Latest news with #CellphireTherapeutics
Yahoo
23-04-2025
- Business
- Yahoo
Cellphire Therapeutics halts enrolment in trial of CLPH-511 after IDMC feedback
US-based biotechnology company Cellphire Therapeutics has stopped enrolling subjects in its CRYPTICS trial of CLPH-511 following feedback from an independent data monitoring committee. The feedback was given on pre-planned interim analysis of safety and efficacy data from more than 150 subjects, indicating positive outcomes. The CRYPTICS trial is assessing CLPH-511, an investigational cryopreserved platelet product designed for treating uncontrolled haemorrhage in individuals who are undergoing cardiopulmonary bypass surgery. It has reportedly achieved its primary efficacy endpoint of 24-hour chest tube drainage, demonstrating CLPH-511's statistical non-inferiority compared with the standard room temperature control platelet product, with a one-sided significance level lower than p-value 0.00965. Cellphire described the results as a 'significant step forward' in the development of bleeding management solutions, helping the company meet its aim of offering a long-shelf-life platelet alternative to improve access to essential care worldwide. With the end of subject enrolment, the company anticipates the final trial visits and the collection of data by the second quarter of this year. It expects to provide further updates as it continues to develop cryopreserved platelet products and other technologies derived from platelets. Cellphire Therapeutics chief medical officer Dr Damien Bates said: '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 haemorrhage. 'We are encouraged by the progress of the CRYPTICS study and remain committed to addressing the challenges associated with platelet shortage and wastage.' The development of CLPH-511 is being supported by the US Army Medical Research and Development Command under Contract W81XWH20C0030. Based in Maryland, Cellphire develops platelet-derived therapies to address critical needs in acute bleeding during cardiac surgery, traumatic brain injuries, trauma and other clinical scenarios. In addition to CLPH-511, the company's portfolio includes CLPH-211, a platelet-derived, freeze-dried haemostatic agent. "Cellphire Therapeutics halts enrolment in trial of CLPH-511 after IDMC feedback" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Associated Press
17-03-2025
- Business
- Associated Press
Cellphire Therapeutics CLPH-511 Fast Track Designation Granted
ROCKVILLE, Md., March 17, 2025 (GLOBE NEWSWIRE) -- Cellphire Therapeutics, Inc., a clinical stage biotechnology company developing next-generation allogeneic, platelet-derived, cellular therapeutics, today announced 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 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 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
