Heidelberg Pharma AG

Regulatory Filings • Sep 1, 2009

News Details

Corporate | 1 September 2009 16:51

WILEX AG: Patient recruitment in Phase III registration trial with REDECTANE(R)

WILEX AG / Research Update

01.09.2009

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Munich, 1 September 2009. The Munich-based biopharmaceutical company WILEX
AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) today
announced that it has successfully completed patient recruitment in the
Phase III trial with its diagnostic candidate REDECTANE(R).

A total of 225 patients with suspected renal cancer have been enrolled in
the study. They are examined prior to surgery by computer tomography (CT)
and by positron emission tomography (PET/CT) scan using the imaging agent
REDECTANE(R) to determine if they have a clear cell renal cell carcinoma.
The trial examines whether using REDECTANE(R) as the imaging agent in
conjunction with PET/CT can improve the diagnosis compared to CT alone,
today's current diagnostic standard. The REDECT trial is being conducted in
14 centres in the US.

Dr. Paul Bevan, Head of Research and Development and Member of the
Executive Management Board at WILEX, said: 'We are pleased to have
successfully completed patient recruitment in the Phase III registration
trial with REDECTANE(R). We have reached an important milestone and are now
eagerly awaiting the results'.

Subsequently, three radiologists and three specialists in nuclear medicine
will perform independent analyses of all patients' CTs and PET/CTs to
determine whether or not clear cell renal cell cancer is present. The
number of radiologists and nuclear medicine specialists was defined in the
Special Protocol Assessment (SPA) in order to avoid potential deadlock.
Histological examination of the surgically removed tumours will be
performed at the same time in order to evaluate the accuracy of the
analyses by the radiologists and nuclear medicine specialists. The data
analysis will take approximately three to six months. Preliminary data are
expected to be available by year end.

About the REDECT trial
REDECTANE(R), the iodine 124-radioactively labelled form of the antibody
WX-G250, binds like WILEX's RENCAREX(R) therapeutic antibody with a high
affinity to the tumour specific antigen CA IX expressed in clear cell renal
cell cancer. The labelled antibody accumulates in the tumour tissue and can
be visualised by means of Positron Emission Tomography (PET). Additional
information provided by computer tomography (CT) can be used to localise
accumulation of the antibody. REDECTANE(R) could determine whether the
patient had clear cell renal cell carcinoma before surgery and the
subsequent pathology. Therefore, REDECTANE(R) may significantly improve and
simplify treatment planning for patients suspected of having renal cancer
and possibly avoid a surgery of the kidney.

About WILEX AG:
WILEX AG is a biopharmaceutical company based in Munich and is listed at
the Frankfurt Stock Exchange at the Regulated Market / Prime Standard.
WILEX's mission is to develop drugs with a low side effect profile and
targeted treatment of different types of cancer as well as diagnostic
agents for specific detection of tumours. The Company's product candidates
are based on antibodies and small molecules. WILEX has an attractive
product pipeline which includes both drug and diagnostic candidates: The
substances RENCAREX(R) and REDECTANE(R) are currently undergoing a Phase
III registration trial. MESUPRON(R) is in Phase II trials in two
indications. WILEX acquired the MEK inhibitor WX-554 and the PI3K inhibitor
WX-037 as well as three antibody programmes under the terms of the
strategic partnership with UCB. An application for approval of a Phase I
trial has been filed for WX-554. The other four oncology programmes are
currently still in preclinical development. WILEX aims within a few years
to be able to finance its research and development programmes from its
operating cash flow.
Website: http://www.WILEX.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6

Contact
WILEX AG
Investor & Public Relations
Katja Arnold (CIRO)
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

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.

01.09.2009 Financial News transmitted by DGAP

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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

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