Soligenix Announces $300,000 NCI SBIR Grant Award Supporting a Phase 2 Trial of orBec® as a Treatment for Chronic GI GVHD

PRINCETON, N.J., Sept. 4, 2012 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that the National Cancer Institute (NCI) has awarded Soligenix a Small Business Innovation Research (SBIR) grant to support the conduct of a Phase 2 clinical trial designed to evaluate orBec® (oral beclomethasone 17,21-dipropionate or BDP) as a treatment for the gastrointestinal (GI) manifestation of chronic Graft-versus-Host disease (GVHD).  The award will provide Soligenix with approximately $300,000 over a two-year period. 

The Phase 2 study is designed as a multicenter, open-label, pilot study enrolling patients that have received allogeneic hematopoietic cell transplantation at least 100 days earlier; have documented chronic GVHD in at least one organ outside the GI tract, and have a GI biopsy consistent with chronic GI GVHD.  The primary efficacy objective of the study is to estimate the proportion of subjects with chronic GI GVHD who achieve a complete response, partial response and overall response of GI GVHD signs and symptoms when treated with orBec® for up to 16 weeks.  The study is expected to be initiated in the first half of 2013.

"We are pleased by the continued support of NCI as a collaborator supporting our oncology focused BDP clinical programs," stated Kevin J. Horgan, MD, Senior Vice President & Chief Medical Officer of Soligenix. "We look forward to working with our clinical centers to initiate this study as soon as possible to continue development of orBec® with the aim of addressing this critical unmet medical need."

"We believe that our success in securing this type of highly competitive funding is driven by the strength of our science and development capabilities," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  "To date, we have been fortunate to receive over $25 million in government support across both the BioTherapeutics and Vaccine/ BioDefense segments of our business, and currently have approximately $6 million in government funding remaining. We will continue to execute on our strategy of identifying and applying for new non-dilutive funding opportunities wherever appropriate." 

About Chronic GVHD

Graft-versus-Host disease (GVHD) is a major complication of allogeneic hematopoietic cell transplantation. GVHD is an inflammatory disease initiated by T cells in the donor graft that recognize histocompatibility and other tissue antigens of the host, and is mediated by a variety of effector cells and inflammatory cytokines. GVHD presents in both acute and chronic forms. The symptoms of chronic GVHD typically present at between 100 days and three years post-transplant.

Chronic GVHD has features resembling autoimmune and other immunologic disorders such as scleroderma, Sjogren syndrome, primary biliary cirrhosis, wasting syndrome, bronchiolitis obliterans (BO), immune cytopenias and chronic immunodeficiency. The manifestations of chronic GVHD may be restricted to a single organ or tissue or may be widespread.  Chronic GVHD can lead to debilitating consequences, e.g., joint contractures, loss of sight, end-stage lung disease, or mortality resulting from profound chronic immune suppression leading to recurrent or life-threatening infections.

Treatment of chronic GVHD is a challenge because it can be refractory to frontline immunosuppression.  High-dose systemic corticosteroids are used with some success but carry significant toxicity. The risks of prolonged immunosuppression include local and disseminated infections, Epstein-Barr virus associated lymphoproliferative disease, hypothalamic-pituitary-adrenal (HPA) axis suppression, myopathy, glucose intolerance, neuropsychiatric disease and bone demineralization.

About orBec®

orBec® represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of chronic GVHD, the organ system where GVHD is most frequently encountered and highly problematic. orBec® is intended to reduce the need for systemic immunosuppressive drugs such as prednisone to treat chronic GI GVHD. The active ingredient in orBec® is beclomethasone dipropionate (BDP), a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in a nasal spray and in a metered-dose inhaler for the treatment of patients with allergic rhinitis and asthma. orBec® is specifically formulated for oral administration as a single product consisting of two tablets, one immediate release (IR) tablet providing BDP to the upper sections of the GI tract and one delayed release (DR) tablet providing BDP to the lower sections of the GI tract.

In addition to issued patents and pending worldwide patent applications held by or exclusively licensed to Soligenix, orBec® has received orphan drug designation in the US for the treatment of chronic GI GVHD. Orphan drug designations provide for 7 years of market exclusivity upon approval in the US.

About Soligenix, Inc.

Soligenix is a development 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® (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid that has been initially developed for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation. Soligenix is also developing proprietary formulations of oral BDP for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), which is the subject of a recently completed National Cancer Institute (NCI)-supported Phase 1/2 clinical trial.

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.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

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.