Corporate | 28 January 2008 11:33
WILEX AG / Miscellaneous
Release of a Corporate News, transmitted by DGAP - a company of EquityStory
AG.
The issuer / publisher is solely responsible for the content of this announcement.
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PRESS INFORMATION
WILEX receives US FDA approval (IND) for clinical Phase II trial with its
uPA inhibitor WX-671 in metastatic breast cancer
Munich, 28 January 2008 The Munich-based biopharmaceutical company WILEX AG
(ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) today
announced that the U.S. Food and Drug Administration (FDA) approved an
Investigational New Drug application (IND) for a clinical Phase II trial
with its drug candidate WX-671. The study will evaluate the efficacy of
WX-671 in combination with the chemotherapeutic agent capecitabine
(Xeloda®, Hoffmann La Roche AG, Basel, Suisse) in patients with
HER2-receptor negative metastatic breast cancer. The trial is supported
under the agreement number DAMD17-03-1-0634 by the US Department of Defense
Breast Cancer Research Program.
The study will be conducted in 114 patients in approximately 40 centres in
six countries. The Fox Chase Cancer Center (FCCC) in Philadelphia, a member
of the Eastern Cooperative Oncology Group (ECOG), will be the lead centre
in the US (the FCCC also participated in the Phase I trial with WX-UK1
reported recently). The study is a randomised, double blind Phase II trial
in patients with metastatic breast cancer. It will evaluate the efficacy of
combination therapy of WX-671 and capecitabine in comparison to
capecitabine monotherapy. Patients will receive daily doses of WX-671 for
three weeks in one of the two treatment groups, while the other treatment
group will receive placebo. All patients will receive daily capecitabine
concomitantly for the first 2 weeks of every cycle. The treatment cycles
will be continued until progression or unacceptable toxicity.
Progression free survival is defined as a primary endpoint of the trial.
The study will also evaluate the overall survival and the objective
response rate. The start of patient recruitment is expected in Q2 2008.
WILEX recently published the results of a Phase I clinical trial with
WX-UK1, the intravenously administered drug candidate, of which WX-671 is
the orally administered pro-drug. In this difficult to treat patient
population with advanced tumours and no standard efficacious treatment
options, combination therapy with WX-UK1 showed encouraging effects in
several patients including evidence of prolonged stable disease and in 3
patients, 2 of whom with metastatic breast cancer showed a partial
response.
'The effects that we have seen in the Phase I trial have supported our
decision to further develop the combination with our uPA inhibitor and
capecitabine', Paul Bevan, PhD, Head of R&D and Member of the Executive
Management Board at WILEX AG remarked. 'We will switch to the oral pro-drug
WX-671, which is converted into WX-UK1 in the body, because it is more
convenient for the patients getting oral therapy. This will facilitate the
long-term treatment of patients.'
About the uPA programme
WILEX’s late stage multi-product portfolio includes two drug candidates,
WX-UK1 and WX-671, which are being developed as part of the Company’s
urokinase-type Plasminogen Activator programme ('uPA programme'). In this
programme WILEX is developing various compounds that inhibit the uPA
system. The uPA system plays a key role in the growth, spread and
metastasis of various malignant tumours. The Company expects that drug
candidates which emerge from the uPA programme may be used for the
treatment of patients with tumours such as breast, pancreatic, ovarian,
gastric and colon cancer.
WILEX successfully completed Phase I studies with WX-UK1 and WX-671. The
compounds were found to be safe and well tolerated. WX-671 can be
administered orally and is converted into WX-UK1 in the body. This
facilitates the long-term treatment of patients. Therefore, the Company
decided to investigate the efficacy of WX-671 in two Phase II trials. In
addition to the trial starting now the Company conducts a Phase II trial in
which patients with pancreatic cancer are treated with WX-671 in
combination with the chemotherapeutic agent Gemcitabine (Gemzar®, Eli Lilly
and Company, Indianapolis, USA). After a positive outcome from these Phase
II trials, the Company intends to test WX-671 in different types of cancer.
About WILEX
WILEX is a biopharmaceutical Company based in Munich founded in 1997 by a
team of physicians and oncologists from the Technical University of Munich.
WILEX is focused on the development of new cancer therapies based on
antibodies and small molecules. The therapeutic approach of WILEX targets
the prevention of growth, spread and the metastasis of malignant tumours
and the destruction of malignant tumours in the body. The late stage
multi-product portfolio includes both drug and medical product candidates
ranging from research to late stage clinical development. Currently the
following compounds are in clinical development: WX-G250 (development name:
RENCAREX®), WX-671, WX-UK1 and CA9-SCAN. The company’s strategy is to
develop WILEX into a commercially successful biopharmaceutical company with
a broad portfolio of new drugs and medical products for the treatment of
cancer. WILEX AG is listed at the Frankfurt Stock Exchange on the Regulated
Market (Regulierter Markt) / Prime Standard.
ISIN DE0006614720 / WKN 661472 / Symbol WL6
This communication contains certain forward-looking statements, relating to
the Company's business, which can be identified by the use of
forward-looking terminology such as 'estimates', 'believes', 'expects',
'may', 'will' 'should' 'future', 'potential' or similar expressions or by
general discussion of strategy, plans or intentions of the Company. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors, which may cause our actual results of operations,
financial condition, performance, or achievements, or industry results, to
be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements. Given
these uncertainties, prospective investors and partners are cautioned not
to place undue reliance on such forward-looking statements. We disclaim any
obligation to update any such forward-looking statements to reflect future
events or developments.
Given these uncertainties, prospective investors and partners are cautioned
not to place undue reliance on such forward-looking statements. We disclaim
any obligation to update any such forward-looking statements to reflect
future events or developments.
28.01.2008 Financial News transmitted by DGAP
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Language: English
Issuer: WILEX AG
Grillparzerstr. 10
81675 München
Deutschland
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: info@wilex.com
Internet: www.wilex.com
ISIN: DE0006614720
WKN: 661472
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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