RESEARCHERS BEGIN STUDY OF PHARMEXA CANCER VACCINE

The UK's National Cancer Research Institute has begun a Phase III trial of GV1001, a new immunotherapeutic drug for pancreatic cancer developed by Pharmexa.

GV1001 will be tested together with a combination of the chemotherapy compounds Gemzar (gemcitabine) and Xeloda capecitabine (capecitabine). A total of 1,110 patients with inoperable pancreatic cancer will be randomly divided into one of the three arms: 370 patients will receive gemcitabine and capecitabine chemotherapy in a standard treatment; 370 patients will initially be treated with gemcitabine and capecitabine for eight weeks, after which they will be treated with GV1001; and 370 patients will be treated with gemcitabine and capecitabine concurrently with GV1001.

The purpose of the trial is to study whether patients treated with a combination of GV1001 and chemotherapy live longer than patients who only receive chemotherapy. It is not expected that GV1001 will cure patients, but that the treatment will prolong their lives and that a small proportion of the patients may experience significantly longer survival.

"We believe that future treatment of pancreatic cancer as well as other types of cancer will include various chemotherapies combined with biological and targeted therapies," Gary Middleton, chief investigator of the trial, said. "GV1001 is an especially attractive vaccine; the antigen that it targets is expressed in largely all pancreatic cancer cells, and the vaccine stimulates the formation of all the immune cells required for an effective attack on these cancer cells. Adding this vaccine to an optimized chemotherapy platform is an exciting strategy which, if successful, will set a new standard for the treatment of this disease."

GV1001 is a peptide vaccine that activates the immune system so that it recognizes and kills cancer cells. GV1001 targets an enzyme called telomerase. Telomerase is seldom found in normal cell types but is overexpressed in most cancer cells, according to the researchers. In theory, GV1001 could therefore be used as a universal cancer vaccine, which is reflected in Pharmexa's broad development program for GV1001. The vaccine has been granted orphan drug designation for the treatment of pancreatic cancer in Europe and the U.S.