Alteon Updates Investors on Alagebrium Development Status

Alteon Updates Investors on Alagebrium Development Status
- Alagebrium Preclinical Toxicity Tests Progressing; Company Intends to Perform
SPECTRA Clinical Trial Interim Analysis - 


PARSIPPANY, N.J., May 4  /PRNewswire-FirstCall/ -- At the Rodman & Renshaw
Techvest 2nd Annual Global Healthcare Conference today, Alteon President and
Chief Executive Officer Kenneth I. Moch reported encouraging interim results
from preclinical toxicity tests of alagebrium, the company's lead A.G.E.
Crosslink Breaker.   Results thus far indicate that the liver alterations
previously seen in rats, which led to the voluntary suspension of enrollment in
the alagebrium clinical trials, are not caused by genotoxicity pathways, but
may be a result of the male rat metabolism.

Mr. Moch also announced that Alteon intends to perform an interim analysis of
the ongoing Phase 2b SPECTRA (Systolic Pressure Efficacy and Safety Trial of
Alagebrium) trial of alagebrium in patients with uncontrolled systolic
hypertension before resuming enrollment of new patients into this trial.  By
mid-year 2005, approximately two-thirds of the targeted 250 patients are
expected to have completed SPECTRA.

"After careful consideration and discussion with our scientific advisors,
Alteon has determined that it is prudent to undertake an interim analysis of
SPECTRA," said Mr. Moch.  "The results of this analysis, together with the
results of the preclinical toxicity tests currently under way, will guide
Alteon in determining the next steps for resuming enrollment in this trial and
the conditions under which such enrollment could resume.  We are using an
independent Data Review Committee to preserve the integrity of the final
statistical analysis."

"We remain enthusiastic about the compound's potential," Mr. Moch continued. 
"Alteon's clinical team is actively working with our study sites in preparing
to identify additional patients for our clinical trials, pending the toxicity
findings and the SPECTRA interim analysis."

The ongoing toxicity tests resulted from findings announced in December 2004 of
a two-year preclinical carcinogenicity study indicating that male Sprague
Dawley rats exposed to high doses of alagebrium over their natural lifetimes
developed dose-related increases in liver cell alterations including
hepatocarcinomas, and that the alteration rate was slightly over the expected
background rate in this gender and species of rat.  The company also initiated
a series of preclinical experiments to explore the mechanism by which the liver
alterations developed and their relevance to human exposure.  In February 2005,
as a precautionary measure, the company suspended enrollment of new patients
into all ongoing clinical trials of alagebrium based on the initial results
from one of the follow-on experiments that suggested the need for further
preclinical testing.  These more recent preclinical toxicity experiments, for
which encouraging news is being announced today, are ongoing and are expected
to be completed by mid-year.  Decisions regarding resumption of enrollment of
patients into the Phase 2 trials will be made at that time.

Mr. Moch further noted that the initial findings in male Sprague Dawley rats
occurred at a low level and much later in the rat's 2-year lifetime (~80 human
equivalent years), and after long exposures (greater than 40 human equivalent
years) of dosing.  Additional experiments are being conducted to further
explore the role of metabolic and cellular processes and any possible
relationship to humans.  To date, there is no relation of the findings to any
potential human carcinogenic risk associated with alagebrium.

The ongoing testing is thus far consistent with previous evaluations of
alagebrium.  Earlier preclinical studies found no mutagenic or carcinogenic
activity in either rats or mice.  In addition, four key genotoxicity studies to
help determine potential toxicities of alagebrium in man did not indicate any
potential carcinogenic risk.  Alteon has reviewed all of the cumulative human
safety data and previous preclinical experience of alagebrium, and these data
have not demonstrated a relationship to the two-year (lifetime) carcinogenicity
study in rats.

The full webcast of Mr. Moch's presentation can be accessed at the company
website, http://www.alteon.com/.  In addition, Alteon will be holding an
investor update conference call on May 11, 2005.  Details will be announced.

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 shown promising results in
several Phase 2 trials and is being developed for systolic hypertension, heart
failure and erectile dysfunction.  Approximately 1,300 patients have been
involved in alagebrium's human clinical trials to date, of whom approximately
1,000 have received active compound.  Clinical studies of alagebrium include
the Phase 2b systolic hypertension trial, SPECTRA (Systolic Pressure Efficacy
and Safety Trial of Alagebrium), the Phase 2a heart failure study, PEDESTAL
(Patients with Impaired Ejection Fraction and Diastolic Dysfunction: Efficacy
and Safety Trial of ALagebrium), the Phase 2a EMERALD study (Evaluation of
Alagebrium in Erectile Dysfunction in Diabetic Males on PDE5 Inhibitors), as
well as a fourth study exploring mechanism of action in endothelial
dysfunction.

In February 2005, Alteon voluntarily and temporarily suspended enrollment of
new patients into the Company's ongoing alagebrium clinical studies pending
receipt of additional pre-clinical data, which are expected by mid-year 2005.
The Company expects that decisions regarding resumption of enrollment will be
made at that time.

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. 

DATASOURCE: Alteon



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

Investor Relations, Alteon, [phone] dir.,  



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

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