Soligenix, Inc., (Soligenix or the Company) (OTC Bulletin Board: SNGX), formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today its financial results for the third quarter of 2009.
Highlights and Recent Developments:
- The initiation of enrollment in its confirmatory Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating orBec® for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD). The initiation of this trial also triggered a $1 million milestone payment from Soligenix's partner Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau).
- The appointment of Robert J. Rubin, MD, to its Board of Directors.
- The completion of a corporate name change to Soligenix, Inc. from DOR BioPharma, Inc.
- The completion of a $4.4 million financing with institutional investors including its partner Sigma-Tau.
- The award of a $9.4 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH). This grant will fund, over a five-year period, the development of formulation and manufacturing processes for vaccines, including RiVax(TM), that are stable at elevated temperatures.
- The award of a $500,000 NIH Small Business Innovation Research (SBIR) grant to support the conduct of a Phase 1/2 clinical trial evaluating SGX201, a time-release formulation of oral beclomethasone dipropionate (oral BDP), for the prevention of acute radiation enteritis.
- The granting of Orphan Drug Designation by the FDA's Office of Orphan Products Development for oral BDP (beclomethasone 17,21-dipropionate, or orBec®) for the treatment of gastrointestinal symptoms associated with chronic GVHD.
"By any measure, the third quarter of 2009 was a pivotal one for Soligenix," stated Christopher J. Schaber, PhD, President and CEO of Soligenix. "With the initiation of our confirmatory Phase 3 clinical trial of orBec® in acute GI GVHD, orBec® is poised to potentially be the first FDA approved therapy for this unmet medical need. Additionally, Soligenix received significant new grant funding for its biodefense and radiation enteritis programs, as well as new equity financing and a $1 million milestone payment from our North American partner Sigma-Tau. We are looking forward to completing a productive 2009 and continuing that positive momentum in 2010."