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) December 2, 1996
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)
<PAGE>
Item 5. Other Events.
On December 2, 1996 Alteon Inc. issued the following press
release relating to the amendment of its ACTION II protocol:
ALTEON AMENDS ACTION II TRIAL;
ANNOUNCES PIMAGEDINE LIPID LOWERING ACTIVITY
Ramsey, NJ, December 2, 1996 - Alteon Inc. (Nasdaq: ALTN)
announced today that a review of its Phase III ACTION (A Clinical
Trial In Overt Nephropathy) Trials has led the Company to amend its
ACTION II protocol. ACTION II is a pivotal trial evaluating the
advanced glycosylation formation and cross-link inhibitor,
Pimagedine, in Type II diabetics with overt nephropathy. Patients
currently on the high-dose arm will be converted to the ongoing
low-dose arm. This amendment is due to dose-related adverse events
seen in a number of the older, more fragile Type II diabetic
patients. ACTION II will continue as a placebo-controlled blinded
study with no further enrollment of patients. These changes will
not compromise the statistical integrity or the statistical power
of the study.
In the younger, less fragile Type I diabetic patient
population enrolled in the Phase III ACTION I Trial, no changes or
modifications will be made. Enrollment in the ACTION I Trial, which
is evaluating Pimagedine in Type I diabetics with overt
nephropathy, was completed in August, 1996. Patients in this trial
will remain on drug until mid-1998, at which time the study will be
completed and the data released.
In addition, ongoing Phase II studies in Type II diabetics
with dyslipidemia (abnormal lipid profile) and Type I and Type II
diabetics with end-stage renal disease will continue unchanged.
Data from these two Phase II studies is expected to be reported
during the first half of 1997.
Alteon further announced that both the ACTION I and ACTION II
Trials are showing a statistically significant lipid lowering
effect, a relevant marker to the activity of Pimagedine. Data
relating to the drug's efficacy against primary medical endpoints
remains blinded.
"The ACTION II Trial changes address the safety and well being
of patients involved in the study, while providing a framework for
the continued evaluation of Pimagedine in Type II diabetics with
overt nephropathy," said James J. Mauzey, Chairman and Chief
Executive Officer of Alteon. "We are also very encouraged by the
lipid lowering results seen with Pimagedine in both ACTION Trials.
<PAGE>
This is the first indication of potential drug efficacy in a long-
term, blinded, placebo-controlled human clinical program."
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 compound, Pimagedine, to inhibit or block
abnormal glucose/protein complexes, called Advanced Glycosylation
End-products (A.G.E.s), that lead to diabetic complications. Four
clinical trials evaluating Pimagedine as a treatment for
complications of diabetes are currently underway, including two
pivotal Phase III clinical trials for diabetic kidney disease being
conducted at more than 100 North American clinical sites. In
addition, Alteon is pursuing potential indications of Pimagedine
for the treatment of various inflammatory conditions and is
investigating the possible applications of its A.G.E. technology in
age-related diseases, such as Alzheimer's disease.
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 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 occurence of unanticipated events.
# # #
<PAGE>
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/ James J. Mauzey
-----------------------
James J. Mauzey
Chairman and
Chief Executive Officer
Date: December 4, 1996
