Alteon Initiates 'PEDESTAL,' a Phase 2 Trial of Alagebrium in Diastolic Dysfunction

Alteon Initiates 'PEDESTAL,' a Phase 2 Trial of Alagebrium in
Diastolic Dysfunction
- Study Builds Upon Positive Data From DIAMOND Trial of Alagebrium in Heart
Failure - 


PARSIPPANY, N.J., April 20  /PRNewswire-FirstCall/ -- Alteon Inc.  announced
today that a Phase 2 trial of its novel A.G.E. Crosslink Breaker alagebrium,
formerly known as ALT-711, has been initiated at Baylor Heart Clinic, Baylor
College of Medicine in Houston.  PEDESTAL (Patients with Impaired Ejection
Fraction and Diastolic Dysfunction: Efficacy and Safety Trial of ALagebrium)
will continue the evaluation of alagebrium on diastolic function and
ventricular mass in patients with significant heart failure.  In the Phase 2a
DIAMOND trial, treatment with alagebrium resulted in an unprecedented reduction
in left ventricular mass within a 16-week treatment period, as well as a marked
improvement in left ventricular diastolic filling and improvement in quality of
life.

PEDESTAL is an open-label exploratory study to determine the effects of
alagebrium at two oral dosages (35 mg qd or 210 mg bid) for 6, 12, 16 and 24
weeks on diastolic function and left ventricular mass in 20 patients diagnosed
with systolic heart failure and diastolic dysfunction.  Safety and quality of
life will also be evaluated.  The study will include men and women at least 30
years of age with or without diabetes, who are classified as having grade II-
IV heart failure under the New York Heart Association guidelines.  The primary
endpoints include quantification of left ventricular mass and complete Doppler
evaluation of changes in diastolic function.  Secondary endpoints include a
quality of life assessment as measured by the Minnesota Living With Heart
Failure Questionnaire.

Diastolic dysfunction is uniformly present in patients with systolic heart
failure.  It is characterized by higher than normal pressures during the
relaxing phase of the heart cycle (diastole).  If the heart tissue
(interstitium) has become stiffened, the relaxation cycle will be greatly
affected.  Current strategies designed to treat systolic heart failure have
limited or no impact on the intrinsic tissue properties of the heart.
Alagebrium is the first agent designed to reverse the stiffness of tissues,
such as the interstitium in patients with systolic heart failure.

"The clinical and preclinical data generated to date by Alteon and outside
investigators clearly support the potential of alagebrium in diastolic
dysfunction," said Robert C. deGroof, Ph.D., Senior Vice President, Scientific
Affairs.  "To our knowledge, no other drug has demonstrated comparable
cardiovascular effects within a 16-week time period as we observed in the
DIAMOND trial.  PEDESTAL will build upon that positive data and will give us
additional insights into how the drug works in this important patient
population."

How Alagebrium Works

Alagebrium is the first in a new class of compounds that have been shown in
vitro and in vivo to reverse A.G.E. crosslinking, thereby restoring more normal
function to tissues, vessels and organs that have lost flexibility. Alteon
believes that alagebrium's mechanism of action is new and novel, and is
unrelated to that of any pharmaceutical agent either currently prescribed or in
clinical development.  Importantly, alagebrium does not disrupt the natural
enzymatic glycosylation sites or peptide bonds that are responsible for
maintaining the normal integrity of the collagen chain.  Thus, normal structure
and function is preserved while abnormal crosslinking is reduced.

In addition to restoring elasticity of stiffened tissues by breaking
pathological crosslinks, in preclinical studies alagebrium consistently
demonstrates the ability to reverse the over-expression of genes for proteins
and growth factors known to be associated with the pathological hypertrophy
(enlargement) of tissues.  Hypertrophy of the aorta and the left ventricle is
correlated with the development of heart failure.  These results indicate that
restoration of normal tissue dynamics through breaking A.G.E. crosslinks may
restore normal control of gene function.

Demonstrated Clinical Benefit

Alagebrium has demonstrated safety and efficacy in several Phase 2 trials and
is actively being developed for systolic hypertension and heart failure. In
previous testing in cardiovascular disease, treatment with alagebrium resulted
in statistically significant and clinically meaningful effects of increasing
vascular wall elasticity and lowering pulse pressure.  In a post hoc analysis
from the recent Phase 2b SAPPHIRE/SILVER trials, treatment with alagebrium
resulted in statistically significant lowering of systolic blood pressures (as
measured by ambulatory blood pressure measurements) in patients with baseline
systolic pressures of 140 mm Hg or greater whose condition was uncontrolled
despite treatment with one or more currently available blood pressure
medications, a difficult-to-treat patient population. In addition, the DIAMOND
trial of alagebrium in patients with diastolic heart failure showed that
treatment with alagebrium over 16 weeks demonstrated a statistically
significant reduction in left ventricular mass and a marked improvement in left
ventricular diastolic filling, as well as statistically significant
improvements in multiple quality of life measurements.  Patients with Class III
heart failure at baseline, the sickest patients in the study, appeared to
benefit the most from alagebrium treatment.

About Alteon

Alteon is developing several new classes of drugs that reverse or slow down
diseases of aging and complications of diabetes.  These compounds have an
impact on a fundamental pathological process caused by 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, organs and vessels 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.  These
include A.G.E. Crosslink Breakers, A.G.E. Formation Inhibitors and Glucose
Lowering Agents.  Alteon's lead compound alagebrium, 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.  For more information on Alteon, visit the
company's website at 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. 

DATASOURCE: Alteon Inc.



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

Investor Relations of Alteon Inc., [phone],  



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

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