PRINCETON, N.J., Nov. 17, 2014 /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 the formation of a Medical Advisory Board (MAB) to provide medical/clinical strategic guidance to the Company as it advances the Phase 3 clinical development of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL), a rare class of non-Hodgkin’s lymphoma (NHL).
Comprised of dermatologic oncology thought leaders with extensive experience in CTCL, the MAB will play an important advisory role in the conduct of the upcoming Phase 3, pivotal clinical study as well as in the design of subsequent clinical studies (in other indications, e.g., psoriasis) 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 CTCL patient population.
“I enthusiastically support Soligenix in their efforts to improve outcomes for patients with CTCL, affecting up to 50,000 patients in the US,” stated Alain Rook, MD, Director, Cutaneous Lymphoma Program, Perelman School of Medicine of the University of Pennsylvania. “I have had a lengthy scientific and clinical interest in hypericin and am pleased that the Soligenix team is advancing this product. I believe that SGX301 has the potential to be a major step forward in the treatment of CTCL by providing a safer alternative therapy in comparison to other forms of phototherapy over the course of the patients’ disease than is currently available. I look forward to working with my esteemed colleagues to support Soligenix in advancing this important development program forward.”
“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 a CTCL program marks the first step in the development of our newly acquired SGX301 program. We look forward to working with the MAB and initiating the pivotal clinical trial in 2015.”
The MAB Members
Alain Rook, MD
Dr. Rook is a Professor of Dermatology at the Perelman School of Medicine at the University of Pennsylvania and is the Director of the CTCL and Extracorporeal Photopheresis Program. He has conducted seminal studies on the photodynamic therapeutic efficacy of synthetic hypericin in CTCL and psoriasis patients and on its apoptotic activity in malignant cancer cells. Dr. Rook’s research has been supported by the Leukemia and Lymphoma Society, the National Institutes of Health and National Cancer Institute. He graduated from the University of Michigan with an MD degree. Dr. Rook is Board Certified in Dermatology, Internal Medicine, and Nephrology.
Youn Kim, MD
Dr. Kim is the Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma at Stanford University. She is an international renowned expert in cutaneous lymphomas and is the director of the Multi-disciplinary Cutaneous Lymphoma Program and Medical Director of the photopheresis Unit at Stanford Medical Center and is Co-Director of the Lymphoma Research Program at the Stanford Cancer Institute. She graduated from Stanford University School of Medicine with an MD degree. Dr. Kim is Board Certified in Dermatology.
Gary Wood, MD
Dr. Wood is the Chair and Professor of Dermatology at the University of Wisconsin. He is an internationally recognized expert in cutaneous lymphomas. Dr. Wood has served as President of the International Society for Cutaneous Lymphomas. He has authored more than 350 articles, chapters and abstracts, mostly focused on cutaneous oncology. He also directs the Immunodiagnosis Lab that offers comprehensive diagnostic testing for skin diseases. Dr Wood graduated from the University of Illinois at Chicago with an MD degree. Dr. Wood is triple board certified in dermatology, dermatopathology and anatomic pathology.
Madeleine Duvic, MD
Dr. Duvic is a Professor of Internal Medicine and Dermatology, and serves as the Deputy Chairman of the Department of Dermatology at The University of Texas, MD Anderson Cancer Center. She is a founding member of the US Cutaneous Lymphoma Consortium, former board member of the American Academy of Dermatology and recent vice president of the Society for Investigative Dermatology. She has been Principal Investigator of numerous clinical trials and translational research studies of T-cell mediated diseases and malignancies, especially CTCL. With over 400 scientific publications, her work is focused on developing and improving therapy for CTCL. Dr. Duvic graduated from Duke University Medical School with a MD degree and completed an internship and residencies in internal medicine and dermatology, served as chief resident, and completed fellowships in molecular biology and geriatrics. Dr. Duvic is Board Certified in Internal Medicine and Dermatology and heads the CTCL multi-disciplinary clinic at MD Anderson Cancer Center.
About CTCL
Cutaneous T-cell lymphoma (CTCL) is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These skin-trafficking malignant T-cells migrate to the skin, causing various lesions to appear that may change shape as the disease progresses, typically beginning as a rash and eventually forming plaques and tumors.
CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 500,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL, that it affects over 20,000 individuals in the US, with approximately 2,800 new cases seen annually.
About SGX301
SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer which is topically applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p 0.04) improvement with topical hypericin treatment whereas the placebo was ineffective: 58.3% compared to 8.3%, respectively. SGX301 has received orphan drug designation from the US Food and Drug Administration.
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 SGX943, our melioidosis therapeutic candidate. The development of our vaccine programs is supported by our heat stabilization technology, known as ThermoVax, under existing and on-going government contract funding.
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, 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.
SOURCE Soligenix, Inc.
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