Spectrum Pharmaceuticals, Inc., has initiated its pivotal phase 3 registrational trials for EOquin, the company's proprietary drug candidate for non-invasive bladder cancer. These phase 3 trials for EOquin will be conducted under the recently agreed upon Special Protocol Assessment (SPA) between Spectrum and the US Food and Drug Administration (FDA).
"Bladder cancer is the fifth most common cause of cancer death in the US and the most costly cancer to treat per patient because of the disease's characteristic high rate of recurrence," said Mark Soloway MD, Professor and chairman of the University of Miami School of Medicine, and Principal Investigator of the EOquin phase 3 trials. "There has been no new treatment approved and marketed for noninvasive bladder cancer in more than 20 years. EOquin is among the most promising new therapies we have observed, with potential to treat this very common, yet difficult-to-treat, cancer."
The EOquin SPA calls for two double blind, placebo-controlled, randomized phase 3 clinical studies, each with 562 patients with Ta G1 G2 non-invasive bladder cancer. Patients will be randomized in a one-to-one ratio to EOquin or placebo. The primary endpoint will be the difference in the rate of tumour recurrence between the two treatment groups by year two. More than 55 centres are currently participating in Phase 3 testing of EOquin. Additional centres will be added as the EOquin trials progress.
"We are encouraged by the SPA we negotiated with the FDA, and we intend to work closely with the agency throughout the duration of the Phase 3 studies for EOquin. We believe that by gaining clarity about the primary and secondary endpoints for the Phase 3 studies with EOquin, we will be able to use the data we generate as the basis of a New Drug Application," said Rajesh C Shrotriya, Spectrum's chairman, president and chief executive officer. "In addition, the advancement of EOquin into Phase 3 testing further validates our team's ability to select and develop promising drug candidates."
Additional information regarding the design, enrolment criteria, and participating centres for the Phase 3 trials with EOquin in non-invasive bladder cancer, is available at www.clinicaltrials.gov (keyword: EOquin).
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 inner most 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 for which patient accrual was completed this year, EOquin instilled into the bladder following TUR-BT was well tolerated and was not absorbed in any detectable amount from the bladder wall into the bloodstream and therefore, would carry a low risk of systemic toxicity.
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. The data from this study were presented to the FDA in early 2006.