Heidelberg Pharma AG

Legal Proceedings Report • Oct 12, 2007

News Details

Corporate | 12 October 2007 10:04

WILEX´ second product enters Phase III trial: IND approval from FDA for registration trial with CA9-SCAN

WILEX AG / Miscellaneous

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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. CA9-SCAN is now the second product candidate of
the WILEX portfolio to enter a Phase III registration trial.

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. As previously announced, WILEX intends to
follow FDA` recommendation to conclude a special protocol assessment (SPA)
before initiating the trial. The clinical research organisation and trial
centres have already been chosen. Results are expected to be available at
the end of 2008.

Dr. Paul Bevan, Head of Research & Development and Member of the Executive
Management Board of WILEX AG comments: 'The IND approval from FDA signals
an important milestone in the development of CA9-SCAN. Furthermore, our
portfolio continues to mature as planned with the addition of a second
Phase lll product in pivotal clinical trials.'

About 'SPA'
By applying for a SPA WILEX is following the recommendation of the FDA
resulting from the pre-IND meeting in which the draft clinical protocol was
reviewed. Following this discussion, which took place in the first quarter
of 2007, the Company revised the trial protocol and drafted the Imaging
Charter which describes the evaluation procedure to be carried out by
independent experts. Special protocol assessment (SPA) is an instrument of
the FDA introduced in 2002 whereby, if granted, the FDA evaluates a
clinical protocol, submitted by a sponsor. The SPA documents the fact that
the FDA assumes, following the assessment of the design and planned
analysis of the clinical trial, that these adequately and appropriately
address the requirements of the application submission. The FDA is then
bound to this protocol assessment as part of the application process. In
general, 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 an investigational imaging diagnostic based on an antibody and
is being developed for the pre-surgical diagnosis of clear cell Renal Cell
Cancer. CA9-SCAN is the 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 con-firmed
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 significantly improve and simplify treatment planning for
patients suspected of having renal cancer. The company is not aware of any
other available imaging technique with comparable specificity and
sensitivity.

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 is focused on the development of new cancer therapies based on
antibodies and small molecules. The therapeutic approach of WILEX targets
the prevention of growth, spread and the metastasis of malignant tumours
and the destruction of malignant tumours in the body. The late stage
multi-product portfolio includes both drug and medicinal product candidates
ranging from research to late stage clinical development. Currently the
following compounds are in clinical development: WX-G250 (development name:
RENCAREX®), WX-671, WX-UK1 and CA9-SCAN. The company’s strategy is to
develop WILEX into a commercially successful biopharmaceutical company with
a broad portfolio of new drugs and medical products for the treatment of
cancer. WILEX AG is listed at the Frankfurt Stock Exchange on the Official
Market Segment (Amtlicher Markt) / Prime Standard.

ISIN DE0006614720 / WKN 661472 / Symbole WL6
12.10.2007 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: Amtlicher Markt in Frankfurt (Prime Standard); Freiverkehr in
Berlin, Düsseldorf, München, Stuttgart

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