Cellphire Therapeutics CLPH-511 Receives Fast Track Status

On March 17, 2025, Cellphire Therapeutics, Inc., a biotechnology company focusing on advanced therapeutics derived from platelets, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its product CLPH-511. This product, a frozen activated platelet injectable suspension, aims to treat acute hemorrhage as an alternative to standard platelets, particularly when these are in short supply or unavailable.

The FDA's Fast Track designation is a crucial regulatory pathway intended to accelerate the review and approval process for drugs aimed at serious conditions, fulfilling unmet medical needs. This status allows for more frequent interactions between Cellphire Therapeutics and the FDA, potentially speeding up regulatory approval. Importantly, it also permits a rolling review of the company's Biologics License Application (BLA), meaning that parts of the application can be submitted and reviewed before the entire document is complete. Moreover, the Fast Track designation could lead to Priority Review at the time of BLA submission, provided the clinical data indicate a substantial advancement in safety or efficacy.

Damien Bates, Chief Medical Officer at Cellphire Therapeutics, emphasized the significance of this designation, noting its potential to meet the critical needs in treating acute hemorrhage. The company is eager to work closely with the FDA to ensure CLPH-511 reaches patients swiftly.

Acute hemorrhage is a significant cause of morbidity and mortality in trauma situations, surgical procedures, and critical care environments. Effective management of severe bleeding heavily relies on platelet transfusions, but these are often hampered by logistical issues like their short shelf life and limited supply. CLPH-511 aims to address these challenges by offering a stable, long-duration alternative that can be used in both civilian and military contexts.

Currently, CLPH-511 is under investigation in a Phase 2/3 study named CRYPTICS, which explores the efficacy of this frozen platelet product compared to liquid-stored platelets in patients undergoing cardiopulmonary bypass surgery.

Cellphire Therapeutics is committed to advancing the clinical progress of CLPH-511, capitalizing on the benefits provided by the Fast Track designation to expedite the delivery of this novel treatment to patients in need.

The company, a private entity in the clinical stage of biotechnology development, is dedicated to creating next-generation, allogeneic therapies derived from platelets. Their product lineup includes CLPH-511, a cryopreserved platelet therapy with prolonged shelf life, and CLPH-211, part of the FPH® family of freeze-dried, platelet-based hemostatic agents. Once approved, these technologies are expected to address significant unmet needs in healthcare, particularly for acute bleeding related to surgeries, trauma, and traumatic brain injuries.

The development of the CLPH-511 project is supported by the US Army Medical Research and Development Command, emphasizing the potential applicability of this therapy in military contexts.