Corporate | 3 May 2010 08:15
WILEX AG / Research Update
03.05.2010 08:15
Dissemination 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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Final Phase II data of MESUPRON(R) confirm impressive increase in overall
survival of patients with pancreatic cancer
Munich, Germany, 3 May 2010. The biopharmaceutical company WILEX AG (ISIN
DE0006614720 /Frankfurt Stock Exchange/Prime Standard) today announced that
the clinical Phase II combination trial with the oral drug candidate
MESUPRON(R) in pancreatic cancer patients has been completed successfully.
Final analysis confirms preliminary data published in September 2009, for
example with regard to improvement in tumour response and increase in
overall survival.
The results will be published at the annual meeting of the American Society
of Clinical Oncology (ASCO), which will take place from June 4 to 8, 2010
in Chicago, USA. ASCO is the most important worldwide clinical conference
for oncology experts.
Prof Volker Heinemann, Medical Centre Grosshadern, University Munich, and
Principal Investigator, said: 'The results regarding tumour response and
overall survival are impressive and signify important progress in the
treatment of cancer patients with a urgently needed, innovative and well
tolerated therapeutic approach. Doctors and patients eagerly await further
developments with MESUPRON(R).'
Information regarding MESUPRON(R) and the uPA programme
The aim of MESUPRON(R) is to inhibit the Urokinase Plasminogen Activator
enzyme system (uPA), which plays a key role in the growth and spread of
various malignant tumours. 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 more than
8,300 patients. The tumour-associated proteolytic factor 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.
MESUPRON(R) is the first uPA inhibitor worldwide in clinical development
and which has shown positive activity in cancer patients in a Phase II
trial. MESUPRON(R) could have the potential to treat cancer like a chronic
disease in a long-term therapy with low side effects.
Information on the trial
In the completed Phase II trial, patients with locally advanced,
inoperable, non-metastatic pancreatic cancer were treated with MESUPRON(R)
together with the chemotherapeutic Gemcitabine (Gemzar(R), Eli Lilly and
Company, USA). The study is a randomised, open label, three-arm trial.
Patients were administered either Gemcitabine alone or in combination with
a daily oral dose of 200 mg or 400 mg MESUPRON(R) respectively until
progression. As previously demonstrated in the eight completed Phase I
trials, MESUPRON(R) proved to be safe and well tolerated.
In addition to the pancreatic cancer trial the Company is conducting a
Phase II trial in which HER2 receptor negative breast cancer patients are
treated with MESUPRON(R) in combination with the chemotherapeutic agent
Capecitabine (Xeloda(R), Hoffmann La Roche AG, Switzerland).
About WILEX AG
WILEX AG 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 with a low side effect profile and
targeted treatment of different types of cancer as well as diagnostic
agents for specific 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
candidates REDECTANE(R) and RENCAREX(R) are undergoing Phase III
registration trials. MESUPRON(R) is in Phase II trials in two indications.
The MEK inhibitor WX-554 is in a Phase I trial, and the other four oncology
projects (PI3K inhibitor WX-037 and three antibody programmes) are in
preclinical development. WILEX aims within a few years to be able to
finance its research and development programmes from its operating cash
flow. Website: http://www.WILEX.com, ISIN DE0006614720 / WKN 661472 /
Symbol WL6
Contact
WILEX AG
Corporate Communications
Katja Arnold (CIRO)
Grillparzerstr. 10
81675 Munich
Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
Email: investors@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.
03.05.2010 Ad hoc announcement, Financial News and Media Release distributed by DGAP.
Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English
Company: 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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