For more information, please see full ClinicalTrials.gov posting NCT05771831.
Rockville, Md. (April 01, 2023) – Cellphire Therapeutics, Inc. (“Cellphire”), a clinical stage biotechnology company developing next-generation, allogeneic, platelet-derived, cellular therapeutics announced today the enrollment and treatment of the first patient in an investigator-initiated clinical trial in Denmark. Thrombosomes® in Acute Thoracic Aortic Dissections (“TTAD”) represents a significant step forward in the development of life saving cellular therapeutics by Cellphire. The trial, sponsored by Principal Investigator, Jakob Stensballe, MD, Ph.D, is supported by Rigshospitalet, University of Copenhagen, Denmark (“Rigshospitalet”).
Thrombosomes® are a freeze-dried platelet-derived hemostat (FPH) prepared from pooled Group O platelets. Unlike currently available platelets with a 5 to 7-day shelf life, Thrombosomes® are stable at room temperature for up to 3 years. Thrombosomes® are being developed to treat a patient’s bleeding in a variety of situations, including patients with platelet dysfunction, and settings that lack platelet supply. TTAD patients frequently require platelet transfusions, creating a strong setting to test Thrombosomes®.
“We are very pleased that patient enrollment has begun quickly, just two weeks after initiation of the trial”, said G. Michael Fitzpatrick, Chief Scientific Officer of Cellphire. “This demonstrates the commitment of Dr. Stensballe, his team and Rigshospitalet to conducting important clinical research. We are pleased to collaborate with this world class group and appreciate their efforts to launch the trial.”
"The TTAD trial is an important milestone toward saving lives with our freeze-dried platelet technology,” said Mike Gaffney, Cellphire’s CEO. “We thank our collaborators, the participating patients, and federal funding agencies for helping us realize this achievement.”
The Thrombosomes® used in this study were funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response, U.S. Department of Health and Human Services, under contract number HHSO100201300021C.
About Cellphire Therapeutics
Cellphire Therapeutics, Inc. is a biotechnology company developing next-generation allogeneic, platelet derived, cellular therapeutics. Cellphire is applying its proprietary cell stabilization technology to platelets, to develop lifesaving products. Its lead investigational product, Thrombosomes®, is a freeze-dried platelet derived hemostat. Cellphire’s technologies support a wide range of potential medical applications including Orphan populations, operating room use for surgery and trauma, and brain bleeding and injury. For more information, visit Cellphire Therapeutics at www.cellphire.com.
The Phase 2 trial, Thrombosomes® in Acute Thoracic Aortic Dissections (TTAD), is investigator initiated and site sponsored by Rigshospitalet, Copenhagen University Hospital, Copenhagen Denmark.
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