ROCKVILLE, Md. (DATE) – Cellphire Therapeutics, Inc., a biotechnology company developing next-generation platelet-based hemostatic therapeutics for application across multiple medical indications, announced today that the first patient has been dosed in the company’s Phase 2 dose-ranging study of Thrombosomes®, a platelet-based freeze-dried hemostatic agent, in bleeding patients with thrombocytopenia. The study will evaluate the safety and efficacy of infusing multiple dose levels of Thrombosomes versus standard liquid stored platelets.
“Today’s announcement represents a significant milestone in the advancement of Thrombosomes toward approval,” said G. Michael Fitzpatrick, Ph.D., Chief Scientific Officer. “We are excited to have dosed the inaugural patient in our Phase 2 clinical trial. We believe Thrombosomes, a next generation platelet-based product, have the potential to stop bleeding rapidly and, due to their long shelf life of three years, ensure availability to all patients.”
Thrombosomes are lyophilized (freeze-dried) activated platelets. Unlike standard liquid platelets that can only be stored for five to seven days after collection, Thrombosomes can be stored for up to three years at ambient temperatures. The product is reconstituted in minutes by adding sterile water.
The objective of this Phase 2 clinical trial 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). The company expects to enroll 160 volunteers in the study across multiple trial sites in North America and in Norway and Israel.
About Cellphire Therapeutics
Cellphire Therapeutics, Inc. is a biotechnology company developing next-generation platelet-based therapeutics. The company is applying its proprietary cell stabilization technology to platelets, to develop lifesaving products. Its lead investigational product is Thrombosomes®, a freeze-dried hemostatic derived from human platelets. Cellphire is expanding its technology portfolio to include a wide range of potential medical applications from trauma to wound care, imaging, targeted drug delivery, and regenerative medicine. For more information, visit www.cellphire.com.
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 number HHSO100201300021C.
The work on CPP is supported by the U.S. Army Medical Research and Development Command under Contract No. W81XWH20C0030.
The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation.
VP, Strategy & Investor Relations, Corporate Secretary