Oculus Innovative Sciences Schedules Conference Call Today to Discuss Positive Top-Line Phase II Data with Microcyn(R) Technology in Mildly Infected Diabetic Foot Ulcers
A live webcast over the Internet will be available at http://ir.oculusis.com/events.cfm and will be archived for one year.
To listen over the phone, please call 1-877-407-4018 (domestic/toll-free) or 1-201-689-8471 (international). A telephone replay will be available for 30 days after the call at 1-877-660-6853 (domestic/toll-free), or 1-201-612-7415 (international). Please enter account number 3055 and conference identification number 271899.
About the Phase II Trial
The Phase II randomized, open-label study enrolled a total of 66 patients with mildly infected diabetic foot ulcers at 15 U.S. sites. Three treatment arms were evaluated: 1) 20 patients received topical Microcyn alone 2) 25 patients received topical Microcyn in combination with oral levofloxacin; and 3) 21 patients received topical saline in combination with oral levofloxacin.
Patient enrollment criteria in all three treatment arms of the study included appropriate blood perfusion and mildly infected ulcers defined by IDSA classification of "mild" and University of Texas wound classification of "1B." Patients were randomized and treated for a total of 10 days. Designed into the trial were three assessment time points: day three, day 10, and day 24. The design provided flexibility for an optimal design of a Phase III trial based on a number of potential positive signals at various time points.
Oculus Innovative Sciences is a biopharmaceutical company that develops, manufactures and markets a family of products based upon the Microcyn(R) Technology platform, which is intended to help prevent and treat infections in chronic and acute wounds. The Microcyn Technology platform is a biocompatible solution containing active oxychlorine compounds. The solutions derived from the Microcyn Technology platform have demonstrated, in a variety of research and investigational studies, the ability to treat a wide range of pathogens, including antibiotic-resistant strains of bacteria (including MRSA and VRE), viruses, fungi and spores. The technology has also demonstrated wound healing in chronic and acute wounds in clinical investigational studies. It has been commercialized outside of the United States for the treatment of infected wounds. Oculus' principal operations are in Petaluma, California, and it conducts operations in Europe, Latin America and Japan through its wholly owned subsidiaries, Oculus Innovative Sciences Netherlands B.V., Oculus Technologies of Mexico, S.A. de C.V. and Oculus Japan K.K. Oculus' website is www.oculusis.com.
Oculus Innovative Sciences, Inc.
Director of Public and Investor Relations
Dan McFadden, 425-753-2105
The Ruth Group
Sara Ephraim, 646-536-7002
Jason Rando, 646-536-7025
Janine McCargo, 646-536-7033
Posted: February 2008