US privately-held biotech Cellphire says the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the US 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 II clinical trial in bleeding thrombocytopenic patients.
"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 Michael Fitzpatrick, 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 II 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 Food and Drug Administration for a Phase II clinical trial in surgery.
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