Pharmexa starts pivotal phase III trial in the United States
The FDA has approved Pharmexas IND to start the PrimoVax trial in the United States. PrimoVax is a pivotal phase III trial testing the peptide vaccine GV1001 in patients with non-resectable pancreatic cancer. According to the plan the trial will enrol a total of 520 patients with pancreatic cancer. The trial started in the fall of 2006 in Europe and Australia and has so far enrolled approximately 100 patients from 60 centres. In Denmark, the trial is running at the university hospitals in Herlev, Odense and Århus. With the approval from FDA Pharmexa expects to open an additional 20 centres in the United States before the end of 2007. The first US centre is expected to be opened in California in a few weeks.
GV1001 is a peptide vaccine that activates the immune system so that it recognises and kills cancer cells. GV1001 targets an enzyme called telomerase which is seldom found in normal cell types but overexpressed in most cancer cells. Telomerase activity is considered a key factor in the process whereby cancer cells loose their normal mortality, a common feature for all cancers. GV1001 could therefore theoretically turn out to be a universal cancer vaccine, which is reflected by Pharmexa's broad development programme for GV1001. GV1001 already has Orphan Drug status in pancreatic cancer both in the United States and Europe.
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