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New antibody based diagnostic imaging agent demon-strates 100 % positive predictive accuracy in feasibility study |
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21 Oct 2006 |
Better treatment planning for kidney cancer thanks to new diagnostic imaging agent / Feasibility study sponsored by the Ludwig Institute for Cancer Research successfully completed.
MUNICH, Germany | Oct 20, 2006 | The results of a feasibility study involving the testing of CA9-SCAN, a new diagnostic agent from WILEX AG, were presented by the Principal Investigator Chaitanya Divgi, MD in September at the Kidney Cancer Congress in Chicago. The study was conduced by the New York-based Ludwig Institute for Cancer Research, a WILEX cooperation partner, together with the Memorial Sloane-Kettering Cancer Center, New York.
A total of 26 patients with suspected kidney tumours were enrolled and examined using CA9-SCAN with hybrid positron emission tomography (PET/CT) prior to surgery. 25 patients could be evaluated (in one patient the antibody lost its ability to bind during the labelling procedure with 124Iodine). 15 patients showed high accumulation of CA9-SCAN: All 15 cases were confirmed as clear cell renal cell carcinoma by means of histopathology. Thus, in the case of a positive result with CA9-SCAN, 100 % (positive predictive value) of the cases could be confirmed as clear cell renal cell carcinoma. Accumulation of CA9-SCAN could not be observed in the remaining ten patients, though one of these patients was diagnosed with clear cell renal cell carcinoma after post-operative histopathology. Thus, in 90 % of negative cases (negative predictive value) there was indeed no clear cell renal cell carcinoma.
CA9-SCAN is based on the same antibody as WX-G250, a drug candidate for the treatment of clear cell renal carcinoma (development name RENCAREX®), which is currently in a pivotal phase III study.
Chaitanya Divgi, MD, now Chief of Nuclear Medicine and Clinical Molecular Imaging at the University of Pennsylvania, is very positive about the study results. “Never in my experience have I seen a test that was so clear in its results. In none of the scans that we evaluated were our findings equivocal – the image was positive or negative in all cases. This test has the potential to significantly alter the manner in which surgery is performed for kidney tumours, with cost savings from reduction of unnecessary surgery being an added benefit.
“The results of the feasibility study are outstanding. To our knowledge there is no procedure with comparable precision available. CA9-SCAN can significantly improve and simplify treatment planning for patients suspected of having kidney cancer,” said Dr. Paul Bevan, Head of R&D at WILEX AG. “Based on the results we are planning a pivotal approval study for CA9-SCAN.”
About WILEX
WILEX is a biopharmaceutical Company based in Munich, which was founded in 1997 by a team of physicians and oncologists from the Technical University of Munich. WILEX is focused on the development of new cancer therapies based on antibodies and small molecules. The therapeutic approach of WILEX targets the prevention of growth, spread and the metastasis of malignant tumours and the destruction of malig-nant tumours in the body. The portfolio includes both drug and medical product candidates ranging from research to late stage clinical development. Currently the following compounds are in clinical development: WX-G250 (development name: RENCAREX®), WX-671, WX-UK1 and CA9-SCAN. The company’s strategy is to develop WILEX into a commercially successful biopharmaceutical company with a broad portfolio of new drugs and medical products for the treatment of cancer.
SOURCE: Wilex |
