Alteon Initiates Phase 2 Trial of Alagebrium in Erectile Dysfunction

Alteon Initiates Phase 2 Trial of Alagebrium in Erectile
Dysfunction
- 'EMERALD' Trial to Test the Efficacy of Alagebrium in Diabetic Men Who
Achieve Limited Benefit from Current Therapies - 


PARSIPPANY, N.J., Jan. 18  /PRNewswire-FirstCall/ -- Alteon Inc. (AMEX: ALT)
announced today that it has initiated a Phase 2 trial of its novel A.G.E.
Crosslink Breaker compound alagebrium chloride (formerly known as ALT-711) in
erectile dysfunction (ED).  EMERALD (Evaluation of Alagebrium in Erectile
Dysfunction in Diabetic Males on PDE5 Inhibitors) will assess the ability of
alagebrium to restore erectile function in diabetic patients with moderate to
severe ED who achieve limited benefit from current treatment with
phosphodiesterase type 5 (PDE5) inhibitors, the first class of orally active
compounds approved for the treatment of ED.  Alagebrium has demonstrated an
ability to reverse ED in a preclinical model of ED in diabetic rats -- through
what appears to be a unique mechanism of action -- and thus may offer
significant potential as an adjunctive treatment for diabetic ED.

About EMERALD

EMERALD is a randomized, double-blind, placebo-controlled, Phase 2 pilot study
being conducted under the direction of Wayne J.G. Hellstrom, M.D., F.A.C.S.,
Professor of Urology at Tulane University School of Medicine and an author of
many of the seminal studies in ED.(1)  Approximately 40 male diabetic patients
age 18 to 70 will be enrolled and randomized to receive oral doses of either
alagebrium (200 mg once daily) or placebo tablets for a 16- week period in
conjunction with their PDE5 inhibitor therapy.  The primary endpoint of the
trial will be based on the International Index of Erectile Function (IIEF)
questionnaire.  Secondary endpoints of efficacy will be self- reported
improvement in erections (according to a Global Assessment Question) and
measurements of change from baseline in penile blood flow.

"Alagebrium appears to have a unique mechanism of action and significant
therapeutic potential for the treatment of diabetic erectile dysfunction," said
Dr. Hellstrom. "We are eager to continue the evaluation of alagebrium in a
clinical setting for the treatment of ED, and help the large number of patients
who are not sufficiently responsive to current ED treatment."

Alagebrium has demonstrated the ability to reverse ED in a preclinical model of
diabetes.  A preclinical study(2) presented by Mustafa F. Usta, M.D. at the
11th World Congress of the International Society for Sexual and Impotence
Research in Buenos Aires in October 2004 demonstrated that 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.  In addition, alagebrium
normalized other diabetes-induced pathologies associated with ED, an effect not
seen with PDE5 inhibitors.  According to the investigative team, these data are
unlike results for currently marketed ED drugs in similar experiments,
particularly due to a beneficial effect on the function of the corpus
cavernosum.  The results of this preclinical study have been submitted for
publication in a peer-reviewed medical journal.

In prior clinical and preclinical studies, alagebrium appeared to have a
remodeling effect on the cardiovascular system(3) as well as a positive effect
on systolic hypertension(4) and vascular compliance.(5) The drug is currently
in Phase 2 studies in patients with hypertension and heart failure.  In
addition, it is being studied for its effect on endothelial dysfunction, a
condition also linked to ED.

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 of
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 are 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.

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 treatments. This occurs,
in part, because the corpus cavernosum, the structure in the penis 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 molecular structures called advanced glycation end-products
(A.G.E.s)(6).  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 the natural penile
vasodilating agent, nitric oxide (NO) via their effects on endothelial and
neuronal nitric oxide synthases.

"The Phase 2 ED trial provides Alteon with a clinical development pathway that
is not only supportive of our ongoing programs in cardiovascular diseases, but
also fits well with our strategic and financial objectives," said Kenneth I.
Moch, President and CEO.

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 appear to 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, heart failure and erectile dysfunction.  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), the Phase 2a heart failure trial,
PEDESTAL (Patients with Impaired Ejection Fraction and Diastolic Dysfunction:
Efficacy and Safety Trial of ALagebrium), the Phase 2 trial EMERALD (Evaluation
of Alagebrium in Erectile Dysfunction in Diabetic Males on PDE5 Inhibitors), as
well as a fourth trial exploring mechanism of action in endothelial
dysfunction.  For more detailed information about alagebrium, 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) "Vardenafil for Treatment of Men with Erectile Dysfunction: Efficacy
      and Safety in a Randomized, Double-Blind, Placebo-Controlled Trial."
      Journal of Andrology, Vol. 23, No. 6, p. 763-771. November/December
      2002.  Wayne J.G. Hellstrom, et al.

  (2) "Delayed Administration of ALT-711, but not of Aminoguanidine,
      Improves Erectile Function in Streptozotocin Diabetic Rats: Curative
      Versus Preventive Medicine."  Abstract presented at the 11th World
      Congress of the International Society for Sexual and Impotence
      Research, October 2004.  Mustafa F. Usta, Muammer Kendirci, Trinity J.
      Bivalacqua, Serap Gur, Wayne J.G. Hellstrom, Neale A. Foxwell, Selim
      Cellek.

  (3) "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.

  (4) "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.

  (5) "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.

  (6) "The Protective Effect of Aminoguanidine on Erectile Function in
      Streptozoticin Diabetic Rats." J Urol  2003 Oct; 170(4 Pt 1):1437-42.
      Usta MF, Bivalacqua TJ, Yang DY et al.


DATASOURCE: Alteon Inc.



CONTACT: Susan M. Pietropaolo, Director, Corporate Communications &

Investor Relations, Alteon Inc., [phone], 



Web site:  http://www.alteonpharma.com/ 

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