Keryx Expands Study Program for Lead Compound, KRX-101
12 August 2003 - 11:30PM
UK Regulatory
Keryx Biopharmaceuticals Launches SOAR Program to Expand Study of KRX-101
(Sulodexide)
Investigators Invited to Explore Potential of Novel Compound in Disease States
Characterized by Glycosaminoglycan Depletion
NEW YORK, Aug. 12 -- Keryx Biopharmaceuticals, Inc.
(Nasdaq: KERX; London AIM: KRX) announced the initiation of a program to
expand the scientific and medical communities' knowledge and understanding of
additional potential clinical applications of KRX-101 (sulodexide), the
Company's lead compound currently scheduled to begin advanced US-based
clinical trials for the treatment of diabetic nephropathy.
Under the program, called SOAR for Sulodexide Open Access Research, the
Company is inviting top researchers from around the world to study sulodexide
in their clinics as well as in their pre-clinical models in order to explore
the drug's potential ability to positively impact a number of disease states,
including diabetic nephropathy.
"This is a very important initiative for us and we believe the SOAR
program will complement and support our lead program for KRX-101 in the
treatment of diabetic nephropathy, for which we are on track to commence our
Phase II/III clinical program late in 3Q or early 4Q of this year," stated
Michael S. Weiss, Keryx's Chairman and CEO. "There is intriguing data
indicating KRX-101 may have substantial positive impact in other disease
states, including other glomerulopathies and those diseases characterized by
glycosaminoglycan depletion. Our SOAR program is designed to create
collaborations with leading investigators from around the world to help us
explore these additional potential applications."
Interested researchers should contact the Company to learn more about the
SOAR program.
About KRX 101 (Sulodexide)
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. Several members of this
chemical family, all heparin agents, have been shown to decrease pathological
albumin excretion in diabetic nephropathy in humans. However, these heparin
agents all require therapy by injection and are all potent anticoagulants,
which are blood thinners capable of inducing bleeding. KRX-101, 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 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 58 303 650 Tel: +972 2 673 2910
E-mail: mspero@keryx.com E-mail: enrique@keryx.com
KERYX CONTACTS:
Ron Bentsur
Vice President Finance and Investor Relations
Tel: +1 212 531 5965
E-mail: ron@keryx.com
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, which will be filed with the SEC on or before August 14, 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- 08/12/2003
/CONTACT: S.O.A.R. Program - Dr. Michael Spero, Medical Director,
+972-58-303-650, mspero@keryx.com, or Dr. Enrique Poradosu, Corporate
Development Manager, +972-2-673-2910, enrique@keryx.com; or KERYX - Ron
Bentsur, Vice President Finance and Investor Relations, +1-212-531-5965,
ron@keryx.com, all of Keryx Biopharmaceuticals, Inc./
/Web site: http://www.keryx.com /
(KERX)
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