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): April 17, 1997
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 April 17, 1997 Alteon Inc. issued the following press
release relating to the results from a Phase II trial of its lead
compound, pimagedine:
ALTEON ANNOUNCES POSITIVE PHASE II DATA ON PIMAGEDINE
--Drug lowers key lipids in diabetic patients; effect on
albuminuria also observed--
Ramsey, NJ, April 17, 1997 -- Alteon Inc. (Nasdaq: ALTN)
announced today results from a Phase II trial in which its lead
compound, pimagedine, lowered key serum lipid levels in Type II
diabetics with dyslipidemia (abnormal lipid profiles). Additional
analysis revealed that pimagedine also lowered albumin, a protein
in the urine, by an average of 40 percent in patients identified
as having albuminuria (protein leakage). These positive results
support the use of Alteon's primary drug candidate, pimagedine, as
a potential therapy for diabetic complications.
The dyslipidemia trial, conducted in Israel, involved 90
randomized patients who received pimagedine or placebo for 3
months. The dosing algorithm used in this trial was the same as
that used in the high-dose arm of the ACTION (A Clinical Trial in
Overt Nephropathy) trials, with renal function being the
determinant of the amount of drug given. Alteon is currently
conducting two pivotal Phase III trials, the ACTION I (Type I) and
the ACTION II (Type II) trials in diabetics with kidney disease.
In the dyslipidemia trial, statistical significance (p<.05)
was achieved in the lowering of LDL, VLDL (very low density
lipids), total cholesterol, triglycerides and ApoB-A.G.E., the
advanced glycated form of the LDL protein. The greatest percent
reduction of lipids occurred in those patients with the most
elevated levels. These data support interim findings from the
ACTION trials on the lowering of lipids announced last December.
Patients in the ACTION II trials who were evaluated at six months
of pimagedine therapy showed statistically significant lowering of
all three key lipid measurements (total cholesterol,
LDL-cholesterol and triglycerides) with no appreciable change in
the level of HDL-cholesterol (good cholesterol). VLDL and
ApoB-A.G.E. are not being evaluated in the ACTION trials. Alteon
believes that lipid lowering is a surrogate marker of pimagedine's
pharmaceutical activity.
Albumin in the urine was also reduced in a statistically
significant manner in the dyslipidemia trial. Protein in the urine
is an indicator of diabetic kidney disease. Urinary albumin fell
by an average of 40% (p=.0068) in patients identified as having
albuminuria (excretion of more than 30 mg of albumin in 24 hours).
While not an endpoint of the Israeli trial, this data provides the
first evidence of the ability of pimagedine to lower urinary
protein in humans, suggesting a positive effect on diabetic kidney
disease. Effect on urinary albumin is, importantly, a secondary
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endpoint of both pivotal ACTION trials. The medical endpoint data
in the ACTION trials remains blinded.
"We are pleased with the ability of pimagedine to lower
lipids in diabetic patients and are encouraged with its ability to
lower urinary protein in diabetics with albuminuria," said James
J. Mauzey, Chairman and Chief Executive Officer. "We now look
forward to additional Phase II data from our end-stage renal
disease trial during the summer of 1997 and results from our Phase
III ACTION I trial in overt nephropathy during 1998."
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 is 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
additional clinical trials evaluating pimagedine for complications
of diabetes are ongoing, including the two pivotal Phase III ACTION
Trials for diabetic kidney disease. These 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 performances are forward-looking statements
that involve risks and uncertainties including, but not limited to,
those relating to technology and product development, regulatory
approval process, intellectual property rights and litigation,
competitive products and other risks identified in the Company's
filing with the Securities and Exchange Commission. Actual
results, events or performances may differ materially. The Company
undertakes no obligation to publicly release the results 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 thereunto duly authorized.
Alteon Inc.
By: /s/ James J. Mauzey
____________________
James J. Mauzey
Chairman and
Chief Executive Officer
Date: April 24, 1997
