Soligenix Announces Formation of Pediatric Crohn's Disease Medical Advisory Board

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Oct 11, 2011, 07:00 ET

PRINCETON, N.J., Oct. 11, 2011 /PRNewswire/ -- Soligenix, Inc. (OTCBB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced today the formation of a Medical Advisory Board (MAB) to provide medical/clinical strategic guidance to the Company as it relates to the development of SGX203 (oral beclomethasone dipropionate, or oral BDP) for the treatment of pediatric Crohn's disease.

Comprised of pediatric gastroenterology thought leaders in the field of Crohn's disease, the MAB will play an important advisory role in the design and conduct of an SGX203 Phase 2 clinical program as well as in the design of future clinical studies and associated regulatory interactions with health authorities. The MAB will meet at specific intervals to provide feedback, input and guidance on clinical strategies and their implementation as well as on other critical issues, such as health economics and reimbursement to assist Soligenix in meeting the needs of the Crohn's patient population.

"Pediatric gastroenterologists really need additional therapeutic options to treat pediatric Crohn's disease," stated Joel Rosh, MD of the University of Medicine and Dentistry of New Jersey and Director of Pediatric Gastroenterology at Goryeb Children's Hospital/Atlantic Health in Morristown, New Jersey. "I'm delighted to be helping develop SGX203 as I believe it is a very interesting potential therapeutic option for treating pediatric Crohn's disease. A topically active steroid like BDP that effectively treats disease throughout the small and large intestine would satisfy an important medical need in these patients who are particularly vulnerable to the adverse consequences of systemic steroids."

"We are pleased to be able to attract such knowledgeable and enthusiastic individuals to participate as members of our pediatric Crohn's Medical Advisory Board," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "The initiation of a pediatric Crohn's program to combat this orphan disease marks the next step in the evolution of our oral BDP platform. Despite the recent setback in the treatment of acute GI GVHD, we believe the known pharmacology of oral BDP has promising applications in other inflammatory gastrointestinal conditions. The formation of this MAB will provide us with essential medical guidance necessary to initiate this important clinical development program. We look forward to working with the MAB and initiating a clinical program in 2012."

The MAB Members

Jeffrey Hyams, MD, is the Head of the Division of Digestive Diseases, Hepatology and Nutrition at Connecticut Children's Medical Center, Hartford, CT, and Professor of Pediatrics at the University of Connecticut School of Medicine. Dr. Hyams led the effort to develop and validate the Pediatric Crohn's Disease Activity Index (PCDAI) that is currently the standard disease activity instrument for pediatric Crohn's disease, and was one of the authors in the development of the Pediatric Ulcerative Colitis Activity Index (PUCAI). He was the primary founder of the Pediatric Inflammatory Bowel Diseases (IBD) Collaborative Research Group, a 30 center consortium that has enrolled over 1750 newly diagnosed children with IBD and was one of 7 founding members of the Pediatric Research Organization for Kids with Intestinal Inflammatory Disorders (PRO-KIIDS), a multicenter Crohn's and Colitis of America sponsored research project designed to identify immunogenetic and microbial markers of rapid disease progression in children with Crohn's disease. He has published over 200 peer reviewed scientific papers and is the Co-Editor of one of the standard textbooks of pediatric gastroenterology. Dr. Hyams received his MD from the University of Pennsylvania. After medical school he trained in pediatrics and pediatric gastroenterology at the Boston Children's Hospital.

James Markowitz, MD, serves as Professor of Pediatrics at Hofstra North Shore – Long Island Jewish (LIJ) School of Medicine and in the Division of Pediatric Gastroenterology and Nutrition at Cohen Children's Medical Center of NY North Shore – LIJ Health System. Dr. Markowitz has held various positions for several national professional societies. He has served on the Executive Council of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN), as well as on NASPGHAN's Patient Care, Professional Education, Internet and IBD committees. He has also served on the Educational Affairs and Pediatric Gastroenterology committees of the American College of Gastroenterology, on ad hoc subcommittees for the Pediatric Committee of the CCFA, and on the NIH Data Safety Monitoring Board for the "PEDS-C" Hepatitis C multicenter clinical trial. Regionally, he is Vice Chairman of an Institutional Review Board of the North Shore – LIJ Health System. Additionally, he serves on the Medical Advisory Boards for Reach Out for Youth with IBD and the Hermansky-Pudlak Syndrome Network. Dr. Markowitz has served on the editorial board for Inflammatory Bowel Diseases and is a reviewer for various major scientific journals. He currently co-directs the Pediatric Collaborative IBD Research Group, a 26 center, North American research project, and serves on the Steering Committee of PRO-KIIDS. Dr. Markowitz received his MD from Cornell University Medical College. After medical school he trained in pediatrics and pediatric gastroenterology at New York Hospital, and North Shore University Hospital, the Division of Pediatric Gastroenterology, in conjunction with Cornell University Medical College.

