Cellphire, Inc., the global leader in long-term stabilization and storage of platelets, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to start a Phase 2 clinical trial of Thrombosomes in bleeding patients with thrombocytopenia.
In July 2019, Cellphire successfully completed a Phase I clinical trial of its lead product, Thrombosomes, 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 objective of the multicenter Phase 2 study is 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).
“We are very excited to have FDA approval of our Phase 2 clinical trial,” said G. Michael Fitzpatrick, Ph.D., Cellphire’s President. “Thrombosomes have the potential to increase the availability of a platelet-based hemostatic product throughout the United States, especially when standard liquid platelets are not available. The product’s 3-year shelf life and ease of storage could allow for stockpiling, which supports national preparedness for times of potential shortages.”
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 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.
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