Corporate | 24 July 2008 09:26
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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Patient recruitment in Phase II trial with MESUPRON® (WX-671) in pancreatic
cancer patients successfully completed
Munich, 24 July 2008
Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 /
Frankfurt Stock Exchange / Prime Standard) announced today that it has
successfully completed patient recruitment in the clinical Phase II trial
with its oral drug candidate MESUPRON® (WX-671) in combination with the
chemotherapeutic agent Gemcitabine (Gemzar®, Eli Lilly and Company, USA) in
pancreatic cancer patients.
The trial is a randomised, open label three-arm Phase II-trial in patients
with locally advanced, inoperable, non-metastatic pancreatic cancer and
evaluates the anti-metastatic activity of the combination therapy. Patients
will continue to be treated to follow several parameters, including
progression free survival and time to first metastases. The study is
conducted in more than 30 centres with 90 patients in six European
countries.
Dr. Paul Bevan, Head of R&D and Member of the Executive Management at WILEX
AG remarked: 'Patient recruitment proceeded according to plan. We will
further monitor this study closely and we expect to have first preliminary
results about the efficacy of our uPA inhibitor available in 2008'.
More information regarding WILEX’ uPA programme
WILEX has a late stage multi-product portfolio. In this portfolio MESUPRON®
is being developed as part of the Company’s urokinase-type Plasminogen
Activator programme (uPA programme.
The aim of MESUPRON® is to inhibit the uPA system, which plays a key role
in the growth, spread and metastasis of various malignant tumours. In 2007,
determining the uPA content in a patient's primary tumour was incorporated
into the treatment guidelines of the American Society of Clinical Oncology
(ASCO). The guideline recommends that the uPA test is used in making the
prognosis for patients who are newly diagnosed with breast cancer that has
not affected lymph nodes in order to determine the appropriate treatment.
The uPA content enables doctors to predict the statistical likelihood of a
patient's survival. This was established on the basis of a meta analysis of
18 different European studies on the length of survival in relation to the
uPA content in the tumour involving a total of 8,377 patients. The
tumour-associated proteolytic factor[1]) uPA and its inhibitor PAI-1 are
the only tumour biological factors which have provided the highest level of
evidence (LOE1) in terms of their prognostic and predictive significance.
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 MESUPRON®. The compound
was found to be safe and well tolerated. MESUPRON® can be administered
orally. This facilitates the long-term treatment of patients. Therefore,
the Company decided to investigate the efficacy of MESUPRON® in two Phase
II trials. In addition to the pancreatic cancer trial the Company conducts
a Phase II trial in which patients with breast cancer are treated with
MESUPRON® in combination with the chemotherapeutic agent Capecitabine
(Xeloda®, Hoffmann La Roche AG, Suisse). After a positive outcome from
these Phase II trials, the Company intends to test MESUPRON® in different
types of cancer.
About WILEX
WILEX is a biopharmaceutical company based in Munich and is listed at the
Frankfurt Stock Exchange at the Regulated Market / Prime Standard. WILEX’s
mission is to develop drugs and diagnostic agents with a low side effect
profile and targeted treatment of different types of cancer as well as for
early detection of tumours. The Company's product candidates are based on
antibodies and small molecules. WILEX has an attractive product pipeline
which includes both drug and diagnostic candidates: The substances
RENCAREX® and REDECTANE® are currently undergoing a Phase III registration
trial. The substance MESUPRON® is currently in a Phase II programme. Based
on this pipeline, WILEX's aim is to achieve profitability within a few
years through the consistent commercialisation of its products and in the
long term to finance its research and development programmes from its
operating business.
Website: http://www.wilex.com
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 a
general discussion of the Company's strategy, plans or intentions. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors, which may cause our actual results of operations,
financial position, earnings, achievements, or industry results, to be
materially different from any future results, earnings 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.
24.07.2008 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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