Ad-hoc | 14 June 2012 21:14
WILEX AG / Key word(s): Study
14.06.2012 21:14
Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
by DGAP - a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
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Ad-hoc release pursuant to § 15 Wertpapierhandelsgesetz
(German Securities Trading Act)
MESUPRON(R) met its primary objective of demonstrating efficacy in the
proof of concept phase II breast cancer trial
Munich, Germany, 14 June 2012. WILEX AG (ISIN DE0006614720 / WL6 /
Frankfurt Stock Exchange) today published data from its Phase II trial with
its oral drug candidate MESUPRON(R) in first line treatment of patients
with HER2-receptor negative metastatic breast cancer.
The uPA inhibitor MESUPRON(R) (INN: Upamostat) was given in combination
with the chemotherapeutic agent Capecitabine (Xeloda(R), Hoffmann La Roche
AG, Switzerland). The double blind randomised Phase II trial evaluated the
efficacy and safety of MESUPRON(R) 200 mg oral once daily in combination
with Capecitabine compared to Capecitabine alone (control group). 132
patients in 20 centres in five countries (Belgium, Brazil, Germany, Israel,
US) were enrolled.
The primary objective of the study was to evaluate the efficacy of the
combination of MESUPRON(R) and Capecitabine compared to Capecitabine alone
by assessment of progression free survival (PFS). The study also evaluated
the objective response rate, overall survival and safety as well as
pharmacokinetics. Efficacy was evaluated by RECIST (Response Evaluation
Criteria on Solid Tumours) by independent central read using computed
tomography and bone scans.
In the total study population (intent to treat; ITT) MESUPRON(R) led to an
increase of median progression free survival from 7.5 months in the control
group to 8.3 months in the combination therapy. Capecitabine alone
demonstrated an objective tumour response rate of 9%. Co-administration of
200 mg MESUPRON(R) almost doubled the response rate to 17%. Overall
survival data have not matured yet as over 60% of patients were still alive
at the time of analysis. The combination therapy of MESUPRON(R) and
Capecitabine was safe and well tolerated. Pharmacokinetic analysis
demonstrated no drug-drug interactions between MESUPRON(R) and
Capecitabine.
Breast cancer is a heterogeneous disease. To test whether MESUPRON(R) also
shows efficacy in a more homogeneous patient population two subgroups were
evaluated which had sufficient numbers of patients to allow separate
analysis: In the subgroup of patients who were Caucasian (n=109) median PFS
improved from 7.5 months in the control group to 9.1 months in patients
treated with MESUPRON(R). In the subgroup of patients (n=95) who received
adjuvant chemotherapy following the primary diagnosis of breast cancer, PFS
improved from 4.3 months in the Capecitabine alone group to 8.3 months in
the MESUPRON(R) combination group.
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Information and Explaination of the Issuer to this News:
Further information in the press release.
Invitation to the conference call
WILEX will hold a conference call for media representatives, analysts and
investors in English on Monday, 18 June 2012, at 10:00 a.m. CET. Please
dial in ten minutes before the conference call using the following dial-in
numbers:
1. Germany: +49 69 71044 5598
2. UK: +44 20 3003 2666
3. USA: +1 212 999 6659
4. USA Freephone: +1 866 966 5335
You will be welcomed by an operator taking your name and company. The
presentation for the conference (in English) will be available for download
10 minutes before the presentation at the website www.wilex.com. A replay
of the conference will be available after the presentation on the website
http://www.wilex.de/IR/Presentations.php.
More information regarding WILEX' uPA programme are available in the press
release or on our website.
About WILEX AG
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused
on oncology, the Company has a broad portfolio of diagnostic and
therapeutic products for the specific detection and targeted treatment of
various types of cancer. WILEX's therapeutic product candidates are based
on antibodies (RENCAREX(R) in Phase III) and small molecules (MESUPRON(R)
in Phase II, WX-554 in Phase Ib/II and WX-037 in preclinical development).
In the field of diagnostics, REDECTANE(R) is an antibody-based, imaging in
vivo diagnostic agent that is currently in a Phase III programme. WILEX's
US subsidiary WILEX Inc. in Cambridge, MA, markets a portfolio of research
use only tests and in vitro diagnostic agents under the brand Oncogene
Science, which are used as companion diagnostics for clinical trials and
therapy monitoring. The wholly owned subsidiary Heidelberg Pharma GmbH
offers an attractive and highly promising antibody drug conjugate
technology platform and preclinical contract research services. The
business model of WILEX comprises research, technology, product development
and commercialisation. WILEX's customers and partners include leading
international pharmaceutical companies.
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
E-mail: 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
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.
14.06.2012 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English
Company: WILEX AG
Grillparzerstr. 10
81675 München
Germany
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 Announcement DGAP News-Service
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