Cellerant, U.S. Department of Health and Human Services other news
Cellerant said HHS's Biomedical Advanced Research and Development Authority (BARDA) awarded the company a two-year, $63 million contract to continue development of CLT-008 for acute radiation syndrome (ARS). The contract includes three option years for up to an additional $89.9 million and will support further clinical and commercial development of CLT-008, including scaling up manufacturing and expanded human safety trials. Cellerant is developing CLT-008 for ARS under FDA's Animal Rule, which allows marketing approval to be granted based on efficacy in relevant animal models and an acceptable safety risk profile in humans. This is Cellerant's second contract to develop CLT-008 and includes $4.5 million remaining from the 2008 contract, which was valued at up to $15.5 million (see BioCentury, Sept. 29, 2008). ...