FDA OKs Fast-Track Trials for Bladder Cancer Treatment
The U.S. Food and Drug Administration has granted Bioniche Life Sciences, Incorporated (TSE: BNC) special protocol assessment status for upcoming clinical studies of a new bladder cancer treatment.
The Ontario-based company plans to enroll 800 patients from Australia, Europe and North America in double-blind, randomized Phase 3 trials of Urocidin, the company’s product for treating bladder cancers with a high risk for recurrence or progression.
The first trial of Urocidin was also given fast-track status by the FDA in 2006. Bioniche expects to begin recruiting patients for the second study in early 2008. The principal investigator for the second trial is Dr. Alvaro Morales, professor of urology and oncology at Queen’s University in Kingston, Ontario.
Over 300,000 people a year are diagnosed with urothelial bladder cancer. If you’d like to learn more about participating in drug trials, please visit clinicaltrials.gov.
Source: CANADIAN BUSINESS ONLINE
Related Links: Pharmaceutical BUSINESS Review; Bladder Cancer Advocacy Network; Bioniche Newsroom
Related Podcast: Remote Broadcast from the AUA Annual Meeting
from vitaloptions.org
Tags: investigational medication; Belleville; transitional cell carcinoma
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