Phase III trial

ENGLISH DEUTSCH

WILEX completed a Phase III trial with REDECTANE® and published final data in May 2010. 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 will evaluate whether imaging with REDECTANE® can improve the diagnosis in comparison to the current standard (CT alone).

REDECTANE® fulfilled expectations in distinguishing clear cell from non-clear cell renal cell carcinoma. The results of the study demonstrate that PET/CT with REDECTANE® lead to a significantly improved diagnosis in comparison to CT alone. 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).

FIG 1: Contrast CT in a patient with a renal mass in the right kidney. FIG 2: REDECTANE® PET/CT clearly identifies ccRCC in the right kidney. Image courtesy of Memorial Sloan-Kettering Cancer Center, New York, NY

Status

The FDA suggested in the second quarter of 2011 to consider conducting an outcomes-based study to obtain additional evidence of the product’s clinical benefit. In the fourth quarter of 2011, a Type C meeting took place at the FDA, in which the further development of REDECTANE® was outlined, including the scheduling of a second trial and the options to conduct an “outcomes-based study” or a “confirmatory” study similar to the REDECT trial to confirm the candidate’s diagnostic performance. In July 2012 the FDA discussed the regulatory pathway with an FDA Advisory Committee.

A Type C meeting with WILEX and the FDA was held in September 2012. The FDA accepted the positive vote of the Oncologic Drugs Advisory Committee (ODAC) regarding the clinical usefulness of an imaging test which identifies ccRCC within the kidney of patients with an indeterminate renal mass. Furthermore, the FDA agreed to conduct a second diagnostic performance trial instead of a previously required outcomes-based study.

In recent months, WILEX has drawn up the development strategy and trial design for a confirmatory Phase III trial (REDECT 2), for which it received a special protocol assessment (SPA) from the FDA. However, WILEX AG will no longer conduct the REDECT 2 trial, but aims to arrange the financing, development and commercialisation for REDECTANE® externally.

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