Danish drugmaker Pharmexa says it plans to file for approval to start a second Phase III trial of its peptide anticancer vaccine GV1001 in pancreatic cancer within the next few weeks.
The trial, dubbed PrimoVax, compares GV1001 and Eli Lilly’s Gemzar (gemcitabine) – the standard drug treatment for pancreatic cancer – in around 520 patients. There is a critical need to identify new drugs that can be used alongside gemcitabine monotherapy in order to boost response rates in pancreatic cancer, according to the company.
Pharmexa also says it plans to enlarge its ongoing Phase III trial of GV1001 in pancreatic cancer, called TeloVax, from 750 to 1,100 patients, which will improve the chances of a successful outcome but will put back the earliest filing date for the product slightly. TeloVax is comparing GV1001 plus gemcitabine and Roche’s Xeloda (capecitabine) - an as yet unapproved chemotherapy regimen known as GEM-CAP - with GEM-CAP alone.
The company now says it expects results from the trials in 2009/2010.
Meanwhile, the Danish firm says it will start a further Phase III trial in patients with liver cancer during 2006, and will file for orphan status for GV1001 in these indications in both Europe and the USA.
GV1001 is a activates the immune system to recognise and kill cancer cells by raising an immune response against an enzyme called telomerase, which is rarely present in healthy cells but is over-expressed in malignant cells. Telomerase is thought to be involved in the immortalization of most cancer cells, so if GV1001 proves effective in trials it could potentially serve as a universal cancer vaccine.
Pharmexa acquired GV1001 as part of its purchase of Norwegian biotechnology company GemVax last year.