MCHM...News..maybe better than Viagra...Joe Kernan will love explaining this one!!
Macrochem Corporation Announces Preliminary Phase IIB Results With
Topiglan Gel
PR Newswire - December 17, 1998 12:57
LEXINGTON, Mass., Dec. 17 /PRNewswire/ -- MacroChem Corporation (NASDAQ: MCHM) announced today a
preliminary review of a Phase IIB study of its topical gel, Topiglan, a proprietary topical formulation of alprostadil, in the
treatment of erectile dysfunction. The study was carried out by Dr. Irwin Goldstein of the Department of Urology at Boston
University Medical Center.
The study was double-blind (i.e., neither the patient nor the investigator nor MacroChem knew any patient's treatment),
randomized, placebo-controlled (i.e., assignment to the Topiglan or placebo group was by chance, with half the subjects
receiving 0.25 ml 1% alprostadil in a SEPA -formulated gel, and the other half a SEPA-formulated gel without alprostadil) in
an office setting with visual and tactile stimulation. Sixty patients with documented erectile dysfunction, were treated with either
Topiglan or placebo, applied topically to the head of the penis. Many of the patients had previously failed to respond to
available therapies, including Viagra, MUSE and surgical revascularization.
Topiglan application was associated with statistically greater penile rigidity and tumescence (p=0.033) compared to placebo,
as assessed by the physician. This was confirmed by the patient's assessment in which Topiglan was also rated as significantly
better than placebo (p=0.003). In fact, six times more patients stated that the erection attained following Topiglan application
was sufficient for vaginal intercourse compared to placebo-treated patients (p=0.005). Treatment was accompanied by
transient, minor to mild symptoms of localized warmth, occasionally minor to mild burning or tingling in some patients, with no
difference observed between Topiglan and placebo treatments.
There were no significant changes in vital signs in any patient in either group.
Dr. Goldstein commented: "These data demonstrate that Topiglan applied topically to the glans of the penis is effective to
increase penile rigidity in patients with significant erectile dysfunction, with the result that an increased number of these
individuals attained erections judged adequate for vaginal penetration."
MacroChem develops and licenses products and technology for the transdermal delivery of agents for pharmaceutical and
cosmetic applications. The Company's patented technology, SEPA, an absorption enhancer for transdermal delivery, can
effectively increase the passage of therapeutic agents through the skin, offering significant advantages over other methods of
delivery. MacroChem's technology is focused on four major therapeutic areas: sexual dysfunction, pain management, hormone
replacement, and dermatological conditions.
To the extent that this press release discusses matters relating to the development of future products, these 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.
Visit our web site at: macrochem.com or mchm.com
SOURCE MacroChem Corporation
/CONTACT: Michael Kaiser of MacroChem Corporation, 781-862-4003/
/Web site: macrochem.com
/Web site: mchm.com
Ed
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