WILEX AG / Research Update
18.05.2010 12:25
Dissemination of a Corporate News, transmitted by
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REDECTANE(R) meets both endpoints specificity and sensitivity with
superiority over CT in its pivotal Phase III trial
Munich, Germany, and Louvain-la-Neuve, Belgium, 18 May 2010. WILEX AG
(ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange) and IBA (Ion Beam
Applications SA: Reuters IBAB.BR and Bloomberg IBAB.BB), announced today
that the final results of the pivotal phase III registration trial REDECT
have been received. The results of the study demonstrate that PET/CT with
REDECTANE(R) lead to a significantly improved diagnosis in comparison to CT
alone.
The aim of the Phase III-REDECT study was to determine whether the
combination of REDECTANE(R) with positron emission tomography (PET) and
computer tomography (CT) versus the standard use of CT alone could improve
the diagnosis of renal masses. Sensitivity and specificity were the defined
endpoints of the study.
In contrast to the preliminary data published in November 2009, the
endpoint sensitivity, the correct diagnosis that clear cell renal cell
cancer is present, was reached with statistical significance (p value, p)
(pâ¤0.016) compared to CT. The study endpoint specificity, the correct
diagnosis that clear cell renal cell cancer is not present, was confirmed
with a highly statistical significance (p<0.001). To rule out that the
superiority of REDECTANE(R) resulted from the poor performance of CT, the
endpoints of REDECTANE(R) were also compared to an arbitrary value of 75%
for specificity and sensitivity as defined in the study protocol.
REDECTANE(R) achieved sensitivity of 86% (pâ¤0.002) and specificity of 87%
(p=0.057). Based on these results, WILEX plans to submit REDECTANE(R) for
approval by the US Food and Drug Administration (FDA) at the end of 2010.
Prof Olaf G. Wilhelm, Chief Executive Officer of WILEX, commented: 'We are
very delighted about the strong and robust final data demonstrating that
PET/CT with REDECTANE(R) is highly superior to CT alone in the diagnosis of
clear cell renal cell cancer. This is a decisive milestone for WILEX; we
plan to submit REDECTANE(R) for approval and, together with our partner
IBA, to bring our first product to market'.
'We are convinced that REDECTANE(R) will be a leader in our PET product
portfolio. This is an additional step towards our strategy to make
available a range of innovative radiopharmaceuticals to the medical
community', said Pierre Mottet, Chief Executive Officer of IBA.
The trial results will be presented at the annual meeting of the American
Urology Association (AUA), on the 1st June, 2010 in San Francisco, USA.
Invitation to the conference call
WILEX will hold a conference call for media representatives, analysts and
investors in English on 18 May 2010, at 4:00 p.m. CET. Please dial in ten
minutes before the conference call using the following dial-in numbers:
1. Germany: +49 (0) 69 6677 75756
2. UK: +44 (0) 2030032666
3. USA: +1 212 999 6659
4. Belgium: +32 (0) 2 789 8603
You will be welcomed by an operator taking your name and company. The
presentation for the conference (in English) will be available for download
at 3:30 p.m. CET at the website. A replay of the conference will be
available after the presentation on the website
http://www.wilex.de/IR/Presentations.php.
About the REDECT trial
The Phase III registration trial REDECT started in 2008. In total 226
patients suspected of having kidney cancer were enrolled in more than 14
centres in the USA. Patients included were scheduled for complete or
partial surgical removal of the affected kidney. They were imaged with
computer tomography (CT) and REDECTANE(R) (PET/CT) prior to surgery to
examine whether they have clear cell renal cell carcinoma. The trial has
evaluated that imaging with REDECTANE(R) can improve the diagnosis in
comparison to the current standard (CT alone). In order to avoid
unnecessary surgery of renal masses in future a diagnostic agent should
predict that clear cell renal cell cancer is not present (specificity).
WILEX has received a special protocol assessment (SPA) from the US Food and
Drug Administration (FDA) for this Phase III registration trial. 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
REDECTANE(R). The FDA is considered to be bound by this protocol assessment
as part of the approval process.
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
candidates REDECTANE(R) and RENCAREX(R) are undergoing Phase III
registration trials. MESUPRON(R) is in Phase II trials in two indications.
The MEK inhibitor WX-554 is in a Phase I trial, and the other four oncology
projects (PI3K inhibitor WX-037 and three antibody programmes) are 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
About IBA
IBA develops and markets leading edge technologies, pharmaceuticals and
tailor-made solutions for healthcare with a focus on cancer diagnosis and
therapy. Leveraging on its scientific expertise, IBA is also active in the
field of industrial sterilization and ionization. Listed on the
pan-European stock exchange EURONEXT, IBA is included in the BelMid Index.
(IBA: Reuters IBAB.BR and Bloomberg IBAB.BB). Website:
www.iba-worldwide.com
Contact WILEX
Katja Arnold (CIRO)
Corporate Communications
Grillparzerstr. 10
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
Email: investors@wilex.com
Contact IBA
Thomas Ralet
VP Corporate Communication
Tel.: +32 10 47 58 90
Email: InvestorRelations@iba-group.com
Additional media contacts for Europe
MC Services AG
Raimund Gabriel
Tel.: +49 (0)89 210 228 0
Email: raimund.gabriel@mc-services.eu
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.
18.05.2010 12:25 Ad hoc announcement, Financial News and Media Release distributed by DGAP. Medienarchiv at |[![CDATA[|[a href="http://www.dgap-medientreff.de"|]www.dgap-medientreff.de|[/a|]]]|] and |[![CDATA[|[a href="http://www.dgap.de"|]www.dgap.de|[/a|]]]|]
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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
End of News DGAP News-Service
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DGAP-News: WILEX AG: REDECTANE(R) meets both endpoints specificity and sensitivity with
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