WILEX AG / Research Update
07.06.2010 08:06
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.
---------------------------------------------------------------------------
WILEX presents at ASCO positive final phase II data of MESUPRON(R) in
pancreatic cancer
- Tumour response rate more than doubled
- One year progression free survival rate improved by 66%
- One year overall survival rate increased by 49%
- Median overall survival in months improved by 26%
Munich, Germany / Chicago, USA, 7 June 2010. WILEX AG (ISIN DE0006614720 /
WL6 / Frankfurt Stock Exchange) presented at ASCO final 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.
Dr. Paul Bevan, Head of R&D and Member of the Executive Management Board of
WILEX commented: 'MESUPRON(R) is the first small molecule kinase inhibitor
blocking the uPA system demonstrating an impressive therapeutic effect in
the proof-of-concept pancreatic cancer study. Because the uPA system has
been implicated in a range of solid tumours, MESUPRON(R) could well find
application in a variety of indications and could have the potential to
treat cancer like a chronic disease with long-term therapy and low side
effects. The data are ground-breaking and very encouraging for the further
development of MESUPRON(R).'
In the study 95 patients with locally advanced, inoperable, non-metastatic
pancreatic cancer were treated with combination therapy. The study is a
randomised, open label, three-arm Phase II 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. The
therapy has proven to be safe and well tolerated.
Gemcitabine alone demonstrated a tumour response rate of 15.4%.
Co-administration of 200 mg MESUPRON(R) led to an increase to 21.4% and to
35.5% with 400 mg MESUPRON(R).
Progression free survival (PFS) improved by 66%. In the group receiving
Gemcitabine alone 16.2% of patients did not progress at 12 months as
determined by computer tomography. Co-administration of 200 mg MESUPRON(R)
improved PFS to 22.5% and to 26.9% with 400 mg MESUPRON(R).
One year survival increased by 49%. With Gemcitabine alone it was 33.9%.
This increased to 40.7% with 200 mg MESUPRON(R) and to 50.6% with 400 mg
MESUPRON(R). The median survival of the patients improved by 26% from 9.9
months with Gemcitabine alone to 12.5 months in combination with 400 mg
MESUPRON(R).
Invitation to the conference call
WILEX will hold a conference call for media representatives, analysts and
investors in English on 07 June 2010, at 4:00 p.m. CET / 9 a.m. CDT. Please
dial in ten minutes before the conference call using the following dial-in
numbers:
1. Germany: +49 (0) 69 6677 75756
2. UK: +44 (0) 2030032666
3. USA: +1 212 999 6659
You will be welcomed by an operator taking your name and company. The
presentation for the conference (in English) will be available for download
at 10:00 a.m. CET 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.
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.
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. 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. 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
Katja Arnold (CIRO)
Corporate Communications
WILEX AG
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.
07.06.2010 08:06 Ad hoc announcement, Financial News and Media Release distributed by DGAP. Medienarchiv at |[![CDATA[|[a href="http://www.dgap-medientreff.de"|]www.dgap-medientreff.de|[/a|]]]|] and |[![CDATA[|[a href="http://www.dgap.de"|]www.dgap.de|[/a|]]]|]
---------------------------------------------------------------------------
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
---------------------------------------------------------------------------
DGAP-News: WILEX presents at ASCO positive final phase II data of MESUPRON(R) in pancreatic cancer
| Source: EQS Group AG