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) April 20, 2004
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ALTEON INC.
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(Exact Name of Registrant as Specified in Charter)
Delaware 001-16043 13-3304550
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(State or Other Juris- (Commission (I.R.S. Employer
diction of Incorporation) File Number) Identification No.)
6 Campus Drive, Parsippany, New Jersey 07054
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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 April 20, 2004, Alteon issued the following press release:
"ALTEON INITIATES 'PEDESTAL,' A PHASE 2 TRIAL OF ALAGEBRIUM IN DIASTOLIC
DYSFUNCTION
-STUDY BUILDS UPON POSITIVE DATA FROM DIAMOND TRIAL OF ALAGEBRIUM IN HEART
FAILURE -
PARSIPPANY, N.J., Apr 20, 2004 /PRNewswire-FirstCall via Comtex/ -- Alteon Inc.
(Amex: ALT) announced today that a Phase 2 trial of its novel A.G.E. Crosslink
Breaker alagebrium, formerly known as ALT-711, has been initiated at Baylor
Heart Clinic, Baylor College of Medicine in Houston. PEDESTAL (Patients with
Impaired Ejection Fraction and Diastolic Dysfunction: Efficacy and Safety Trial
of ALagebrium) will continue the evaluation of alagebrium on diastolic function
and ventricular mass in patients with significant heart failure. In the Phase 2a
DIAMOND trial, treatment with alagebrium resulted in an unprecedented reduction
in left ventricular mass within a 16-week treatment period, as well as a marked
improvement in left ventricular diastolic filling and improvement in quality of
life.
PEDESTAL is an open-label exploratory study to determine the effects of
alagebrium at two oral dosages (35 mg qd or 210 mg bid) for 6, 12, 16 and 24
weeks on diastolic function and left ventricular mass in 20 patients diagnosed
with systolic heart failure and diastolic dysfunction. Safety and quality of
life will also be evaluated. The study will include men and women at least 30
years of age with or without diabetes, who are classified as having grade II- IV
heart failure under the New York Heart Association guidelines. The primary
endpoints include quantification of left ventricular mass and complete Doppler
evaluation of changes in diastolic function. Secondary endpoints include a
quality of life assessment as measured by the Minnesota Living With Heart
Failure Questionnaire.
Diastolic dysfunction is uniformly present in patients with systolic heart
failure. It is characterized by higher than normal pressures during the relaxing
phase of the heart cycle (diastole). If the heart tissue (interstitium) has
become stiffened, the relaxation cycle will be greatly affected. Current
strategies designed to treat systolic heart failure have limited or no impact on
the intrinsic tissue properties of the heart. Alagebrium is the first agent
designed to reverse the stiffness of tissues, such as the interstitium in
patients with systolic heart failure.
"The clinical and preclinical data generated to date by Alteon and outside
investigators clearly support the potential of alagebrium in diastolic
dysfunction," said Robert C. deGroof, Ph.D., Senior Vice President, Scientific
Affairs. "To our knowledge, no other drug has demonstrated comparable
cardiovascular effects within a 16-week time period as we observed in the
DIAMOND trial. PEDESTAL will build upon that positive data and will give us
additional insights into how the drug works in this important patient
population."
How Alagebrium Works
Alagebrium is the first in a new class of compounds that have been shown in
vitro and in vivo to reverse A.G.E. crosslinking, thereby restoring more normal
function to tissues, vessels and
organs that have lost flexibility. Alteon believes that alagebrium's mechanism
of action is new and novel, and is unrelated to that of any pharmaceutical agent
either currently prescribed or in clinical development. Importantly, alagebrium
does not disrupt the natural enzymatic glycosylation sites or peptide bonds that
are responsible for maintaining the normal integrity of the collagen chain.
Thus, normal structure and function is preserved while abnormal crosslinking is
reduced.
In addition to restoring elasticity of stiffened tissues by breaking
pathological crosslinks, in preclinical studies alagebrium consistently
demonstrates the ability to reverse the over-expression of genes for proteins
and growth factors known to be associated with the pathological hypertrophy
(enlargement) of tissues. Hypertrophy of the aorta and the left ventricle is
correlated with the development of heart failure. These results indicate that
restoration of normal tissue dynamics through breaking A.G.E. crosslinks may
restore normal control of gene function.
Demonstrated Clinical Benefit
Alagebrium has demonstrated safety and efficacy in several Phase 2 trials and is
actively being developed for systolic hypertension and heart failure. In
previous testing in cardiovascular disease, treatment with alagebrium resulted
in statistically significant and clinically meaningful effects of increasing
vascular wall elasticity and lowering pulse pressure. In a post hoc analysis
from the recent Phase 2b SAPPHIRE/SILVER trials, treatment with alagebrium
resulted in statistically significant lowering of systolic blood pressures (as
measured by ambulatory blood pressure measurements) in patients with baseline
systolic pressures of 140 mm Hg or greater whose condition was uncontrolled
despite treatment with one or more currently available blood pressure
medications, a difficult-to-treat patient population. In addition, the DIAMOND
trial of alagebrium in patients with diastolic heart failure showed that
treatment with alagebrium over 16 weeks demonstrated a statistically significant
reduction in left ventricular mass and a marked improvement in left ventricular
diastolic filling, as well as statistically significant improvements in multiple
quality of life measurements. Patients with Class III heart failure at baseline,
the sickest patients in the study, appeared to benefit the most from alagebrium
treatment.
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 alagebrium, 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.
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: April 22, 2004