FDAnews
www.fdanews.com/articles/81179-biomira-delays-start-of-lung-cancer-study

BIOMIRA DELAYS START OF LUNG CANCER STUDY

September 26, 2005

Biomira will delay the start of a late-stage clinical trial for its experimental cancer vaccine BLP25 until 2006 after discovering a manufacturing problem.

Originally, the company had hoped to start the Phase III clinical trial to study the vaccine in patients with non-small cell lung cancer by the end of 2005, but found a stability problem in the treatment's manufacturing process. Stability is defined as how well a drug holds up under storage conditions. Biomira said it is working with its contract manufacturer to correct the problem, most likely caused by excess moisture in the product.

Non-small cell lung cancer is the most common of lung cancers, accounting for 75 percent to 80 percent of cases. About 25 percent of cases are potentially curable with surgery, the company said.