Corporate | 11 August 2008 09:00
WILEX AG / Miscellaneous
Release 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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PRESS INFORMATION
WILEX starts patient recruitment in Phase II breast cancer trial with its
uPA inhibitor MESUPRON® (WX-671)
Munich, 11 August 2008 The Munich-based biopharmaceutical company WILEX AG
(ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) has
randomised the first patient in its second clinical Phase II trial with the
oral drug candidate MESUPRON® (WX-671). The drug will be given in
combination with the chemotherapeutic agent Capecitabine (Xeloda®, Hoffmann
La Roche AG, Suisse) to patients with HER2-receptor negative* metastatic
breast cancer for first line treatment.
The double blind two arm randomised Phase II trial will evaluate the
efficacy of the combination therapy in comparison to capecitabine
monotherapy. The study will treat 114 patients in approximately 40 centres
in six countries. Progression free survival is defined as a primary
endpoint of the trial. The study will also evaluate the overall survival
and the objective response rate. More details regarding the study design,
information about the participating centres and the inclusion criteria are
available for review on the company’s website www.wilex.com or
www.clinicaltrials.gov.
Dr. Paul Bevan, Head of R&D and Member of the Executive Management at WILEX
AG remarked: 'By starting the patient recruitment in this study our uPA
programme with the drug candidate MESUPRON® progressed as scheduled.'
The trials with WX-UK1 and MESUPRON® have been supported since 2003 by the
US Department of Defense (DOD; Award DAMD17-03-1-0634) in their Breast
Cancer Research Program (BCRP). The DOD hosted the '5th Era of Hope'
meeting in June this year where more than 1,600 researchers, oncologists
and breast cancer patients met to discuss the progress in research in this
field.
'MESUPRON®, together with three other projects out of 1,200 presented, was
selected for a separate press release by the DOD. From the Company’s
perspective this is a special distinction underlining our uPA inhibitor
programme', Dr. Paul Bevan added.
More information regarding WILEX’ uPA programme
WILEX has a late stage multi-product portfolio. In this portfolio MESUPRON®
is being developed as part of the Company’s urokinase-type Plasminogen
Activator programme (uPA programme).
The aim of MESUPRON® is to inhibit the uPA system, which plays a key role
in the growth, spread and metastasis of various malignant tumours. In 2007,
determining the uPA content 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 content 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 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.
The Company expects that drug candidates which emerge from the uPA
programme may be used for the treatment of patients with tumours such as
breast, pancreatic, ovarian, gastric and colon cancer.
WILEX successfully completed Phase I studies MESUPRON®. The compound is
found to be safe and well tolerated. MESUPRON® can be administered orally.
This facilitates the long-term treatment of patients. Therefore, the
Company decided to investigate the efficacy of MESUPRON® in two Phase II
trials. In addition to the trial starting now the Company conducts a Phase
II trial in which patients with pancreatic cancer are treated with
MESUPRON® in combination with the chemotherapeutic agent Gemcitabine
(Gemzar®, Eli Lilly and Company, USA). After a positive outcome from these
Phase II trials, the Company intends to test MESUPRON® in different types
of cancer.
* Breast tumours that are HER2 receptor negative have a reduced risk of
relapse and respond more positively to chemotherapy and anti-hormone
therapy than HER2 receptor positive tumours.
** Proteolytic factor: A factor which helps to degrade the surrounding
tissue
About WILEX
WILEX 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 and diagnostic agents with a low side effect
profile and targeted treatment of different types of cancer as well as for
early 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® and REDECTANE® are currently undergoing a Phase III registration
trial. The substance MESUPRON® is currently in a Phase II programme. Based
on this pipeline, WILEX's aim is to achieve profitability within a few
years through the consistent commercialisation of its products and in the
long term to finance its research and development programmes from its
operating business.
Website: http://www.wilex.com
ISIN DE0006614720 / WKN 661472 / Symbol WL6
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.
11.08.2008 Financial News transmitted by DGAP
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Language: English
Issuer: 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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