Cellphire Therapeutics, Inc., a biotechnology company developing next-generation pooled allogeneic cellular therapeutics for application across multiple medical indications, announced that the 1st patient has been treated in its Phase 2/3 clinical trial, Randomized Controlled Trial Comparing Dimethyl Sulfoxide (DMSO) Cryopreserved Platelets to Liquid Stored Platelets in Patients Undergoing Cardiopulmonary Bypass Surgery (CRYPTICS). The surgery occurred on March 14th according to Dr. Kenichi Tanaka, Principal Investigator, at University of Oklahoma Health Sciences Center.
Cellphire is developing DMSO cryopreserved platelets (CPP) for treatment of acute hemorrhage in patients with a platelet deficiency or a platelet dysfunction when liquid stored platelets are unavailable. CPP consists of leukocyte reduced, concentrated apheresis platelets with DMSO added before freezing at ≤ -65°C for up to 5 years. Prior to clinical administration, CPP is thawed and resuspended with sterile sodium chloride for injection. After thawing and resuspension, CPP units are stable at room temperature (20°C to 24°C) for up to 8 hours.
Launched in Q3 2021, this randomized, adaptive Phase 2/3 clinical trial requires a minimum of 200 patients undergoing coronary artery bypass graft (CABG) surgery. The trial compares CPP to standard liquid stored platelets. The primary efficacy endpoint is comparison of the volume of chest tube drainage of blood within the first 24 hours after surgery, with a secondary endpoint being time to hemostasis as judged by the surgeon in the operating room. Cellphire has 18 clinical trial sites selected with three activated.
“We are excited to get this important clinical trial underway,” said Dr. Michael Fitzpatrick, Chief Scientific Officer. “We hope that this study can demonstrate both the safety and the efficacy of the CPP product.”
About Cellphire Therapeutics
Cellphire Therapeutics, Inc. is a biotechnology company developing next-generation allogeneic cellular therapeutics. The company is applying its proprietary cell stabilization technology first to platelets, to develop lifesaving products. Its lead investigational product is Thrombosomes® human platelet-derived lyophilized hemostatic. Cellphire’s technologies support a wide range of potential medical applications from stopping bleeding, anti-platelet drug antidote, and imaging to targeted drug delivery and regenerative medicine. For more information, visit www.cellphire.com.
This CPP Project 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.