WILEX AG receives preliminary results of the phase III trial with
the diagnostic REDECTANE®
Munich, 29 November 2009
- The biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt
Stock Exchange / Prime Standard) was informed by the external
clinical research organisation (CRO) that the results of the preliminary
data of the phase III trial with REDECTANE® expected at the
end of December have now been completed earlier than anticipated.
The aim of the Phase III-REDECT
study was to determine whether the combination of REDECTANE® with
positron emission tomography (PET) and computer tomography (CT)
versus the standard use of CT
alone could improve the diagnosis of renal masses. Sensitivity
and specificity were the defined endpoints of the study. In order
to
avoid unnecessary surgery of renal masses in future a diagnostic
agent should predict that clear cell renal cell cancer is not
present (specificity).
The results of the study demonstrate that PET/CT with REDECTANE® lead
to an improved diagnosis in comparison to CT. The study endpoint
specificity, the correct diagnosis that clear cell renal cell cancer
is not present, was achieved with a highly statistical value (p
value, p) (p<0.001). The second endpoint, the correct diagnosis
of clear cell renal cell cancer (sensitivity), just failed to achieve
statistical significance (p=0.052 instead of p<0.050). CT performed
better with respect to sensitivity in the study than expected and
than generally observed in clinical practise. The final patient
data is still to be analysed. Small changes can significantly impact
the statistical results.
WILEX expects the final results in the first quarter 2010 and
plans to discuss these with external experts and to consult
the process
going forward with the US Food and Drug Administration (FDA).
Dr. Paul Bevan, Head of R&D and member of the executive management
board commented: „The preliminary data support our hypothesis
that PET/CT with REDECTANE® is superior to CT alone in the diagnosis
of clear cell renal cell cancer. We are especially surprised at
the superiority of REDECTANE® to CT in the diagnosis that clear
cell renal cell cancer is not present. This could avoid unnecessary
surgery of renal masses in future“.
Invitation to a conference call
On 30 November 2009, WILEX will hold a conference call for
media representatives, analysts and investors in English
at 3:00 p.m.
CET. Please dial in ten minutes before the conference call
using the following dial-in numbers:
1. Germany: +49 (0)89 2040 3812
2. UK: +44 (0)207 0980 693
3. USA: +1 703 621 9129
When asked, please enter the PIN code 400404# and clearly
state your name and company. The presentation for the
conference (in
English) will be available for download at www.wilex.com from 2:30 p.m. CET.
Important notes
This press release does not constitute either an offer to sell or
an invitation to buy securities. In particular, this document
does not constitute an offer to sell securities or a solicitation
of an offer to buy securities in the United States of America.
The shares of WILEX AG (the "Shares") may not be offered
or sold in the United States of America or to or for the account
or benefit of "U.S. persons" (as defined in Regulation
S under the U.S. Securities Act of 1933, as amended (the "Securities
Act")), unless they have been registered or are exempt from
registration under the Securities Act. The Shares have not been
and will not be registered under the Securities Act. There will
be no public offer of Shares in the United States of America.
Contact
Katja Arnold (CIRO)
WILEX AG
Grillparzerstr. 10
81675 Munich
Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
E-Mail: investors@wilex.com
Additional media contacts for Europe
MC Services AG
Raimund Gabriel
Tel.: +49 (0)89 210 228 0
E-Mail: raimund.gabriel@mc-services.eu
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
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strategy, plans or intentions. Such forward-looking statements involve
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our actual results of operations, financial position, earnings,
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industry results, to be materially different from any future results,
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partners are cautioned not to place undue reliance on such forward-looking
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We disclaim any obligation to update any such forward-looking statements
to reflect future events or developments.
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