Keryx Biopharmaceuticals, Inc. Announces Collaboration
November 25 2003 - 7:45AM
UK Regulatory
Keryx Biopharmaceuticals, Inc. Announces S.O.A.R. (Sulodexide Open Access
Research) Program Collaboration with the University of Michigan
Top researcher to explore potential beneficial effects of KRX-101
in cardiovascular injury
NEW YORK, Nov. 25 -- In connection with its S.O.A.R. (Sulodexide Open Access
Research) Program, Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX, London AIM:
KRX) announced today that it has entered into a S.O.A.R. collaboration with the
University of Michigan on behalf of Dr. Benedict R. Lucchesi, Professor of
Pharmacology at the University in Ann Arbor. Pursuant to this collaboration,
Dr. Lucchesi and his research team will undertake to assess the potential
benefit of KRX-101 (sulodexide) in the treatment of cardiovascular injury. KRX-
101, Keryx's lead drug candidate, is currently in a Phase II/III clinical
program for the treatment of diabetic nephropathy.
A person suffering from a heart attack suffers myocardial damage, both
during the ischemic phase when blood flow to regions of the heart is
compromised, and during the reperfusion phase when blood flow is restored as a
result of drug treatment and/or angioplasty. Dr. Lucchesi's laboratory,
which has developed preclinical models for analyzing the pathophysiological
basis for myocardial injury and the pharmacological protection of the ischemic
heart, intends for this proposed research to evaluate KRX-101's ability to
modulate inflammatory events associated with myocardial ischemia and
reperfusion and its potential benefit in treating these conditions.
"We are very excited about the commencement of this collaboration since it
will be the first time we are exploring KRX-101's therapeutic potential in
myocardial damage, a condition which significantly limits the probability of
full recovery for the millions of patients who suffer cardiac events and one
in which inflammation is a key component. We are hopeful that KRX-101, with
its potential distinct anti-inflammatory characteristics, will provide
therapeutic benefit in this disease area," said Michael S. Weiss, the
Company's Chairman and CEO. Mr. Weiss continued, "It is an honor to be
associated with the University of Michigan and Dr. Lucchesi's highly regarded
laboratory, and we very much look forward to the results from these exciting
studies."
Dr. Lucchesi commented, "Sulodexide, the subject of numerous publications,
possesses distinct advantages over other heparins and related GAG's, namely
its oral bioavailability. As it is known that the GAG class possesses anti-
inflammatory characteristics, we certainly look forward to exploring KRX-101's
potential beneficial effect in reducing or preventing myocardial injury
associated with ischemia and reperfusion."
ABOUT THE S.O.A.R. PROGRAM
The S.O.A.R. program is designed to expand the knowledge and understanding
of the potential clinical applications of KRX-101.
Pursuant to the S.O.A.R. program, the Company is inviting top researchers
from around the world to evaluate sulodexide in clinical studies as well as in
pre-clinical models to explore and critically assess the drug's potential
mechanisms of action and the ability to impact a number of disease states,
including diabetic nephropathy. Interested researchers should contact the
Company to learn more about the S.O.A.R. program.
ABOUT KRX-101
KRX-101 (sulodexide), a first-in-class oral heparinoid compound, is being
developed for the treatment of diabetic nephropathy, a progressive and life-
threatening kidney disease which afflicts approximately 3 million diabetics in
the United States alone.
KRX-101 belongs to a proposed new class of nephroprotective (kidney
protecting) drugs, called glycosaminoglycans. A variety of members of this
chemical family have been shown to decrease pathological albumin excretion in
diabetic nephropathy in man. However, these heparin agents all require therapy
by injection and are all potent anticoagulants, which are blood thinners
capable of inducing bleeding. Sulodexide, on the other hand, is given orally
and, in this form, has demonstrated little, if any, anticoagulant effects to
date.
