Carmell Therapeutics Announces Publication of Results of Pre-Clinical Studies on its Tissue Healing Accelerant for the Treatment of Cutaneous Radiation Injury

Carmell Therapeutics, a pioneer in the development and commercialization of innovative Plasma-based Bioactive Materials (PBMs) to accelerate bone and soft tissue healing, today announced the publication of findings that characterize the effectiveness of its plasma-based biomaterials for tissue wound healing in the journal Wound Repair and Regeneration published in association with the Wound Healing Society. The study evaluated the use of plasma-based biomaterials for the mitigation of acute and late toxicity for cutaneous radiation injury (CRI) in mouse models. The data indicated more complete wound resolution, as shown by weekly imaging, when compared to the control group, demonstrating that plasma-based biomaterials were effective at promoting wound closure.

Cutaneous wounds caused by an exposure to high doses of ionizing radiation remain a therapeutic challenge, with no current off-the-shelf treatments proven to promote the repair of the damaged tissue, said Randy Hubbell, CEO of Carmell Therapeutics, the supplier of the plasma-based biomaterials used in the study. This pre-clinical study, using our Tissue Healing Accelerant PBM technology, demonstrated that PBMs may be used to help stimulate wound healing of cutaneous tissue following an acute exposure to a high dose of radiation. The results are promising and we look forward to additional investigations to help realize the potential of PBMs to treat these challenging wounds.

The study, Plasma-based biomaterials for the treatment of cutaneous radiation injury, was authored by researchers at Department of Radiation Oncology, Comprehensive Cancer Center, Ohio State University; Center for Biostatistics, Ohio State University; and Carmell Therapeutics. Weekly imaging demonstrated more complete wound resolution in the plasma-based biomaterial vs. vehicle group which became statistically significant (p < 0.05) at weeks 12, 13, and 14 post-maximum wound area.

We were impressed with these results and are planning more studies in larger animals to build on the existing evidence of PBMs ability to accelerate healing after radiation injury, said Naduparambil K. Jacob, PhD at Ohio State University. We believe there is still opportunity for even greater impact for the treatment of CRI using PBMs with further modifications to the dosing, formulation and delivery mechanism.

About Carmell Therapeutics Plasma-based Bioactive Materials Carmells proprietary Plasma-based Bioactive Materials (PBMs) are made from allogenic, platelet enriched plasma, which contains a concentration of growth factors that naturally stimulate wound repair. Our PBMs can be manufactured in a variety of forms, including flexible sheets, powders, pastes, and putties, and their biodegradation rates can be fine-tuned for controlled release of bioactivity spanning weeks to months. Carmells unique manufacturing process retains the biological activity of the blood plasma, such that the biomaterial will release natural blood plasma-derived growth factors (e.g., insulin-like growth factor [IGF-1], platelet-derived growth factor (PDGF), vascular endothelial growth factor, and others) into the tissue site.

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Carmells first-in man clinical trial of a putty form of PBM for the repair of open tibia fractures was completed in South Africa. The study demonstrated that treatment with PBM improved bone healing at 6 months, demonstrating statistically significant fewer infections compared to the control group and trending for accelerated soft tissue healing around the tibia. These data indicate the efficacy of PBMs for soft tissue healing as well as infection reduction, which are both directly applicable to wound healing.

About Carmells 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 time-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. Carmells novel approach takes allogenic, whole platelet-rich 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. This groundbreaking technology can be applied to address tremendous unmet need across orthopedics, soft tissue healing, burn, dermatology and other aspects of medicine. For more information, please visit www.carmellrx.com.

LaVoieHealthScience
Anthony Karamourtopoulos
O: 617-374-8800
x104
M: 617-792-3540
[email protected]