GALVESTON, Texas, Aug. 27, 2019 /PRNewswire/ -- Chrysalis BioTherapeutics, Inc. today announced that the Biomedical Advanced Research and Development Authority (BARDA), an agency of the US government's Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, has awarded Chrysalis a contract (HHSO100201900016C) to support the continued development of TP508, rusalatide acetate, as a nuclear medical countermeasure. The drug is intended to be used in the event of a nuclear accident or the intentional detonation of a nuclear device to prevent radiation sickness and increase both survival and quality-of-life for those who survive.
Under this contract, Chrysalis will receive initial funding of $10,074,093 to support preclinical development to assess efficacy of TP508. The contract includes subsequent options that may be exercised by BARDA in its sole discretion upon achievement of certain milestones. If the options are exercised in full, Chrysalis could receive up to an additional $95,163,711 over the next 5 years. These funds are intended to support drug development, pivotal studies, and clinical trials through FDA approval.
Chrysalis has been developing TP508 as a medical countermeasure to be administered to thousands of people under emergency field conditions. In preclinical studies, TP508 has significantly increased survival when injected 24 hours after lethal doses of radiation exposure.
"TP508 has a unique mode of action that targets both vascular endothelial cells and progenitor stem cells to restore tissue function after injury or radiation exposure," said Dr. Laurie Sower, Executive VP of Chrysalis. "TP508 also accelerates repair of radiation damaged DNA suggesting it may help prevent cellular death and delayed effects of radiation exposure," explained Sower.
This base award of just over $10 million brings the total of Chrysalis non-dilutive funding from federal sources (National Institutes of Health (NIAID and NCI) and BARDA) to over $24 million. Chrysalis is exploring funding options to develop TP508 for treating unmet clinical needs.
"The use of radiation therapy in treating tumors in the brain and other organs is often limited by the amount of damage to normal tissues," said Darrell Carney, President and CEO of Chrysalis. "Preclinical studies show that TP508 can mitigate damaging effects of radiation on normal tissues in brain and other organs. Thus, in addition to its use in the case of a nuclear accident, TP508 may be beneficial to patients undergoing radiotherapy for brain cancer, head neck cancer, and cancer in other areas of the body."
TP508 is a regenerative peptide drug representing a natural part of human thrombin that is released upon tissue injury to initiate a healing cascade. TP508 has demonstrated safety and potential efficacy in non-clinical and in human clinical tissue repair trials. TP508 is not FDA-approved and is currently only available for investigational use.
About Chrysalis BioTherapeutics
Chrysalis BioTherapeutics, Inc., a Galveston, Texas based, privately held pharmaceutical development company, has licensed exclusive worldwide rights to TP508 from the University of Texas Medical Branch.
Funding for the development of TP508 as a Radiation Countermeasure is supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (R44AI086135 and HHSN272201700011C), and the Biomedical Advanced Research and Development Authority (BARDA), an agency of the US government's Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (HHSO100201900016C). Chrysalis is responsible for statements in this release. The content does not necessarily represent official views of the National Institutes of Health, BARDA or The University of Texas Medical Branch.
For more information about Chrysalis BioTherapeutics or TP508 please visit http://www.chrysbio.com.
SOURCE Chrysalis BioTherapeutics, Inc.