Soligenix Announces Results From Its Phase 1/2 Clinical Trial of SGX201 for the Prevention of Acute Radiation Enteritis

Clinical Trial Supported by $510,000 Grant from the National Cancer Institute
PRINCETON, N.J., Feb. 10, 2012 /PRNewswire/ -- Soligenix, Inc. (OTCBB: SNGXD) (Soligenix or the Company), a development stage biopharmaceutical company, announced preliminary results today from a Phase 1/2 clinical trial evaluating SGX201, a time-release formulation of oral beclomethasone 17,21-dipropionate (oral BDP), for the prevention of acute radiation enteritis.

The Phase 1/2 protocol BDP-ENT-01 was designed as an open label, randomized, dose-finding study at five centers. Sixteen patients with rectal cancer scheduled to undergo concurrent radiation and chemotherapy prior to surgery were enrolled in one of four dose groups, with dosing administered throughout the duration of radiation therapy plus one week. The primary objective of the study was to evaluate the safety and tolerability of escalating doses of SGX201, as well as to assess the preliminary efficacy of SGX201 for prevention of signs and symptoms of acute radiation enteritis. The study was supported in large part by a two-year Small Business Innovation Research (SBIR) grant award from the National Cancer Institute (NCI), which provided Soligenix with approximately $510,000.

The study demonstrated that oral administration of SGX201 was safe and well tolerated across all four dose groups.  There was also evidence of a potential dose response with respect to diarrhea, nausea and vomiting and the assessment of enteritis according to NCI Common Terminology Criteria for Adverse Events for selected gastrointestinal events. In addition, the incidence of diarrhea was lower than that seen in recent published historical control data in this patient population.

"This clinical trial in radiation enteritis with SGX201 provided encouraging exploratory data, which we will be submitting for publication," stated Kevin Horgan, MD, Chief Medical Officer of Soligenix. "Though the numbers are small, the low incidence of diarrhea relative to other similar studies was notable. These findings appear to be consistent with the potential for SGX201 having efficacy for this disorder for which there is currently no available therapy."

"Radiation enteritis is a serious complication for colorectal cancer patients receiving radiation therapy that impacts their quality of life and can require treatment modification," stated William Small, Jr., MD, FACRO, FACR, FASTRO Professor and Vice Chairman, Department of Radiation Oncology, Associate Medical Director, Robert H. Lurie Comprehensive Cancer Center of Northwestern University Feinberg School of Medicine, and a Principal Investigator for the Phase 1/2 clinical study. "Based on oral BDP's proven pharmacology in treating severe gastrointestinal inflammation, SGX201 represents a potential prophylactic option that would enable physicians/patients to maintain planned treatment regimens to battle the underlying malignancy. I find these exploratory data encouraging and I look forward to continuing to work with Soligenix on the continued development of SGX201 in this area of great unmet medical need."

About Acute Radiation Enteritis

Acute radiation enteritis is caused by radiation-induced death of cells in the lining of the bowel. As bowel cells die and are not replaced, gastrointestinal toxicity develops due to an inflammatory response to dead cells and bacteria, with diarrhea, nausea, vomiting and pain prominent symptoms. The addition of chemotherapy may exacerbate the intestinal symptoms and itself cause significant toxicity. This treatment-related enteritis can result in delay or interruption of the cancer treatment. There are over 100,000 patients annually in the United States who receive abdominal or pelvic external beam radiation treatment for cancer, and these patients are at risk of developing radiation enteritis.

About SGX201

SGX201 is a time-release, oral formulation of BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. 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. SGX201 has been awarded fast-track designation from the FDA for the prevention of radiation enteritis. Fast-track designation is designed to facilitate the development and expedite the review of new drugs intended to treat serious or life threatening conditions that are also unmet medical needs.

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 acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation. Soligenix is also conducting a National Cancer Institute (NCI)-supported Phase 1/2 clinical trial of SGX201 in the prevention of acute radiation enteritis. Additionally, Soligenix is developing SGX203 for the treatment of pediatric Crohn's disease.

Through its Biodefense Division, Soligenix is developing countermeasures pursuant to the Project BioShield Act of 2004. Soligenix's 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 SGX204, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers. RiVax™ and SGX204 are currently the subject of a $9.4 million National Institute of Allergy and Infectious Disease (NIAID) grant supporting development of new heat stable vaccines. Soligenix is also developing SGX202 for the treatment of gastrointestinal acute radiation syndrome (GI ARS) and has demonstrated positive preliminary preclinical results in a canine GI ARS model.

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, including orBec®, SGX201, SGX202, SGX203, SGX204, RiVax™, and LPM™, 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 its cash expenditures will not exceed projected levels, 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, that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program, that it will be able to patent, register or protect its technology from challenge and products from competition or maintain or expand its license agreements with its current licensors, or that its business strategy will be successful. Important factors which may affect the future use of orBec® for gastrointestinal GVHD include the Data Safety Monitoring Board's recent determination disclosed in our Form 8-K dated September 15, 2011 recommending that Soligenix stop its confirmatory Phase 3 clinical trial of orBec® in acute GI GVHD and the likelihood that: the FDA will  require that Soligenix conduct additional clinical trials to demonstrate the safety and efficacy of orBec® which will take a significant amount of time and money to complete and positive results leading to regulatory approval cannot be assumed; Soligenix is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacturing, marketing, sales and distribution of its products; orBec® may not gain market acceptance if it is eventually approved by the FDA; and others may develop technologies or products superior to orBec®. Factors affecting the development and use of SGX201, SGX202, SGX203, SGX204, RiVax™ and LPM™ are similar to those affecting orBec®. These and other 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.

 

Posted: February 2012

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