Princeton, NJ – February 4, 2013 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development-stage biopharmaceutical company, announced today the formation of a Medical Advisory Board (MAB) to provide medical/clinical strategic guidance to the Company as it advances the development of SGX942 for the treatment of oral mucositis, a common complication of cancer treatments.
Comprised of cancer supportive care thought leaders with extensive experience in oral mucositis, the MAB will play an important advisory role in the design and conduct of the upcoming Phase 2 clinical study as well as in the design of subsequent clinical studies and associated regulatory interactions with health authorities. The MAB will 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 oral mucositis patient population.
“Oral mucositis is a significant unmet medical need which ultimately impacts the tolerability of radiation and chemotherapy and therefore the survivability of cancer” stated Stephen T Sonis, DMD, DMSc, Clinical Professor of Oral Medicine at Harvard School of Dental Medicine. “The lack of an effective treatment has frustrated healthcare providers and caused misery for innumerable patients. I’m delighted to be helping to develop SGX942 as I believe it holds significant promise as a mucositis intervention. As an innate defense regulator (IDR), SGX942 directly targets a fundamental biological mechanism which leads to mucosal injury caused by radiation and chemotherapy.”
“We are pleased to be able to attract such esteemed and enthusiastic professionals to participate as members of our Medical Advisory Board,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “The initiation of an oral mucositis program marks the first step in the development of our IDR technology platform. We look forward to working with the MAB and initiating a clinical program in 2013.”
The MAB Members
Stephen T. Sonis, DMD, DMSc
Dr. Sonis currently serves as Clinical Professor of Oral Medicine at Harvard School of Dental Medicine and Senior Surgeon and Chief, Divisions of Oral Medicine at Brigham and Women’s Hospital and the Dana-Farber Cancer Institute, and as Chief Scientific Officer, Biomodels, LLC. He also serves as a consultant to a number of biotechnology and pharmaceutical companies, advising directly on the conduct of clinical trials of oral mucositis. Throughout his career, Dr. Sonis has focused on the biology and clinical significance of cancer regimen-related mucosal toxicities. In particular, Dr. Sonis was pivotal in identifying the crucial role of innate immunity in the generation of severe oral mucositis. The results of his studies have provided treatment targets for biological and pharmaceutical development. Dr. Sonis and his collaborators have identified specific pathways that are critical in toxicity development and have used these to form the basis for models of gene-based risk prediction. Dr. Sonis has published and lectured extensively on the clinical, biological, and health economic aspects of cancer and complications associated with its treatment. He serves on a number of editorial boards, and is a founding member of the International Society of Oral Oncology and the International Academy of Oral Oncology. Dr. Sonis received his Doctor of Dental Medicine (DMD) from Tufts University, his Doctor of Medical Science (DMSc) from Harvard University and was a Knox Fellow at Oxford University.
Dorothy Keefe, MD, FRACP, FRCP
Professor Keefe is Service Director, SA Cancer Services, Professor of Cancer Medicine at the University of Adelaide and a Senior Medical Oncologist at Royal Adelaide Hospital Cancer Centre. She is Head of the Mucositis Research Group in the Hanson Institute, and Immediate Past-President of the Multi-national Association of Supportive Care in Cancer (MASCC). Professor Keefe’s research interests include mucositis in its broadest sense, covering patho-biology, epidemiology, prevention and treatment. She has been highly involved in leading the development of evidence-based guidelines for the management of mucositis through MASCC, as well as co-chairing an international, multi-centre study investigating burden of illness and cost of care for patients with mucositis. Professor Keefe graduated in Medicine (Bachelor of Medicine, Bachelor of Surgery; MBBS) from the University of London. She migrated to Australia, where she undertook her Physician Training in General Medicine and Medical Oncology at the Queen Elizabeth Hospital in South Australia. She became a Fellow of the Royal Australasian College of Physicians (FRACP) and later a Fellow of the Royal College of Physicians in London (FRCP). She received her Doctorate of Medicine from the University of Adelaide.
Mark Schubert, DDS, MSD
Dr. Schubert is a Professor in the Department of Oral Medicine, School of Dentistry at the University of Washington and is the Director of Oral Medicine with the Seattle Cancer Care Alliance as well as a Member in the Clinical Research Division at the Fred Hutchinson Cancer Research Center. Dr. Schubert’s research interests have focused on the oral complications of cancer and cancer therapy, especially as they relate to hematopoietic cell transplantation. A primary area of interest has been the management of oral mucositis associated with cancer therapy. Research in oral mucositis management has focused on topical anti-infectives (defensins), growth factors and cytokines (KGFs and IL-11), cytoprotective agents (benzydamine, amifostine), and low level lasers therapy. Additional research interests include basic research and management strategies for other oral complications of cancer therapy including salivary gland dysfunction, oral graft-versus-host disease in allogeneic hematopoietic cell transplant recipients, and dental growth and development problems following hematopoietic cell transplant. Additionally, Dr. Schubert has been involved with research related to oral changes and infections in HIV-infected patients. Dr. Schubert received his Doctor of Dental Surgery from the University of Washington, where he completed a residency in Hospital Dentistry, and later received his Masters of Dental Sciences degree from the University of Washington.
SGX94 is an IDR, a new class of short, synthetic peptides that has a novel mechanism of action in that it has simultaneous anti-inflammatory and anti-infective activity. IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation-therapy. SGX94 has demonstrated safety in a Phase 1 clinical study in healthy human volunteers and efficacy in numerous animal disease models including mucositis, colitis, skin infection and other bacterial infections. SGX94 is the subject of an open Investigational New Drug (IND). SGX94 was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada and approximately $40 million has been put towards its development inclusive of government grants.
About Oral Mucositis
Mucositis is the clinical term for damage done to the mucosa by anticancer therapies (e.g., radiation or chemotherapy). It can occur in any mucosal region, but is most commonly associated with the mouth (i.e., oral mucositis), followed by the small intestine. Mucositis affects 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy. Mucositis almost always occurs in patients with head and neck cancer treated with radiation therapy (>80% incidence of severe mucositis) and is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of mucositis depends greatly on the nature of the conditioning regimen used. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes. Direct and indirect consequences of mucositis have been estimated to add ~$18K per patient to cancer treatment costs.
The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.
About Soligenix, Inc.
Soligenix is a development stage biopharmaceutical company developing products to treat serious inflammatory 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.
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.