Izun Pharmaceuticals Announces Positive Results from Phase 2 Double Blind Oral Mucositis Trial

Izun Pharmaceuticals Corporation announced that the results from a recently completed double blind, Phase 2 clinical study in oral mucositis indicated promising positive outcomes for the investigational product IZN-6N4.

The study was conducted at 12 centers in the United States and Israel. The trial enrolled a total of 110 patients with head and neck cancer who were scheduled to receive standard regimens of concomitant chemoradiation. Not only did patients treated with IZN-6N4 have less mouth and throat pain and soreness than controls, but importantly, they were also more able to maintain their weights throughout the course of radiotherapy. The data supports that the best efficacy of IZN-6N4 was related to its initiation of use at the start of chemoradiation.

Jack V. Talley, Chief Executive Officer of Izun Pharmaceuticals commented, “We are pleased with the outcome of this study. The results point toward utility in a large cancer patient population for which there are few, if any, approved therapeutic alternatives. The FDA has approved a prior product based on symptomatic improvement in oral mucositis patients. We plan to meet with the FDA as soon as possible to chart the next steps in the development of IZN-6N4.”

“Oral mucositis is a dominant, painful toxicity of radiation therapy in patients being treated for head and neck cancer,” said Dr. Stephen Sonis, an expert in the field and an advisor to the Company. Sonis continued, “IZN-6N4’s successful mitigation of symptoms bodes well for a new treatment option which will ease the burden of mucositis.”