Rockville, Md. (February 18, 2025) – Cellphire Therapeutics, Inc., a clinical stage biotechnology company developing next-generation platelet-derived therapies, today announced the completion of its 150 subject enrollment milestone triggering initiation of the pre-specified interim analysis for the CRYPTICS (Cryopreserved Platelet Trial for Control of Bleeding in Surgery) clinical study (NCT04709705). This pivotal study is evaluating the safety and efficacy of CLPH-511, Cellphire’s investigational cryopreserved platelet product (CPP), for the treatment of uncontrolled hemorrhage in patients undergoing cardiopulmonary bypass surgery.
The CRYPTICS S-16-15 study, a multi-center, randomized, controlled trial, represents a significant step forward in advancing innovative solutions for bleeding management. By reaching this milestone, Cellphire is progressing toward its goal of providing a platelet alternative product with a significantly extended shelf life that may expand access to critical care for patients worldwide.
“The completion of this enrollment milestone brings us a step closer to a transformative solution for patients in need of an alternative safe and effective platelet-based therapy,” said Dr. Damien Bates, Chief Medical Officer of Cellphire Therapeutics. “We are encouraged by the progress of the CRYPTICS study and remain committed to addressing the challenges associated with platelet shortage and wastage.”
The upcoming interim analysis will assess whether the study can be stopped for overwhelming efficacy or if an increase in sample size is warranted to maintain desired conditional power. Cellphire will continue patient enrollment and data collection for the study during this period, with full results expected upon trial completion. The company looks forward to sharing further updates as it advances the development of CPP and other platelet-derived technologies.
For more information on the CRYPTICS study, visit ClinicalTrials.gov.
About Cellphire Therapeutics
Cellphire Therapeutics, Inc.’s vision: No one should die from controllable hemorrhage. A private, clinical stage biotechnology company developing next-generation platelet-derived therapies, Cellphire has a portfolio of platelet-derived biologics including two assets in clinical development: its late-stage biologic CLPH-511, a cryopreserved platelet (CPP) therapy with extended shelf life, and CLPH-211, part of the FPH® family of freeze-dried, platelet-derived hemostatic agents. Once approved, Cellphire’s differentiated technologies will address significant unmet health system and medical unmet needs across various clinical settings including acute bleeding associated with cardiac surgery, trauma and traumatic brain injury. For more information, visit www.Cellphire.com.
This CPP Project is supported by the US 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.
Contact:
Robert Woods
Vice President, Business Operations
(240) 268-2469