WILEX AG / Research Update
18.05.2010 12:19
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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REDECTANE(R) meets both endpoints specificity and sensitivity with
superiority over CT in its pivotal Phase III trial
Munich, 18 May 2010. WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock
Exchange) announced today that the final results of the pivotal phase III
registration trial REDECT have been received. The results of the study
demonstrate that PET/CT with REDECTANE(R) lead to a significantly improved
diagnosis in comparison to CT alone.
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 contrast to the preliminary data published in November 2009, the
endpoint sensitivity, the correct diagnosis that clear cell renal cell
cancer is present, was reached with statistical significance (p value, p)
(pâ¤0.016) compared to CT. The study endpoint specificity, the correct
diagnosis that clear cell renal cell cancer is not present, was confirmed
with a highly statistical significance (p<0.001). To rule out that the
superiority of REDECTANE(R) resulted from the poor performance of CT, the
endpoints of REDECTANE(R) were also compared to an arbitrary value of 75%
for specificity and sensitivity as defined in the study protocol.
REDECTANE(R) achieved sensitivity of 86% (pâ¤0.002) and specificity of 87%
(p=0.057). Based on these results, WILEX plans to submit REDECTANE(R) for
approval by the US Food and Drug Administration (FDA) at the end of 2010.
Further information will be published in a press release.
Contact
WILEX AG
Katja Arnold (CIRO)
Corporate Communications
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
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.
18.05.2010 12:19 Ad hoc announcement, Financial News and Media Release distributed by DGAP. Medienarchiv at |[![CDATA[|[a href="http://www.dgap-medientreff.de"|]www.dgap-medientreff.de|[/a|]]]|] and |[![CDATA[|[a href="http://www.dgap.de"|]www.dgap.de|[/a|]]]|]
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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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DGAP-Adhoc: WILEX AG: REDECTANE(R) meets both endpoints specificity and sensitivity with
| Source: EQS Group AG