Soligenix Submits BARDA Contract Proposal for Development of OrbeShield™ in GI ARS

Feb 20, 2013, 07:00 ET from Soligenix, Inc.

PRINCETON, N.J., Feb. 20, 2013 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today submission of a full contract proposal to the Biomedical Advanced Research and Development Authority (BARDA) Division of Chemical, Biological, Radiological and Nuclear (CBRN) Medical Countermeasures. This submission supports a potential multi-year, multi-million dollar contract to develop OrbeShield™ (oral beclomethasone 17,21-dipropionate or oral BDP) as a medical countermeasure (MCM) for the treatment of gastrointestinal acute radiation syndrome (GI ARS).

Soligenix was invited to submit this proposal following a review of its white paper entitled "OrbeShield™, oral beclomethasone 17,21-dipropionate (BDP), a candidate broad spectrum therapeutic countermeasure for GI ARS," to BARDA in response to a Broad Agency Announcement (BARDA-BAA-12-100-SOL-00011) for advanced research and development of MCMs for chemical, biological, radiological and nuclear threats. BARDA is interested in the advanced development and eventual licensure/approval of effective MCMs that mitigate, treat, affect, delay, or interrupt the progression of injuries resulting from acute exposure to radiation from a nuclear accident or attack.

In a canine model of GI ARS, OrbeShield™ demonstrated a statistically significant survival advantage in animals that received OrbeShield™ therapy up to 24 hours following exposure to lethal doses of total body irradiation when compared with placebo-control animals (p=0.04).  Median survival following irradiation in the control group was 8 days, compared to 87 days in the OrbeShield™ treated group. This work was largely supported by a $1 million grant to Soligenix's academic partner, the Fred Hutchinson Cancer Research Center, from the National Institute of Allergy and Infectious Diseases (NIAID).

A subsequent study to replicate and expand upon the observations made in the canine model is ongoing and is supported by a $600,000 Small Business Innovation Research (SBIR) grant award from the NIAID. 

"We are excited about the contract proposal submission to BARDA," stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix. "Although there are no guarantees, we believe that we are well-positioned to receive BARDA development support for this indication allowing us to further demonstrate the growing body of compelling scientific evidence supporting OrbeShield™'s potential as a countermeasure for GI ARS. Having recently received Orphan Drug and Fast Track designations from the FDA, we look forward to continued productive interactions with BARDA, NIAID and FDA as we move the OrbeShield™ GI ARS development program forward."

The submission of our proposal is non-binding and does not guarantee the award of a BARDA contract.  The contract award will require a favorable technical and scientific review by BARDA followed by negotiation of fair and reasonable contract terms.

About GI ARS

ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow the GI tract and later the lungs.   In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to >2 Gy are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury which can result in death in 5-15 days.  The GI tract is highly sensitive due to the requirement for incessant proliferation of crypt stem cells and production of mucosal epithelium. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI.  Although the hematopoietic syndrome can be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that occurs after high-dose radiation. Therefore, there is an urgent need to develop specific MCMs against the lethal pathophysiological manifestations of radiation-induced GI injury.

About OrbeShield

OrbeShield™ is formulated for oral administration in GI ARS patients as a single product consisting of two tablets; one tablet releases BDP in the proximal portions of the GI tract and the other tablet releases BDP in the distal portions of the GI tract.  BDP has been marketed in the United States and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. Oral BDP may also have application in treating other GI disorders characterized by severe inflammation such as Crohn's disease and radiation enteritis.

The FDA has cleared the Investigational New Drug (IND) application for OrbeShield™ for the mitigation of morbidity and mortality associated with GI ARS.  OrbeShield™ has also been granted Orphan Drug and Fast Track designations by the FDA for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing products to treat serious gastrointestinal diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral Mucositis.     

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.

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This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes," "intends," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

SOURCE Soligenix, Inc.