Compound Class Iodine-124 radiolabelled antibody
INN (International Nonproprietary Name) Iodine (124I) Girentuximab
Indication Kidney tumours
Target The drug candidate REDECTANE® (INN: 124I-Girentuximab) 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 Girentuximab. The monoclonal antibody Girentuximab binds specifically to a protein structure on the cell surface of malignant tumour cells. This protein structure, called Carbonic anhydrase IX (also CA-IX, MN or G250 antigen) is found on over 90 % of clear cell renal cell carcinomas, but not on normal renal tissue.
Mode of Action Diagnosis of malignant kidney tumours by means of PET/CT:
As the antibody is radiolabelled malignant tumours can be visualised by means of positron emission tomography (PET). In combination with CT the accumulation in the tumour tissue can be localised.
Development Status WILEX and the FDA agreed to conduct a second diagnostic performance trial instead of an outcomes-based study that the Agency had previously required.
Development Rationale REDECTANE® may be used before surgery to detect clear cell renal cancer in patients with renal masses. At present, only histopathology results after surgery can determine whether the tumour is benign or malignant. As clear cell renal cancers are associated with an aggressive phenotype their a priori determination may help guide appropriate surgical/therapeutic management.
Background Information The Company´s cooperation partner, the Ludwig Institute for Cancer Research, New York completed a proof-of-concept trial in cooperation with the Memorial Sloan-Kettering Cancer Center, New York in 2006. This feasibility study found that a positive result with REDECTANE® was confirmed as clear cell renal cell carcinoma in 100% of cases (positive predictive value). In May 2010 WILEX published final data of the Phase III REDECT trial with REDECTANE®. REDECTANE® fulfilled expectations in distinguishing clear cell from non-clear cell renal cell carcinoma.
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