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Ad-hoc-announcement
according to § 15 WpHG
WILEX´ second
product enters Phase III trial: IND approval from FDA for registration
trial with CA9-SCAN
Munich, 12 October 2007 – The Munich-based
biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock
Exchange / Prime
Standard) has received an Investigational New Drug (IND) approval
from the U.S. Food and Drug Administration (FDA) for a pivotal Phase
III trial with the medical product candidate CA9-SCAN.
190 patients suspected of having kidney cancer will be enrolled in
approximately 17 study centres in the USA. Patients with a renal mass
are scheduled for surgery to remove the affected kidney. These patients
will be imaged with CA9-SCAN prior to the surgery to determine whether
they have clear cell renal cell cancer. Results are expected to be
available at the end of 2008.
Contact
Juliane Giese
Manager Public Relations
WILEX AG
Grillparzerstr. 10
81675 München
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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