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) August 7, 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 August 7, 1996 Alteon Inc. issued the following press
release relating to the completion of enrollment in its first Phase
III clinical trial:
ENROLLMENT COMPLETED IN ALTEON'S
FIRST PHASE III CLINICAL TRIAL OF PIMAGEDINE
Ramsey, New Jersey, August 7, 1996 -- Alteon Inc.
(Nasdaq:ALTN) announced today that it has completed enrollment
of the required 660 patients for the Company's ACTION-I [A Clinical
Trial In Overt Nephropathy] study, a Phase III clinical trial of
pimagedine in Type I (juvenile-onset) diabetics with kidney
disease. The ACTION-I study will now continue until the third
quarter of 1998, at which time the trial will end and data will be
unblinded.
Over 55 centers across the U.S. and Canada are actively
treating diabetic patients in the ACTION-I trial.
"We are pleased to have reached this significant milestone,"
said James J. Mauzey, Alteon Chairman and Chief Executive Officer,
"and now look forward to concluding the ACTION-I trial. It is
important to note that over 315 patients have been undergoing
treatment in the study for well over a year."
ACTION-II, a similar multicenter Phase III clinical trial
testing pimagedine's effectiveness in Type-II (adult-onset)
diabetics, is still open for enrollment. Potential patients can
call 1-800-41-ENROLL for more information.
Diabetes, the body's failure to process blood sugar normally,
affects an estimated 16 million Americans. Complications arising
from diabetes include kidney failure, blindness and nerve damage.
Diabetics are also more susceptible to developing heart disease,
high blood pressure and stroke. Diabetic kidney disease occurs in
34 percent of Type I and 19 percent of Type III insulin-taking
people after fifteen years of the disease.
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's efforts have
focused primarily on developing its lead compound, pimagedine, to
inhibit or block abnormal glucose/protein complexes that lead to
diabetic complications. The Company is now conducting four
clinical trials evaluating pimagedine as a treatment for
complications of diabetes, including the two pivotal ACTION trials
under way, which together are scheduled to enroll approximately
1560 Type I and Type II diabetics at over 100 North American
clinical sites.
# # #
The statements in this news release that are not historical facts
include forward-looking statements that involve risks and
uncertainties. The rate of completion of the Company's clinical
trials may be delayed by many factors. Delays may occur in
enrolling patients as a result of the lack of availability of
patients who satisfy the protocol for a particular trial,
variations in the performance of the principal investigators in
the trials, and the response of potential patients to recruitment
efforts. Delays in completion of the trials may also occur as a
result of difficulties in retaining patients in the trials,
preliminary safety data analysis which requires changes in the
protocols and delays in approval of the trials by institutional
review boards at the trial sites. Accordingly, no assurance can
be given that enrollment in any of the Company's clinical trials
can be achieved on a timely basis, if at all, or that clinical
trials can be successfully completed within any particular time
frame or at all.
* * *<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 thereunto duly authorized.
Alteon Inc.
By: /s/ James J. Mauzey
-----------------------
James J. Mauzey
Chairman and
Chief Executive Officer
Date: August 14, 1996
