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news.Shares in novel drugs developer Sonus Pharmaceuticals have seen a slight rise after its lead oncology candidate, Tocosol Paclitaxel, was granted orphan drug designation by the FDA in a bladder cancer indication.
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The product candidate has been granted orphan status for the treatment of non-superficial urothelial cancer, the most common form of which is bladder cancer. This designation adds to the fast track designation awarded in 2003 for the development of Tocosol Paclitaxel in urothelial transitional cell carcinoma (TCC).
Tocosol Paclitaxel is a novel formulation of paclitaxel, a widely prescribed anticancer drug for the treatment of solid tumors which is also the active ingredient in Bristol-Myers Squibb’s Taxol.
As well as developing Tocosol Paclitaxel in bladder cancer, Sonus is pursuing initial market entry in an indication for which paclitaxel-based products have already been approved, for example breast, ovarian or lung cancers. The company is currently in discussions with the FDA to finalize the protocol for a pivotal phase III trial it hopes to initiate in 2005.
The company is conducting phase IIb bladder cancer studies in Cleveland, Philadelphia, Baltimore and Seattle, and will soon be opening sites in Spain and the UK. In addition to the bladder cancer program, Sonus is also conducting a phase IIb study of Tocosol Paclitaxel in patients with metastatic breast cancer.
Tocosol Paclitaxel comes in the form of a ready-to-use formulation, which does not require reconstitution, dilution or pharmacy preparation as is required currently the marketed paclitaxel products. An additional advantage over Taxol, Sonus believes, is that Tocosol Paclitaxel is administered to patients in a short 15-minute infusion, whereas Taxol requires three-hour infusion.