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Spectrum Pharmaceuticals to file IND for EOquin for bladder cancer; phase 3 trial planned
By Lisa Kerner
Erie, Pa., March 14 - Spectrum Pharmaceuticals, Inc. said it is filing an Investigational New Drug application with the Food and Drug Administration for EOquin (apaziquone) for use in superficial bladder cancer.
EOquin is activated by certain enzymes present in higher amounts in cancer cells than in normal cells, according to a company news release.
The anticancer agent has undergone clinical studies in Europe, including a successful phase 2 marker lesion study, which showed good tolerance and a durable, high-complete response rate of 67%, Spectrum said.
Spectrum said it met with the FDA in January to discuss its filing plans as well as its phase 3 study design and objectives.
"We are pleased to have reached a consensus with the FDA, and plan to initiate a pilot study as soon as the IND is approved," president, chief executive officer and chairman Rajesh C. Shrotriya said in the release.
"We also plan to request a Special Protocol Assessment for the registrational phase 3 study and expect to commence the phase 3 clinical study in the second half of the year."
The company plans to develop its product in Europe and to conduct a phase 3 study in conjunction with a European urology research group.
The American Cancer Society estimates that there will be more than 61,420 new cases of and 13,060 deaths from bladder cancer in 2006 in the United States, according to the release.
Spectrum Pharmaceuticals is a specialty pharmaceutical company that acquires, develops and commercializes prescription drug products for the treatment of cancer and other unmet medical needs. The company is located in Irvine, Calif.
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