Oral mucositis results in inflammation and ulceration of the mouth and throat tissue lining and is the most common debilitating toxicity induced by chemotherapy and radiation therapy regimens.
Serenex’ SNX-1012 targets multiple inflammatory and other key pathways involved in the pathophysiology of oral mucositis. The compound is administered as a topical, transmucosal agent in the form of an oral rinse that interferes with many of the biological targets necessary for mucositis development.
Four phase I trials with SNX-1012 have been successfully completed, including a phase Ib study that showed strong indications of pharmacological activity and an excellent safety profile.
The phase II study will compare multiple doses of SNX-1012 against a placebo control and is expected to be completed in early 2007.
“A large body of safety data currently exists for this compound,” noted Dr Richard Kent, CEO of Serenex. “Therefore, demonstrating efficacy and identifying the optimal dose during this phase II clinical trial will be an especially significant step toward the development of SNX-1012.”