FDA Maintains Clinical Hold on Alteon's ED Study of Alagebrium
30 September 2005 - 11:00PM
PR Newswire (US)
PARSIPPANY, N.J., Sept. 30 /PRNewswire-FirstCall/ -- Alteon Inc.
(AMEX:ALT) announced today that it has been notified by the U.S.
Food & Drug Administration's (FDA) Reproductive and Urologic
Drug Products Division that it is maintaining the clinical hold
previously placed on the Company's Phase 2a study of alagebrium in
diabetic patients with erectile dysfunction. In June, the Company
announced that it had submitted preclinical toxicity data on
alagebrium to two divisions of the FDA's Center for Drug Evaluation
and Research (CDER), specifically the Division of Cardio-Renal Drug
Products and the Division of Reproductive and Urologic Drug
Products. The preclinical toxicity data were submitted in support
of the Company's view that liver alterations previously observed in
rats were related to the male rat metabolism and not to genotoxic
pathways. Preliminary data on liver alterations in rats had caused
the Company to voluntarily suspend enrolling new patients into its
clinical trials. Following review of the rat liver data, CDER's
Division of Reproductive and Urologic Drug Products placed on
clinical hold further enrollment in the EMERALD study, the
Company's Phase 2a study of alagebrium in diabetic patients with
erectile dysfunction, and it requested further preclinical toxicity
data, which the Company submitted in August. Now that the Division
has reviewed these data, it has decided to maintain the clinical
hold pending further preclinical testing. "In our response to the
clinical hold, we believed we substantially met the requirements
for showing human safety of alagebrium in this experimental
setting. We intend to continue to work with the FDA with the goal
of resolving their additional questions," said Kenneth I. Moch,
President and Chief Executive Officer. The Company's clinical
protocols in cardiovascular diseases, which are under the oversight
of CDER's Division of Cardio-Renal Drug Products, were not placed
on clinical hold by the FDA. Data from the Phase 2a PEDESTAL study
in heart failure and additional data from the Phase 2a study of
alagebrium in endothelial dysfunction are scheduled to be presented
at the American Heart Association meeting in November. Separately,
as disclosed in the Company's Form 10-Q filing for the quarter
ended June 30, 2005, Alteon has engaged the services of third
parties to assist in identifying and pursuing strategic options for
the Company. About Alteon Alteon is developing 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-carbohydrate 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. For more on Alteon, please visit our
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 the Company's
ability to resolve the FDA's additional questions concerning the
preclinical toxicity data submitted for alagebrium and to resume
enrollment in its clinical trials, and its 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 herein 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, Web site: http://www.alteon.com/
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