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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/