Soligenix, a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there is an unmet medical need, has announced a personalized medicine collaboration with SciClone Pharmaceuticals in the company's oral mucositis clinical program with SGX942. Soligenix will receive access to SciClone's oral mucositis clinical and regulatory data library in exchange for commercialization rights in China, including Hong Kong and Macau.

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. OM affects approximately 90,000 head and neck cancer patients per year in the U.S.  SGX942 recently received IND clearance from the FDA and is poised to start a phase II clinical trial by the end of the year.

SciClone completed two sequential phase II 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 Soligenix is pursuing, this information has the potential to increase the probability of success of its upcoming phase II 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. Analysis of blood samples from these patients 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 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 the first time that a personalized medicine approach has been comprehensively integrated with an oral mucositis development program," said Christopher J. Schaber, Ph.D., president and chief executive officer of Soligenix. "The extension of these biomarker approaches in the SGX942 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, thereby increasing the likelihood of program success.”

Schaber said, "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."