Keryx Expands Study Program for Lead Compound, KRX-101
17 September 2003 - 11:35PM
UK Regulatory
Keryx Biopharmaceuticals, Inc. Announces First S.O.A.R.
(Sulodexide Open Access Research) Program Collaboration for KRX-101
Esteemed Researcher to explore impact of KRX-101 on development and
progression of Diabetes in Pre-Clinical Models
NEW YORK, Sept. 17 -- Keryx Biopharmaceuticals,
Inc. (Nasdaq: KERX; London AIM: KRX) announced today that, in connection with
its recently announced S.O.A.R. (Sulodexide Open Access Research) Program, it
has entered into its first S.O.A.R. collaboration with Dr. Hanna Abboud,
Professor of Medicine and Chief of the Division of Nephrology at the
University of Texas Health Sciences Center in San Antonio.
Dr. Abboud's proposed research is expected to provide further insight into
how KRX-101 impacts the development and progression of diabetes-related
nephropathy.
"This is a very exciting beginning to our S.O.A.R. program," stated
Michael S. Weiss, the Company's Chairman and CEO. "Our ability to rapidly
convert a concept to collaboration in just a few short weeks, reflects a high
level of interest in KRX-101 and in our ability as a company to execute our
research programs. Dr. Abboud is a world-class clinician and researcher and
we eagerly await the results of his very exciting research."
Dr. Abboud commented, "KRX-101 is a very interesting compound with several
distinct mechanisms of action of potential relevance in Diabetic Nephropathy.
Our research will hopefully add to the current body of knowledge on how
KRX-101 affects the progression of diabetic nephropathy. Keryx's S.O.A.R.
program provides an innovative platform for researchers to access KRX-101, and
this is particularly exciting because KRX-101 has never before been available
to US investigators."
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
biopharmaceuticals 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 is currently planning its
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 CONTACTS:
Ron Bentsur
VP Finance and Investor Relations
Tel: 212 531 5965
E-mail: ron@keryx.com
Thomas Redington
Redington Inc.
203 222 7399
212 926 1733
www.redingtoninc.com
Cautionary statement
Some of the statements included in this press release, particularly those
anticipating future financial performance, business prospects, growth 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 begin and 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
June 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- 09/17/2003
/CONTACT: S.O.A.R. Program - Dr. Michael Spero, Medical Director,
mspero@keryx.com, or Dr. Enrique Poradosu, Corporate Development Manager,
Enrique@keryx.com, +972-2-673-2910, or Ron Bentsur, VP Finance and Investor
Relations, +1-212-531-5965, ron@keryx.com, all of Keryx Biopharmaceuticals,
Inc.; Thomas Redington, Redington Inc., +1-203-222-7399, +1-212-926-1733, for
Keryx Biopharmaceuticals, Inc./
/Web site: http://www.keryx.com /
(KERX)
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