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Alteon Updates Clinical Trial Programs in Investor Conference
Call
- Highlights Include Positive Interim Findings from Phase 2 Trials, IND in
Erectile Dysfunction -
PARSIPPANY, N.J., Dec. 20 /PRNewswire/ -- In a conference call today, Alteon
Inc. (AMEX:ALT) updated investors on the status of its ongoing clinical
programs, as well as other corporate initiatives. Highlights of the conference
call include:
* The ongoing Phase 2b SPECTRA (Systolic Pressure Efficacy and Safety
Trial of Alagebrium) trial is on target to complete enrollment during
the first half of 2005, with data expected to be reported during the
second half of 2005. SPECTRA is designed to evaluate alagebrium's
ability to lower systolic blood pressure (SBP) in patients with a
reading of greater than or equal to 145 mm Hg (by 24-hour ambulatory
blood pressure measurement). Patients who are randomized into SPECTRA
receive alagebrium tablets or placebo in addition to
hydrochlorothiazide (a diuretic pill) once a day for 12 weeks.
Approximately 70 clinical sites are enrolling patients into the trial.
Alagebrium's activity in prior clinical trials demonstrated the drug's
apparent safety and ability to lower SBP and pulse pressure in ageing
patients, especially in a difficult-to-treat hypertensive patient
population. Notably, alagebrium's beneficial effects in previous Phase
2 trials were demonstrated over and above current hypertension therapy,
and data thus far point to a mechanism of action unlike any existing
blood pressure agent.
* Alteon announced positive findings from an interim analysis of PEDESTAL
(Patients with Impaired Ejection Fraction and Diastolic Dysfunction:
Efficacy and Safety Trial of ALagebrium). This ongoing Phase 2a
open-label exploratory study is being conducted at Baylor Heart Clinic
in Houston to evaluate alagebrium's effects on diastolic function and
ventricular mass in patients with significant heart failure.
Preliminary data from the initial 14 (of planned 20) patients indicate
trends consistent with positive data from the previously reported Phase
2a DIAMOND (Distensibility Improvement and Remodeling in Diastolic
Heart Failure) trial and preclinical studies in heart failure. While
patients in PEDESTAL cannot be compared directly with those from
DIAMOND (patients in PEDESTAL have impaired ejection fraction, larger
hearts and are sicker overall), treatment with alagebrium appears to
have important and consistent effects in both patient groups. In
accordance with the protocol, the clinical investigators for PEDESTAL
are continuing to enroll patients. Final data will be reported in 2005.
* Alteon announced positive findings from an interim analysis of the
Phase 2a open-label trial in endothelial function conducted at Johns
Hopkins under grants from the National Heart, Lung and Blood Institute
and the Society of Geriatric Cardiology. The primary purpose of this
trial is to determine whether increasing arterial elasticity by
breaking A.G.E. crosslinks improves endothelial function as assessed by
evaluating vessel relaxation and biomarkers of endothelial function.
These data are showing strong trends in key measures relating to
improvements in carotid artery stiffness based on a series of advanced
non-invasive measurements. In accordance with the protocol, the
clinical investigators are continuing to enroll patients. The next
update will be reported in 2005.
* The company discussed a recent preliminary report of a two-year
toxicity study that found that male 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. Male Sprague Dawley rats are known to be susceptible to liver
tumors. There were no significant findings in female rats. Earlier
preclinical toxicity studies found no mutagenic or carcinogenic
activity in either rats or mice. Alteon has discussed these findings
with the Food and Drug Administration (FDA) and intends to conduct
additional studies to explore the mechanism by which the liver tumors
developed and will provide that information to the agency. 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 announced that the company has submitted to the FDA an
Investigational New Drug (IND) application for the initiation of a
Phase 2 clinical trial of alagebrium in erectile dysfunction (ED). The
30-day review period for the IND recently was completed, and Alteon
intends to initiate the trial by early 2005. In October 2004, a study
presented by an independent research group demonstrated that alagebrium
had the ability to reverse erectile dysfunction in a preclinical model
of ED associated with diabetes. The researchers concluded that
alagebrium -- through what appears to be a unique mechanism of action
-- offers potential for the treatment of diabetic erectile dysfunction.
ED is an early indicator of vascular disease and, in the opinion of
Alteon and its advisors, a positive therapeutic effect in human ED
studies would not only represent a significant potential development in
the treatment of ED but could also be indicative of alagebrium's
potential to reverse pathologies in a number of other human vascular
diseases. Alteon will announce the initiation of the new ED trial when
the first patient is enrolled.
* Data from the Phase 2b SAPPHIRE/SILVER clinical trial of alagebrium in
systolic hypertension was published in the supplement of the December
15 issue of the American Journal of Hypertension, a publication of the
American Society of Hypertension (ASH). As presented in a Continuing
Medical Education (CME) session at the ASH meeting last May, the
article details the ability of alagebrium to significantly reduce
systolic blood pressure in patients with a baseline 24-hour ambulatory
SBP of 140 mm Hg or greater. In a difficult-to-treat patient population
with a baseline 24-hour ambulatory SBP of 150 mm Hg or greater and on
two or more background medications, patients had an average drop in
their 24-hour ambulatory SBP of 18 mm Hg vs. placebo (p< 0.01).
The full conference call replay will be accessible at the Investor Relations
section of Alteon's company website, http://www.alteon.com/ . In addition, a
digital rebroadcast will be available through December 27, 2004 at 11:59 P.M.
by dialing 1-888-203-1112, pass code 979982 for domestic callers and
+719-457-0820, pass code 979982 for international callers.
About Alteon
Alteon is developing several new classes of drugs that have shown the potential
to reverse or slow down diseases of ageing 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 shown promising results in
several Phase 2 trials and is actively being developed for systolic
hypertension and heart failure. Over 1200 patients have been involved in
alagebrium's human clinical trials to date, of whom approximately 900 have
received active compound. Ongoing clinical trials include the phase 2b systolic
hypertension trial, SPECTRA (Systolic Pressure Efficacy and Safety Trial of
Alagebrium), and the phase 2a heart failure trial, PEDESTAL (Patients with
Impaired Ejection Fraction and Diastolic Dysfunction: Efficacy and Safety Trial
of ALagebrium), as well as a third 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 update any 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/