Macrochem (NASDAQ:MCHM)
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MacroChem Announces Initiation of Next Clinical Trial of
Opterone(R), First Testosterone Cream For Male Hypogonadism
Company plans to initiate Phase 3 program in 2005
LEXINGTON, Mass., Dec. 8 /PRNewswire-FirstCall/ -- MacroChem Corporation
(NASDAQ:MCHM) has announced the initiation of the next clinical study in its
development program for Opterone(R), its investigational topical cream for male
hypogonadism. Opterone combines testosterone with SEPA(R), MacroChem's
patented skin-absorption enhancer. The SEPA in Opterone makes the stratum
corneum of the skin more permeable to testosterone, enhancing the delivery of
this hormone into the body.
The purpose of this bioavailability study is to compare the rate and extent of
absorption of testosterone into the bloodstream following administration of
different dose volumes of Opterone to different application areas. The study
was initiated at a U.S. clinical site following successful completion of a
pharmacokinetic study of Opterone cream in hypogonadal males, results of which
were announced in August 2004.
"Results from these two studies will allow us to move into a Phase 3 program
that we expect to initiate next year," explained Robert J. DeLuccia, president
and chief executive officer of MacroChem.
"Male hypogonadism is a medical condition of increasing importance, and
represents a growing market open to new and improved therapies," Mr. DeLuccia
said. "I believe Opterone can make an important contribution to managing this
condition."
About Testosterone Therapy
Low circulating testosterone is an underdiagnosed medical condition with
potential long term health consequences if left untreated. Some men do not
produce enough testosterone, resulting in a condition known as hypogonadism.
Signs and symptoms of hypogonadism include low sex drive, erectile dysfunction,
fatigue, depression, reduced muscle mass and strength, increased body fat and
decreased bone mineral density. According to the Endocrine Society,
approximately four to five million men in the U.S. may be hypogonadal.
Currently, only about 5 percent are treated.
In 2003, U.S. sales of testosterone products for male hypogonadism grew 20% and
exceeded half a billion dollars.
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. 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.
Visit our web site at: http://www.macrochem.com/
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 Media - Donna LaVoie of LaVoie Group, +1-781-596-0200
x103, for MacroChem Corporation
Web site: http://www.macrochem.com/