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Phase 3 Trial of GV1001 in Pancreatic Cancer Halted After Analysis Shows No Survival Benefit

May 14, 2008 -- GV1001 is tested in two large-scale Phase III studies called the PrimoVax trial and the Telovac trial. An important objective of these two trials is to determine the best way to use GV1001 in combination with chemotherapy in patients with non-resectable pancreatic cancer. Today, Pharmexa has decided to stop further enrolment for the PrimoVax trial.

The PrimoVax trial was planned to include 520 patients with non-resectable pancreatic cancer. 77 hospitals in ten European countries as well as Australia and the United States have been enrolling patients for the trial. Approximately 360 patients have been enrolled in the trial to date. The primary endpoint of the trial is survival and secondary endpoints include time to progression and safety.

The patients in the PrimoVax trial were randomly divided into two equally sized groups:

  • Half of the patients received the standard treatment with gemcitabine chemotherapy; and
  • Half of the patients received GV1001. If/when the condition of these patients deteriorated, treatment with gemcitabine was added.
The preliminary data based on deaths of 174 patients showed that the survival was no better in the GV1001 group in which gemcitabine chemotherapy was added to GV1001 only after progression of disease as defined in the study protocol, compared to the group that received standard gemcitabine chemotherapy immediately. The final conclusions with respect to survival and all secondary endpoints must await the further follow-up of patients and full analyses of the data.

The PrimoVax trial was designed as a continuation of a previous Phase I/II clinical study with GV1001 which showed that treatment with GV1001as monotherapy significantly prolonged patient survival, compared to the effect previously seen with gemcitabine.

Pharmexa's CEO Jakob Schmidt says: “We are disappointed that the PrimoVax trial fails to demonstrate a survival benefit for these severely ill patients. Our job now will be to collect and analyse all the data this trial has generated to fully understand the results of the PrimoVax trial and to support the ongoing Telovac trial and the other clinical activities with GV1001. It has been an open question from the start whether GV1001 should be administered before chemotherapy, as in the PrimoVax trial, or during or after chemotherapy as in the Telovac trial. We now know that giving it first does not improve overall survival in non-resectable pancreatic cancer patients. The focus going forward will be to show that GV1001 has a role in combination with chemotherapy and we have therefore decided to continue our support of the Telovac trial. The failure of the PrimoVax trial to show a survival benefit of GV1001 in these severely ill patients does not diminish our conviction that targeting the universal tumor antigen telomerase with GV1001 can be a valuable immunotherapeutic adjunct in several cancer indications, including pancreatic cancer.”

Source: Pharmexa

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