Alteon Temporarily Suspends Enrollment of New Patients in Clinical Trials of Alagebrium Pending Additional Preclinical Data
25 February 2005 - 8:10AM
PR Newswire (US)
Alteon Temporarily Suspends Enrollment of New Patients in Clinical
Trials of Alagebrium Pending Additional Preclinical Data - Clinical
Programs are Continuing - PARSIPPANY, N.J., Feb. 24
/PRNewswire-FirstCall/ -- Alteon Inc. (AMEX:ALT) announced today
that it has temporarily suspended enrollment of patients in its
ongoing clinical trials of alagebrium pending additional
preclinical data and discussions with the Food and Drug
Administration (FDA). The company is currently testing alagebrium
in patients with systolic hypertension, heart failure and erectile
dysfunction. Patients already enrolled in the clinical trials are
continuing treatment. The company took this action voluntarily and
has notified the FDA. In December 2004, the company announced that
findings of a two-year toxicity study indicated that male Sprague
Dawley rats exposed to high doses of alagebrium over their natural
lifetime developed dose-related increases in liver cell alterations
and tumors, and that the liver tumor rate was slightly over the
expected background rate in this gender and species of rat. The
company also announced its intent to conduct a series of
preclinical experiments to explore the mechanism by which the liver
tumors developed and the relevance of such tumors to human
exposure. These preclinical experiments are still ongoing, with
results expected by mid-year. "This decision was made after we
received initial data from one of our ongoing studies in rats,
which provided insights and direction for further analysis," said
Judith S. Hedstrom, Chief Operating Officer. "The relevance of
these rat findings to humans has not been established, and we do
not believe that the recent data change the information previously
provided to patients who are already in the alagebrium studies.
Nevertheless, in the current environment, we have decided it is
prudent to temporarily suspend enrolling new patients." "We have
decided to slow down our development programs until the preclinical
experiments are completed and the results evaluated over the next
several months," said Kenneth I. Moch, President and Chief
Executive Officer. "We remain committed to continuing the
development of alagebrium." Earlier preclinical toxicity studies
found no mutagenic or carcinogenic activity in either rats or mice.
In addition, the company had previously completed four key
genotoxicity studies to help determine potential toxicities of
alagebrium in man, and these studies did not indicate any potential
carcinogenic risk. Alteon has reviewed all of the cumulative human
safety profile and previous preclinical experience of alagebrium;
these data have not demonstrated an association with the lifetime
carcinogenicity study in rats. All patients in the clinical trials
of alagebrium had been previously informed of the initial findings
in rats, and the incremental data do not alter the information that
had already been provided to them. 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 being developed for systolic hypertension, heart
failure and erectile dysfunction. Approximately 1300 patients have
been involved in alagebrium's human clinical trials to date, of
whom approximately 1000 have received active compound. Clinical
trials of alagebrium 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 2a 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. DATASOURCE: Alteon Inc. CONTACT: Susan M.
Pietropaolo, Director, Corporate Communications & Investor
Relations of Alteon Inc., +1-201-818-5537 (direct), Web site:
http://www.alteon.com/
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