From rxpgnews.com
MacroChem completes patient enrollment for Phase II trial of EcoNail for treatment of onychomycosis
By MacroChem,
Apr 11, 2007 - 3:59:37 AM
Wellesley Hills, MA, April 11 -- MacroChem Corporation (OTCBB: MACM.OB) announced the completion of patient enrollment in a 40 patient U.S. multi-center open label Phase II efficacy study of EcoNail, a topical antifungal lacquer for the treatment of onychomycosis (nail fungus). EcoNail is the company's patented lacquer which contains the antifungal econazole and MacroChem's enhancer SEPA®.
Patients participating in the study, which is being conducted under MacroChem's U.S. Investigational New Drug application filed with the FDA, will receive 48 weeks of treatment and will undergo efficacy assessments using standard criteria of nail appearance and mycology. However, the Company will collect and evaluate 24-week interim data later this year. This trial was specifically designed, with the assistance of well-known onychomycosis experts, to address three important objectives: to assess early signs of efficacy, to maintain robust clinical endpoints in the full study, and, if successful, to facilitate advancement to Phase III as soon as possible.
Full enrollment in this Phase II study is an important milestone in advance of our planned interim assessment later this year. An earlier than originally intended evaluation of clinical data from a subset of patients treated for 24 weeks may be conducted to facilitate planning for potential future clinical development, stated Robert DeLuccia, President and CEO of MacroChem. He continued, I believe that the recent precedent-setting deal activity for topical nail fungus products in clinical development by two major international pharmaceutical companies reflects the high level of interest in the marketplace for new treatments for onychomycosis.
DeLuccia further noted: If we can develop a topical therapy without the treatment-limiting side effects experienced with the current market-leading oral products and with better efficacy than the only currently available topical product, we believe this could be a substantial commercial opportunity. We also believe that an effective, well-tolerated and easy-to-use topical onychomycosis therapy could both attract patients currently receiving other treatments and also expand the existing market to include patients who are not currently being treated.
Onychomycosis affects 20-30 million people in the United States alone, including nearly half of those over age 70. Untreated, the disease causes nails to thicken, resulting in localized pressure-related pain. Topical treatments currently marketed in the U.S. reportedly succeed in fewer than 12 percent of patients, and existing systemic treatments, which are effective in less than half of all cases, have known toxicity. Despite the shortcomings of these existing drugs, sales of treatments for onychomycosis top $1.5 billion annually worldwide.
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