Prima BioMed commences Phase II trial ofCancerVac Treatment for...

Prima BioMed commences Phase II trial of
CancerVac Treatment for Ovarian Cancer
Following its successful Phase 1 trial results Prima BioMed Ltd (’Prima’: ASX PRR)
subsidiary, CancerVac, will today begin a Phase II trial of its immunotherapy technology
in patients with progressive ovarian cancer. The study will be conducted in Melbourne at
the Austin Hospital in conjunction with scientists from the Austin Research Institute.
CancerVac’s immunotherapy technology is patient-specific: the patients will be treated
with their own cells which have been modified in the laboratory to incorporate a cancer
protein Mucin-1 before injection. Tumour stabilisation or tumour shrinkage will signify a
positive outcome of the CancerVac trial.
Dr Paul Mitchell, Principal Investigator (Austin Hospital), explained: “Our immunotherapy
treatment will isolate specialised cells of the immune system known as dendritic cells
from the patient's blood. Once treated in the laboratory, these cells are returned to the
patient to activate the immune system against Mucin-1, a cancer protein expressed in a
number of different cancers including ovarian tumours.
This trial is expected to recruit up to 20 ovarian cancer patients. Patients are being
referred by a selection of Melbourne’s leading Gynecological Oncologists including Dr
Peter Grant and Dr David Allen of the Mercy Hospital, Assoc Prof Tom Jobling of
Monash Medical Centre and Prof Michael Quinn of the Royal Women’s Hospital, “The
patients will receive seven treatments over the 12-month period of the trial during which
we will regularly assess the tumour by the level of, CA-125 in the blood, a sensitive
measure of tumour size.
The principle behind CancerVac's technology is to increase the body's response to the
cancer by manipulating specialised cells of the immune system known as dendritic cells
(DC). These cells interact with proteins and present segments of them to T-cells (which
mount an immune attack). In early trials, CancerVac has found that the strength of the
T-cell attack can be increased by exposing the DC to a protein that has first been
attached to a large carbohydrate molecule (mannan).
“The patients selected for this trial will be relatively well but are not expected to be
curable with conventional treatment. A major advantage of CancerVac's technology is
that relatively long term treatment with this proposed therapeutic approach appears to
have no, or minimal, side effects.
“Due to the nature of the therapy we believe there is no reason why it cannot be
continued indefinitely as long as proving beneficial to the patient. Two patients from the
Phase I trial – in which 10 patients were initially treated - have remained on treatment for
over two and a half years and both are doing very well,” said Dr Mitchell.
CancerVac’s Technology
CancerVac's cancer treatment combines two elements: a product, Mannan Fusion
Protein (MFP), which instructs the immune system to target cancer cells; and a process,
Dendritic Cell Therapy, to deliver the product to the patient's immune system.
The MFP is made by attaching the cancer protein Mucin-1 to a long string of sugar units
called mannan in a process which has been shown to boost a patient's immune
response. Dendritic Cell Therapy involves isolating dendritic cells from the patient's
blood and exposing them to the MFP in the laboratory. The primed dendritic cells are
then introduced back into the skin of the patient where they initiate a complex response
in which cells from the immune system attack the cancer.
CancerVac holds intellectual property over the product and the process.
Contacts:
Company Enquiries Ms Vanessa Waddell 0412 153 524
Media Enquiries Kate Mazoudier 0403 497 424
Patient Enquiries Lisa Allwell 03 9496 3460
About Prima Biomed Ltd
Based in Melbourne, Prima BioMed (ASX: PRR) is a biotechnology organization with first
and last rights over technologies in the fields of immunology and cancer immunotherapy
from the Austin Research Institute, in Melbourne, Australia. Prima Biomed adopts and
develops technology that shows potential for commercial returns within three years.
About CancerVac Pty Ltd
CancerVac is a subsidiary of Prima BioMed. The company was formed to develop and
commercialize immunotherapy-based technology licensed from the Austin Research
Institute. This technology covers recombinant proteins expressed on tumour cells and a
vaccine adjuvant to trigger the immune system to identify cancer cells as foreign, leading
to attack by immune killer cells and consequent destruction of tumour cells.
In March 2004, CancerVac announced a significant commercial agreement with a
Canadian based NASDAQ listed company Biomira Inc for the development and
commercialisation of MFP based immunotherapy product. This agreement grants
CancerVac a worldwide licence for the use of Mucin-1 in dendritic cell based therapies
and then provides Biomira with first rights to develop the MFP product outside of
Australia and New Zealand post completion of the phase IIa trial in ovarian cancer.
Biomira holds a 10% interest in CancerVac.