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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) June 2, 1999
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ALTEON INC.
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(Exact Name of Registrant as Specified in Charter)
Delaware 0-19529 13-3304550
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(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)
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Item 5. Other Events.
On June 2, 1999, Alteon Inc. issued the following press
release:
"ALTEON RELEASES PHASE I HUMAN TRIAL RESULTS OF POTENTIAL TREATMENT
FOR AGING-RELATED DISEASES
"--ALT-711, First A.G.E. Crosslink Breaker Compound in Clinical
Development, Was Well Tolerated in Clinical Trials--
"Ramsey, New Jersey, June 2, 1999 Alteon Inc. (Nasdaq: ALTN)
announced today that ALT-711, the company's lead A.G.E crosslink
breaker, successfully completed initial Phase I human trials of the
compound. Alteon is now planning further clinical development of
the compound. These findings were released today in a report on the
Phase I multi-dose program.
"The Phase I program of ALT-711 was initiated in June 1998. The
trials were performed by Kendle in Utrecht, The Netherlands. Two
placebo-controlled, double-blind, single and ascending dose studies
were completed, enrolling 88 subjects, consisting of a younger
cohort, aged 18 to 50 years, and an older cohort, aged 55 to 75
years. In addition, a 14-day multiple dosing trial was conducted in
16 older (65 to 75 years) subjects. Analyses of the clinical and
safety data did not show any medically relevant events.
"'We are enthusiastic about the potential of ALT-711 and our entire
class of A.G.E. crosslink breakers,' said Kenneth I. Moch,
President and Chief Executive Officer of Alteon. 'We are currently
pursuing our strategy for Phase II clinical development of ALT-711
with the help of experts in the cardiovascular field. Because ALT-
711 was well tolerated, we are considering further dose escalation
studies to prepare for our U.S. IND filing. A.G.E. crosslink
breakers may prove to be an answer to many age-related and
diabetes-related illnesses.'
"Aging is associated with a general increase in tissue stiffening,
including the cardiovascular and bronchioalveolar systems and the
skin. This aging process has been attributed, in part, to the
crosslinking of long-lived proteins, such as collagen and elastin,
initiated by the interaction of simple sugars, like glucose. This
process is accelerated in diabetic individuals. By 'breaking' these
crosslinks, ALT-711 and other crosslink breaker compounds under
development at Alteon, may have an impact on late stages of aging-
related and diabetic complications.
"In preclinical studies undertaken at The National Institute on
Aging and the Johns Hopkins Geriatric Center, researchers in
collaboration with Edward G. Lakatta, M.D., Chief of the NIA
Laboratory of Cardiovascular Science demonstrated the ability of
ALT-711 to reduce arterial stiffness in elderly Rhesus monkeys.
Announced at the November 1998 meeting of the American Heart
Association, Dr. Lakatta said of this research: 'If clinical
studies in humans bear out the results we have seen in animals,
substances like ALT-711 could be the breakthrough we've been
working toward to reverse some types of age-related heart and
vessel disease.'
"Other potential indications for crosslink breaker compounds
include ophthalmic and dermatological conditions. Alteon
researchers demonstrated the ability of ALT-711 to significantly
improve skin hydration and elasticity.
"'We are pleased to have completed a multi-dose series of Phase I
human safety testing and to be one step closer in the development
of this exciting compound,' said Mr. Moch. 'We look forward to the
initiation of further human clinical testing to validate our
important findings.'
"Alteon is a leader in the discovery and development of
pharmaceutical products for the treatment of the complications of
diabetes and age-related diseases. Alteon's proprietary technology
focuses on Advanced Glycosylation End-products, or A.G.E.s, formed
as a result of circulating blood glucose reacting with proteins.
A.G.E.s have been shown to be a causative factor in many of the
complications of diabetes and age-related diseases, including
kidney disease, nerve damage, atherosclerosis and retinopathy.
Alteon's approach is to inhibit or break A.G.E.s or their chemical
crosslinks, thereby potentially impacting such disease states. The
company is continuing its evaluation of its lead A.G.E.-formation
inhibitor, pimagedine, based on the results of the Phase III trial
of pimagedine in Type 1 diabetic patients with progressive kidney
disease. Alteon's lead A.G.E. crosslink breaker, ALT-711, has
successfully completed a series of Phase I human clinical trials,
and the company is currently planning Phase II clinical trials of
the compound. Alteon is also pursuing the development of a novel
series of glucose lowering agent (GLA) compounds.
# # #
"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, 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. Actual results, events or performances 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.
"This press release is also available at
http://www.alteonpharma.com
"'Safe Harbor' Statement under the Private Securities
Litigation Reform Act of 1995: Statements in this press
release regarding Alteon Inc.'s business which are not
historical facts are 'forward-looking statements' that
involve risks and uncertainties. For a discussion of such
risks and uncertainties, which could cause actual results
to differ from those contained in the forward-looking
statements, see 'Risk Factors' in the Company's Annual
Report or Form 10-K for the most recently ended fiscal
year."
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SIGNATURE
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
President and
Chief Executive Officer
Date: June 2, 1999
