Rockville, Md. (March 11, 2025) – Cellphire Therapeutics, Inc., a clinical stage biotechnology company developing next-generation allogeneic, platelet-derived, cellular therapeutics, is excited to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CLPH-511 (Frozen Activated Platelets) Injectable Suspension for the treatment of acute hemorrhage as an alternative to conventional platelets when not available or in short supply.
Fast Track designation, granted under section 506(b) of the Federal Food, Drug, and Cosmetic Act (FDCA), is designed to expedite the development and review of drugs that address serious conditions and have the potential to fill an unmet medical need. The designation allows Cellphire Therapeutics to engage in more frequent communication with the FDA, facilitating a more efficient path toward regulatory approval. Additionally, Fast Track status enables the company to take advantage of rolling review for its Biologics License Application (BLA), which allows submission and review of a portion of the BLA prior to the application being complete. Products with Fast Track Designation could also be eligible for Priority Review at the time of BLA submission, if clinical data demonstrates a significant improvement in safety or efficacy.
“This Fast Track designation recognizes CLPH-511's potential to address the unmet need of acute hemorrhage and Cellphire looks forward to continued collaboration with FDA to get this product to patients that need it as soon as possible”, said Damien Bates, CMO of Cellphire Therapeutics.
Acute hemorrhage remains a leading cause of morbidity and mortality in trauma, surgery, and critical care settings. Platelet transfusions are essential in managing severe bleeding, but logistical challenges, including short shelf life and limited availability, often hinder timely access. CLPH-511, a frozen and activated platelet product, is designed to overcome these limitations by providing a readily available, long-lasting alternative that can be deployed in both civilian and military settings.
The use of CLPH-511 in acute hemorrhage is currently being investigated in 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).
Cellphire Therapeutics will continue to advance the clinical development of CLPH-511, leveraging the benefits of this Fast Track designation to bring this innovative therapy to patients as quickly and efficiently as possible.
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. Cellphire is 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 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
VP, Business Operations
(240) 268-2469
This email address is being protected from spambots. You need JavaScript enabled to view it.