GALVESTON, Texas–(BUSINESS WIRE)–Chrysalis BioTherapeutics, Inc., a clinical stage biopharmaceutical company developing Chrysalin as a Medical Countermeasure and for the treatment of Acute Respiratory Distress Syndrome (ARDS), announced today that it has signed a Non-Clinical Evaluation Agreement (NCEA) with the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) for evaluating Chrysalin for the treatment of Cutaneous Radiation Injury (CRI).
“Cutaneous (dermal) exposure to high dose radiation, from a nuclear event or from radiation therapy, causes dermal cell death and vascular dysfunction that result in a burn-type of injury that resists normal healing and can result in chronic ulcers,” explained Dr. Laurie Sower, Chrysalis Executive Vice President. She continued, “With radiation therapy, a burn injury is problematic for the patient and doctor, but in a nuclear event, dermal burns and injuries cause added radiosensitivity and greatly increase the probability of death.”
Chrysalin is a regenerative peptide drug initially developed for its wound healing properties. In diabetic foot ulcer human clinical trials, Chrysalin significantly increased the complete healing of chronic ulcers. Chrysalis preclinical studies, supported by NIAID and conducted at the University of Texas Medical Branch (UTMB), demonstrated that following whole-body irradiation and dermal injury, Chrysalin treatment restored normal wound healing and increased animal survival. “These results indicate that Chrysalin reverses radiation-induced inflammation and the dermal microvasculature and progenitor cell damage caused by RCI,” stated Dr. Sower.
Previous studies funded by NIAID and the Biomedical Advanced Research Development Authority (BARDA) have shown the potential of Chrysalin to reduce mortality in individuals exposed to nuclear radiation and reduce delayed radiation effects to increase quality of life for survivors. “We are pleased to continue our collaboration with NIAID and are excited to be testing Chrysalin in NIAID’s CRI large animal model,” said Dr. Darrell Carney, Chrysalis President & CEO. “We anticipate that positive results in this model and subsequent pivotal trials will provide a direct path toward FDA approval.”
Chrysalis BioTherapeutics, Inc., a Galveston based privately held pharmaceutical development company, has licensed exclusive worldwide rights to Chrysalin from the University of Texas Medical Branch. In addition to its CRI collaboration with NIAID, Chrysalis is developing Chrysalin for clinical respiratory and neural indications and has just initiated FDA-IND human clinical trials to demonstrate the safety of Chrysalin injection with subsequent trials planned to test its use as a potential cure for acute respiratory distress syndrome.
Chrysalis is responsible for statements in this release. Research reported in this Press Release was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Numbers R43AI086135, R44AI086135 and BARDA Contract #HHSO100201900016C. The content does not necessarily represent official views of the National Institutes of Health or The University of Texas Medical Branch.