FDA grants Carmell Therapeutics Expedited Review for CT-101, Bone Healing Accelerant

Carmell to begin enrolling in pivotal clinical program for first-of-its-kind Plasma-based Bioactive Material product used in long-bone fractures as an adjunctive treatment

PITTSBURGH, PA, USA I April 27, 2020 ICarmell 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 week has granted Fast Track designation for the Company’s first product, a Bone Healing Accelerant (BHA). The Fast Track designation provides the company benefits in expediting and accelerating the company’s lead program to the goal of a Biologic License Application (BLA) approval.

“Receiving expedited review allows for more frequent meetings with FDA to discuss our biologic's development plan reducing risk throughout our development process,” said Stephanie Kladakis, Ph.D., Carmell’s Chief Scientific Officer. “Also this Fast Track designation allows for a rolling review for our Biologic License Application (BLA), which means that Carmell® can submit sections of our BLA package for review by FDA as they are completed, rather than waiting until the entire application is complete as is usually required. This rolling review process allows for a significantly shorter period for approval after clinical trial completion.”

“Fast Track expedited review is awarded to aid in the development and expedite regulatory review of therapies which show promise in treating a serious or life-threatening medical condition and that address an unmet medical need” said James Hart, MD, Carmell’s Chief Medical Officer. “We are pleased to have reached this agreement with FDA.”

In December, U.S. Food and Drug Administration (FDA) 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).

“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,” said Donna Godward, Carmell Therapeutics’ Chief Quality Officer.

“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 Godward.

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.

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 product safety and that bioactive regenerative factors are delivered as the product degrades allowing for optimal healing. Carmell currently has two PBM products in development – a Bone Healing Accelerant and a 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 transformational biologic will have significant impact on important therapeutic areas with many unmet clinical needs such as trauma fixation healing, spine fusion, sports medicine, dental bone regrowth, wound care, aesthetic medicine and animal health. For more information, please visit www.carmellrx.com

SOURCE: Carmell Therapeutics

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