IRVINE, Calif., March 13 (UPI) -- U.S. firm Spectrum Pharmaceuticals said Tuesday it has reached a deal with the Food and Drug Administration for trials of cancer drug EOquin.
The company said its Special Protocol Assessment with the agency covers aspects of two phase 3 studies of the non-invasive bladder cancer drug, including the trial's design, clinical endpoints, conduct and data analysis.
"Bladder cancer is one of the most common cancers in the United States and there has not been a new treatment approved by the FDA in over 20 years," said Rajesh Shrotriya, chairman, president and CEO of Spectrum.
"We believe the initiation of the phase 3 trial of EOquin is an important step in bringing a more effective treatment for bladder cancer."
He said the company has chosen approximately 50 investigators for the pair of U.S. trials, which will each enroll 562 patients with Ta G1 G2 non-invasive bladder cancer. Enrollment will begin in the second quarter of 2007, Spectrum said.
Study investigators will assess the rate of tumor recurrence between the two treatment groups after two years.
Bladder cancer affects roughly 62,000 new patients in the United States and approximately 180,000 new patients in Europe each year, the company estimated.
