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."