Soligenix CEO discusses biodefense activity with DDNews
The company has many treatment and preventive candidates in various stages of clinical trials and development. These include a vaccine candidate to prevent ricin poisoning, RiVax; treatments for cutaneous T cell lymphoma; treatments for pediatric Crohn's disease; treatments for oral mucositis associated with neck cancer treatments; and treatments for gastrointestinal acute radiation syndrome (GI ARS).
Both RiVax and OrbeShield, the treatment for GI ARS, have been awarded Orphan Drug Designations from the Food and Drug Administration (FDA), and the latter has also been awarded a Fast Track Designation. Both of these candidates have shown to be effective in preclinical trials, and human safety trials are expected to begin in the latter half of 2016.
Treatments for pediatric Crohn's disease and T cell lymphoma are expected to begin Phase 3 of clinical testing this year. Both candidates have also received Orphan Drug and Fast Track designations from the FDA. Schraber states that initial data is expected by the second half of 2017 in the Crohn's trial and in the second part of 2016 for T cell lymphoma.
The treatment candidate for oral mucositis has also been awarded Fast Track Designation and initial data from its Phase 2 clinical trials is expected this year.