Summary: Pharmexa sees good progress in the four clinical trials of GV1001,
including the two phase III trials PrimoVax and Telovac
PrimoVax: A pivotal phase III trial of GV1001 in non-resectable pancreatic
cancer patients
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).
Hørsholm, October 10, 2007
Jakob Schmidt
Chief Executive Officer
Additional information: Jakob Schmidt, Chief Executive Officer, telephone +45
4516 2525
Claude Mikkelsen, Vice President, Corporate Affairs and Communication,
telephone +45 4516 2525 or +45 4060 2558
Note to editors: Pharmexa A/S is a leading company in the field of active
immunotherapy and vaccines for the treatment of cancer, serious chronic and
infectious diseases. Pharmexa's proprietary technology platforms are broadly
applicable, allowing the company to address critical targets in cancer and
chronic diseases, as well as serious infectious diseases such as HIV,
influenza, hepatitis and malaria. Its leading programs are GV1001, a peptide
vaccine that has entered phase III trials in pancreatic cancer and phase II
trials in liver cancer, and HIV and hepatitis vaccines in phase I/II.
Collaborative agreements include H. Lundbeck, Innogenetics, IDM Pharma and
Bavarian Nordic. With operations in Denmark, Norway and USA, Pharmexa employs
approximately 105 people and is listed on the Copenhagen Stock Exchange under
the trading symbol PHARMX.