More than 20 studies have been published in leading medical journals
assessing the safety and efficacy of KRX-101 in diabetic nephropathy and
other vascular conditions. Most recently, KRX-101 demonstrated significant
efficacy in treating diabetic nephropathy in a randomized, placebo-controlled,
223-patient Phase II clinical trial (the DiNAS Study) conducted in Europe. In
this study, Type 1 and Type 2 diabetics with diabetic nephropathy were treated
daily for 4 months with 50, 100- and 200-milligram gelcaps of KRX-101 and
showed substantial dose-dependent reduction in proteinuria, with the highest
dose achieving a 74% reduction versus placebo following four months of
treatment. In addition, the data in the DiNAS Study showed that the
therapeutic effect of KRX-101 was additive to ACE-inhibitor treatment,
suggesting that KRX-101 operates under a different mechanism of action than do
ACE inhibitors and Angiotensin Receptor Blockers ("ARBs"), which represent the
existing first line of treatment for the disease. These findings were
published in the June 2002 issue of the Journal of American Society of
Nephrology.
KRX-101 (sulodexide) has a well-established safety profile based upon
nearly twenty years of marketing experience by the Company's licensor and use
by thousands of patients (representing over 50 million patient days of use) in
Italy, Spain, Eastern Europe, Asia, and South America as a cardiovascular
drug.
In 2001, KRX-101 was granted Fast-Track designation for the treatment of
diabetic nephropathy and, in 2002, the Company announced that the FDA had
agreed, in principle, to permit the Company to avail itself of the accelerated
approval process under subpart H.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX; London AIM: KRX) is a
biopharmaceutical company focused on the acquisition, development and
commercialization of novel pharmaceutical products for the treatment of
life-threatening diseases, including diabetes and cancer. Keryx is developing
KRX-101 (sulodexide), a novel first-in-class oral heparinoid compound, for the
treatment of diabetic nephropathy, for which Keryx has initiated a U.S.-based
Phase II/III clinical program. Keryx also has an active in-licensing program
designed to identify and acquire clinical-stage drug candidates. Additionally,
Keryx is seeking partners for its KinAce(TM) drug discovery technology and
related products. Keryx Biopharmaceuticals is headquartered in New York City.
S.O.A.R. PROGRAM CONTACTS:
Dr. Michael Spero Dr. Enrique Poradosu
Medical Director Corporate Development Manager
Tel: +972 2 673-2910 Tel: +972 2 673-2910
E-mail: mspero@keryx.com E-mail: Enrique@keryx.com
KERYX CONTACT:
Ron Bentsur
VP Finance and Investor Relations
Tel: 212 531 5965
E-mail: ron@keryx.com
Cautionary statement
Some of the statements included in this press release, particularly those
anticipating business prospects and operating strategies and similar matters,
are forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the safe
harbor for forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995. Important factors may cause our actual
results to differ materially, including: the success of the S.O.A.R. program
and its ability to develop uses for KRX-101 that can impact a number of
disease states beyond diabetic nephropathy; our ability to successfully
complete cost-effective clinical trials of KRX-101; and other risk factors
identified from time to time in our SEC reports, including, but not limited
to, the report on Form 10-K for the year ended December 31, 2002, and our
quarterly report on Form 10-Q for the quarter ended September 30, 2003. Any
forward-looking statements set forth in this news release speak only as of the
date of this news release. We do not intend to update any of these forward-
looking statements to reflect events or circumstances that occur after the
date hereof. This press release and prior releases are available at
www.keryx.com. The information in Keryx's website is not incorporated by
reference into this press release and is included as an inactive textual
reference only.
SOURCE Keryx Biopharmaceuticals, Inc.
-0- 11/25/2003
/CONTACT: For S.O.A.R. Program - Dr. Michael Spero, Medical Director,
+972-2-673-2910, mspero@keryx.com, or Dr. Enrique Poradosu, Corporate
Development Manager, +972-2-673-2910, Enrique@keryx.com; or For Keryx - Ron
Bentsur, VP Finance and Investor Relations, Tel: +1-212-531-5965,
E-mail: ron@keryx.com, all of Keryx Biopharmaceuticals, Inc./
/FCMN Contact: dabbotts@redingtoninc.com /
/Web site: http://www.keryx.com /
(KERX)
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