Alteon Research Collaborator Receives Funding from Juvenile Diabetes Research Foundation for Diabetic Complications Clinical St
10 July 2006 - 11:30PM
PR Newswire (US)
- Grant Part of JDRF's Initiative to Advance Effort to Find a Cure
for Diabetes and its Complications - PARSIPPANY, N.J., July 10
/PRNewswire-FirstCall/ -- Alteon Inc. (AMEX:ALT) announced today
that one of its collaborators, Mark Cooper, M.D., Ph.D., Professor,
the Baker Heart Research Institute, Melbourne, Australia, has been
awarded a grant from the Juvenile Diabetes Research Foundation
(JDRF) to help fund a multinational Phase 2 clinical study of the
effect of Alteon's lead compound alagebrium on renal function in
patients with type 1 diabetes and microalbuminuria. An A.G.E.
Crosslink Breaker, alagebrium will be tested for its ability to
reverse kidney damage caused by diabetes, and to reverse the
protein excretion which is characteristic of diabetic nephropathy.
Diabetes is the leading cause of kidney failure in the United
States. When blood sugar increases, as it does in diabetes, it
non-enzymatically modifies proteins to form chemical structures
known as advanced glycation end-products (A.G.E.s), leading to a
loss of flexibility and function in tissues and organs throughout
the body, including the kidney. Alagebrium chloride is the first in
a new class of compounds developed by Alteon to break the A.G.E.
crosslinks, and may therefore be a promising new treatment to
prevent the kidney failure caused by diabetes. Dr. Cooper has
performed many preclinical studies that appear to validate the use
of alagebrium in diabetic nephropathy. "In preclinical studies, we
have shown that renal damage in diabetes is partly caused by
sugar-protein complexes called Advanced Glycation End- products
(A.G.E.s), and that treatment with alagebrium, an A.G.E. Crosslink
Breaker, can improve renal function and structure,"(1) said Dr.
Cooper. "We are grateful to the JDRF for this grant that will
enable us to explore these exciting findings in diabetic patients."
A Phase 2 protocol for the clinical study has been developed. The
randomized, double-blind, placebo-controlled study will test
alagebrium in 80 patients with type 1 diabetes between the ages of
18-65 who are in the early stages of kidney disease. There will be
an 8-week single-blind, run-in period during which placebo and an
ACE inhibitor, standard background therapy for this patient
population, will be administered to all patients. This will be
followed by 24 weeks of double-blind treatment with either placebo
or alagebrium in combination with an ACE inhibitor. Changes in
albumin excretion rate will be the primary endpoint of the study.
The study, which is expected to be initiated in the fourth quarter
of 2006, will be conducted at three sites in Australia and one in
Denmark. Notable nephrologist Hans-Henrik Parving, M.D., Professor
of Medicine, Chief Physician, Steno Diabetes Center, Gentofte,
Denmark, and Faculty of Health Science, University of Aarhus,
Denmark, will serve as the investigator in Denmark. "We are
delighted that we will be working with Drs. Cooper and Parving on
this Phase 2 evaluation of alagebrium in diabetic kidney disease, a
medical condition in great need of new therapies," said Kenneth I.
