Alteon Initiates Phase 2 Trial of ALT-2074 in Diabetes and Haptoglobin 2-2
28 Junio 2007 - 8:30AM
PR Newswire (US)
Proof of Concept Study for Pharmacogenomic Indication MONTVALE,
N.J., June 28 /PRNewswire-FirstCall/ -- Alteon Inc. (AMEX:ALT)
announced today that it has dosed its first patient in a 60-patient
Phase 2 clinical trial (Study 201) of ALT-2074, its lead
glutathione peroxidase mimetic, in diabetic patients with a variant
of haptoglobin that renders them at high risk for cardiovascular
complications. This dose escalating study is designed to evaluate
ALT-2074's ability to lower inflammatory cardiovascular biomarkers
in patients with an elevated risk for cardiovascular events. It
builds on positive data from previous cardiovascular animal
studies. ALT- 2074's activity in prior clinical trials demonstrated
its safety and ability to lower inflammatory markers in ulcerative
colitis. "The initiation of Study 201 is a key milestone in our
program for the development of ALT-2074 as a treatment for diabetic
patients with a high risk of cardiovascular events," said Malcolm
W. MacNab, M.D., Ph.D., Alteon's Vice President, Clinical
Development. "We are enthusiastic about the potential that ALT-2074
has demonstrated in our preclinical models and we are aggressively
pursuing clinical development in this indication." Diabetes and
Metabolic Syndrome, diseases linked to obesity and increased
oxidative stress, are growing in epidemic proportions in the United
States and many other developed countries. The major complications
associated with these diseases are cardiovascular in nature, and
lead to such events as stroke, heart attack, kidney failure and
death. Not all patients with diabetes, however, experience these
complications. Several multinational studies have demonstrated that
the increased risk of cardiovascular disease attributed to diabetes
is more aptly attributed to the development of diabetes "on top of"
a predisposing genetic factor called Haptoglobin 2-2 (Hp2-2), which
is found in 40% of the human population. The combination of
diabetes and Hp2-2 increases the susceptibility of patients to a
defect in their cholesterol metabolism, which may promote
atherosclerosis, and to a weakness in their antioxidant defense, so
essential to the human body when oxygen is less available (during a
heart attack for example). Targeting a potent antioxidant drug
candidate like ALT-2074 to these high risk patients is an example
of targeted therapy. By redefining diabetes, Alteon believes that
it can advance an efficient clinical development program in which a
more appropriately targeted therapy is given to a more susceptible
patient population. About Study 201 In Study 201, ALT-2074 will be
tested in approximately 60 patients at 3 clinical sites managed by
Radiant Research. The trial will include male and female patients
with diabetes at least 18 years of age with documented or suspected
coronary artery disease. Patients will be screened for their
haptoglobin type at ARUP Laboratories in Salt Lake City, Utah, the
only U.S. reference lab, to which Alteon has granted a license for
testing haptoglobin type, for the purpose of determining
cardiovascular risk. Recruited patients will be treated with
ALT-2074 for 28 days, and tracked for changes in levels of urinary
isoprostanes and of other cardiovascular biomarkers, as well as
functional measures of reverse cholesterol transport. About Alteon
Alteon is a product-based biopharmaceutical company engaged in the
development of small molecule drugs to treat and prevent the
inflammatory aspects of cardiovascular disease and diabetes. The
Company has identified several product candidates that it believes
represent novel approaches to some of the largest pharmaceutical
markets. The Company's portfolio includes orally bioavailable,
organoselenium mimics of glutathione peroxidase. These compounds
metabolize lipid peroxides and have the potential to limit
myocardial damage subsequent to a myocardial infarction. Alteon's
lead compound for that program, ALT-2074, is in Phase 2 clinical
trials. The Company also has rights to the use of haptoglobin
characterization. The Company is developing a clinical diagnostic
test that can be used to identify patients at high risk for
cardiovascular complications of diabetes and other diseases.
Alagebrium, a proposed breaker of Advanced Glycation End-Products
(A.G.E.'s) is a product candidate of Alteon's drug discovery and
development program. It is being developed for the treatment of
diastolic heart failure. This disease represents a rapidly growing
market of unmet medical need, particularly common among diabetic
patients. Alagebrium has demonstrated relevant clinical activity in
two Phase 2 clinical trials in heart failure, as well as in animal
models of heart failure and nephropathy, among others. Alagebrium
has been tested in approximately 1,000 patients in multiple Phase 1
and Phase 2 clinical trials, allowing Alteon to assemble a sizeable
human safety database. For more detailed information about Alteon's
research and development, please visit Alteon's website at
http://www.alteon.com/. 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, the risks associated with the
license arrangement described in this press release, future
clinical development of ALT-2074, and other risks identified in
Alteon's filings with the Securities and Exchange Commission.
Further information on risks faced by Alteon are detailed under the
caption "Risk Factors" in Alteon's Annual Report on Form 10-K for
the year ended December 31, 2006. These filings are available on a
website maintained by the Securities and Exchange Commission at
http://www.sec.gov/. The information contained in this press
release is accurate as of the date indicated. Actual results,
events or performance 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. DATASOURCE: Alteon CONTACT: Company, Alteon
Inc., +1-201-934-5000, ; Investor Relations, Emmanuelle Ferrer, ,
or Kim Sutton Golodetz, , both of Lippert-Heilshorn &
Associates, Inc. for Alteon, +1-212-838-3777 Web site:
http://www.alteon.com/
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