Overview REDECTANE®
ENGLISH DEUTSCH
| 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 | Announcement of positive final data of Phase III registration trial in Mai 2010, FDA issued Special Protocol Assessment (SPA) in February 2008. In the second quarter of 2011 the pre-BLA meeting with the FDA has taken place. The development for the next steps will be further discussed with the FDA. |
| 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 carried out a proof-of-concept trial in cooperation with the Memorial Sloane-Kettering Cancer Center, New York. 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). |
Seite gelesen: 511 | Heute: 9