BioCentury
ARTICLE | Clinical News

SGX94 regulatory update

September 23, 2013 7:00 AM UTC

FDA granted Orphan Drug designation to Soligenix's SGX94 to treat acute radiation syndrome (ARS). Soligenix said preclinical data with SGX94 showed the potential to mitigate damage to the skin and gastrointestinal tract, and enable clearance of infection resulting from damage to the hematopoietic system, all of which occur with varying severity in ARS. SGX942, which is the compound number for SGX94 in OM, has Fast Track designation in the U.S. to treat OM as a result of radiation or chemotherapy in patients with head and neck cancer. Soligenix plans to begin a Phase II trial with the innate defense regulator that binds to sequestosome 1 ( SQSTM1; p62) to treat oral mucositis (OM) by year end. ...