Soligenix Announces Award of $1.2 Million FDA Orphan Products Development Grant
Grant Supports Soligenix's Ongoing Confirmatory Phase 3 trial of orBec(R) in Acute GI GVHD
PRINCETON, N.J., Aug 23, 2010 /PRNewswire via COMTEX/ -- Soligenix, Inc., a late-stage biopharmaceutical company, announced today that it has been awarded a three year $1.2 million clinical research grant by the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA) pursuant to its Orphan Products Development (OPD) Program.
The grant will be used to defray a significant portion of the costs associated with the conduct of the Company's ongoing, confirmatory, Phase 3 clinical trial of orBec(R) in acute gastrointestinal Graft-versus-Host-Disease (GI GVHD). This trial, also referred to as the SUPPORTS protocol (Sparing Unnecessary Prednisone Phase 3 orBec(R) Randomized Treatment Study), will enroll an estimated 166 subjects to confirm the clinically meaningful endpoints observed in previous Phase 2 and Phase 3 clinical studies. The primary endpoint in the SUPPORTS protocol is the treatment failure rate at Study Day 80. This endpoint was successfully measured as a secondary endpoint (p-value 0.005) in the Company's previous Phase 3 study as a key measure of durability following a 50-day course of treatment with orBec(R) (i.e., 30 days following cessation of treatment). The Phase 3 study includes major stem cell transplantation centers in the United States, Europe and Australia, and is expected to complete in the first half of 2011.
"We are grateful to have been awarded this significant grant to support our ongoing confirmatory Phase 3 study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We believe the award is a validation of the design of our Phase 3 trial and a clear indicator of the importance of orBec(R) and its potential application in the treatment of acute GI GVHD. Through the award of this grant, the FDA clearly recognizes the need for treatment options in the unmet medical need of GVHD. As a result, orBec(R) could become the first FDA-approved therapy to treat and prevent GVHD."
In addition to issued patents and pending worldwide patent applications, orBec(R) benefits from orphan drug designations in the U.S. and in Europe for the treatment of GI GVHD, as well as an orphan drug designation in the U.S. for the prevention of acute GVHD and the treatment of chronic GI GVHD. Orphan drug designations provide for 7 and 10 years of market exclusivity upon approval in the U.S. and Europe, respectively. In the U.S., orphan drug designations also make the Company eligible for research funding provided by OOPD, in addition to receiving tax credits for certain research expenses and a waiver of expensive FDA application user fees.
About the FDA's Orphan Products Development Program
The goal of FDA's OPD Program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. The FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. The OPD grant awards are based on a review of how the proposed study will either help support product approval or provide essential data needed for product development. Applications are reviewed by panels of outside experts and are funded by priority score.
About Soligenix, Inc.
Soligenix, Inc. (Soligenix) is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. Soligenix's lead product, orBec(R) (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 hematopoietic cell transplantation. orBec(R) is currently the subject of a confirmatory Phase 3 clinical trial for the treatment of acute GI GVHD and an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. Soligenix has also initiated an NIH-supported Phase 1/2 clinical trial of SGX201 in the prevention of acute radiation enteritis. Additionally, Soligenix has a Lipid Polymer Micelle (LPM(TM)) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.
Through its Biodefense Division, Soligenix is developing biomedical countermeasures pursuant to the Project BioShield Act of 2004. Soligenix's lead biodefense product in development is a recombinant subunit vaccine called RiVax(TM), which is designed to protect against the lethal effects of exposure to ricin toxin. RiVax(TM) has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers. RiVax(TM) is also the subject of a $9.4 million NIH grant received by the Company supporting development of new heat stable vaccines.
For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.