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Cell
Genesys launches phase I/II trials of Gvax
BridgeNews
- Foster City, Calif.
This
trial will evaluate a new format of Gvax lung cancer vaccine
CELL
Genesys, Inc said it has initiated a second multicentre phase I/II
clinical trial of Gvax lung cancer vaccine in patients with advanced
stage non small-cell lung cancer who have failed previous therapies,
a company said in press release.
This trial, which will evaluate a new format of Gvax lung cancer
vaccine, was prompted by encouraging interim results in an ongoing
phase I/II clinical trial of Gvax lung cancer vaccine that demonstrate
antitumour activity in advanced stage patients who had previously
failed chemotherapy and/or radiation treatment.
The new trial will enroll approximately 40 patients and will be
conducted at eight medical centres across the United States. ‘‘We
are increasingly encouraged by the safety and efficacy data for
Gvax vaccines, particularly with respect to the evidence of antitumour
activity in all five types of cancer tested to date,’’
stated Joseph J Vallner, Ph D, executive vice- president and chief
operating officer of Cell Genesys.
‘‘We
are now targeting the initiation of phase III trials in both prostate
and lung cancer beginning in late 2002 which would bring us an important
step closer to providing a new treatment option for patients with
these types of cancer. Moreover, our financial resources allow us
to evaluate multiple Gvax vaccines in multiple types of cancer in
order to expedite our goal of bringing a product to the market,’’
he said.
At the May Meeting of the American Society of Clinical Oncology
(ASCO), Cell Genesys reported interim clinical data on 30 currently
evaluable patients with advanced or early-stage lung cancer from
an ongoing multicentre phase I/II trial of Gvax lung cancer vaccine.
These results demonstrated objective evidence of antitumour activity
including a major response rate of 18 per cent in 22 patients with
advanced non small-cell lung cancer who have failed chemotherapy
and/or radiation therapy.
Three patients, two of whom had failed chemotherapy and one who
failed radiation therapy, showed a complete disappearance of metastatic
tumours following treatment with Gvax lung cancer vaccine and a
fourth patient who failed both radiation and chemotherapy had partial
(greater than 50 per cent) reduction in his tumour. In addition
to these major responses, four additional patients were reported
to have stable (non-progressive) disease. All of these responses
were ongoing with a median follow-up time of approximately five
months.
In addition to the responses in patients with advanced disease,
seven of eight patients with early-stage lung cancer who received
Gvax vaccine following surgery, were free of disease with a median
follow-up time of seven months. Gvax cancer vaccines are currently
being tested in multiple types of cancer including lung, prostate,
pancreatic and certain types of haematologic cancers. Gvax cancer
vaccines are comprised of genetically modified, irradiated tumour
cells which produce an immune hormone which stimulates an antitumour
immune response directed against the patient’s tumour.
Gvax lung cancer vaccines are patient-specific vaccines derived
from the patient’s own tumour cells. In contrast, Gvax prostate
and pancreatic cancer vaccines are non patient-specific vaccines
that can be developed as off-the-shelf pharmaceuticals. Lung cancer
was selected for the evaluation of a patient-specific vaccine since,
in contrast to prostate and pancreatic cancer, there are multiple
types of lung cancer and therefore, a single non patient-specific
product would be more difficult to develop.
Cell Genesys is currently testing both patient-specific and non
patient-specific Gvax vaccines since it believes that different
types of cancer may benefit from treatment with one or the other
type of vaccine.
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