MCHM Macrochem (MM)

MacroChem Announces Successful Results From EcoNail(TM) Clinical Trial in Patients with Onychomycosis Company Plans to Initiate Efficacy Trial in 2005 LEXINGTON, Mass., Nov. 16 /PRNewswire-FirstCall/ -- MacroChem Corporation (NASDAQ:MCHM) today announced successful results from its Phase 1 human safety and tolerability study of EcoNail(TM) antifungal lacquer (a formulation of SEPA(R), the Company's patented enhancer, plus econazole), in patients with onychomycosis, a common fungal infection of the nail. The Company plans to initiate an efficacy trial as soon as feasible in 2005. "Based on the excellent tolerability of EcoNail in these patients, and the lack of systemic exposure to econazole when it is applied as a lacquer," commented Thomas C.K. Chan, PhD, vice president of R&D and chief technology officer at MacroChem, "we plan to proceed to an efficacy trial to determine whether the substantial in vitro drug penetration from EcoNail seen in human cadaver nails translates to clinical benefit. Data from that in vitro study were reported by University of California, San Francisco researchers and published last year in the Journal of Pharmaceutical Sciences."(1) The EcoNail clinical trial was a randomized, double-blind, controlled Phase 1 trial conducted at two U.S. clinical sites. Eighteen patients with onychomycosis of the toenails completed the safety- tolerability segment of the study, in which all fingernails and toenails were treated twice daily for 6 weeks with either EcoNail or a control nail lacquer. In the ongoing open- label segment of the trial, all patients are receiving EcoNail applied once daily to all nails for an additional 12 weeks to extend patient exposure experience. The main objectives of this Phase 1 study were to test the safety and local tolerability of EcoNail in patients with onychomycosis, and to determine systemic exposure to econazole. In the 6 week segment, EcoNail was very well tolerated, and investigators reported no serious drug-related adverse events. Serum assays showed no detectable levels of econazole, further supporting EcoNail's systemic safety profile. "We are pleased with the results from this first-in-man trial of EcoNail. This 6-week safety and tolerance data gives us the confidence to move our clinical development program forward with an efficacy trial," said Robert J. DeLuccia, MacroChem president and CEO. "EcoNail could provide physicians and their patients with an important new therapy to treat this difficult disease and represents a very significant commercial opportunity for our company," Mr. DeLuccia said. Onychomycosis affects more than 30 million Americans, less than a quarter of whom receive prescription therapy. Low utilization of available prescription treatments may be attributed to toxicity risks associated with oral medications, and low efficacy of the currently marketed topical lacquer. Given that toenails take approximately 12 months to grow out completely, effective treatment of infected nails generally requires several months of therapy. 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(TM), a SEPA-enhanced topical 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. Visit our website at: http://www.macrochem.com/. 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. (1) Hui, et al, J Pharm Sci. 2003;92:142-148. Investor Contact: Bernard Patriacca -- VP/CFO (781) 862-4003 Media Contact: Donna LaVoie (LaVoie Group) (781) 596-0200 x103 DATASOURCE: MacroChem Corporation CONTACT: Bernard Patriacca, VP/CFO of MacroChem Corporation, +1-781-862- 4003; or Donna LaVoie of LaVoie Group, +1-781-596-0200 ext. 103 Web site: http://www.macrochem.com/

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