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Pharmexa provides update on the development of GV1001 |
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11 Oct 2007 |
Pharmexa sees good progress in the four clinical trials of GV1001, including the two phase III trials PrimoVax and Telovac
HØRSHOLM, Denmark | October 10, 2007 | Enrollment of patients for the PrimoVax trial has now passed 200 patients and the recruitment rate is satisfactory. Assuming the recruitment rate is kept at the current level, all 520 patients in the trial will be enrolled by the end of Q3 2008. 67 centers are now actively recruiting for the trial in 12 countries, including 10 European countries and the United States and Australia. In the United States, so far 8 centers are recruiting and more centers will be opened during the fall.
As in other clinical trials, the PrimoVax trial has a Data Monitoring Committee (DMC) consisting of three independent experts. The role of the DMC is to safeguard the interest of the patients, including monitoring the safety of the vaccine during the trial and the overall conduct of the trial. The latest DMC meeting took place in London in late August, where the DMC evaluated data collected from the preceding 13 months of recruitment of patients. After an evaluation of the data at the meeting, the DMC issued a statement that they were satisfied with the overall safety of the trial, and that the committee would now be reviewing data every 6 months against previously every 3 months
Telovac: An investigator sponsored Phase III trial of GV1001 in non-resectable pancreatic cancer patients
The Telovac trial started in late March 2007 and has already recruited 51 patients from 28 centers in the UK. In the course of the coming months, additional centers will be opened. The trial has generated significant interest and enthusiasm among the British cancer doctors, which has so far been reflected in a high recruitment rate.
Pharmexa recently welcomed a delegation of the British investigators and staff coordinating the Telovac trial. In this connection, Chief Investigator in the trial Dr. Gary Middleton from the Royal Surrey County Hospital gave a presentation of the scientific rationale behind combining GV1001 with chemotherapy. This presentation can be found on Pharmexa's website: www.pharmexa.com.
HeptoVax: A Phase II trial of GV1001 in hepatocellular carcinoma (liver cancer) patients
The HeptoVax trial is close to being fully enrolled and is just one patient from reaching the planned 41 patients. The trial takes place in three centers in Spain, France and Germany.
The HeptoVax trial looks at both tumor size and number (tumor effect) and at different measures of the time until disease progression and ultimately, death.
According to plan, Pharmexa will announce preliminary tumor efficacy data from the first 21 patients before the end of the year, although these data will provide just an indication whether the vaccine works as intended. These data will not be available to Pharmexa and the doctors until the second half of November. The important conclusions about time-to-progression and survival can first be drawn next year.
As a comparison, it is worth mentioning that a recently concluded phase III trial of the cancer drug sorafenib (Nexavar®) showed partial tumor response in just seven out of 299 patients (2.3%). Nevertheless, patients treated with sorafenib in general lived almost three months longer than patients in the control group. Sorafenib is expected to be the new first-line treatment of liver cancer and will likely be the drug GV1001 will be compared with in phase III.
CTN8/2006: A small investigator sponsored trial of GV1001 in Non-Small Cell Lung Cancer (NSCLC) patients
In this trial, GV1001 is tested in patients with advanced lung cancer (stage III and stage IIIb), following chemotherapy and radiation. The trial, which takes place at three centers in Norway, has so far enrolled 10 out of the planned 20 patients and is expected to be fully enrolled by the end of the year. Following this, data will be available after approximately one year.
Briefly about GV1001
GV1001 is a so called peptide vaccine that activates the patients' immune system - primarily the T-cells - to recognize and kill cancer cells. GV1001 differs from most other peptide vaccines by containing epitopes that can stimulate both the immune systems T-helper cells, which coordinate the immune response and killer T-cells which selectively attack cancer cells. GV1001 is targeted towards an enzyme called telomerase. Telomerase is rarely found in normal cells but is over expressed in most cancer cells, which makes telomerase a good target for a cancer vaccine. In addition, telomerase activity is a key factor in the process whereby cancer cells lose their normal mortality, which is a common feature for all cancers. GV1001 therefore has the potential to be a universal cancer vaccine and Pharmexa's broad development strategy for GV1001 reflects this. A projection of the patient population for GV1001 in pancreatic cancer and liver cancer can be found on Pharmexa's homepage (http://www.pharmexa.com/site.asp?p=598).
SOURCE: Pharmexa |
