Ad-hoc | 29 November 2009 23:21
WILEX AG / Research Update
29.11.2009
Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted by
DGAP - a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
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- Not for distribution, publication or transmission in the USA, Canada,
Japan and Australia-
WILEX AG receives preliminary results of the phase III trial with the
diagnostic REDECTANE(R)
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(R) 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(R) 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(R) 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).
With respect to the ongoing capital increase with best effort rights issue,
the Executive Management Board and the Supervisory Board have approved an
extension of the subscription period by two additional days. The
subscription period now ends on 2 December 2009 instead of 30 November
2009. This should give shareholders the opportunity to consider the
earlier-than-expected results of the REDECT study for their investment
decision. The other conditions of the subscription offer remain unchanged
including the subscription price of EUR 4.10 fixed on 25 November 2009. The
respective addendum to the subscription offer will be published on the
internet under www.wilex.de and the electronic Federal Gazette.
Important notes
This ad-hoc 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
WILEX AG
Katja Arnold (CIRO)
Investor & Public Relations
Grillparzerstr. 10
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
Email: 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 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.
29.11.2009 Financial News distributed by DGAP. Media archive at www.dgap-medientreff.de and www.dgap.de
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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@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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