Cellphire Therapeutics announces CRYPTICS Phase 2/3 Clinical Study Final Topline Results
- CRYPTICS study met the primary efficacy endpoint measure, 24-hour chest tube drainage (Difference in LS Means was 142.0 mL; 95.576% confidence interval of volume difference lower than noninferiority margin)
- Sensitivity analyses of the primary endpoint were consistent and supportive
- Comprehensive review of the study efficacy data based on clinically relevant secondary endpoints further supports noninferiority of CLPH-511 to room temperature platelets
- Adverse events were well balanced between the two treatment groups.
ROCKVILLE, Md., Oct. 01, 2025 (GLOBE NEWSWIRE) -- Cellphire Therapeutics, Inc., a clinical stage biotechnology company developing next-generation allogeneic, platelet-derived, cellular therapeutics, today announced that it has received the final topline results from its CRYPTICS clinical study and is pleased to report that it met the study’s primary efficacy endpoint.
To address a US public health crisis caused by platelet shortages, Cellphire is developing CLPH-511 (Frozen (Activated) Platelets) Injectable Suspension for the treatment of acute hemorrhage as an alternative to room-temperature platelets. Hemorrhage is a leading cause of preventable death in the United States- responsible for nearly 40% of early trauma-related mortality of civilians less than 65 years (Kauvar & Wade, 2005; Sauaia et al., 1995)and approximately 90% of potentially survivable deaths in combat (Eastridge et al., 2012). Each year, hemorrhage accounts for more than 60,000 deaths nationwide and remains the number one cause of preventable deaths in the US for individuals under 45 years of age. Behind these statistics are thousands of families and communities devastated by sudden, avoidable loss. Platelet shortages further exacerbate this crisis, leaving patients without timely, life-saving interventions.
The CRYPTICS study was a Phase 2/3 adaptive design study, titled “Randomized Controlled Trial Comparing Dimethyl Sulfoxide Cryopreserved Platelets to Liquid Stored Platelets in Patients Undergoing Cardiopulmonary Bypass Surgery” (CRYPTICS - NCT04709705) that investigated the use of CLPH-511 in acute hemorrhage.
The completion of this trial represents a significant milestone for Cellphire’s clinical program and advancement of our platelet therapeutics portfolio. The company is now preparing for its End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA). “This is an important step in advancing our platelet-based platform,” said Damien Bates, Chief Medical Officer of Cellphire Therapeutics. “We look forward to discussing these important results with the FDA.”
"Topline data will be presented at the upcoming 2025 AABB Annual Meeting in San Diego by Dr. Glenn Whitman of Johns Hopkins Medical Institute during the Educational Session, Update on the Use of Cryopreserved Platelets in Acute Surgical Settings, scheduled for Sunday, October 26, 2025.”
Cellphire Therapeutics will continue to advance the clinical development of CLPH-511, leveraging the benefits of the product Fast Track and Medical Priority Product designations to bring this innovative therapy to patients as quickly and efficiently as possible.
For more information on the CRYPTICS study, visit here.
About Cellphire Therapeutics
Cellphire Therapeutics, Inc.’s vision: No one should die from controllable hemorrhage. A private, clinical stage biotechnology company developing next-generation, allogeneic, 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 needs across various clinical settings including acute bleeding associated with surgery, trauma and traumatic brain injury. For more information, visit www.Cellphire.com.
This CPP Project is supported by the US Defense Health Agency Contract Activity (DHACA) 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 Defense position, policy or decision unless so designated by other documentation.
Citations:
Eastridge BJ, Mabry RL, Seguin P, Cantrell J, Tops T, Uribe P, Mallett O, Zubko T, Oetjen-Gerdes L, Rasmussen TE, Butler FK, Kotwal RS, Holcomb JB, Wade C, Champion H, Lawnick M, Moores L, Blackbourne LH. Death on the battlefield (2001-2011): implications for the future of combat casualty care. J Trauma Acute Care Surg. 2012 Dec;73(6 Suppl 5):S431-7. doi: 10.1097/TA.0b013e3182755dcc. Erratum in: J Trauma Acute Care Surg. 2013 Feb;74(2):706. Kotwal, Russell S [corrected to Kotwal, Russ S]. PMID: 23192066
Kauvar, D. S., & Wade, C. E. (2005). The epidemiology and modern management of traumatic hemorrhage: Us and international perspectives. Critical Care (London, England), 9(Suppl 5), S1-9. https://doi.org/10.1186/cc3779
Sauaia, A., Moore, F. A., Moore, E. E., Moser, K. S., Brennan, R., Read, R. A., & Pons, P. T. (1995). Epidemiology of trauma deaths: A reassessment. The Journal of Trauma, 38(2), 185–193. https://doi.org/10.1097/00005373-199502000-00006
Contact:
Robert Woods
VP, Business Operations
(240) 268-2469
rwoods@cellphire.com
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