Threshold Pharmaceuticals Inc has announced that the US FDA has granted Fast Track status to one of the company's lead drug candidates, glufosfamide, for injection to treat unresectable locally advanced or metastatic pancreatic adenocarcinoma previously treated with gemcitabine.

According to the FDA, glufosfamide was designated as a fast track product both because of the severity of pancreatic cancer and glufosfamide may provide a therapeutic benefit to the intended patient population. The potential of glufosfamide to provide therapeutic benefit was based on preclinical results and anti-tumour activity (tumour shrinkage) demonstrated in early clinical trials. There are currently no approved therapies for patients with metastatic pancreatic cancer refractory to gemcitabine. These patients have an expected survival of approximately three months.

"Glufosfamide's fast track status underscores the urgency of developing new treatment options for pancreatic cancer patients and the potential of glufosfamide to improve current survival rates for this devastating disease," said George Tidmarsh, founder and president of Threshold Pharmaceuticals.

Data from the company's pivotal Phase 3 clinical trial, currently under enrolment in the United States, will be submitted to FDA as part of Threshold's marketing application, should the study meet its primary endpoint. This study, for which Threshold has received a Special Protocol Assessment (SPA) from the FDA, will evaluate the survival of patients treated with Glufosfamide in conjunction with best supportive care (BSC) versus those patients treated with BSC alone, the company release said.

Data from a phase 2 trial of glufosfamide for the treatment of pancreatic cancer were reported at the 93rd Annual Meeting of the America Association for Cancer Research (AACR), April 6-10, 2002, as well as published in the November 2003 issue of the European Journal of Cancer.

Under the FDA Modernization Act of 1997, the Fast Track drug development programme provides for expedited regulatory review for new drugs demonstrating the potential to address unmet medical needs for the treatment of serious or life-threatening conditions. In addition, the FDA will facilitate and expedite the development and review of the application for the approval of the product.