Sponsored by
Associated Press
11.30.2004, 09:06 AM
YM BioSciences Inc. on Tuesday said the Food and Drug Administration has given an orphan-drug designation to its experimental drug for treating patients with brain cancer.
Orphan-drug status gives Ontario, Canada-based YM a seven-year exclusivity period, potential tax breaks, possible funding and assistance with clinical trials while the company develops its drug, TheraCIM hR3, to treat a rare condition that affects fewer than 200,000 people in the United States.
TheraCIM, which has already been designated an orphan drug by European regulators, is currently undergoing two mid-stage trials in Europe and is expected to begin late-stage testing early next year.
YM said its European licensee, Oncoscience AG, anticipates launching a late-stage trial of TheraCIM in adults with glioma, or brain cancer, in early 2005.
The drug, a monoclonal antibody that targets the epidermal growth factor receptor, has been shown to double a patient's response to chemotherapy in mid-stage trials of patients with head and neck cancer, the company said