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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 or 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported) January 3, 2001
ALTEON INC.
(Exact Name of Registrant as Specified in Charter)
Delaware 0-19529 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
(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (201) 934-5000
(Former Name or Former Address, If Changed Since Last Report)
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Item 5. Other Events
On January 3, 2001 Alteon Inc. issued the following press release:
ALTEON'S ALT-711 DEMONSTRATES POTENTIAL AS NOVEL TREATMENT FOR ISOLATED SYSTOLIC
HYPERTENSION
RAMSEY, N.J., Jan. 3 /PRNewswire/ -- Alteon Inc. (Amex: ALT) today
announced positive results from a Phase IIa clinical trial evaluating the
safety, efficacy and pharmacology of ALT-711, a first of its kind Advanced
Glycosylation End-product Crosslink Breaker (A.G.E. Crosslink Breaker). The
formation of A.G.E. Crosslinks is a natural part of the aging process that
can lead to stiffening and loss of function in tissues, organs and vessels
including large arteries.
Study results show that patients who received ALT-711 experienced a
statistically significant reduction in the arterial pulse pressure, defined by
the difference between systolic and diastolic blood pressures. Results also show
a clinically relevant increase in large artery compliance, an indicator of
greater vascular flexibility and volume capacity, using a traditional
measurement of the ratio of stroke volume to pulse pressure. Additionally, the
drug was well-tolerated.
The ability to decrease pulse pressure and increase large artery compliance
offers an opportunity to provide a treatment option specifically for isolated
systolic hypertension (ISH), a currently unmet medical need. ISH, defined as
elevated systolic blood pressure (greater than 160 mmHg) accompanied by normal
diastolic blood pressure (less than 90 mmHg), can result in a substantially
increased risk of cardiovascular disease and death. ISH affects nearly eight
million Americans and is primarily a consequence of stiffening of the large
arteries. ALT-711 is the first drug to show activity against ISH by targeting
stiff vessel disease that contributes to this form of hypertension.
"These study results are important because currently available cardiovascular
treatments do not directly target vascular stiffening and, as a result, are not
optimal for the treatment of isolated systolic hypertension," said Edward G.
Lakatta, M.D., Chief of the Laboratory of Cardiovascular Science at The National
Institute on Aging and an investigator in this study. "The ALT-711 results are
exciting in that selective enhancement of large artery distensibility with
reduced pressure pulsation was achieved, providing a novel approach for the
treatment of isolated systolic hypertension."
The Phase IIa human clinical trial was a double-blinded, placebo-controlled
study evaluating the safety, efficacy and pharmacology of ALT-711. The trial
included 93 patients over the age of 50 with measurably stiffened
cardiovasculature including systolic blood pressure of at least 140 mmHg and
pulse pressure of at least 60 mmHg. Patients were randomized to receive 56
consecutive daily oral doses of either 210 mg of ALT-711 (n=62) or placebo
(n=31) during an 8-week period. During the study, which was conducted at nine
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U.S. clinical sites, patients were evaluated for cardiovascular elasticity and
function as measured by pulse pressure, cardiovascular compliance, pulse wave
velocity and cardiac output. Treatment with ALT-711 was in addition to all other
medications.
"The results of this study represent a significant milestone for Alteon. The
trial was designed to provide us with a better understanding of ALT-711's
potential therapeutic benefits to the cardiovascular system and, as a result,
impart meaningful guidance for the clinical direction of this compound," said
Kenneth I. Moch, President and Chief Executive Officer of Alteon. "Based on
these results, during 2001 Alteon plans to initiate Phase IIb efficacy trials to
further assess ALT-711's activity in isolated systolic hypertension.
Additionally, the Company will continue to evaluate the compound for other
therapeutic applications."
Preclinical testing showed that ALT-711 reversed aging- and diabetes-related
cardiovascular disease and restored function to the cardiovascular system. In
preclinical evaluations, ALT-711 reversed stiffening of the aorta in rodents,
canines and non-human primates. Although a statistically significant effect was
not seen in cardiac output and pulse wave velocity as observed in preclinical
trials, Alteon will continue to evaluate these measures in larger populations
over longer periods of time as part of the Phase IIb program in ISH.
"Alteon was founded on the belief that by targeting the A.G.E. pathway, we can
treat the cause of certain aging- and diabetes-related pathologies and reduce
the severity and incidence of resulting diseases," said Robert C. deGroof,
Ph.D., Senior Vice President, Scientific Affairs of Alteon. "This trial was an
important step in proving our technology platform and demonstrating the
potential to reverse cardiovascular disease caused by pathologies of diabetes
and aging and, as a result, we believe that ALT-711 may represent a new frontier
in cardiovascular medicine."
A.G.E. Crosslink Breakers
Advanced Glycosylation End-products (A.G.E.s) are permanent glucose structures
that form when glucose binds to the surface of proteins. These structures
interact with adjacent proteins to form pathological links called A.G.E.
Crosslinks. Diabetic individuals form excessive amounts of A.G.E.s earlier in
life than non-diabetic individuals. The formation of A.G.E. Crosslinks leads to
increased stiffness of tissues, abnormal protein accumulation and organ
dysfunction, which result in many complications of aging and diabetes.
Structural proteins, such as collagen and elastin, play an integral role in the
maintenance of cardiovascular elasticity function and vascular wall integrity
and are prime targets for A.G.E. crosslinking. This mechanical process can
impair the normal function of contractile organs, such as blood vessels and
cardiac muscle, which depend on flexibility for normal function. Loss of
flexibility of the vasculature leads to isolated systolic hypertension, which
creates increased workload for the heart and may lead to myocardial hypertrophy
and heart failure.
Cardiovascular Disease and Isolated Systolic Hypertension
According to the American Heart Association, nearly 60 million Americans have
one or
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more types of cardiovascular disease. Cardiovascular disease has been the number
one killer of Americans since the early 1900's. Isolated systolic hypertension
is associated with a significantly increased risk of overall mortality,
cardiovascular mortality and congestive heart failure. The latest World Health
Organization - International Society of Hypertension guidelines for the
management of hypertension emphasize the importance of pulse pressure and
arterial stiffness as predictors of cardiovascular risk.
About Alteon
Alteon is a leader in the discovery and development of novel pharmaceuticals for
the treatment of pathologies of aging and diabetes, with an initial emphasis on
cardiovascular disease. The Company's proprietary technology is based on
reversing or slowing or a fundamental pathological process caused by
protein-glucose complexes called Advanced Glycosylation End-products (A.G.E.s).
The formation and crosslinking of A.G.E.s is an inevitable part of the aging
process that leads to a loss of flexibility and function in body tissues, organs
and vessels.
Alteon has created a library of novel classes of compounds based on the A.G.E.
pathway. These include A.G.E. Crosslink Breakers, A.G.E. Formation Inhibitors
and Glucose Lowering Agents. The Company's lead drug candidate, ALT-711, is an
A.G.E. Crosslink Breaker currently in Phase II clinical trials for the treatment
of cardiovascular disorders including isolated systolic hypertension.
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.
Alteon is holding an analyst/investor conference call today, January 3, 2001, at
2:00 PM, Eastern Time. To access this call live, please dial 1-888-222-2994.
Callers outside of the United States, please call +973-694-6836. This call will
be archived on the Company's website at http://www.alteonpharma.com and will be
rebroadcast until January 10, 2001, at 1-800-428-6051, passcode 151696. Callers
outside of the United States, please call +973-709-2089, passcode 151696.
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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/ Kenneth I. Moch
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Kenneth I. Moch
Chief Executive Officer
Dated: January 3, 2001