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Soligenix Announces FDA Protocol Clearance of Pivotal Phase 3 Clinical Trial of SGX203 in Pediatric Crohn's Disease
Date:4/14/2015

PRINCETON, N.J., April 14, 2015 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that agreement has been reached with the US Food and Drug Administration (FDA) on the design of a pivotal, Phase 3 clinical trial evaluating its product, SGX203 (oral beclomethasone 17,21-dipropionate or BDP), in the treatment of pediatric Crohn's disease.  SGX203 has previously been granted both orphan drug and fast track designations from the FDA for the treatment of Crohn's Disease in the pediatric population.  

SGX203 is a proprietary formulation of BDP that uses a two-tablet immediate and delayed release system to orally deliver high mucosal concentrations of the topical steroid to both the upper and lower bowel walls.  This makes SGX203 particularly well suited for Crohn's disease in younger patients that are reported to have gastrointestinal (GI) inflammation in both areas of the bowel as opposed to adults who have mainly lower (colon) involvement.  Oral BDP has a limited systemic absorption into the blood stream, decreasing the potential for the development of adverse side-effects frequently seen with systemic steroid therapies, like prednisone.  These side effects include bone demineralization and interference with normal growth, which are particularly concerning in children.  

The upcoming pivotal Phase 3 study will be a double-blind, randomized, controlled, multi-national trial and will seek to enroll approximately 150 subjects 6-17 years of age with endoscopically proven mild to moderate Crohn's disease.  The trial will compare the rates of improvement of the signs and symptoms of Crohn's disease after 8 weeks of treatment among subjects randomized to one of three SGX203 dose groups (split 60:30:60 among the lowest, middle and highest dose of SGX203).  Subjects will be followed for an additional 6 months after the completion of treatment.  Entry criteria for the trial are the presence of Crohn's disease symptoms (abdominal pain and/or diarrhea) associated with laboratory evidence of active disease in the blood.  The primary clinical efficacy endpoint of the trial will compare the percentage of subjects in each of the three dose groups having resolved their signs and symptoms after an 8-week course of treatment.  An adaptive design will be employed in which an independent Data Monitoring Committee will review the efficacy data after approximately 90 subjects have completed treatment and determine if the trial size requires adjustment based on the actual event rate or halted for futility or overwhelming efficacy.  The trial is anticipated to begin in the second half of 2015 with primary data available in the first half of 2017. 

"We are excited to move forward with this trial in an effort to improve the signs and symptoms of acute attacks of pediatric Crohn's disease while minimizing the deleterious side-effects often seen with systemic steroids," stated Richard Straube, MD, Chief Medical Officer of Soligenix.  "Currently, most pediatric patients with mild to moderate active disease are treated with off-label prednisone.  The side effects of prednisone, such as bone demineralization and interference in normal growth, are particularly concerning in children.  We believe that SGX203 has the potential to deliver adequate doses of BDP to the GI tract with markedly reduced systemic toxicity.  This, in turn, may offer physicians and patients an effective, and safer, therapy to control disease symptoms."

"We are pleased to have FDA agreement on this Phase 3 protocol after having worked closely with the FDA on its design," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We are excited to move forward with this pivotal trial in an effort to address the significant unmet medical need that currently exists in this orphan disease."

About Pediatric Crohn's Disease

Crohn's disease is a chronic inflammatory disorder of the GI tract.  The major symptoms of Crohn's disease include abdominal pain, diarrhea, GI bleeding, malabsorption, and weight loss.  A frequent problem of particular significance in children is the lack of growth.

It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of pediatric Crohn's disease, that Pediatric Crohn's disease is a subpopulation of approximately 80,000 patients in the US with a comparable number in Europe.  Of the approximate 160,000 children/adolescents with Crohn's disease worldwide, about 50% of these patients will have disease proximal to terminal ileum (upper GI).

Crohn's disease is a naturally recurring and remitting orphan disease.  As intestinal disease progresses, uncontrolled inflammation can lead eventually to fibrosis causing fixed narrowing of the bowel.  These strictures can lead to obstructive symptoms and bowel obstruction which frequently require surgery.  Approximately 25-75% of newly diagnosed patients with Crohn's disease will require at least one surgical procedure over the first five years of disease and many will need multiple abdominal surgeries over their lifetime.  Crohn's disease is characterized by transmural intestinal inflammation.  The inflammation can extend through the bowel wall and into adjacent organs and spaces causing fistulas and abscesses.  Over half of pediatric Crohn's disease patients have evidence of upper GI disease, a substantially higher rate than reported in adult Crohn's disease patients.  Crohn's disease presents special challenges for children and teens.  In addition to bothersome and often painful symptoms, the disease can stunt growth, delay puberty, and weaken bones.  Crohn's disease symptoms may sometimes prevent a child from participating in enjoyable activities.  The emotional and psychological issues of living with a chronic disease can be especially difficult for young people.

Although several drugs have been approved to treat Crohn's disease in adults, the only drugs currently approved in the US for the treatment of Crohn's disease in children are the biologics, Remicade® and Humira®.  Because both drugs are required to have "Black Box" warnings noting their potential for increased infections and cancers, many physicians, patients, and parents are reluctant to start this type of therapy.  Although not approved for this use, systemic prednisone is often used to control the signs and systems of acute bouts of the disease.  The initiation and duration of systemic steroid use is limited by concerns of the long-term side-effects seen with the high blood levels of the steroid.  

About SGX203

SGX203 represents a novel, locally acting therapy tailored to treat/ameliorate the bowel wall inflammation of Crohn's disease that leads to the majority of signs and symptoms of the disease.  Its ability to deliver high mucosal concentrations of topical steroid to both the upper and lower parts of the GI tract make it particularly well suited for Crohn's disease in younger patients that are reported to have a much higher involvement of both areas of the bowel as opposed to adults who have mainly lower (colon) involvement.  The active ingredient in SGX203 is BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue but limited absorption from the mucosal surfaces into the bloodstream.  Therefore, SGX203 has the potential to provide amelioration of the local GI disease similar to systemic steroids, like prednisone, while avoiding the side-effects caused by high steroid levels in the blood.  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. 

SGX203 is specifically formulated for oral administration as a single product consisting of two tablets, one immediate release tablet providing BDP to the upper sections of the GI tract and one delayed release tablet providing BDP to the lower sections of the GI tract.  SGX203 has been tested in approximately 350 subjects to date without any major or unanticipated side effects observed.  SGX203 has received both orphan drug and fast track designations in the US for the treatment of Crohn's Disease in the pediatric population.  Orphan drug designation provides for 7 years of market exclusivity upon approval in the US.  Fast track designation was designed to facilitate the development, and expedite the review of a drug that is targeted to treat conditions that the FDA judged to be serious or life-threatening and fill an unmet medical need.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense.  Our BioTherapeutics business segment is developing SGX301 as a first-in-class photo-dynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.

Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, VeloThrax™, our anthrax vaccine candidate, OrbeShield™, our GI acute radiation syndrome therapeutic candidate and SGX101 and SGX943, our melioidosis therapeutic candidates.  The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax™.  Currently, this business segment is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).  Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (NYSE: XON) focused on the joint development of SGX101 for the treatment for melioidosis.

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

This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," 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, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, 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 funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, 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.


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