Healthcare Industry News: diabetic foot ulcers
News Release - March 17, 2008
Oculus Innovative Sciences Announces Positive Results From Three Abstracts Evaluating the Use of Microcyn(R) Technology in Diabetic Foot UlcersAbstracts Accepted and Presented at DFCon 08 in Hollywood this Past Week
PETALUMA, Calif.--(HSMN NewsFeed)--Oculus Innovative Sciences, Inc. (Nasdaq:OCLS ) announced that three abstracts, which relate to the safety and efficacy of Microcyn® Technology in the treatment of diabetic foot ulcers, were peer reviewed and presented at DFCon 08 this past week in Hollywood, California. The conference, which is one of the premier diabetic foot conferences in the world, is a showcase for the latest advances in the treatment and care of the diabetic foot. The three abstracts evaluating the use of the Microcyn® Technology were:
A 39-patient prospective and randomized study, “Efficacy and Safety of a Novel, Super-Oxidized Solution in Managing Post-Surgical Lesions of the Diabetic Foot,” was led by Dr. Alberto Piagessi of the Azienda Ospedaliera Universitaria in Pisana, Italy. Diabetic patients with post-surgical infected lesions greater than 5 centimeters were randomized and received topical SOS (Microcyn in 20 patients) or povidone iodine (19 patients). Each group also received metabolic control, systemic antibiotics and offloading. At the endpoint of 24 weeks, 85% of the SOS (Microcyn) patients had healed versus 53% of the povidone iodine patients (p<.01). The healing time was 10.5 weeks (+ or – 1.3 weeks) for the SOS (Microcyn) group versus 16.5 weeks (+ or – 1.7 weeks) for the povidone iodine group. No differences were observed in adverse events occurrence with two in the SOS (Microcyn) group and three in the povidone iodine group.
Investigator Conclusion: “Local treatment with SOS (Microcyn) proved to be as safe as and more effective than povidone iodine in the management of wide post-surgical lesions of the diabetic foot.”
A 100-patient randomized trial entitled, “The Effect of Neutral-pH Super-Oxidized Solution for the Treatment of Infected Diabetic Foot Wounds” was directed by Amar Pal Sing Suri, DPM, a Harvard graduate and director of the Diabetic Footcare Center in New Delhi, India. Both type I and type II diabetic patients with solitary infected foot ulcers 2 to 15 centimeters were randomized into two groups. Each group was instructed to bathe their wounds in 20-50 mL of nSOS (Microcyn in 50 patients) or normal saline (50 patients) for 5 minutes, once per day for 16 weeks. Debridement was performed as needed. Patients were evaluated weekly by an examiner who was blinded to the solution being used for wound cleaning. All patients completed the 16-week study. A 5-log reduction in bioburden was documented in 76% of the nSOS (Microcyn) patients whereas only 32% of the patients in the saline group achieved a 2-log reduction in bioburden (p=0.01). At the conclusion of the trial, the wounds had healed in 78% of the nSOS (Microcyn) patients versus only 40% in the saline group (p=0.05).
Investigator Conclusion: “This study demonstrates that nSOS (Microcyn) is superior to saline for treating mildly infected foot wounds in diabetic patients and that mechanical eradication of bacteria is not the sole explanation of its efficacy.”
A 23-patient study, “Wound Healing in Chronic Lower Extremity Wounds Comparing Super-Oxidized Solution vs. Saline,” was overseen by Robert G. Frykberg, DPM, MPH, of the Carl T. Hayden VA Medical Center in Phoenix, Arizona. Diabetic patients were enrolled in this open-label study and consecutively assigned 1:1 to either SOS (Microcyn) or saline treatment. Local standard of care included debridement, off-loading and daily wound care. Patients were followed weekly for two weeks and were monitored for wound size, extent of epithelialization and other clinical assessments. In this preliminary report, clinically evaluable patients included 13 in the SOS (Microcyn) group and 10 in the saline group with wound size of 3.06 vs 1.56 centimeters respectively. All patients had diabetes and most wounds were present for at least 7 weeks. At week 1, median wound size had decreased 45% to 1.68 cm with 3 wounds 100% epithelialized in the SOS (Microcyn) arm versus 19% reduction in size to 1.26 cm and no wounds 100% epithelialized in the saline group. At week 2, 2 wounds were cured and 9 were 100% epithelialized in the SOS (Microcyn) Group compared to 0 cured and only one 100% epithelialized in the saline group. The study will continue to complete the enrollment of 20 patients in each arm.
Investigator Conclusion: “These preliminary data suggest that daily use of SOS (Microcyn) may promote wound healing in chronic wounds when compared to saline.”
Andres A. Gutierrez M.D., Ph.D., director of medical affairs of Oculus Innovative Sciences, said, “The positive results from these abstracts continue to support the experience we have had with nearly one million patients worldwide and the data we have seen in 23 other studies on over 700 patients—most recently in our U.S. Phase II trial in which Microcyn demonstrated a positive clinical response with a 93% cure or improvement of infection in diabetic foot ulcers in the final follow-up visit. These consistent results are very encouraging since in the second arm of this study we are compared to a highly respected antibiotic in levofloxacin, which demonstrated only a 56% clinical success rate during the same visit. Now we see our next major milestone being further analysis of the Phase II trial as we prepare for our end-of-Phase II meeting with the FDA and another step towards a new drug approval in the United States.”
Oculus presented additional results from the recently completed U.S. Phase II trial assessing the safety and efficacy of the Microcyn Technology in the treatment of mildly infected diabetic foot ulcers via a teleconference at DFCon 08 as well. (http://www.oculusis.com/phase2data_update/).
Oculus Innovative Sciences is a biopharmaceutical company that develops, manufactures and markets a family of products based upon the Microcyn® 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 "support," "suggest,” “may,” and "prepare," 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.
Source: Oculus Innovative Sciences
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