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WILEX
updates the status of the RENCAREX® Phase III-ARISER Study following
the positive interim analysis for futility
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Over
760 patients enrolled in the study so far; drop out rate of approximately
3.9 % remains low
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Patient recruitment in Europe
should be successfully completed within the next 6 weeks
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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
Contact
Juliane Giese
Manager Public Relations
WILEX AG
Grillparzerstr. 10
81675 Munich
Germany
Tel.: +49 (0)89-41 31 38-29
Fax: +49 (0)89-41 31 38-99
email: investors@wilex.com
Website: http://www.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 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.
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