Heidelberg Pharma AG

Regulatory Filings • May 19, 2008

News Details

Corporate | 19 May 2008 11:51

WILEX AG: Patient recruitment started in Phase III registration trial with CA9-SCAN

WILEX AG / Miscellaneous

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PRESS INFORMATION

Patient recruitment started in Phase III registration trial with CA9-SCAN

Munich, 19 May 2008 The Munich-based biopharmaceutical company WILEX AG
(ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) announced
today that it has recruited the first patients in its Phase III
registration trial with the diagnostic product candidate CA9-SCAN. This
marks the next important milestone in this project after the
Investigational New Drug (IND) approval in October 2007 and a special
protocol assessment (SPA) in February 2008.

WILEX will conduct the study in accordance with the approved protocol. The
FDA confirms with the SPA that the design and planned analysis of the
clinical trial adequately address the requirements for a regulatory
submission for CA9-SCAN. The FDA considers itself bound by this protocol
assessment as part of the approval process.

166 patients suspected of having kidney cancer will be enrolled in more
than 15 centres in the USA. Patients included are scheduled for complete or
partial surgical removal of the affected kidney. They will be imaged with
computer tomography (CT) and CA9-SCAN (positron emission tomography
(PET)-CT) prior to surgery to examine whether they have clear cell renal
cell carcinoma. The trial will evaluate whether imaging with CA9-SCAN can
improve the diagnosis in comparison to the current standard (CT alone).
CA9-SCAN could improve the planning of treatment and the post-operative
monitoring of renal tumour patients.

Patient recruitment and follow-up is expected to be completed by the end of
2008 with the data and report available three to six months later.
Dr. Paul Bevan, Head of R&D and Member of the Executive Management Board at
WILEX AG remarked: 'We are pleased to have commenced patient recruitment
and expect the trial to progress as scheduled. CA9-SCAN represents the
second product from WILEX developed in a Phase III registration trial.'

About CA9-SCAN
CA9-SCAN is one of two product candidates from WILEX’s late stage
multi-product portfolio which is in a Phase III registration trial.
CA9-SCAN is a radioactively labelled form of the antibody WX-G250. The
labelled antibody WX-G250 targets clear cell renal cell carcinoma and
accumulates in the tumour tissue. This accumulation can be visualised by
means of Positron Emission Tomography (PET). An earlier feasibility study
found that a positive result with CA9-SCAN was confirmed as clear cell
renal cell carcinoma in 100% of cases (positive predictive value). CA9-SCAN
could determine whether the patient had clear cell renal cell carcinoma
before surgery and the subsequent pathology. Therefore, CA9-SCAN could
improve treatment planning for patients suspected of having renal cancer.

About WILEX
WILEX is a biopharmaceutical Company based in Munich which is listed at the
Frankfurt Stock Exchange at the Regulated Market / Prime Standard. WILEX’s
mission is to develop drugs and diagnostic agents with a low side effect
profile and targeted treatment of different types of cancer as well as for
early detection of tumours. WILEX’s product candidates are based on
antibodies and small molecules. WILEX possesses an attractive pipeline
which includes both drug and diagnostic product candidates: The substances
RENCAREX® and CA9-SCAN are currently undergoing a Phase III registration
trial. The substance WX-671 is currently in a Phase II programme. Based on
this pipeline, WILEX’s aim is to achieve profitability within a few years
through the commercialisation of its products and in the long term to
finance its research and development programmes from its operating
business.

ISIN DE0006614720 / WKN 661472 / Symbole WL6

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
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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.
19.05.2008 Financial News transmitted by DGAP

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Language: English
Issuer: 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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