British doctors to start new phase III trial with Pharmexa's GV1001

A Phase III trial testing a new treatment for pancreatic cancer has now been initiated. Biotech company Pharmexa has developed the drug and is co-financing the trial together with pharmaceuticals company Roche and Cancer Research UK.

HØRSHOLM, Denmark | Mar 15, 2007 |
Referred to as the TeloVac trial, the recently initiated Phase III trial is a so-called investigator-sponsored trial. The trial is designed and managed by the Pancreas Cancer Sub-group of the National Cancer Research Institute in the UK, with Dr. Gary Middleton of the Royal Surrey County Hospital as Chief Investigator, whilst the group of Principal Investigators include Professor David Cunningham of the Royal Marsden Hospital and Professor John Neoptolemos of the Royal Liverpool University Hospital. Up to 80 UK cancer centres are participating in the trial. The trial is testing GV1001, a new immunotherapeutic drug for pancreatic cancer developed by Danish-based biotech company Pharmexa.

Pancreatic cancer is a rare but very serious disease, which affects approximately 7,000 people a year in the UK. These patients generally have a poor prognosis, and only about 15% of patients are alive a year after being diagnosed with the disease. Pancreatic cancer is currently mainly treated with chemotherapy, and unfortunately with limited effect.

Dr. Gary Middleton, Chief Investigator of the trial, said: "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. 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 optimised chemotherapy platform is an exciting strategy which, if successful, will set a new standard for the treatment of this disease."

Professor John Neoptolemos, Co-Investigator of the TeloVac trial, said: "The National Cancer Research Institute demonstrates its strong commitment to this trial by not supporting any other Phase III trial until enrolment for the TeloVac trial has been completed. This means that we strongly believe GV1001 could become an important key to future treatment of pancreatic cancer."

Brief details on the trial
In the TeloVac study, GV1001 will be tested together with a combination of the chemotherapy compounds gemcitabine (Gemzar®) and capecitabine (Xeloda®). 1110 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.

The TeloVac study is co-financed by Cancer Research UK (CRUK) and will be conducted by the CRUK's Liverpool Cancer Trials Unit. Pharmexa will pay for vaccine for the trial and a number of costs related to monitoring and data collection from the trial. Pharmaceuticals company Roche has agreed to pay for the chemotherapy drug Xeloda®, which will be used in all three arms of the trial.

GV1001: A therapeutic vaccine against cancer
GV1001 is a peptide vaccine that activates the immune system so that it recognises 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. In scientific circles, telomerase activity is considered a key factor in the process whereby cancer cells lose their normal mortality, a common feature for all cancers. In theory, GV1001 could therefore turn out to be a universal cancer vaccine, which is reflected in Pharmexa's broad development programme for GV1001. GV1001 has achieved orphan drug designation for the treatment of pancreatic cancer in both Europe and the United States. Pharmexa holds all the commercial rights to GV1001.

Hørsholm, 15 March 2007

Jakob Schmidt
Chief Executive Officer

SOURCE: Pharmexa

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