Top-Line Data from Oculus Innovative Sciences' Phase II Trial to Be Presented at DFCon 08 (Diabetic Foot Global Conference) on March 14, 2008
Hoji Alimi, founder and CEO of Oculus Innovative Sciences, said, "We previously announced that the Phase II data would be released this quarter and we're excited to make public the results of our Phase II trial on mildly infected diabetic ulcers at DFCon, one of the leading conferences for the study of diabetic foot ulcers.
"In addition to the primary endpoint of clinical success -- cure or improvement of infection -- for Microcyn alone or in combination with oral antibiotics, the Phase II trial design allows for the evaluation of multiple outcome assessments at different time points. The results will provide valuable insight for designing successful Phase III trials."
As is typical with Phase II studies in general, the primary objective of this Phase II trial is to identify strong trends relative to the clinical benefits and establish a baseline of safety. These trends or signals will provide the basis and rationale for performing larger Phase III trials. Rather than a superiority or wound healing study, the clinical strategy in conducting Phase II trials is to use the various data points and trends as the foundation for moving the company's clinical program forward.
About the Study
The open-label, randomized Phase II study enrolled a total of 67 patients with mildly infected diabetic foot ulcers at 15 U.S. sites. Patients were randomized to one of three treatment arms: 1) topical Microcyn alone 2) topical Microcyn in combination with oral levofloxacin; and 3) topical saline in combination with oral levofloxacin. Patient enrollment criteria in all three arms of the study included appropriate blood perfusion as well as mildly infected ulcers based on the Infectious Diseases Society of America (IDSA) classification of "mild" and University of Texas wound classification of "1B." Patients were randomized and treated for a total of 10 days in all three arms. Designed into the trial were three assessment time points: day 3, day 10, and day 24. This design allows the most flexibility for an optimal design of a Phase III trial based on a number of potential positive signals at various time points.
Levofloxacin was chosen for the control group because it is one of the more potent, broad-spectrum oral antibiotics indicated for the treatment of complicated skin and skin structure infections (including diabetic foot infections) and is recommended by the IDSA in its guidelines for treatment of diabetic foot infections. The final patient evaluation occurred on December 24, 2007.
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.
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 ability to replicate the results of the test in clinical trials, if at all, or for such trials or other tests to establish the conclusions suggested by the results of the test. These forward-looking statements are identified by the use of words such as "will be," "to identify," "to make public," "designing," "evaluating," "allows," and "will provide," among others. These forward-looking statements are based on Oculus Innovative Sciences, Inc.'s current expectations. Investors are cautioned that such forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the Company's business including risks inherent in the development and commercialization of potential products, the risk that scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, risks that revenues will not reach expected levels, 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 September 30, 2007 and Form 10-K for the fiscal year ended March 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, 646-536-7025
Janine McCargo, 646-536-7033
Posted: January 2008