21 Apr, 2020, 14:06 ET
ROCKVILLE, Md., April 21, 2020 /PRNewswire/ -- Cellphire, Inc., the global leader in long-term stabilization and storage of platelets, announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, has exercised its third contract option valued at $33.3 million to support Cellphire's next generation platelet-based hemostatic product, Thrombosomes®, through a Phase 2 clinical trial in bleeding thrombocytopenic patients. The option was exercised under the company's multi-year contract with BARDA, valued up to $82.6 million, to advance the development of freeze-dried platelets for disaster response.
"The continued funding commitment from BARDA is a testament to the government's foresight and recognition of the potential of Thrombosomes to stop bleeding and be readily available at all treatment levels to secure the nation's blood supply," said G. Michael Fitzpatrick, Ph.D., President of Cellphire. "In partnering with BARDA, we have developed a product that could be stockpiled to potentially alleviate shortage or critical supply situations occurring during natural disasters, radiological accident or attack, or pandemics like COVID-19. We look forward to continuing our partnership with BARDA and bringing Thrombosomes through to FDA approval."
Option 3 of the BARDA contract supports Cellphire's Phase 2 trial in thrombocytopenic patients, as well as the scaling up of manufacturing and pre-clinical studies that are required to submit an additional investigational new drug (IND) application to FDA for a Phase 2 clinical trial in surgery.
In March, Cellphire received approval from the FDA to begin its Phase 2 clinical trial of Thrombosomes to evaluate the safety and efficacy of infusing multiple doses of Thrombosomes in bleeding patients with thrombocytopenia due to primary bone marrow disorders or chemotherapy, immunotherapy radiation therapy, and/or refractory response to fresh platelet concentrate transfusion with or without splenomegaly (enlarged spleen).
BARDA contracted with Cellphire in 2013. The multi-year contract includes a 3-year base performance period (2013-2016) and three option periods. The contract also includes an Option 4, which could be funded to support an additional clinical trial to treat surgical bleeding.
Thrombosomes is a platelet-based freeze-dried hemostatic. Utilizing its patented technology to stabilize and freeze-dry platelets, Cellphire is developing next-generation therapeutics to treat bleeding patients. Standard liquid platelets only have a 5- to 7-day shelf life, making inventory management difficult and can lead to widespread platelet shortages during public health emergencies. By contrast, Thrombosomes have a 3-year shelf life.
The Thrombosomes project has been funded in whole or in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201300021.
Cellphire, Inc. is a biotechnology company developing next-generation therapeutics. The company is applying its proprietary cell stabilization technology to all cell types, including platelets, to develop lifesaving products. Its lead product is Thrombosomes®, a freeze-dried hemostatic derived from human platelets. Cellphire's technology has potential applications across a wide range of medical applications from trauma to wound care, imaging, targeted drug delivery, and regenerative medicine. For more information, visit www.cellphire.com.
SOURCE Cellphire Inc.
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