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Alteon's Alagebrium Reverses Erectile Dysfunction In Preclinical
Study
Leading Investigators in ED Field Note Unique Mechanism of Action
PARSIPPANY, N.J., Oct. 18 /PRNewswire-FirstCall/ -- Alteon Inc. (AMEX:ALT)
announced today that its lead A.G.E. Crosslink Breaker compound alagebrium
(formerly known as ALT-711) has demonstrated an ability to reverse erectile
dysfunction (ED) in a preclinical model of diabetes. The preclinical study,
entitled "Delayed Administration of ALT-711, but not of Aminoguanidine,
Improves Erectile Function in Streptozotocin Diabetic Rats: Curative Versus
Preventive Medicine," was presented today at the 11th World Congress of the
International Society for Sexual and Impotence Research in Buenos Aires.
Independent study authors, Mustafa F. Usta(1,3), Muammer Kendirci(1), Trinity
J. Bivalacqua(1,4), Serap Gur(1), Wayne J.G. Hellstrom(1), Neale A. Foxwell(2),
and Selim Cellek(2), conclude that alagebrium -- through what appears to be a
unique mechanism of action -- offers significant potential for the treatment of
diabetic erectile dysfunction.
According to the investigative team, these data are unlike results for existing
ED drugs in similar experiments, particularly due to a beneficial effect on the
function of the corpus cavernosum. "Alagebrium appears to have significant
therapeutic potential for the treatment of diabetic erectile dysfunction, with
a unique mechanism of action," said Wayne J.G. Hellstrom, M.D., an author of
this study and many of the seminal studies in ED.
An estimated 30-40 percent of diabetic and aged patients with ED do not receive
benefit from currently available drugs, and patients with diabetes or severe
vascular disease are among the most refractory to such treatment. This occurs,
in part, because the corpus cavernosum, the structure that acts as an
expandable reservoir for blood, has become significantly glycated and fibrotic,
unable to properly dilate due to the accumulation and crosslinking of
pathological structures called advanced glycation end-products (A.G.E.s).
A.G.E.s have been implicated in the fibrosis and stiffening of tissues and
organs throughout the body and have been shown to contribute to many
inflammatory processes. A.G.E.s have been demonstrated to impair erectile
function in diabetes by affecting the functional capabilities of the corpus
cavernosum and by interfering with the production of natural penile
vasodilating agents, endothelial and neuronal nitric oxide (NO).
Study authors investigated the effect of delayed administration of alagebrium,
a crosslink breaker of A.G.E.s, as compared to aminoguanidine (pimagedine), an
inhibitor of A.G.E.s, in a well-established ED animal model. In previous
preclinical and clinical testing, alagebrium has demonstrated the ability to
cleave advanced glycation end-product crosslinks as well as diminish
deleterious inflammatory responses caused by A.G.E.s. Aminoguanidine has
previously been shown to prevent ED in diabetic animals if given immediately
after the induction of diabetes. In the current study, both aminoguanidine and
alagebrium were initiated at the 6th week of diabetes and the two treated
groups were compared to a group of age-matched controls and a group of
untreated diabetic animals. Twelve weeks after diabetes induction, in vivo
intracavernosal pressure measurements were assessed, as well as serum and
penile A.G.E. levels. The diabetic rats had a significant decrease in erectile
function as assessed by the level of intracavernosal pressure obtained after
cavernosal nerve stimulation and elevated A.G.E. levels when compared to the
control rats. The administration of alagebrium resulted in a significant
improvement in erectile function, as well as a decrease in serum and tissue
A.G.E. levels, while the delayed administration of aminoguanidine did not
correct either A.G.E. levels or erectile dysfunction. In addition, alagebrium
normalized other diabetes-induced pathologies associated with ED, an effect
unlike any currently marketed therapies used to treat symptoms of the
condition. The results of the preclinical study have been submitted for
publication in a peer-reviewed medical journal.
In prior clinical and preclinical studies, alagebrium has been shown to have a
remodeling effect on the cardiovascular system(5) as well a positive effect on
systolic hypertension(6) and vascular compliance(7). The drug is currently in
Phase 2 studies in patients with hypertension and heart failure. In addition,
it is being studied for its effect in endothelial dysfunction, a condition also
linked to erectile dysfunction.
"We are actively evaluating a clinical development pathway for the ED
indication," said Kenneth I. Moch, President and CEO. "Because ED is an early
indicator of vascular disease, this exciting research by world-renowned ED
investigators is fully consistent with, and supportive of, our ongoing clinical
development programs for alagebrium in hypertension and heart failure. Should
alagebrium's therapeutic effect be seen in human studies in ED, this would not
only represent a breakthrough for ED, but would also be indicative of
alagebrium's potential to reverse pathologies in a number of other human
vascular diseases."
