Out-licensing

Phase III Clinical Development of REDECTANE® for the Diagnosis of Renal Cell Carcinoma

Introduction/Background

The drug candidate REDECTANE® is based on an antibody and is being developed for the pre-surgical diagnosis of clear cell Renal Cell Cancer. REDECTANE® is the 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).

Aims/Hypothesis

We are furthering the clinical development of REDECTANE®.

Results

The Company's cooperation partner, the Ludwig Institute for Cancer Research, New York carried out a proof-of-concept trial in cooperation with the Memorial Sloane-Kettering Cancer Center, New York. The trial examined whether REDECTANE®* before the operation could provide an accurate prediction of whether or not the tumour was a clear cell renal cell carcinoma.

With this aim in mind, 26 patients with renal tumours were diagnosed with PET/CT using REDECTANE® and these diagnoses were compared with histological findings regarding the renal tumour after the operation. The data of 25 patients with renal tumours were evaluated, as in the case of one patient the antibody lost its ability to bind during the labelling procedure with Iod-124. 15 patients showed a high level of accumulation of REDECTANE®. All 15 patients were diagnosed with clear cell renal cell carcinoma based on histological results (100 % positive predictive value). A high accumulation of REDECTANE® could not be observed with the remaining ten patients, though one of these patients was diagnosed with clear cell renal cell carcinoma after the post-operative histological examination (90 % negative predictive value).

WILEX is about to start a Phase III registration trial with REDECTANE®*. 166 patients suspected of having kidney cancer will be enrolled in more than 15 centres in the USA. Patients included are scheduled for complete or partial surgical removal of the affected kidney. They will be imaged with computer tomography (CT) and REDECTANE® (positron emission tomography (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).

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.

Conclusion

REDECTANE® 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.

Relevance/Opportunity

Please enquire regarding licensing or codevelopment partnerships.

Phase III