Alteon Discontinues Systolic Blood Pressure Study of alagebrium After Interim Efficacy Review
June 09 2005 - 5:15PM
PR Newswire (US)
Alteon Discontinues Systolic Blood Pressure Study of alagebrium
After Interim Efficacy Review Announces FDA Clinical Hold on
Further Enrollment in Erectile Dysfunction Study Pending Additional
Preclinical Data PARSIPPANY, N.J., June 9 /PRNewswire-FirstCall/ --
Alteon Inc. (AMEX:ALT) announced today it will discontinue the
SPECTRA trial, a Phase 2b clinical trial for alagebrium, following
an interim evaluation of data indicating that the drug has not
demonstrated efficacy against uncontrolled systolic hypertension.
While the drug has been observed to be safe and well-tolerated in
clinical trials to date, the independent efficacy review committee
conducting the interim analysis of SPECTRA found that the data did
not indicate a treatment effect of alagebrium against systolic
hypertension and that there was a low probability of meeting
clinical endpoints by the planned conclusion of the study.
Separately, the Company announced that it had submitted preclinical
toxicity data on alagebrium to two divisions of the Food and Drug
Administration's (FDA) Center for Drug Evaluation and Research
(CDER). The preclinical toxicity information submitted by the
Company was in support of its view that liver alterations
previously observed in rats, which led to the Company's voluntary
suspension of enrolling new patients into its clinical trials, were
related to the male rat metabolism and not to genotoxic pathways.
The Company has been notified by the CDER's Division of
Reproductive & Urologic Drug Products that further enrollment
in the EMERALD trial, the Phase 2a study of alagebrium in erectile
dysfunction, has been placed on clinical hold pending the
submission of additional data. The Company said it is actively
continuing to develop data to support resumption of the EMERALD
trial. The Company's clinical protocols in cardiovascular diseases,
which come under the jurisdiction of CDER's Division of
Cardio-Renal Drug Products, remain open. There will be an investor
update conference call Friday morning, June 10, 2005, at 9:00 a.m.,
ET, to discuss these recent events. The dial-in telephone number
for the conference call will be 1-800-481-7713. International
participants may call +719-457-2730. The passcode # for both is
3529485. Participants should call approximately 5-10 minutes before
9:00 a.m. In addition, the conference call will be accessible
through a webcast on the company website, http://www.alteon.com/ in
the Investor Relations section, and a digital rebroadcast will be
available from June 10, 2005, at noon through June 16, 2005, at
11:59 P.M. by dialing 1-888-203-1112, passcode 3529485 for domestic
callers and +719-457-0820, passcode 3529485 for international
callers. Kenneth I. Moch, Alteon's President and CEO, said, "These
developments represent a setback in our efforts to bring alagebrium
to market. It is our intention to focus our future clinical
development of alagebrium on indications for which we believe there
to be a solid scientific foundation, such as heart failure,
erectile dysfunction and renal disease. In heart failure, we are in
the process of convening our scientific advisors to plan our
clinical strategy. For erectile dysfunction, we are working to
provide additional data to the Division of Reproductive &
Urologic Drug Products over the next several months." 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- 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 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 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, +1-201-818-5537 (direct), Web site:
http://www.alteon.com/
Copyright
Ishares Diversified Alternatives Trust (AMEX:ALT)
Historical Stock Chart
From Jun 2024 to Jul 2024
Ishares Diversified Alternatives Trust (AMEX:ALT)
Historical Stock Chart
From Jul 2023 to Jul 2024