THRESHOLD'S GLUFOSFAMIDE WINS ORPHAN DRUG STATUS

Threshold Pharmaceuticals announced that under the FDA has granted orphan drug designation to the company's product candidate, glufosfamide, for the treatment of pancreatic cancer.

Orphan drug designation is intended to encourage research and development of new therapies for diseases that affect fewer than 200,000 patients in the United States. The designation also provides eligibility for a special seven-year period of market exclusivity upon approval, potential tax credits for research, funding for research and development, reduced filing fees for marketing applications and assistance with the review of clinical trial protocols.

Last month the company announced that it had completed enrollment in a Phase III clinical trial evaluating glufosfamide for the potential second-line treatment of pancreatic cancer and a Phase II clinical trial evaluating glufosfamide in combination with gemcitabine for the potential first-line treatment of pancreatic cancer. The company expects to have results from both of these clinical trials by the end of 2006.

The Phase III trial will evaluate approximately 300 previously treated patients with locally advanced and/or metastatic pancreatic cancer who receive best supportive care (BSC) or glufosfamide (4,500 mg/m2) once every three weeks plus BSC. The primary endpoint of this trial is overall survival. The Phase II trial will evaluate up to 28 previously untreated patients with locally advanced and/or metastatic pancreatic cancer who receive the standard dose of gemcitabine (1,000 mg/m2) weekly for three of every four weeks plus glufosfamide (4,500 mg/m2) administered once every four weeks.