Joel Rosh, MD, serves as Associate Professor of Pediatrics at the University of Medicine and Dentistry of New Jersey as well as Director of Pediatric Gastroenterology at Goryeb Children's Hospital/Atlantic Health in Morristown, New Jersey. Certified by the American Board of Pediatrics in pediatric gastroenterology and nutrition, and by the National Board of Medical Examiners, Dr. Rosh has served as the National Chairman for Pediatric Education for the Crohn's and Colitis Foundation of America, the Vice Chairman of the American Academy of Pediatrics GI practice committee and the National Pediatric Endoscopy committee. He is on the Editorial Board of the Journal of Pediatric Gastroenterology and Nutrition and serves as a reviewer for various major scientific journals. Additionally, Dr. Rosh is a Founder of the New Jersey Pediatric GI Society and a Fellow of the American College of Gastroenterology and the American Gastroenterological Association. Dr. Rosh received his MD from the Albert Einstein College of Medicine in New York. His postdoctoral training included an internship and residency in the Babies Hospital–Columbia Presbyterian Medical Center Department of Pediatrics and a fellowship in pediatric gastroenterology at Mt. Sinai Hospital in New York. Prior to joining the faculty at University of Medicine and Dentistry of New Jersey, Dr. Rosh served in the Department of Pediatrics at Mt. Sinai Hospital and Columbia Presbyterian Hospital in New York.

About SGX203

SGX203 contains 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. BDP is also the active ingredient in orBec^®, currently in development by Soligenix for the treatment and prevention of acute gastrointestinal Graft-versus-Host disease (GI GVHD). SGX203 is a two pill delivery system of BDP specifically designed for oral use that allows for delivery of BDP throughout the small bowel and the colon. The FDA has awarded SGX203 Orphan Drug Designation for the treatment of pediatric Crohn's disease.

About Pediatric Crohn's Disease

Crohn's disease is an ongoing disorder that causes inflammation of the gastrointestinal (GI) tract. Crohn's disease can affect any area of the GI tract, from the mouth to the anus, but it most commonly affects the lower part of the small intestine, called the ileum. The swelling caused by the disease extends deep into the lining of the affected organ. The swelling can induce pain and can make the intestines empty frequently, resulting in diarrhea. Because the symptoms of Crohn's disease are similar to other intestinal disorders, such as irritable bowel syndrome and ulcerative colitis, it can be difficult to diagnose. People of Jewish heritage have an increased risk of developing Crohn's disease.

Crohn's disease can appear at any age, but it is most often diagnosed in adults in their 20s and 30s. However, approximately 30% of people with Crohn's disease develop symptoms before 20 years of age. Pediatric Crohn's disease is a subpopulation of approximately 100,000 patients 0-19 years of age in the United States. Crohn's disease tends to be both severe and extensive in the pediatric population and a relatively high proportion (25-40%) of pediatric Crohn's patients have involvement of their upper gastrointestinal tract.

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.

About 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^® (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 has a Lipid Polymer Micelle (LPM™) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.

Through its Biodefense Division, Soligenix is developing countermeasures pursuant to the Project BioShield Act of 2004. Soligenix's lead biodefense product in development is a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin. RiVax™ has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers. RiVax™ is currently the subject of a $9.4 million NIAID grant supporting development of new heat stable vaccines. Soligenix is also developing SGX202 for the treatment of radiation injury and has recently released positive preliminary preclinical results in a canine gastrointestinal acute radiation syndrome 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, 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 DSMB'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 risk 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, and LPM^TM 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.