Spectrum Pharmaceuticals, Inc., announced that the Therapeutic Product Directorate of Health Canada has approved the trials to be conducted in Canada by issuing a No Objection Letter to Spectrum's Clinical Trial Application for EOquin, the company's drug candidate in phase 3 clinical trials for non-invasive bladder cancer. Phase III protocols are open and currently recruiting patients in the United States. This action authorizes the initiation of clinical trials in Canada, where preparations have been underway for several months.
"An investigator's meeting involving more than 30 urologists and their study coordinators has already been conducted in Toronto, Canada. We expect to begin enrolling patients at these sites soon," said Rajesh C. Shrotriya, M.D., chairman, president and CEO of Spectrum Pharmaceuticals. "More than 250 patients have already been enrolled in the United States in the first phase III study, which was opened in May 2007. With the expansion of clinical trials with this large group of Canadian urologists, we expect to increase the rate of accrual in the second study, which was initiated in the US in September 2007."
The EOquin registration plan calls for two double blind, placebo-controlled, randomized phase III clinical studies, each with 562 patients with Ta G1 or G2 low risk non-invasive bladder cancer. Patients are randomized in a one-to-one ratio to EOquin or placebo. The primary endpoint is a statistically significant difference (p less than 0.05) in the rate of tumour recurrence between the two treatment groups by year two. The first Phase 3 study is currently expected to complete enrolment by end of this year, and the second phase III trial to be fully enrolled by mid 2009.
EOquin (apaziquone for intravesical instillation) is a drug currently being developed for the treatment of non-invasive bladder cancer, which is a cancer that has invaded the lining of the bladder. EOquin, an anti-cancer agent that becomes activated by reductase enzymes found in cancer cells, is formulated for administration directly into the urinary bladder. In a Phase 2 pilot study which was completed earlier this year, EOquin instilled into the bladder following surgery was well tolerated and was not absorbed in any detectable amount from the bladder wall into the bloodstream and therefore, is expected to carry a low risk of systemic toxicity, if any.
Spectrum Pharmaceuticals completed a multi-centre, phase II clinical trial in Europe. The results of the trial showed that EOquin was well-tolerated and produced a 67 per cent CR (complete response) in patients, many of whom had been treated multiple times. The data from this study were presented to the FDA in early 2006.
Spectrum Pharmaceuticals acquires, develops and commercializes a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options.