Wilex' REDECTANE meets both endpoints specificity and sensitivity with superiority over CT in its pivotal Phase III trial

20-May-2010 - Germany

WILEX AG and IBA (Ion Beam Applications SA) announced 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) (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(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% (p<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'.

https://www.bionity.com/en/news/117787/wilex-redectane-meets-both-endpoints-specificity-and-sensitivity-with-superiority-over-ct-in-its-pivotal-phase-iii-trial.html