Spectrum Pharmaceuticals has announced that it has enrolled enough patients to move forward with one of two pivotal Phase III clinical trials of apaziquone, a new drug to treat bladder cancer that has been granted fast-track status in the US.
The company announced that it had achieved its enrollment target of 800 patients with non-invasive bladder cancer ahead of schedule and that the second Phase III clinical trial of apaziquone is expected to complete enrollment by the end of 2009.
Spectrum Pharmaceuticals chairman and chief executive officer Rajesh C Shrotriya said that completing the enrollment of this study ahead of schedule was a remarkable achievement.
“Bladder cancer is the fifth most common type of cancer, and is the most expensive cancer to treat on a lifetime basis. The ‘fast-track’ designation should further help expedite the drug’s review process with the FDA,” Shrotriya said.
Fast-track designation is used by the US Food and Drug Administration to support and accelerate the development of new drugs with the potential to meet unmet medical needs and to treat serious conditions.
Spectrum has also received clearance from the European Medicines Agency whereby the two Phase III studies should be sufficient for a regulatory decision regarding European registration, as well as in the US.