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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) July 31, 1997
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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 July 31, 1997 Alteon Inc. issued the following press
release relating to the expansion of its End-Stage Renal Disease
clinical trial:
Alteon Expanding End-Stage Renal Disease Trial
in Response to Positive Trends in Mortality Data
RAMSEY, N.J., July 31 /PRNewswire/ -- Alteon Inc. (Nasdaq:
ALTN) announced today that its Phase II trial evaluating
Pimagedine in diabetic patients with End-Stage Renal Disease
(ESRD) is being extended into a pivotal Phase III trial focusing
on mortality as the primary endpoint. This decision is based
upon an interim analysis of the ongoing Phase II trial, which
revealed a positive trend in the mortality of treated patients
versus placebo patients. This study was originally designed for
possible conversion to a Phase III trial. Given the critical
need for approaches to extend the life of patients with ESRD, the
Company has proceeded immediately to a Phase III evaluation.
Alteon cautions this trend data reflects a small number of
events and must, therefore, be shown to be statistically
significant in a larger Phase III clinical trial. These Phase II
results have been discussed with Alteon's end-stage renal disease
consultants and the U.S. Food and Drug Administration to
determine how best to proceed with a Phase III program.
Interim analysis also showed a positive effect on certain
lipid measurements, similar to those seen in other studies. In
addition, the drug appears to be well tolerated in this very ill
patient population.
Currently, 120 patients are participating in this ESRD
trial. The majority of patients have been in the trial for at
least 6 months, with some participating as long as 15 months. An
independent statistical organization will continue monitoring
trial results.
"We are pleased to note these positive trends in this very
ill patient population. However, we emphasize these results need
to be confirmed in an adequate and well controlled Phase III
trial," said James J. Mauzey, Chairman and Chief Executive
Officer. "We remain encouraged by the fact that our human
efficacy data on Pimagedine continues to parallel what has been
previously seen in preclinical studies."
Alteon is a leader in the discovery and development of
pharmaceutical products for the treatment of the complications of
diabetes and age-related diseases. The Company is actively
developing its lead first-in-class compound, Pimagedine, to
inhibit or block abnormal glucose/protein complexes that lead to
diabetic complications such as kidney disease and dyslipidemia.
Three clinical trials evaluating Pimagedine for complications of
diabetes are ongoing, two pivotal Phase III ACTION trials for
diabetic kidney disease and the expanded ESRD trial. The ACTION
trials are being conducted at more than 100 North American
clinical sites and involve over 1,200 patients. In addition,
Alteon is pursuing potential indications of Pimagedine for the
treatment of various inflammatory conditions, and is continuing
its research on A.G.E. cross-link breakers and the glucose
lowering agent (GLA) series of 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, clinical trials, regulatory approval processes,
intellectual property rights and litigation, competitive
products, ability to obtain financing and other risks identified
in the Company's filings with the Securities and Exchange
Commission. Actual results, events or performances may differ
materially. The Company undertakes no obligation to publicly
release the result of any revisions 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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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/ Jere E. Goyan
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Jere E. Goyan
President and
Chief Operating Officer
Date: August 8, 1997
