Cellphire Completes Enrollment of Phase 1 Clinical Trial of Thrombosomes®

July 18, 2019 – Cellphire, Inc., the global leader in long-term cell stabilization and storage of platelets and other cells, announced today that the company completed enrollment of its Phase 1 clinical trial to evaluate Thrombosomes® in bleeding, thrombocytopenic patients. Thrombosomes is a freeze-dried hemostatic agent derived from human platelets.

“The success in completing enrollment in our clinical trial is critical to advancing next-generation platelet-based therapeutics to treat bleeding patients,” said G. Michael Fitzpatrick, Ph.D., President. “Currently, clinicians rely on donated platelets that have a shelf life of just 5 days. We believe that Thrombosomes, which have a shelf life of 3 years, have the potential to help advance clinical practice and save lives.”

The purpose of this multi-center, open-label study is to evaluate, in a dose-escalation manner, the safety and preliminary impact on bleeding and the preliminary effect on coagulation measures of increasing doses of allogeneic Thrombosomes in thrombocytopenic patients. For more information about this study, please visit ClinicalTrials.gov (Identifier: NCT03394755).

Cellphire completed an exploratory Phase I clinical trial that evaluated the safety of autologous Thrombosomes in healthy subjects in 2016. Safety data from that study supported the approval the current trial. Results were published in Transfusion, Vol. 58, December 2018.

This 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. HHSO100201300021C.

 

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About Cellphire

Cellphire, Inc. is a Rockville, Maryland-based 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, Thrombosomes®, a freeze-dried hemostatic agent derived from human platelets, is currently in a Phase I clinical trial. 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

Cautionary Note Regarding Forward-Looking Statements 

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words, such as “anticipated,” “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Cellphire’s current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, increased regulatory requirements, Cellphire’s reliance on third parties over which it may not always have full control, and others. Any forward-looking statements speak only as of the date of this press release and are based on information available to Cellphire as of the date of this release, and Cellphire assumes no obligation to, and does not intend to, update any forward-looking statements, whether because of new information, future events or otherwise.