December 01, 2020 09:10 AM Eastern Standard Time
GALVESTON, Texas–(BUSINESS WIRE)–Chrysalis BioTherapeutics, Inc., a clinical-stage biotechnology company focused on the development of regenerative medicines to save lives, announced today that the Biomedical Advanced Research and Development Authority (BARDA) part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services executed options to add $10.4 million under contract # HHSO100201900016C with the Company to develop TP508 (ChrysalinTM ) as a nuclear medical countermeasure.
“Our hope is that TP508 will never have to be used as a nuclear countermeasure”Tweet this
Chrysalis will conduct safety studies and additional options required to achieve Emergency Use Authorization and Animal Rule approval for TP508 as a medicinal treatment for acute and delayed effects of ionizing radiation exposure. TP508 mechanism of action represents a potential first in class countermeasure to mitigate radiation-induced vascular damage, reduce inflammation, prevent hemorrhage, and restore tissue function.
“The decision of BARDA to further support the development of TP508 is evidence of successful milestones achieved under the original contract and emphasizes the potential of TP508 to save lives as an effective stand-alone post-exposure countermeasure or as a valuable therapeutic for use in combination with other countermeasure agents,” said Chrysalis CEO, Dr. Darrell Carney.
This contract modification includes options to initiate nonclinical and human clinical safety/PK studies, assay development, large scale manufacturing, and clinical formulation development. This increases the total BARDA funding for this contract to over $21 million.
“Our hope is that TP508 will never have to be used as a nuclear countermeasure,” said Executive VP, Dr. Laurie Sower, “But results show that if needed, a single injection of TP508 given 24 hours after a nuclear event may increase survival and prevent delayed radiation effects throughout the body.”
TP508 is a regenerative peptide drug representing a natural part of human thrombin that is released upon tissue injury to stimulate vascular and stem cell repair and to regenerate damaged tissue. TP508 has demonstrated safety and potential efficacy in non-clinical and in human clinical tissue repair trials, but it is not yet FDA-approved and only available for investigational use. TP508 is also in development as a potential solution to prevent thrombosis and systemic vascular damage caused by SARS-CoV-2 infection.
Chrysalis BioTherapeutics, Inc. is a biopharmaceutical company located in Galveston, TX. TP508 (rusalatide acetate) is licensed from The University of Texas Medical Branch Galveston, TX. For additional information, contact Dr. Darrell Carney, CEO, at email@example.com or visit http://www.chrysbio.com.
Darrell H. Carney, PhD, CEO