SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 or 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Date of report (Date of earliest event reported) November 10, 2003
ALTEON INC.
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(Exact Name of Registrant as Specified in Charter)
Delaware 001-16043 13-3304550
(State or Other Juris- (Commission (I.R.S. Employer
diction of Incorporation) File Number) Identification No.)
170 Williams Drive, Ramsey, New Jersey 07446
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (201) 934-5000
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(Former Name or Former Address, If Changed Since Last Report)
Item 5. Other Events
On November 10, 2003, Alteon Inc. issued the following press release:
ALT-711 IMPROVES CARDIAC FUNCTION IN THE AGING DIABETIC HEART
- Preclinical Canine Study Presented at the American Heart Association
Scientific Sessions 2003 -
RAMSEY, N.J., Nov. 10 /PRNewswire-FirstCall/ -- Alteon's lead A.G.E. Crosslink
Breaker ALT-711 has been found by an independent research team to improve
overall cardiac function in aged diabetic dogs by restoring left ventricular
ejection fraction (LVEF), reducing aortic stiffness and reducing left
ventricular (LV) mass. These changes were observed to be associated with a
reversal of the overexpression of cardiac collagen seen with aging and diabetes.
The study, "A Glycation End-Product Cross Link Breaker Reduces Collagen and
Improves Cardiac Function in the Aging Diabetic Heart," was conducted by
researchers at UMDNJ-New Jersey Medical School and presented today at the
American Heart Association Scientific Sessions 2003 today in Orlando, FL. The
authors propose that A.G.E. Crosslink Breakers, a class of compounds pioneered
by Alteon, could provide therapeutic potential in the treatment of aged patients
with diabetes. ALT-711 is under Phase 2 investigation in humans by Alteon for
its potential in systolic hypertension and heart failure.
In this investigation, researchers first observed how aging and diabetes
affected the structure and function of the hearts of 12 dogs, 9-12 years old.
Five months of induced diabetes resulted in a 25% reduction in LVEF, a 28%
decrease in stroke volume and an approximate 1.7-fold increase in aortic
stiffness. Another major finding was that diabetes increased both type I and
type III collagen, which accounts for roughly 96% of total collagen in the
heart, by approximately 2-3 fold, contributing to an increase in LV mass. The
decline of heart function and change in structure was attributed in part to the
formation and crosslinking of Advanced Glycation End-products (A.G.E.s), a
pathological process of aging that occurs at an accelerated rate in diabetes and
has damaging effects on proteins such as collagen and elastin.
Treatment with the A.G.E. Crosslink Breaker ALT-711 over one month resulted in a
reversal of these conditions, normalizing LVEH (p<0.05) and stroke volume
(p<0.05). Similarly, the upregulation of collagen type I and collagen type III
was reversed, contributing to a reduction in LV weight (p<0.05). In addition,
myocardial LV collagen solubility increased significantly after treatment with
ALT-711 (p<0.05, from 34 + or - 4.9% to 51 + or - 6.8%), which supports the
breaking of A.G.E. crosslinks as the mechanism of action of ALT-711.
"This preclinical data is consistent with, and strongly supportive of, the
cardiovascular activity we have seen in our human clinical trials of ALT-711 to
date," said Robert C. deGroof, Ph.D., Senior Vice President Scientific Affairs.
"The growing body of scientific
evidence demonstrating the ability of ALT-711 to reverse certain cardiovascular
complications of aging and diabetes strengthens our commitment to develop
ALT-711 for the treatment of heart failure."
The study was supported by grants from the American Diabetes Association and the
National Institutes of Health. An article detailing the study results is also
available through PubMed, prior to its impending publication in the American
Journal of Physiology (epub ahead of print at http://ajpheart.physiology.org). A
previous study by the UMDNJ research group demonstrated the ability of ALT-711
to reverse cardiac stiffness in aged non-diabetic dogs, restoring the
cardiovascular system to a state found in younger animals. Administration of
ALT-711 daily for one month resulted in a 40% reduction in age-related
ventricular stiffness (Proceedings of the National Academy of Sciences, March
14, 2000). These findings are consistent with results by other researchers in
preclinical studies of ALT-711 in rats and primates.
ALT-711 is the only A.G.E. Crosslink Breaker in advanced human testing. Based on
ALT-711's demonstrated efficacy and biological activity in several Phase 2
trials, as well as a strong and consistent safety profile, Alteon is proceeding
with development of ALT-711 in two major cardiovascular indications, systolic
hypertension and heart failure. Additional Phase 2 trials in these indications
are expected to be initiated in the first half of 2004.
About Alteon
Alteon is developing several new classes of drugs that reverse or slow down
diseases of aging and complications of diabetes. These compounds have an impact
on a fundamental pathological process caused by 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, organs and
vessels 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. These include A.G.E.
Crosslink Breakers, A.G.E. Formation Inhibitors and Glucose Lowering Agents.
Alteon's lead compound 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 actively being developed for systolic hypertension and heart failure. For
more information on Alteon, visit the company's website at 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.
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Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Alteon Inc.
By: /s/ Elizabeth O'Dell
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Elizabeth O'Dell
Vice President, Finance
Dated: November 11, 2003