Ishares Diversified Alternatives Trust (AMEX:ALT)
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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/