Moch, President and CEO of Alteon. "This study complements our
ongoing Phase 2 efforts in diastolic heart failure, another disease
that can be a complication of diabetes." "Based on the preclinical
studies performed by Dr. Cooper using alagebrium, we are encouraged
that this clinical trial may demonstrate clinical utility in type I
diabetics," said Dr. Parving. I look forward to participating in
this multinational study." About JDRF JDRF (http://www.jdrf.org/)
was founded in 1970 by the parents of children with juvenile
diabetes -- a disease that strikes children suddenly, makes them
insulin dependent for life, and carries the constant threat of
devastating complications. Since inception, JDRF has provided more
than $1 billion to diabetes research worldwide. More than 80
percent of JDRF's expenditures directly support research and
education about research. JDRF's mission is constant: to find a
cure for diabetes and its complications through the support of
research. About Alteon Alteon is a product-based biopharmaceutical
company engaged in the development of small molecule drugs to treat
and prevent cardiovascular disease and diabetes. The Company has
identified several promising product candidates that it believes
represent novel approaches to some of the largest pharmaceutical
markets. On April 19, 2006, Alteon announced a definitive merger
agreement with privately-held HaptoGuard, Inc., and the granting of
certain royalty and negotiation rights to Genentech, Inc. as part
of the restructuring of Genentech's preferred stock position in
Alteon. Alteon and HaptoGuard have complementary products under
development in cardiovascular diseases and diabetes, including two
Phase 2 clinical-stage compounds, ALT-2074 and alagebrium. Data is
expected in early 2007 from an ongoing Phase 2 trial of ALT-2074 to
minimize the cardiac damage from the intervention to treat acute
coronary syndrome in diabetic patients. Alteon's alagebrium has
demonstrated potential efficacy in two clinical trials in heart
failure, as well as in animal models of heart failure and
nephropathy, among others. It has been tested in approximately
1,000 patients in a number of Phase 1 and Phase 2 clinical trials.
Alagebrium has been shown to improve cardiac function, including
the ability to significantly reduce left ventricular mass and
improve diastolic filling parameters, and plans are to continue its
development for diastolic heart failure. This disease represents a
rapidly growing market of an unmet medical need, and is
particularly common among diabetic patients. The merger and stock
conversion transactions are subject to the approval of Alteon and
HaptoGuard shareholders and are expected to close in the third
quarter of 2006. For more information please visit Alteon's
website, 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, that Alteon may not complete the
acquisition of HaptoGuard, and if completed, that the combined
company's financial condition may not be as expected, and those
relating to Alteon's ability to obtain sufficient financing to
allow it to continue as a going concern and to continue the
development of alagebrium, technology and product development
(including the possibility that early clinical trial results may
not be predictive of results that will be obtained in large-scale
testing or that any clinical trials will not demonstrate sufficient
safety and efficacy to obtain requisite approvals or will not
result in marketable products), regulatory approval processes,
intellectual property rights and litigation, competitive products,
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, 2005 and
in subsequent filings with the SEC. 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. Participants in the Solicitation In
connection with the proposed merger, Alteon Inc. and HaptoGuard,
Inc. have filed a joint proxy statement with the Securities and
Exchange Commission. Investors and security holders of Alteon Inc.
and HaptoGuard, Inc. are advised to read the joint proxy statement
regarding the proposed merger referred to in this communication
because it contains important information. Alteon Inc. and
HaptoGuard, Inc. have mailed the joint proxy statement about the
proposed merger to their respective stockholders. In addition to
the proxy statement, Alteon Inc. files annual, quarterly, and
special reports, proxy statements and other information with the
Securities and Exchange Commission. Investors and security holders
may obtain a free copy of the proxy statement and any other
documents filed by Alteon Inc. at http://www.sec.gov/ and directly
from Alteon Inc. Alteon Inc. and its officers and directors may be
deemed to be participants in the solicitation of proxies from
stockholders of Alteon Inc. with respect to the proposed merger.
Information regarding such officers and directors is included in
Alteon Inc.'s Annual Report on Form 10-K for the fiscal year ended
December 31, 2005 and in its proxy statement for the 2006 Annual
Meeting, which have been filed with the Securities and Exchange
Commission. These documents are available free of charge at the
Securities and Exchange Commission's website at http://www.sec.gov/
and directly from Alteon Inc. HaptoGuard, Inc. and its officers and
directors may be deemed to be participants in the solicitation of
proxies from stockholders of HaptoGuard, Inc. HaptoGuard, Inc. is a
private company and does not file annual or quarterly reports with
the SEC. (1) Forbes, et al. The Breakdown of Pre-Existing Advanced
Glycation End Products is Associated With Reduced Renal Fibrosis in
Experimental Diabetes, Federation of American Societies in
Experimental Biology (FASEB) Journal, July 2003 DATASOURCE: Alteon
Inc. CONTACT: Susan M. Pietropaolo of SMP Solutions, Inc.,
+1-201-818-5537, for Alteon Inc. Web site: http://www.alteon.com/
http://www.jdrf.org/ http://www.sec.gov/
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