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

NEW YORK–Izun Pharmaceuticals Corporation (“Izun”, “Company”, izunpharma.com), a clinical-stage company focused on developing high efficacy products based on pharmaceutically active compounds derived from botanical sources announced today 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.”

About Izun Pharmaceuticals

Izun Pharmaceuticals is a US based clinical stage pharmaceutical company with a wholly owned R&D center in Israel. Izun’s technology platform allows it to develop botanical drugs by optimizing and purifying the extracted botanical compounds to yield polymolecular drug candidates. These patented products are designed to impact on multiple specific receptor targets. The main therapeutic focus is on agents that can reduce inflammation and accelerate healing. Izun is currently active in developing therapeutic products for a number of indications including: oral care, oncology support, wound care, women’s health care, gastrointestinal disease and dermatologic conditions. Izun uses the inherent advantage of the natural botanical sources to deliver robust clinical results with an excellent safety profile. Izun has received approval for a number of oral care products that are marketed.

Izun Disclosure Notice: This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein or which are otherwise made by or on behalf of the Company that are not statements of historical facts may be deemed forward looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “to,” “plan,” “expect,” “believe,” “anticipate,” “intend,” “could,” “should,” “would,” “estimate,” or “continue,” or the negative or other variations thereof or comparable terminology are intended to identify forward looking statements. Investors are cautioned that all forward looking statements involve risk and uncertainties which may cause results to differ materially from those set forth in the statements. Such risks and uncertainties include, but are not limited to the following: the success of research and development activities and the speed with which regulatory authorizations and product launches may be achieved; government regulation generally; competitive developments; the ability to successfully market products domestically and internationally; difficulties or delays in manufacturing or issues relating to manufacturing capacity; commercial obstacles to the successful introduction of brand products generally; legal defense costs, insurance expenses, settlement costs, and the risk of an adverse decision or settlement relating to product liability, patent protection, governmental investigations, and other legal proceedings; the Company’s ability to acquire and protect patents and other intellectual property both domestically and internationally; the absence of certainty regarding the receipt of required regulatory approval or the timing or terms of such approvals; any changes in business, political and economic conditions; business interruption due to hurricanes or other events outside of the Company’s control.

Investors are cautioned not to place reliance on these forward looking statements, which are valid only as of the date they were made. The Company undertakes no obligation to update or revise any forward looking statements to reflect new information or the occurrence of unanticipated events or otherwise, except as expressly required by law.

Contacts

Izun Pharmaceuticals
Jack V. Talley, 203-895-1524
Chief Executive Officer
jtalley@izunpharma.com