Carmell Therapeutics, a pioneer in the development and commercialization of innovative Plasma-based Bioactive Materials (PBMs) to accelerate bone and soft tissue healing, announced that the U.S. Food and Drug Administration (FDA) last month has cleared the company’s Investigational New Drug application (IND) for the Company’s first product, a Bone Healing Accelerant (BHA). This IND clearance enables Carmell® to begin enrolling patients in a pivotal study for long bone fractures to support a Biologics License Application (BLA).
“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.
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