Corporate | 18 December 2007 12:10
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.
----------------------------------------------------------------------
WILEX updates the status of the RENCAREX® Phase III-ARISER Study following
the positive interim analysis for futility
- Over 760 patients enrolled in the study so far; drop out rate of
approximately 3.9 % remains low
- Patient recruitment in Europe should be successfully completed within the
next 6 weeks
- Next milestone is the interim analysis for efficacy after 343 relapses
which is anticipated early 2009
Munich, 18 December 2007. The Munich-based biopharmaceutical company WILEX
AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard)
announces updated details of the Phase III ARISER study with its drug
candidate RENCAREX® after the positive interim analysis for futility.
RENCAREX® is being developed for the adjuvant therapy of clear cell renal
cell cancer, an indication for which there is currently no drug approved.
So far over 760 of the 856 patients planned have been enrolled. The drop
out rate at 3.9 % remains low. This again suggests that the treatment
regimen of weekly injections is acceptable and well tolerated. The
recruitment in Europe should be completed within the next six weeks.
Recruitment in North America will continue for a few months to maintain the
proportion of US patients planned.
To date a lower number of patients have relapsed than projected. After the
positive interim analysis for futility a new estimate was calculated as to
when the 343 relapses required for the next milestone would be reached.
Currently, this is expected early in 2009. The study protocol specifies an
interim analysis for efficacy of the antibody at this point which would be
the basis for filing for approval in the European Union. This interim
analysis will evaluate whether RENCAREX® shows a significant superiority
over placebo in disease-free survival time. WILEX will continue to
carefully monitor the relapse rate.
Dr. Paul Bevan, Head of Research and Development and member of the
executive management board of WILEX, commented: 'We are very pleased with
the progress of the Phase III RENCAREX® trial with patient recruitment in
Europa expected to be completed soon. The endpoints of the study are
dependent on patients’ relapse which we will continue to monitor
carefully'.
Invitation to a conference call:
WILEX will hold a public conference call on 18 December 2007 at 15:00 CET.
Dial-in number for the Conference Call (listen-only):
Germany: +49 (0) 69 – 25 499 300
UK: +44 (0) 207 – 108 6206
Please dial in 10 minutes before the beginning of the conference.
About the ARISER study
The international, multicentre, randomised trial, called ARISER (Adjuvant
Rencarex Immunotherapy trial to Study Efficacy in non-metastasized Renal
cell carcinoma), examines the efficacy of the antibody RENCAREX® in
comparison to placebo for the treatment of clear cell renal cell cancer
patients after complete or partial surgical removal of the affected kidney
in patients with no detectable metastases. This cancer belongs to one of
the particularly aggressive indications. RENCAREX® aims to inhibit these
malignant kidney tumours from further growth and recurrence and to help to
destroy cancer cells and thereby prolong the disease-free survival of
patients. The study is designed to detect a 35% improvement of disease-free
survival time in patients treated with RENCAREX® compared to patients
treated with placebo with a statistical significance of 1%.
About WILEX
WILEX is a biopharmaceutical Company based in Munich founded in 1997 by a
team of physicians and oncologists from the Technical University of Munich.
WILEX is focused on the development of new cancer therapies based on
antibodies and small molecules. The therapeutic approach of WILEX targets
the prevention of growth, spread and the metastasis of malignant tumours
and the destruction of malignant tumours in the body. The late stage
multi-product portfolio includes both drug and medicinal product candidates
as well as research candidates. Currently the following compounds are in
clinical development: WX-G250 (development name: RENCAREX®), WX-671, WX-UK1
and CA9-SCAN. The company’s strategy is to develop WILEX into a
commercially successful biopharmaceutical company with a broad portfolio of
new drugs and diagnostic products for the treatment of cancer. WILEX AG has
been listed in the Official Market Segment (Amtlicher Markt) / Prime
Standard of the Frankfurt Stock Exchange
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
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.
18.12.2007 Financial News transmitted by DGAP
----------------------------------------------------------------------
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
---------------------------------------------------------------------------