MCHM Macrochem (MM)

MacroChem to Present EcoNail(TM) Clinical Data at Society For Investigative Dermatology Meeting Full 18-week data set confirms 6-week safety-tolerability findings previously reported LEXINGTON, Mass., April 7 /PRNewswire-FirstCall/ -- MacroChem Corporation (NASDAQ:MCHM) announced today that it will present the results of its Phase 1 safety and tolerability study of EcoNail(TM) lacquer, the Company's investigational treatment for nail fungal infections, at the annual meeting of the Society for Investigative Dermatology on May 6 in St. Louis. EcoNail contains SEPA(R), the Company's patented enhancer, plus econazole, a topical antifungal agent that effectively inhibits in vitro growth of the fungi that commonly cause a nail infection known as onychomycosis. This condition affects more than 30 million people in the U.S. MacroChem's poster presentation, "EcoNail lacquer in patients with severe onychomycosis: Safety, local tolerability, and systemic exposure," will be based on the complete results of an 18-week Phase 1 human safety and tolerability study of EcoNail. Results from the first six weeks of that study were reported in November of last year. The complete 18-week data confirmed the six-week assessment that EcoNail was well-tolerated and warrants advancement to efficacy trials. In addition to safety and tolerability data, clinical observations included nail photographs. Although not formally part of the clinical protocol procedures, photographs from 5 of the first 14 completed patients (having received either 12 or 18 weeks of EcoNail treatment) were judged by independent dermatologists to have shown initial signs of nail improvement. "We are very pleased with the results of this trial and the early clinical observations," said Robert J. DeLuccia, MacroChem president and CEO. "We look forward to sharing this data with the scientific community and advancing EcoNail to a formal efficacy trial." The primary objectives of the Phase 1 study were to assess the safety and local tolerability of EcoNail lacquer, and to determine systemic exposure to econazole, in patients with onychomycosis. In the blinded segment of the study, either EcoNail or the control lacquer was applied twice daily for six weeks to all fingernails and toenails of patients with onychomycosis. Following this randomized, blinded segment of the study, all patients received once-daily applications of EcoNail to all nails for an additional 12 weeks. The study was neither intended nor powered to evaluate the efficacy of EcoNail. MacroChem plans to initiate a formal EcoNail efficacy study later this year, assuming availability of adequate financial resources. The Society for Investigative Dermatology is a worldwide organization of clinicians and researchers devoted to the science of skin health and diseases. About MacroChem MacroChem is a specialty pharmaceutical company that innovates, develops and commercializes pharmaceuticals administered in novel ways, to treat important medical conditions. MacroChem is developing two products containing its patented enhancer, SEPA(R): Opterone(R), a SEPA-enhanced topical testosterone treatment for male hypogonadism; and EcoNail(TM), a SEPA-enhanced antifungal nail lacquer to treat a common and potentially debilitating nail infection known as onychomycosis. For more information on MacroChem, and its technology and products, please visit our website at: http://www.macrochem.com/. Forward-Looking Statements With the exception of historical information contained in this press release, the matters described herein are forward-looking statements that involve risks and uncertainties. MacroChem's actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed or referred to in the section entitled "Risk Factors" in MacroChem's Annual Report on Form 10-K, as well as those discussed elsewhere therein, and include, without limitation, risks regarding product development, the timing and results of clinical trials, the regulatory approval process, capital requirements, financial condition, patent protection and dependence on third parties for development and licensing arrangements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. MacroChem undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. For more information visit our website, http://www.macrochem.com/ . DATASOURCE: MacroChem Corporation CONTACT: Investor Contact, Bernard Patriacca - VP/CFO, +1-781-862-4003 of MacroChem; or Media Contact, Donna L. LaVoie (LaVoie Group), +1-781-596-0200 ext. 103 for MacroChem Web site: http://www.macrochem.com/

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