Investigators from the Netherlands Cancer Institute Report Encouraging Results from Phase I Trial of KRX-0401 (Perifosine) in Co
June 07 2004 - 10:22AM
PR Newswire (US)
Investigators from the Netherlands Cancer Institute Report
Encouraging Results from Phase I Trial of KRX-0401 (Perifosine) in
Combination with Radiotherapy at the 2004 American Society of
Clinical Oncology (ASCO) Annual Meeting Data demonstrated
acceptable safety/tolerability and preliminary evidence of
antitumor activity, including multiple complete and partial
responses, at all dosage levels NEW YORK, June 7
/PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc.
(NASDAQ:KERXNASDAQ:LondonNASDAQ:AIM:NASDAQ:KRX) announced today
that Investigators from the Netherlands Cancer Institute reported
encouraging results from a recently completed Phase I trial
evaluating KRX-0401 (Perifosine), a novel, first-in- class, oral
AKT inhibitor, in combination with radiotherapy in patients with
unresectable locally advanced tumors. Poster #N3-3064, "Phase I
Study of Combined Treatment with the Oral Alkyl-Lysophospholipid
(ALP) Perifosine and Radiation in Patients with Advanced Solid
Tumors," was presented this morning at the 2004 American Society of
Clinical Oncology (ASCO) Annual Meeting in New Orleans, LA by
Marcel Verheji, MD, of the Netherlands Cancer Institute. This study
was conducted because it is anticipated that Perifosine will
provide synergistic effects when combined with established cancer
treatments such as radiotherapy, chemotherapy, tyrosine kinase
inhibitors and endocrine therapies. This study demonstrated that
Perifosine and radiotherapy can be safely administered together and
produced multiple complete and partial responses at all dosage
levels tested. This study was sponsored by our licensor, AEterna
Zentaris, Inc. (TSX: AEZ; Nasdaq: AEZS), which holds ex-North
American rights to the drug. A full press release on the data is
available on their website http://www.aeternazentaris.com/.
KRX-0401 (Perifosine) is also currently being evaluated as a single
agent in nine Phase II clinical trials in six tumor types being
conducted by the National Cancer Institute (NCI) in accordance with
a Collaborative Research and Development Agreement (CRADA). ABOUT
KERYX BIOPHARMACEUTICALS, INC. Keryx Biopharmaceuticals, Inc. 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 recently commenced its
U.S.-based Phase II/III clinical program. Additionally, Keryx is
developing three clinical-stage oncology compounds including
KRX-0401, a novel, oral, first-in-class AKT inhibitor in Phase II.
Keryx also has an active in-licensing and acquisition program
designed to identify and acquire clinical-stage drug candidates.
Keryx Biopharmaceuticals is headquartered in New York City.
Cautionary Statement Some of the statements included in this press
release, particularly those anticipating future financial
performance, timelines for the completion of the KRX-0401 clinical
trial programs and the release of data from these programs, size of
the programs, market size estimates for KRX-0401, 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: our ability to
successfully complete cost-effective clinical trials of KRX-101 and
KRX-0401; 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, 2003, and our quarterly report
on Form 10-Q for the quarter ended March 31, 2004. 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 http://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. KERYX CONTACT: Ron Bentsur Vice President - Finance
& Investor Relations Keryx Biopharmaceuticals, Inc. Tel:
212.531.5965 E-mail: DATASOURCE: Keryx Biopharmaceuticals, Inc.
CONTACT: Ron Bentsur, Vice President, Finance & Investor
Relations, Keryx Biopharmaceuticals, Inc., +1-212-531-5965, Web
site: http://www.keryx.com/ http://www.aeternazentaris.com/
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