AVI Biopharma starts pivotal trial of Avicine
Following a successful Phase II program and discussions with the US Foodand Drug Administration, AVI Biopharma has decided to proceed with a Phase III trial of Avicine, the firm's lead cancer vaccine, as a first-line treatment for metastatic colorectal cancer. The trial will start next year and involve around 500 patients who will be randomized to receive either Avicine and chemotherapy or chemotherapy alone.
The Phase II program for the vaccine, which elicits an immune response to human chorionic gonadotrophin - a tumor-associated oncofetal protein - is scheduled for presentation at the forthcoming American Society of Clinical Oncology meeting in May 2000. Avicine is also being tested in Phase II trials in pancreatic cancer in combination with Eli Lilly's Gemzar (gemcitabine).
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