Cell therapies firm Cytori won a potentially $106 million contract from the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) for preclinical and clinical development of its cell therapy for treating thermal burns combined with radiation injury. The treatment uses autologous adipose-derived stem and regenerative cells (ADRCs) processed using Cytori’s Celution® System platform.
The contract is for a two-year base period, extendable to up to five years, and will support all preclinical, clinical, regulatory, and technology activities required to take the cell therapy through FDA approval via a device-based PMA regulatory route. Cytori will receive about $4.7 million to support the first two years of work, including preclinical research and further development of the Celution System to improve cell processing. BARDA will review the program at specified milestones.
“This relationship with the U.S. government will facilitate development of our cell therapy for thermal burns, which could then serve as an important new path to market for soft tissue indications in the U.S.," comments Christopher J. Calhoun, Cytori’s CEO. Additionally, the findings under this contract will complement our existing efforts to develop cell therapies for a range of wound-healing applications outside the scope of this contract.”
Cytori is focused on developing ADRC-based cell therapies, primarily for the treatment of cardiovascular disease and soft tissue. The cells are processed using the Celution System and then delivered back into the patient. The system has been CE marked in Europe for breast reconstruction, Crohn’s wound healing, and other soft tissue applications including cryptoglandular fistula. Earlier this month the Japanese authorities gave the go-ahead for a clinical study evaluating the use of ADRCs processed by the Celution System in patients with peripheral artery disease, or arteriosclerosis obliterans. At the start of this year Cytori received Investigational Device Exemption (IDE) approval from FDA to start its first U.S. study, designated Athena, evaluating Celution System ADRCs in the treatment of chronic myocardial ischemia.