Macrochem Announces Preliminary Phase 2 Results for Topiglan(R), its Topically Applied Erectile Dysfunction Product
April 14 2004 - 4:41PM
PR Newswire (US)
Macrochem Announces Preliminary Phase 2 Results for Topiglan(R),
its Topically Applied Erectile Dysfunction Product
Webcast/Conference Call Scheduled on Thursday, April 15, 2004 at
9:00 a.m. EDT* LEXINGTON, Mass., April 14 /PRNewswire/ -- MacroChem
Corporation announced today that preliminary data from its Phase 2
pharmacodynamic study of Topiglan(R), a topical cream for erectile
dysfunction, demonstrate that Topiglan did not meet the study's
primary clinical endpoints. The randomized, double-blind clinical
study, which utilized the RigiScan(R) monitoring technique,
compared the efficacy of Topiglan in men with mild-to- moderate
erectile dysfunction to a placebo cream. "While we are disappointed
by these preliminary Topiglan data, we continue to advance our
clinical studies of EcoNail(TM) and Opterone(TM)," said Robert J.
DeLuccia, chief executive officer of MacroChem. "We plan in the
weeks ahead to further analyze all of the Topiglan study data."
MacroChem currently has two other clinical programs underway. A
dose- proportionality study of Opterone cream, an
absorption-enhanced topical treatment for male testosterone
deficiency, is ongoing. Patients are currently being dosed and
results from that study are expected later this year. The Company
has also initiated a Phase 1 study of EcoNail in patients with
onychomycosis, a fungal infection of nails. Patient screening is
nearly complete and data from this study are expected to be
available by the end of the year. 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 products
containing its patented drug-absorption enhancer, SEPA(R).
MacroChem's clinical stage products include: Topiglan(R), a
SEPA-enhanced alprostadil for topical treatment of erectile
dysfunction; Opterone(TM), a SEPA-enhanced topical treatment for
men with testosterone deficiency; and EcoNail(TM), a SEPA- enhanced
antifungal nail lacquer to treat a common and potentially
debilitating nail infection known as onychomycosis. For further
information please consult http://www.macrochem.com/ RigiScan(R) is
a registered trademark of Endocare, Inc. SEPA(R), Topiglan(R),
Opterone(TM) and EcoNail(TM) are trademarks of MacroChem Corp. *
You are welcome to listen to a live webcast of this conference call
by visiting MacroChem's web site at http://www.macrochem.com/ and
selecting the Investor Relations page. To participate and ask
questions, the dial-in number for the conference call is
800-299-7635 for domestic callers and 617-786-2901 for
international callers. All callers should use reservation number
40122848 to gain access to the call. A replay of the call will be
available by dialing 888-286-8010 for domestic callers and
617-801-6888 for international callers. All callers should use
reservation number 72104049 to gain access to the replay. The
replay will be available through Thursday, April 22. With the
exception of historical information contained in this press
release, the matters described herein are forward-looking
statements and are subject to various risk factors that could cause
actual results to differ materially from those expressed in the
forward-looking statements. The relevant risk factors are set forth
in MacroChem's annual report on Form 10-K as filed with the SEC and
include, without limitation, risks regarding product development,
clinical trials, dependence on third parties for development and
licensing arrangements, and risks involving regulatory approval of
products, and patents and licenses. 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
x 103 DATASOURCE: MacroChem CONTACT: Bernard Patriacca - VP/CFO of
MacroChem, +1-781-862-4003; or Donna LaVoie of LaVoie Group,
+1-781-596-0200 x 103 Web site: http://www.macrochem.com/
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