The prostate cancer study is the first trial of Aplidin in solid tumors to be carried out in the US. The objective of the study is to determine the anti-tumor activity of Aplidin in patients with androgen-independent prostate cancer, relapsing or progressing after a previous line of docetaxel-based chemotherapy.
The bladder cancer study is a European multicenter study to evaluate the efficacy of Aplidin in patients with advanced or metastatic bladder cancer who have relapsed or progressed after first line chemotherapy. The primary end-point is objective tumor response.
In preclinical development, human leukemia, myeloma and lymphoma tumor cell lines were shown to be particularly sensitive to Aplidin and the treatment candidate was granted orphan drug designations in acute lymphoblastic leukemia in the EU in 2003 and in the US in 2004. The FDA and the EC also granted this designation for the treatment of multiple myeloma in 2004.