DGAP-News: WILEX AG: Patient recruitment in Phase II breast cancer trial with MESUPRON(R) successfully completed
(firmenpresse) - DGAP-News: WILEX AG / Key word(s): Research Update
WILEX AG: Patient recruitment in Phase II breast cancer trial with
MESUPRON(R) successfully completed
05.05.2011 / 07:15
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PRESS INFORMATION
Patient recruitment in Phase II breast cancer trial with MESUPRON(R)
successfully completed
Munich, Germany, 5 May 2011. 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(R) in first line treatment of patients with
HER2-receptor negative ) metastatic breast cancer.
The uPA inhibitor MESUPRON(R) is given in combination with the
chemotherapeutic agent Capecitabine (Xeloda(R), Hoffmann La Roche AG,
Switzerland). The double blind two arm randomised Phase II trial will
evaluate the efficacy and safety of the combination therapy in comparison
to capecitabine monotherapy. In the study 132 patients in 20 centres in
five countries (Belgium, Brazil, Germany, Israel, US) were enrolled.
Progression free survival is defined as the primary endpoint of the trial.
The study will also evaluate the objective response rate, the overall
survival and safety as well as pharmacokinetics.
Dr. Paul Bevan, Head of R&D and Member of the Executive Management at WILEX
AG remarked: 'We are pleased that we were able to complete patient
recruitment in a competitive indication like breast cancer and we
anticipate the data being available during 2012. After the impressive proof
of concept data of MESUPRON(R) in pancreatic cancer, we eagerly await the
results for efficacy of our uPA inhibitor in this second indication'.
This trial is supported by the US Department of Defense in their Breast
Cancer Research Program.
More information regarding WILEX' uPA programme
With MESUPRON(R), WILEX has developed a drug candidate to inhibit the
Urokinase Plasminogen Activator (uPA) system. The uPA system has been shown
to play a key role in tumour cell invasion and metastasis, as well as in
primary tumour growth, of various solid tumours including breast, ovarian,
gastric, colon and pancreatic cancer. The uPA programme of WILEX can be
considered as a promising new non-cytotoxic approach in cancer therapy to
specifically block tumour metastasis in solid cancers.
In 2007, determining the uPA level 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 level 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 level 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 has developed the orally available drug candidate MESUPRON(R), as a
pro-drug of WX-UK1. WX-UK1 and MESUPRON(R) are the first inhibitors of uPA
in clinical oncology trials worldwide. Eight different clinical Phase I,
Phase Ia and Ib trials with WX-UK1 and MESUPRON(R) in several indications
with more than 150 patients were successfully conducted. Furthermore,
MESUPRON(R) was tested very effective in a Phase II efficacy trial with 95
pancreatic cancer patients. MESUPRON(R) was found to be safe and well
tolerated and can be administered orally. This facilitates the long-term
treatment of patients.
About WILEX AG
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused
on oncology, the company has a broad portfolio of near-to-market
therapeutic and diagnostic products for the targeted treatment and specific
detection of various types of cancer. The company's therapeutic product
candidates are based on antibodies and small molecules. Through its US
subsidiary WILEX Inc. in Cambridge, MA, USA, WILEX markets a portfolio of
oncological biomarker tests under the brand Oncogene Science. These
biomarkers can be used as companion diagnostics in clinical trials and for
therapy monitoring. Furthermore, the acquisition of Heidelberg Pharma AG,
Ladenburg, Germany, is set to give WILEX access to an attractive and highly
promising antibody drug conjugate technology platform and a pre-clinical
service business. The business model of WILEX covers the entire value chain
in the oncology market and comprises research, technology, development
collaboration as well as sales and marketing. WILEX's customers and
partners include leading international pharmaceutical companies.
Website: http://www.WILEX.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6
Contact
WILEX AG
Katja Arnold (CIRO)
Grillparzerstr. 10
81675 Munich, Germany
Phone: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
Email: investors [at] 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
End of Corporate News
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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(at)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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122972 05.05.2011
Datum: 05.05.2011 - 07:15 Uhr
Sprache: Deutsch
News-ID 33966
Anzahl Zeichen: 0
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Kategorie:
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