Wilex AG's Redectane(R) Meets Both Endpoints Specificity And Sensitivity With Superiority Over CT In Its Pivotal Phase III Trial
5/19/2010 8:11:03 AM
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® 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® 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) (p=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® resulted
from the poor performance of CT, the endpoints of REDECTANE® were also compared to an
arbitrary value of 75% for specificity and sensitivity as defined in the study protocol.
REDECTANE® achieved sensitivity of 86% (p=0.002) and specificity of 87% (p=0.057).
Based on these results, WILEX plans to submit REDECTANE® 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® 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® for approval and, together with our
partner IBA, to bring our first product to market“.
“We are convinced that REDECTANE® 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
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.
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® (PET/CT) prior to surgery to
examine whether they have clear cell renal cell carcinoma. The trial has evaluated that
imaging with REDECTANE® 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®. 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® and
RENCAREX® are undergoing Phase III registration trials. MESUPRON® 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
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