Soligenix, a clinical-stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures, has established a personalized medicine collaboration with SciClone Pharmaceuticals in SNGX’s oral mucositis clinical program with SGX942 for the treatment of oral mucositis (OM).
Soligenix is developing SGX942 to address the unmet medical need of OM in solid tumor patients, especially those with head and neck cancer. OM affects approximately 90,000 head and neck cancer patients each year in the U.S. SGX942 recently received investigational new drug (IND) clearance from the U.S. Food and Drug Administration (FDA) and is prepared to initiate a phase 2 clinical trial by year-end.
The collaboration provides SNGX with access to SciClone’s oral mucositis clinical and regulatory data library in exchange for commercialization rights in the People’s Republic of China. According to SGNX CEO Christopher J. Schaber, PhD, this collaboration is the first time that a personalized medicine approach has been comprehensively integrated with an oral mucositis development program.
“Our collaboration with SciClone is an ideal match,” Dr. Schaber stated in the press release. “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.”
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. Because SNGX is pursuing this same population for its OM program, the company believes this information has the potential to increase the probability of success of its upcoming phase 2 clinical study.
For more information visit www.Soligenix.com
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