Jan 03, 2008
Oculus Innovative Sciences, Inc. (NASDAQ:OCLS) today announced that it has completed patient treatment and follow-up in its randomized and controlled Phase II clinical trial evaluating its Microcyn(R) Technology in the treatment of mildly infected diabetic foot ulcers. The final patient evaluation occurred on December 24, 2007.
Hoji Alimi, chairman and CEO of Oculus Innovative Sciences said, "We are pleased to have successfully completed the Phase II trial in December 2007 and look forward to reporting top line data in Q1 2008.
"The primary objective of the Phase II trial is to provide the clinical basis and rationale for larger Phase III trials. It is not a superiority or wound healing study. The patients enrolled in this trial have been screened to ensure that they have appropriate blood perfusion, thus enabling the antibiotic levofloxacin the opportunity to access and impact the infected ulcer. Our intent is to use the various data points in the Phase II trial as the foundation for moving the company's clinical program forward."
About the Study
The Phase II randomized, controlled open-label study enrolled a total of 67 patients with mildly infected diabetic foot ulcers at 15 U.S. sites. Three treatment arms were evaluated: 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 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 Infectious Diseases Society of America in its guidelines for treatment of diabetic foot infections.
The company expects to provide preliminary top line Phase II clinical trial results in Q1 of 2008. More detailed results will be submitted for publication and/or presentation in various medical journals and conferences. Further information on this Phase II trial can be found at
www.clinicaltrials.gov.
About Oculus
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 U.S. for the treatment of infected wounds.
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