About Soligenix
Corporate Profile
Soligenix, Inc. (formerly known as DOR BioPharma, Inc.) is a late-stage biopharmaceutical company committed to the development of life-saving therapeutics and vaccines. Soligenix has two areas of focus: 1) a therapeutics platform dedicated to the development of products for life-threatening conditions such as gastrointestinal Graft-versus-Host disease and cancer, and 2) a biodefense platform to develop vaccines for military and civilian applications.
Biotherapeutics
Soligenix is developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases. Soligenix's lead product, orBec® (oral beclomethasone dipropionate or BDP), is a potent, locally acting corticosteroid being developed for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of allogeneic hematopoietic cell transplantation (HCT).
orBec® represents a first-of-its-kind oral, locally acting therapy tailored to treat the GI manifestation of GVHD by reducing the need for systemic immunosuppressive drugs. BDP is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. orBec® is uniquely formulated for oral administration as a single product consisting of two tablets: one intended to release BDP in the upper portions of the GI tract, and the other in the distal portions.
Soligenix has reached agreement with the US Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) on the design of a confirmatory Phase 3, double-blind, randomized, placebo-controlled clinical study evaluating the safety and efficacy of orBec® for the treatment of acute GI GVHD and plans to initiate this study in the second half of 2009. The agreed clinical trial design is the subject of a Special Protocol Assessment (SPA) agreement with the FDA. orBec® is also currently the subject of an NIH-supported Phase 2, randomized, double-blind, placebo-controlled clinical study for the prevention of acute GVHD. This study is active and expected to achieve completion of enrollment in the second half of 2009.
Soligenix is also developing oral BDP for the prevention/treatment of other gastrointestinal disorders characterized by severe inflammation, including acute radiation enteritis (SGX201), radiation injury (SGX202) and Crohn's disease (SGX203).
Oral BDP was granted an Orphan Drug Designation by the FDA for the treatment of pediatric Crohn's disease.
In addition, Soligenix is developing its proprietary Lipid Polymer Micelle (LPM™) drug delivery technology to enhance the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.
Biodefense
Soligenix's biodefense activities are focused on developing biomedical countermeasures pursuant to the Project BioShield Act of 2004. Specifically, Soligenix is developing bioengineered vaccines designed to protect against the deadly effects of ricin toxin and botulinum toxin, both of which are considered serious bioterrorism threats.
Soligenix is the world leader in ricin toxin vaccine research. Soligenix has achieved positive Phase 1 clinical trial results with RiVax™, demonstrating that the vaccine is well tolerated and induces antibodies in humans that neutralize the ricin toxin, recently shown to be 2,000-fold more toxic than previously thought. Soligenix can also manufacture RiVax™ at scale and under cGMP conditions. Having met these clinical and manufacturing conditions, RiVax™ is eligible for government procurement orders. There are no FDA-licensed vaccines or therapeutics against ricin toxin.
BT-VACC™ is a mucosally administered vaccine developed by Soligenix to protect against exposure to botulinum neurotoxin, the most poisonous natural substance known to man. Exposure by ingestion or by inhalation results in disruption of peripheral nerve function, paralysis and death. Preclinical studies of a multivalent formulation of BT-VACC™ have demonstrated immune responses to toxic botulinum toxin serotypes A, B and E. The animals were then protected against exposure to each of the native toxin molecules given at 1,000-fold the fatal dose. There are no FDA-licensed vaccines or therapeutics against botulinum neurotoxin.
