Soligenix Inc, U.S. Department of Health and Human Services (HHS) other news

Soligenix said it submitted a full proposal to HHS's Biomedical Advanced Research and Development Authority (BARDA) for a multi-year, multi-million dollar contract to develop OrbeShield to treat gastrointestinal acute radiation syndrome (GI ARS). In January, the company said BARDA had invited the company to submit the proposal following a review of the company's response to a broad agency announcement for medical countermeasures for chemical, biological, radiological and nuclear threats (see BioCentury, Jan. 14).

The oral formulation of beclomethasone dipropionate (BDP) is in preclinical development for GI ARS and has Orphan Drug and Fast Track designations to prevent death following a potentially lethal dose of total body irradiation during or after a radiation disaster. Soligenix plans to conduct a Phase I/II trial of the product in healthy adolescent and young adult volunteers following the completion of an ongoing preclinical canine study, from which data are expected in 1H14. The canine study is being funded by a $600,000 Small Business Innovation Research (SBIR) grant from NIH's National Institute of Allergy and Infectious Diseases (NIAID) received last year (see BioCentury, July 23, 2012). ...