Corporate | 29 September 2009 17:12
WILEX AG / Research Update
29.09.2009
Dissemination of a Corporate News, transmitted by
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- MESUPRON(R) in combination with Gemcitabine shows clear improvement in
tumour response as well as median survival and one year survival
Munich, 29 September 2009. The Munich-based biopharmaceutical company WILEX
AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) today
announced preliminary data from the clinical Phase II trial with the oral
drug candidate MESUPRON(R) in combination with the chemotherapeutic agent
Gemcitabine (Gemzar(R), Eli Lilly and Company, USA) in pancreatic cancer
patients.
Prof Volker Heinemann, Medical Centre Grosshadern, University Munich,
Principal Investigator, summarised the independent analysis of the data:
'The current data demonstrate an impressive effect of MESUPRON(R) and raise
the prospect with patients and doctors of a safe, well tolerated and
innovative therapy.'
Patients with locally advanced, inoperable, non-metastatic pancreatic
cancer have been treated with combination therapy in the study since June
2007. The study is a randomised, open label, three-arm Phase II trial.
Patients are administered either Gemzar(R) alone or in combination with a
daily oral dose of 200 mg or 400 mg MESUPRON(R) respectively until
progression. The study is being conducted in more than 30 centres in six
European countries. The last of the 95 patients was enrolled in the trial
in July 2008. At present five patients remain on treatment with treatment
cycles currently of up to 21 months. The therapy has proven to be safe and
well tolerated.
Gemzar(R) alone demonstrated a tumour response rate of 9.7%.
Co-administration of 200 mg MESUPRON(R) led to an increase to 22.6% and to
33.3% with 400 mg MESUPRON(R). One year survival with Gemzar(R) alone was
37%. This increased to 45% with 200 mg MESUPRON(R) and to 53% with 400 mg
MESUPRON(R). The median survival of the patients improved by 30% from 10.2
months with Gemzar(R) to 13.5 months in combination with 400mg MESUPRON(R).
The data, which were discussed with the Medical Advisory Board, are
preliminary as only 59 of the patients enrolled in the trial have died; 72
deaths are required for the final analysis.
Dr. Paul Bevan, Head of R&D and Member of the Executive Management Board of
WILEX commented: 'The aim of this proof-of-concept study is to demonstrate
for the first time activity of MESUPRON(R) in patients. These encouraging
results demonstrate that the inhibition of the uPA system may represent an
innovative and promising therapeutic approach for the treatment of cancer
patients.'
Invitation to the conference call:
On 30 September 2009, WILEX will hold a conference call for media
representatives, analysts and investors in English at 3:00 p.m. CET. Please
dial in ten minutes before the conference call using the following dial-in
numbers:
1. Germany: +49 (0)89 2040 3812
2. UK: +44 (0)207 0980 693
3. USA: +1 703 621 9129
When asked, please enter the PIN code 400404# and clearly state your name
and company.
Further 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 8,377
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.
WILEX successfully completed several Phase I studies with MESUPRON(R). The
compound was found to be safe and well tolerated. MESUPRON(R) can be
administered orally. This facilitates the long-term treatment of patients.
Therefore, the Company decided to investigate the efficacy of MESUPRON(R)
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(R) in combination with the chemotherapeutic agent
Capecitabine (Xeloda(R), Hoffmann La Roche AG, Suisse). WILEX expects that
following a positive outcome from these Phase II trials MESUPRON(R) can be
tested in other indications such as ovarian, gastric and colon cancer.
About WILEX:
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
substances RENCAREX(R) and REDECTANE(R) are currently undergoing a Phase
III registration trial. MESUPRON(R) is in Phase II trials in two
indications. WILEX acquired the MEK inhibitor WX-554 and the PI3K inhibitor
WX-037 as well as three antibody programmes under the terms of the
strategic partnership with UCB. An application for approval of a Phase I
trial has been filed for WX-554. The other four oncological programmes are
currently still 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
Grillparzerstr. 10
81675 Munich, Germany
Investor & Public Relations
Katja Arnold (CIRO)
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.
29.09.2009 Financial News transmitted by DGAP
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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
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