Some news...generally, this "good" news will drive down the IVX price, right? :-)
Preclinical Studies Conducted With NIH Indicate IVAX' Elmiron(R) Holds Promise As a
Treatment for Progressive Kidney Disease and Atherosclerosis
PR Newswire, Monday, April 21, 1997 at 09:10
Study Results Presented at National Kidney Foundation Meeting
MIAMI, April 21 /PRNewswire/ -- IVAX Corporation (AMEX:IVX) announced
today that, in preclinical animal and in vitro studies conducted in
collaboration with the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) of the National Institutes of Health (NIH), IVAX' oral
compound Elmiron(R) (pentosan polysulfate sodium) stopped or reversed
glomerular scarring in the kidney and significantly reduced vascular scarring
caused by atherosclerosis (hardening of the arteries). Based on these
studies, Gary E. Striker, M.D., principal investigator in the studies and
former director of the Kidney, Urologic and Hematologic Diseases Division of
the NIDDK, has concluded that Elmiron merits further investigation as a
potential treatment for kidney disease and atherosclerosis in humans.
Dr. Striker presented his conclusions on April 18 at the National Kidney
Foundation's Sixth Annual Clinical Nephrology Meetings held in Dallas, Texas,
where he delivered the Shaul G. Massry Distinguished Lecture entitled Plaque
Attack: Treatment and Prevention of Atherosclerosis and Progressive
Glomerulosclerosis.
The studies were conducted pursuant to a Cooperative Research and
Development Agreement (CRADA) between the NIDDK and IVAX' wholly owned
subsidiary, Baker Norton Pharmaceuticals, Inc., initiated to study whether
Elmiron may have activity in kidney disease, atherosclerosis and other
indications. Studies utilized transgenic and diabetic mice models with
rapidly progressive kidney/vascular disease, the Watanabe rabbit model with
accelerated atherosclerosis, and in vitro cultures of smooth muscle cells
taken from humans. As part of the CRADA, the NIDDK and IVAX will continue to
study Elmiron on the kidney and the vascular system.
The data from the cooperative studies suggest that Elmiron inhibits
scarring related to abnormalities in the smooth muscle cells in the aorta and
in the blood vessels of the kidney. A similar scarring process in humans has
previously been considered to be progressive and irreversible, leading to
severe atherosclerosis and kidney failure. Because Elmiron appears to inhibit
scarring in the animal and in vitro studies, Elmiron is deemed to merit
further investigation in treating progressive kidney and vascular disease.
Patent applications have been submitted relating to the use of Elmiron for
the treatment of kidney disease and atherosclerosis, and IVAX has certain
related intellectual property rights under the CRADA.
In September 1996, the U.S. Food and Drug Administration granted IVAX
clearance to market Elmiron for the relief of the pain or discomfort
associated with the debilitating urinary bladder disease known as interstitial
cystitis (IC). Elmiron is not presently approved for any indication other
than IC.
IVAX Corporation, headquartered in Miami, Florida, is a holding company
with subsidiaries engaged primarily in the research, development, manufacture
and marketing of health care products, including generic and branded
pharmaceuticals, intravenous solutions and related products, and in vitro
diagnostics. Elmiron is a registered trademark of Baker Norton
Pharmaceuticals, Inc.
SOURCE IVAX Corporation
-0- 4/21/97
/CONTACT: Joseph C. Jones, Vice President - Corporate Communications of
IVAX Corporation, 305-575-6042/
/IVAX Corporation press releases are available at no charge through
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menu of IVAX' press releases or to retrieve a specific release, call
800-758-5804, extension 457725, or use the Internet via
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