- CRYPTICS study met the primary efficacy endpoint to demonstrate statistical non-inferiority of the cryopreserved CLPH-511 platelet product to the standard of care room temperature control platelet product (RTP) with a one-sided significance level less than p-value 0.00965.
- Based on IDMC feedback, after assessing efficacy and safety data of over 150 subjects, CRYPTICS will be stopped early.
ROCKVILLE, Md., April 22, 2025 (GLOBE NEWSWIRE) -- Cellphire Therapeutics, Inc., a clinical stage biotechnology company developing next-generation platelet-derived therapies, today announced receipt of feedback from the (IDMC) on the pre-planned interim analysis of its CRYPTICS (Cryopreserved Platelet Trial for Control of Bleeding in Surgery) clinical study (NCT04709705). This 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 outcome of the interim analysis brings us a step closer to having a widely available alternative to conventional platelets for the treatment of acute hemorrhage,” 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.”
Completion of the CRYPTICS S-16-15 study, a multi-center, randomized, controlled trial, represents a significant step forward in advancing innovative solutions for bleeding management. Based on the feedback received from the IDMC, Cellphire will stop enrollment early for efficacy. This decision was based on a pre-planned interim analysis of efficacy and safety data in over 150 subjects. The CRYPTICS study met the primary efficacy endpoint of 24-hour chest tube drainage to demonstrate statistical non-inferiority of the cryopreserved CLPH-511 platelet product to the standard room temperature control platelet product (LSP) with a one-sided significance level less than p-value 0.00965.
“The early completion of this study is an important milestone in getting life-saving platelet treatments to treat traumatic injuries,” said Congressman John “Judge” Carter (TX-31). “I’m proud to see Cellphire making real progress on a product that can help our wounded warfighters and civilians alike – while also tackling nationwide platelet shortages and reducing waste in the system.”
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, earlier than anticipated.
The CRYPTICS trial is now closed for recruitment, with final study visits and data collection anticipated during the second quarter of 2025.
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
rwoods@cellphire.com
