Orphan drug designation is intended to encourage research and development into new therapies for rare diseases. Orphan drug designation also provides eligibility for a special seven-year period of market exclusivity upon approval, grant funding for research and extra financial incentives.
“This designation underscores the need for additional treatment options for this devastating disease,” said Barry Selick, CEO at Threshold.
Last month the company announced that it had completed enrollment in a phase III clinical trial evaluating glufosfamide for the second-line treatment of pancreatic cancer. The company has also initiated a phase II clinical trial evaluating glufosfamide in combination with gemcitabine for the first-line treatment of pancreatic cancer.
The trials will evaluate any improvement the drug has on survival rates and determine the safety and efficacy of the glufosfamide. The company expects to have results from both of these clinical trials by the end of 2006.