Spectrum Pharmaceuticals, Inc. announced the formation of a Canadian affiliate, Spectrum Pharma Canada, Inc. headquartered in the Province of Quebec, Canada.
"The establishment of Spectrum Pharma Canada is another important milestone as we build a global pharmaceutical organization," said Rajesh C. Shrotriya, chairman, president, and chief executive officer of Spectrum Pharmaceuticals. "The Canadian research infrastructure, highly qualified talent pool, and economic incentives provided by the individual provinces, especially the Province of Quebec, were all factors in the establishment of this affiliate. Furthermore, we were impressed with the receptiveness of Investissement Quebec, and are currently working with this state-owned corporation to help Spectrum Pharma Canada succeed in its mission."
As announced in February 2008, the Therapeutic Product Directorate of Health Canada approved clinical trials to be conducted in Canada by issuing a no objection letter to Spectrum's clinical trial application for EOquin. Patients are being enrolled at approximately 30 clinical centres in Canada, including the Province of Quebec.
The EOquin registration plan calls for two double blind, placebo-controlled, randomized Phase 3 clinical studies, each with 562 evaluable patients with Ta G1 or G2 low risk non-muscle invasive bladder cancer (NMIBC).
Clinical studies with our second leading drug, Ozarelix, are likely to be initiated later this year, and to be followed by other drug development activities.
EOquin (apaziquone for intravesical instillation) is an anti-cancer agent that becomes activated by certain enzymes often present in higher amounts in cancer cells than in normal cells. It is currently being developed for the treatment of NMIBC, which is a cancer that is only in the innermost layers of the bladder and has not spread to the deeper, muscle layer of the bladder. EOquin is formulated for administration directly into the urinary bladder.
Spectrum Pharmaceuticals completed a multi-centre, phase 2 clinical trial in Europe. The results of the trial showed that EOquin was well-tolerated and produced a 67% CR (complete response) in patients, many of whom had been treated multiple times with other intravesical agents. The data from this study were presented to the FDA in early 2006.