GALVESTON, Texas, Aug. 21, 2019 /PRNewswire/ -- Chrysalis BioTherapeutics, Inc. today announced that the US Food and Drug Administration (FDA) Office of Orphan Product Development and the European Medicines Agency (EMA) have granted Orphan Drug Designation (ODD) to the company's lead compound, TP508 (rusalatide acetate) for the treatment of acute radiation syndrome (ARS). With exposure to high levels of nuclear radiation, individuals develop ARS or radiation sickness affecting multiple organ systems and often leading to death within days, weeks, or months of exposure. TP508 is a regenerative peptide drug being developed by Chrysalis BioTherapeutics to mitigate effects of nuclear radiation and radiation therapy used in cancer treatment.
"Preclinical studies have shown that TP508 significantly increases survival when administered as a single injection 24 hours after nuclear radiation exposure," commented Dr. Laurie Sower, Executive Vice President at Chrysalis. "Studies show that TP508 reverses effects of radiation on blood vessels and multiple organ systems to increase survival."
The Orphan Drug Act provides for granting special status to a drug or biological product to treat a rare disease or condition. Obtaining ODD provides a seven-year term of market exclusivity upon final FDA approval, waiver of expensive FDA user fees, and certain tax credits. Thus, the granting of ODD is an important step for Chrysalis BioTherapeutics, Inc. as it moves TP508 through the regulatory process.
"This designation represents an important step in our regulatory strategy to establish TP508 to mitigate effects of radiation exposure," said Dr. Darrell Carney, President and CEO of Chrysalis. "The significant effects of TP508 and the FDA and EMA granting of these ODD designations reaffirm our commitment to develop this drug both as a nuclear countermeasure and for use in combination with radiation therapy to mitigate radiation effects on normal tissues."
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.
About Chrysalis BioTherapeutics
Chrysalis BioTherapeutics Inc., a Galveston, Texas, privately held pharmaceutical development company, has licensed exclusive worldwide rights to TP508 from the University of Texas System.
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, under Award Number R44AI086135 and HHSN272201700011C. Chrysalis is responsible for statements in this release. The content does not necessarily represent official views of the National Institutes of Health or of The University of Texas System.
SOURCE Chrysalis BioTherapeutics, Inc.