PETALUMA, Calif. -- Oculus Innovative Sciences, Inc. announces positive top-line results from its U.S. Phase II clinical trial evaluating Microcyn® technology as a topical antimicrobial treatment for mildly infected diabetic foot ulcers. 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.
Hoji Alimi, CEO and founder of Oculus Innovative Sciences, said, We believe that Microcyn has the potential to be the first topical drug to provide patients with a favorable safety profile and effective antimicrobial properties. The top-line results of the study are a major milestone for Oculus. Microcyn demonstrated a positive clinical success rate by meeting the primary endpoint of clinical cure or improvement of infection. We are extremely encouraged by the preliminary Phase II data available today and are pleased to announce an initial analysis of the primary endpoint ahead of schedule. We are now focusing on further analysis of the complete trial data to prepare for our end-of-Phase II meeting with the FDA.
Andres A. Gutierrez MD, PhD, director of medical affairs for Oculus Innovative Sciences, stated, We look forward to continuing our evaluation and presenting expanded results on March 14, 2008 at DF Con, which is one of the premier international diabetic foot conferences held annually.
The primary Phase II endpoint was clinical cure or improvement of infection at the end of therapy (day 10). Clinical cure of infection is defined as the elimination of all five of the Infectious Diseases Society of America (IDSA) visual symptoms that characterize mildly infected diabetic foot ulcers, including: presence of erythema less than two centimeters around the ulcer, detectable increase in temperature of the wound or periwound area, culturable exudate and/or extension of redness is present, localized swelling or induration, and localized tenderness or pain. Clinical improvement of infection is defined as the elimination of at least two of the five ISDA symptomatic visual indications.
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 (CSSSIs). IDSA guidelines also recognize Levofloxacin as an appropriate treatment for the treatment of diabetic foot infections. According to the Datamonitor Pharmaceutical Report, Levofloxacin generated $2.4 billion in global sales in 2005.
Preliminary Phase II Data Analysis
No serious drug-related adverse events were reported in any of the three treatment arms. In the Microcyn-Levofloxacin combination arm, two patients experienced stomach discomfort and amnesia, respectively, both related to levofloxacin while one patient experienced a burning sensation attributed to Microcyn, which is consistent with observations in prior Microcyn studies.
Although microbiological data does not impact the clinical success achieved in meeting our primary endpoint, we continue to clean and analyze this raw data. A preliminary review of the raw data suggests that there were fewer eradications of bacterial strains in the Microcyn monotherapy arm. The initial impression is that it would appear the population of bacteria was lowered sufficiently to induce a clinical response rate of 75 percent.
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: 20 patients received topical Microcyn alone; 25 patients received topical Microcyn in combination with oral levofloxacin; and 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.
According to the American Diabetes Association, 20.8 million children and adults in the United States, or 7 percent of the population, are afflicted with diabetes. If present trends continue, one in three Americans that were born in 2000 will develop diabetes during their lifetime. Each day, approximately 4,110 people are diagnosed with diabetes. The average cost of treatment is $8,000 for a single ulcer, $17,000 for an infected ulcer, and $45,000 for an ulcer requiring major amputation. More than 80,000 amputations are performed each year on diabetic patients in the United States. Fifty percent of patients who have undergone amputations will develop ulcerations and infections in the contralateral limb within 18 months, while 58 percent will have a contralateral amputation three to five years after the first amputation. In addition, the estimated three-year mortality rate is as high as 20 percent to 50 percent after a first amputation. These figures have not changed much in the past 30 years, despite huge advances in the medical and surgical treatment of patients with diabetes.
A 2006 study published in Clinical Diabetes by Ingrid Kruse, DPM, and Steven Edelman, MD, indicated that diabetic foot problems, such as ulcerations, infections, and gangrene, are the most common causes of hospitalization among diabetic patients. Routine ulcer care, treatment of infections, amputations, and hospitalizations cost billions of dollars every year and place a tremendous burden on the healthcare system.
Source: Oculus Innovative Sciences