Oculus Innovative Sciences to Announce Additional Phase II Data and Data from Two Recent International Studies at DFCon 08
-- Additional Phase II data will be presented by the study's principal investigator, Adam Landsman, DPM and Ph.D., of Beth Israel Deaconess Medical Center in Boston.
-- Dr. Alberto Piagessi of the Azienda Ospedaliera Universitaria in Pisana, Italy, will review his 39-patient prospective and randomized study, "Efficacy and Safety of a Novel, Super-Oxidized Solution in Managing Post-Surgical Lesions of the Diabetic Foot."
-- Amar Pal Sing Suri, DPM, of the Diabetic Footcare Center in New Delhi, India will present a summary of his 100-patient randomized trial entitled, "The Effect of Neutral-pH Super-Oxidized Solution for the Treatment of Infected Diabetic Foot Wounds."
The live webcast over the Internet will be available at http://ir.oculusis.com/events.cfm and archived for 30 days. Please access the site 15 minutes before the presentation in the event that a software download is required. 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 278320.
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.
In positive top-line results announced on February 27, 2008, Microcyn demonstrated a positive clinical response, defined as the clinical cure or improvement of infection, as a monotherapy and in combination with levofloxacin, a systemic antibiotic. The company plans to request an end-of-Phase II meeting with the FDA to discuss Phase II results and define the scope and parameters for advancing the clinical program for Microcyn.
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, shelf-stable 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.
Except for historical information herein, some matters set forth in this press release are forward-looking within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including statements about our plans to request a meeting with the FDA, our belief that the design of our Phase II trial should provide important information for our planned Phase III trial, our ability to provide expanded analysis, or that our Phase II trials will be sufficient to allow the Company to move forward in its clinical program. These forward-looking statements are identified by the use of words such as "plans," "advancing," and "discuss," among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the Company's business that could cause actual results to vary, including risks inherent in the development and commercialization of potential products, the risk that regulatory clinical and guideline developments may change, the risk that scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, the risk that clinical results may not be replicated in actual patient settings, the risk that protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, the risk that present trends will continue and that the available market for our products will not be as large as expected, the risk that our products will not be able to penetrate one or more targeted markets, the risk that revenues will not be sufficient to fund further development and clinical studies, the Company's future capital needs, and its ability to obtain additional funding and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission including the quarterly report on Form 10-Q for the quarter ended December 31, 2007. Oculus Innovative Sciences disclaims any obligation to update these forward-looking statements.
Oculus and Microcyn are trademarks or registered trademarks of Oculus Innovative Sciences, Inc. All other trademarks and service marks are the property of their respective owners.
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 / Janine McCargo, 646-536-7025 / 7033
Posted: March 2008