Corporate | 29 June 2007 09:14
WILEX AG / Miscellaneous
Release of a Corporate News, transmitted by DGAP - a company of EquityStory
AG.
The issuer / publisher is solely responsible for the content of this announcement.
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WILEX to follow FDA advice and apply for a special protocol assessment
(SPA) for CA9-SCAN
Munich, 29 June 2007 – The Munich-based biopharmaceutical company WILEX AG
(ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) is to apply
to the Food & Drug Administration (FDA) for a special protocol assessment
(SPA) for the registration trial for its medicinal product candidate
CA9-SCAN. This will be the second product candidate out of WILEX’ portfolio
to be tested in a Phase III registration trial. 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
which is expected to improve treatment planning for patients with renal
cancer.
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. Both the
protocol and Imaging Charter were recently submitted to the US authorities.
The clinical research organisation and trial centres have already been
chosen for this registration trial which will begin as soon as the Company
receives the SPA. WILEX AG has confirmed the schedule for the development
of CA9-SCAN; the submission of the IND later this year would allow filing
for approval in 2008 at the earliest, assuming positive results.
Dr. Paul Bevan, Head of R&D and Member of the Executive Management at WILEX
AG, pointed out: 'The strategic decision to request an SPA from the FDA
will enhance the quality and speed up the review process once the study is
completed. To the best of our knowledge, CA9-SCAN would represent the first
diagnostic radiopharmaceutical to be granted an SPA.'
About 'SPA'
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
WILEX’s late stage multi-product portfolio includes CA9-SCAN as 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
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.
Patients with suspected renal cancer will be enrolled in about ten centres
in the USA under the registration trial. They will be examined prior to
surgery using the CA9-SCAN imaging procedure.
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 since November 13, 2006.
ISIN DE0006614720 / WKN 661472 / Symbol WL6
DGAP 29.06.2007
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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
Indices:
Listed: Amtlicher Markt in Frankfurt (Prime Standard); Freiverkehr in
Berlin-Bremen, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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