BIOMIRA BEGINS ENROLLMENT IN PANCREATIC CANCER STUDY

Biomira announced that its Phase II clinical trial of PX-12 in patients with advanced pancreatic cancer is open for enrollment. PX-12 is a proprietary small molecule designed to inhibit the activity of thioredoxin (Trx-1), a protein that regulates a number of cancer-related pathways. Biomira anticipates that the first patient in the trial will be treated this month.

The randomized, open-label, Phase II trial will evaluate two dose levels of PX-12 in patients with advanced pancreatic cancer whose tumors have progressed while being treated with gemcitabine or gemcitabine-containing regimens. Up to 80 patients are expected to be enrolled in the trial at three centers in the U.S. The National Cancer Institute is partially funding the trial under a clinical trials agreement with the Translational Genomics Research Institute.

PX-12 is an irreversible inhibitor of Trx-1, a protein that regulates many transcription factors including hypoxia inducible factor-1 alpha, vascular endothelial growth factor and activator protein 1. These factors play a critical role in cancer cell growth, survival and resistance to chemotherapy. Increased Trx-1 levels in cancer cells have been linked to the aggressive proliferation of solid tumors, including colon, lung and gastric cancers.

PX-12 has successfully completed Phase I safety evaluation and is currently being studied in a Phase IB trial for the treatment of gastrointestinal cancers. An initial Phase I trial involving 38 patients with advanced metastatic cancer showed that PX-12 was well tolerated and produced a decrease in plasma concentrations of Trx-1 that was significantly correlated with increased patient survival. Seven of the 38 patients achieved stable disease of up to 322 days.