Heidelberg Pharma AG

Legal Proceedings Report • Feb 11, 2008

News Details

Corporate | 11 February 2008 14:52

WILEX AG: FDA issues Special Protocol Assessment (SPA) for pivotal Phase III trial with CA9-SCAN

WILEX AG / Miscellaneous

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The issuer / publisher is solely responsible for the content of this announcement.

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PRESS INFORMATION

FDA issues Special Protocol Assessment (SPA) for pivotal Phase III trial
with CA9-SCAN

Munich, 11 February 2008 – The Munich-based biopharmaceutical company WILEX
AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) has
received a special protocol assessment (SPA) for the Phase III registration
trial with its diagnostic product candidate CA9-SCAN from the US Food and
Drug Administration (FDA). With this SPA the FDA confirms that the
design and planned analysis of the clinical trial adequately address the
requirements for a regulatory submission for CA9-SCAN. The FDA is
considered to be bound by this protocol assessment as part of the approval
process.

WILEX will start patient recruitment in the second quarter of 2008 and will
conduct the study in accordance with the approved protocol. 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, commented: 'We are delighted with the SPA because it demonstrates
the positive communication we have had with the FDA. Assuming positive
results, we will be able to file for approval soon after the end of the
trial. We expect the SPA to significantly reduce the time for approval of
CA9-SCAN'.

About SPA

By applying for an SPA WILEX has followed the recommendation of the FDA
resulting from the pre-IND meeting in which the draft clinical protocol was
reviewed. Special protocol assessment (SPA) is an instrument of the FDA
whereby, if granted, the FDA evaluates a clinical protocol submitted by a
sponsor. The SPA documents that the FDA confirms that the design and
planned analysis of the clinical trial adequately address the requirements
for a regulatory submission for CA9-SCAN. The FDA is considered to be bound
by this protocol assessment as part of the approval process. The SPA can
significantly reduce development time since the design of the pivotal
protocol has been approved in advance.

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) / Computer Tomography (CT). 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 founded in 1997 by a
team of physicians and oncologists from the Technical University of Munich.
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. WILEX AG is listed at the Frankfurt Stock Exchange at the
Regulated Market / Prime Standard.

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
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.
11.02.2008 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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