Access to SciClone Oral Mucositis Clinical Data Enables Personalized Medicine Approach for Design of Clinical Trials
Princeton, NJ – July 8, 2013 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced a personalized medicine collaboration with SciClone Pharmaceuticals in the Company’s oral mucositis clinical program with SGX942. As part of this collaboration, Soligenix will receive access to SciClone’s oral mucositis clinical and regulatory data library in exchange for commercialization rights in the People’s Republic of China, including Hong Kong and Macau. Specific deal terms have not been disclosed at this time.
Soligenix is developing SGX942, an innate defense regulator, for the treatment of oral mucositis (OM). OM in solid tumor patients, especially those with head and neck cancer, is an area of unmet medical need, with no approved drug therapy. It is estimated that OM affects approximately 90,000 head and neck cancer patients per year in the US. SGX942 recently received investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) and is poised to start a Phase 2 clinical trial by the end of the year.
SciClone completed two sequential Phase 2 clinical studies in 2010 and 2012 evaluating its drug, SCV-07, for the treatment of OM caused by chemoradiation therapy in head and neck cancer patients, before terminating its program. As this is the same population that Soligenix is pursuing for its OM program, this information has the potential to increase the probability of success of its upcoming Phase 2 clinical study. By analyzing data available from the placebo subjects in the SciClone trials, Soligenix will acquire essential insight into disease progression, along with quantitative understanding of its incidence and severity in this patient population. This has the potential to enable the design of the SGX942 clinical trials to be optimized and may allow for novel and more robust response criteria to be defined. In addition, analysis of blood samples from these subjects has the potential to identify key biomarkers that could enable development of a prognostic enrichment tool capable of predicting patients expected to develop severe OM on the basis of their deoxyribonucleic acid (DNA) signature. The ability to identify the patient population most likely to develop severe disease increases the likelihood of observing a treatment response.
“This collaboration is unique in that it is the first time that a personalized medicine approach has been comprehensively integrated with an oral mucositis development program,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “The extension of these biomarker approaches in the SGX942 clinical trials also has the potential to form the basis of a predictive enrichment tool and companion diagnostic to identify patients more likely to respond to SGX942 treatment, thereby increasing the likelihood of program success. We feel strongly that personalized treatment approaches are best for patients, physicians and the healthcare system.”
Dr. Schaber continued, “Our collaboration with SciClone is an ideal match. SciClone has a significant commercial presence and expertise in China, and their clinical and regulatory contribution to the SGX942 OM program has the potential to accelerate development while dramatically improving clinical response.”
The FDA has been an enthusiastic advocate of enrichment strategies. As Margaret Hamburg, MD, Commissioner, US FDA remarked at the Personalized Medicine Coalition’s Sixth Annual Keynote Luncheon in February 25, 2010, “…tailoring medicine such that the right therapies are delivered to the right people is likely to be one of the most important themes for healthcare of the future. The concept of personalized medicine is the understanding that people differ in their genetic makeup, their environment and their lifestyle and that these differences are critical factors in the severity and type of disease and how individuals respond to therapies.”
Recently this enthusiasm was reiterated by Robert Temple, MD, Deputy Director for Clinical Science in FDA’s Center for Drug Evaluation and Research in a posting by the FDA Voice on December 17, 2012, in which he commented that techniques for clinical trial enrichment, “…are potentially powerful strategies for the pharmaceutical industry because appropriate use of enrichment could result in smaller studies, shortened drug development times, and lower development costs.”
SGX942 is an innate defense regulator (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. SGX942 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. SGX942 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 to date, inclusive of government grants.
About Oral Mucositis
Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastro-intestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.
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.
It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe. Oral 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 oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.
About SciClone Pharmaceuticals Inc.
SciClone Pharmaceuticals is a US-based, China-focused specialty pharmaceutical company with a product portfolio of therapies for oncology, infectious diseases and cardiovascular, urological, respiratory, and central nervous system disorders. SciClone’s ZADAXIN® (thymalfasin) is approved in over 30 countries and may be used for the treatment of hepatitis B (HBV), hepatitis C (HCV) and certain cancers, and as a vaccine adjuvant, according to the local regulatory approvals. Besides ZADAXIN, SciClone markets about 14 mostly partnered products in China, including Depakine®, the most widely prescribed broad-spectrum anti-convulsant in China; Tritace®, an ACE inhibitor for the treatment of hypertension; Stilnox®, a leading hypnotic for the short-term treatment of insomnia (marketed as Ambien® in the US); and Aggrastat®, a recently-launched interventional cardiology product. SciClone is also pursuing the registration of several other therapeutic products in China. SciClone is headquartered in Foster City, California. For additional information, please visit www.sciclone.com.
About Soligenix, Inc.
Soligenix is a clinical 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 NIAID. Recently, Soligenix announced a worldwide exclusive collaboration with Intrexon Corporation that will focus on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.
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, 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.