Alteon Updates Investors on Alagebrium Development Status
04 Mayo 2005 - 9:40AM
PR Newswire (US)
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, +1-201-818-5537 dir., Web site:
http://www.alteon.com/
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