Carmell’s Chief Scientific Officer. “To meet these stringent requirements, our ISO 13485 certified manufacturing facility includes a Class 7 Cleanroom and we have successfully manufactured multiple batches of BHA, which have consistently passed strict finished-product and long-term stability testing.” “Carmell is ready and eager to move into full testing of safety and efficacy of our Bone Healing Accelerant in large, randomized, clinical studies,” said Janet M. Vargo, Ph.D., Carmell’s Vice President of Clinical Sciences. “We will initiate enrollment for the approximately 220-patient study at 25 centers in the United States, Europe, and South Africa.” “I’m thankful to our team of dedicated employees and our distinguished scientific and clinical advisors who have helped us achieve this milestone,” concluded Hubbell. “Our goal is to demonstrate that our Bone Healing Accelerant product, when combined with the current standard of care, can not only accelerate healing, but provide a significant benefit to the patient, while reducing costs for the hospital and the overall healthcare system.” About the trial The multi-region, multicenter, randomized, controlled, blinded study will evaluate the efficacy and safety of Carmell Therapeutics’ Bone Healing Accelerant versus standard of care in subjects when applied to tibia (leg bone) fractures with an external wound or skin break (also called open tibia fractures). The study is expected to enroll about 220 patients in 25 centers across the United States, Europe, and South Africa. Open tibia fractures were chosen for this study because healing rates are typically longer than for other bone fractures due to the limited vascular supply, limited soft tissue coverage, and higher risk of infection. BHA active ingredients include blood-derived components and beta-tricalcium phosphate. It is applied directly to the bone fracture and nearby viable bone at the time of wound closure. For more information, visit: https://clinicaltrials.gov/ct2/show/NCT04056429?term=bone+healing+accelerant&rank=2 or contact BHA-U31@carmellrx.com. About Carmell’s PBM Technology Platform Carmell Therapeutics’ unique PBM technology platform can be delivered in multiple formats to the site of injury – from putties to pastes to surgical screws. A proprietary manufacturing process ensures safety and that bioactive regenerative factors are delivered in a controlled-released manner for optimal healing. Carmell currently has two PBM products in development – a Bone Healing Accelerant and Tissue Healing Accelerant. About Carmell Therapeutics Carmell Therapeutics (Carmell) is addressing the burden of bone and tissue healing with its proprietary Plasma-based Bioactive Materials (PBM) technology, designed to improve patient outcomes and reduce health care costs. Carmell’s novel approach takes whole platelet enriched plasma, processes it in a manner that retains its regenerative properties, and delivers it to the injured site in a controlled-release capacity for faster, more effective healing. For more information, please visit www.carmellrx.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20200107005845/en/ For Media Inquires: Randy Hubbell Rhubbell@carmellrx.com (412) 894-1875 Source: Carmell Therapeutics View this news release online at: http://www.businesswire.com/news/home/20200107005845/en
Carmell Therapeutics 总裁兼首席执行官兰迪•哈贝尔( Randy Hubbell )表示:“获得 IND 许可开始临床试验,是我们突破性再生医学平台技术开发的关键里程碑。”“ Carmel Therapeutics 现在正走上一条道路,成为骨愈合领域的第一家公司, BLA 得到了两项前瞻性、随机、多中心临床研究的支持,证明其优于目前的护理标准。” “我们的 IND 核可了我们的骨治疗加速剂,一种生物和设备产品的组合,表明 Carmel 在生物产品知识水平、质量体系实施和制造工艺验证方面取得了显著进步,” Hubbell 继续说。 “通过 BLA 批准我们的骨治疗加重剂,表明 Carmel 致力于目前骨科/伤口愈合领域最健全、最具商业价值的监管途径,” Hubble 说。 Carmel 公司的骨骼治疗项目由美国 FDA 的生物医学评估和研究中心管理。FDA 接受了该公司的双臂、多中心、二期临床试验的数据和整体研究设计。在这项研究中, BHA 显示了一个显着减少感染相比,控制,没有不良反应,一个明显的趋势,加速伤口愈合30天,并加快骨愈合相比,控制。最严重的 IIIA 型和 IIIB 型开放性胫骨骨折伴有广泛的软组织损伤,骨愈合加速尤为明显。 Carmel 首席科学官 Stephanie Kladakis 博士说:“ IND 许可对我们来说意义重大,因为 IND 提交的严格化学、控制和产品制造( CMC )要求为 BLA 申请完成关键研究后提交的内容提供了框架。”“为了满足这些严格的要求,我们通过 ISO 13485认证的制造工厂包括7级清洁工厂,我们成功地生产了多批 BHA ,这些产品始终通过严格的成品和长期稳定性测试。” “ Carmel 已经准备好并渴望在大规模、随机、临床研究中全面测试我们的骨治疗药物的安全性和有效性,” Janet M.Vargo 博士说,他是 Carmel 的临床科学副总裁。“我们将在美国、欧洲和南非的25个中心发起大约220名患者的研究。” “我感谢我们的敬业员工团队和杰出的科学和临床顾问,他们帮助我们实现了这一里程碑,” Hubble 总结道。“我们的目标是证明,结合当前的护理标准,我们的骨愈合加速产品不仅可以加速愈合,而且可以为患者提供显著的好处,同时降低医院和整个医疗保健系统的成本。” 关于审判 多区域、多中心、随机、对照、盲法研究将评估 Carmel Therapeutics ’ Bone Healing Accelert 适用于外伤或皮肤骨折(也称为开放性胫骨骨折)的胫骨(腿骨)骨折患者的疗效和安全性。这项研究预计将在美国、欧洲和南非的25个中心招收大约220名患者。本研究选择胫骨开放性骨折,因为由于血管供应有限、软组织覆盖范围有限以及感染风险较高,骨折的治愈率通常比其他骨折要长。BHA 活性成分包括血源性成分和β-磷酸三钙。它直接应用于伤口闭合时的骨折和附近的活性骨。有关更多信息,请访问: https://临床医学。gov / ct2/ show / NCT04056429?期限=骨+愈合+促进剂&排名=2或联系 BHA-U31@ carmelrx.com 。 关于 Carmel 的 PBM 技术平台 Carmel Therapeutics 独特的 PBM 技术平台可以以多种形式提供到损伤部位——从推杆到贴膜再到手术螺钉。一个专有的制造过程确保安全和生物活性再生因素交付控制释放的方式,以最佳愈合。Carmel 目前有两个 PBM 产品正在开发中——骨治疗加成和组织治疗加成。 关于 Carmel 疗法 Carmel Therapeutics ( Carmel )正在利用其专有的基于血浆的生物活性材料( PBM )技术解决骨和组织愈合的负担,该技术旨在改善患者的预后并降低医疗费用。Carmel 的新方法采用全血小板浓缩血浆,以保留其再生特性的方式进行处理,并以可控释放的能力将其送到受伤部位,以实现更快、更有效的愈合。详情请访问 www.carmelrx.com 。 查看 businesswire 上的源代码。http://www.businesswire.com/news/home/2020010705845/en/ 传媒查询: Randy Hubbell Rhubbell @ carmelrx.com (412)894-1875 资料来源: Carmel 疗法 在线查看本新闻稿,网址为: http://www.businesswire.com/news/home/2020010705845/en

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