Understanding the Link between Erectile Dysfunction and Vascular Disease
Erectile dysfunction is defined as the persistent inability to attain and
maintain an erection sufficient to permit satisfactory sexual intercourse. ED
has been reported to affect as many as 20 to 30 million men in the United
States and 152 million men worldwide, according to the National Institutes on
Health. The risk for ED increases progressively with advancing age, with an
estimated 54 percent of men ages 65 to 70 reporting some degree of impotence
(Nicolosi, 2003). It is believed that 85-90 percent of ED cases are related to
a physical or medical condition, while 10-15 percent is due to psychological
causes.
Many studies have identified ED as an early indicator of cardiovascular
diseases, including hypertension, heart attack and stroke, and point to the
underlying dysfunction of the arteries and vascular system as a principal
cause. ED is commonly associated with a number of other conditions frequently
occurring in aging men, including prostatic hypertrophy, arterial hypertension,
ischemic heart disease, peripheral vascular disease, atherosclerosis,
hyperlipidemia, and diabetes mellitus.
About Alteon
Alteon is developing several new classes of drugs that have shown the potential
to reverse or slow down diseases of aging and complications of diabetes. These
compounds have an impact on a fundamental pathological process caused by the
progressive formation of protein-glucose complexes called Advanced Glycation
End-products (A.G.E.s). The formation and crosslinking of A.G.E.s lead to a
loss of flexibility and function in body tissues and organs and have been shown
to be a causative factor in many age- related diseases and diabetic
complications. Alteon has created a library of novel classes of compounds
targeting the A.G.E. Pathway.
Alteon's lead compound alagebrium chloride (formerly ALT-711), the only A.G.E.
Crosslink Breaker in advanced human testing, has demonstrated safety and
efficacy in several Phase 2 trials and is actively being developed for systolic
hypertension and heart failure. Over 1200 patients have been involved in
alagebrium's human clinical trials to date, of whom approximately 900 have
received active compound. Ongoing clinical trials include the phase 2b
systolic hypertension trial, SPECTRA (Systolic Pressure Efficacy and Safety
Trial of Alagebrium), and the phase 2a heart failure trial, PEDESTAL (Patients
with Impaired Ejection Fraction and Diastolic Dysfunction: Efficacy and Safety
Trial of ALagebrium), as well as a third trial exploring mechanism of action in
endothelial dysfunction. For more detailed scientific information about
alagebrium and a copy of the full abstract, please visit the scientific
publications section of the Alteon website, http://www.alteon.com/ .
Any statements contained in this press release that relate to future plans,
events or performance are forward-looking statements that involve risks and
uncertainties including, but not limited to, those relating to technology and
product development (including the possibility that early clinical trial
results may not be predictive of results that will be obtained in large-scale
testing or that any clinical trials will not demonstrate sufficient safety and
efficacy to obtain requisite approvals or will not result in marketable
products), regulatory approval processes, intellectual property rights and
litigation, competitive products, ability to obtain financing, and other risks
identified in Alteon's filings with the Securities and Exchange Commission. The
information contained in this press release is accurate as of the date
indicated. Actual results, events or performance may differ materially. Alteon
undertakes no obligation to publicly release the result of any revision to
these forward-looking statements that may be made to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events.
1 Department of Urology, Tulane Health Sciences Centre, New Orleans, USA
2 Wolfson Institute for Biomedical Research, University College London,
London, UK
3 Present address: Urology Department, Akdeniz University, Antalya,
Turkey
4 Present address: Department of Surgery, Johns Hopkins Hospital,
Baltimore, USA
5 "Effect of ALT-711, a Novel Glucose Cross-link Breaker, in the
Treatment of Diastolic Heart Failure." Poster presentation, European
Society of Cardiology Congress 2003. Dalane W. Kitzman, Michael Zile,
William C. Little, W. Gregory Hundley, Terrence X. O'Brien, Robert C.
deGroof.
6 "A Clinical Trial of an A.G.E. Cross-link Breaker, Alagebrium Chloride
(ALT-711), in Systolic Hypertension." Abstract presented at the
American Society of Hypertension Nineteenth Annual Scientific Meeting,
May 19, 2004. George L. Bakris, Alan Bank, David C. Kass, Joel Neutel,
Richard Preston.
7 "Improved Arterial Compliance by a Novel Advanced Glycation End-Product
Crosslink Breaker." Circulation: 2001; 104: r8-r14. David A. Kass,
Edward P. Shapiro, Miho Kawaguchi, Anne R. Capriotti, Angelo Scuteri,
Robert C. deGroof, Edward G. Lakatta.
DATASOURCE: Alteon Inc.
CONTACT: Susan M. Pietropaolo, Director, Corporate Communications &
Investor Relations, +1-201-818-5537(direct) for Alteon Inc.
Web site: http://www.alteonpharma.com/