|
2006/OB/18
|
SOUTHWEST
ONCOLOGY GROUP TO START PHASE II TRIAL OF OXFORD BIOMEDICA'S
TROVAX IN BREAST CANCER
-
Regulatory clearance for start of patient recruitment in 120-patient
Phase II trial of TroVax in patients with late-stage breast
cancer -
Oxford BioMedica
(LSE: OXB), a leading gene therapy company, announces that
the Southwest Oncology Group (SWOG), a US clinical trials
cooperative group, has received regulatory clearance to commence
a Phase II trial of Oxford BioMedica’s cancer immunotherapy,
TroVax, in patients with late-stage breast cancer. The US
National Cancer Institute is sponsoring the trial and is responsible
for the principal costs.
In June 2006, SWOG
submitted the trial plan to the US Food and Drug Administration
and no issues were raised by the FDA. In August 2006, the
study was submitted to the US Recombinant DNA Advisory Committee
and was similarly accepted, which means that the trial can
now commence.
The targeted population
for this study will be late-stage (Stage III and IV) breast
cancer patients who have received standard therapy and have
either minimal residual disease or no evidence of disease.
These patients are at high risk of relapse. The current published
literature indicates a median progression-free survival of
18 to 22 months for this patient group. Approximately 120
patients will be enrolled in this open-label trial. Patients
will receive monthly injections of TroVax for three months,
followed by booster immunisations at six, nine and 12 months.
Key endpoints will
include immunological response rates to the 5T4 tumour antigen
and progression-free survival versus historical controls.
SWOG, which is responsible for all aspects of the trial, could
commence patient enrolment before the end of 2006 in centres
in the USA. The trial is expected to complete in approximately
two to three years. Should this trial prove successful, SWOG
may conduct a Phase III trial in the same setting.
This is the first
trial of Oxford BioMedica’s cancer immunotherapy, TroVax,
in patients with breast cancer. The 5T4 tumour antigen, which
is targeted by TroVax, is broadly distributed across most
solid tumours. Previous studies have shown that high levels
of the 5T4 tumour antigen are present on over 80% of breast
cancer cases. To date, approximately 150 patients have been
treated with TroVax in ten clinical trials in colorectal,
renal and prostate cancer. Oxford BioMedica plans to start
a Phase III trial (TRIST) in renal cell carcinoma in the second
half of 2006.
Commenting
on the progress of SWOG towards starting the Phase II trial
in breast cancer, Oxford BioMedica’s Chief Medical Officer,
Dr Mike McDonald, said: “We are delighted that the
Southwest Oncology Group is committed to evaluate TroVax as
a potential treatment for breast cancer. Given what we know
of the product’s safety profile and the anti-cancer
immune response that it stimulates, we are hopeful that TroVax
can delay relapse of disease in this population of advanced-stage
patients.”
- ends -
|
Return to the News
| Notes
| 1. |
Oxford
BioMedica plc |
| |
Oxford
BioMedica (LSE: OXB) is a biopharmaceutical
company specialising in the development
of novel gene-based therapeutics with a
focus on oncology and neurotherapy. The
Company was established in 1995 as a spin
out from Oxford University, and is listed
on the London Stock Exchange.
Oxford
BioMedica has core expertise in gene delivery,
as well as in-house clinical, regulatory
and manufacturing know-how. In oncology,
the pipeline includes two candidates in
multiple Phase II trials, and a preclinical
targeted antibody therapy in collaboration
with Wyeth. A Phase III trial in renal cancer
with TroVax, the lead cancer immunotherapy
candidate, is expected to start in the second
half of 2006. In neurotherapy, the Company's
lead product is a gene therapy for Parkinson's
disease, which is expected to enter clinical
development in 2006, and four further preclinical
candidates. The Company is underpinned by
over 80 patent families, which represent
one of the broadest patent estates in the
field.
The
Company has a staff of approximately 70
split between its main facilities in Oxford
and its wholly owned subsidiary, BioMedica
Inc, in San Diego, California. Oxford BioMedica
has corporate collaborations with Wyeth,
Intervet, Sigma-Aldrich, Viragen, MolMed,
Virxsys and Kiadis; and has licensed technology
to a number of companies including Merck
& Co, Biogen Idec and Pfizer. |
| 2. |
TroVax® |
| |
TroVax
is Oxford BioMedica's leading cancer immunotherapy
product. It is designed specifically to
stimulate an anti-cancer immune response
and has potential application in most solid
tumour types. TroVax targets the tumour
antigen 5T4, which is broadly distributed
throughout a wide range of solid tumours.
The presence of 5T4 is correlated with poor
prognosis. The product consists of a poxvirus
(MVA) gene transfer system, which delivers
the gene for 5T4 and stimulates a patient's
body to produce an anti-5T4 immune response.
This immune response destroys tumour cells
carrying the 5T4. TroVax has attracted external
support from Cancer Research UK and the
US National Cancer Institute. Over 120 patients
have now been treated with TroVax in eight
clinical trials (collectively over 450 doses).
The Company is targeting colorectal cancer
and renal cell carcinoma as lead indications
for the development of TroVax. Renal cell
carcinoma is an indication where TroVax
might achieve a rapid route to product registration.
A clinical trial in prostate cancer is also
underway and a trial in breast cancer is
planned. |
| 3. |
Breast
Cancer |
| |
Breast
cancer is the leading cause of cancer-related
death among women in the USA and Europe.
It is second only to lung cancer. According
to the American Cancer Society, 212,920
women in the USA will be diagnosed with
breast cancer in 2006, and 40,970 will die
from the disease. Excluding skin cancer,
breast cancer is the most common form of
cancer among women. The numbers are even
higher in the European Union, with an estimated
270,000 new cases of the disease diagnosed
annually and 88,000 deaths. While today
in the USA, the 5-year relative survival
rate for localised breast cancer is 98%,
the figure for patients with distant metastases
is 26%.
Analyses
of sample tissues from patients with breast
cancer have shown that the 5T4 tumour antigen
is present at high levels on over 80% of
breast tumours. Hence, breast cancer is
a logical target for a 5T4-targeted immunotherapeutic.
|
| 4. |
Southwest
Oncology Group |
| |
The Southwest
Oncology Group (SWOG) is one of the largest
cancer clinical trials cooperative research
groups in the USA. The Group is a network
of more than 5,000 physician-researchers located
at nearly 550 institutions. In addition to
their regular medical practices, Group investigators
work together on clinical trials funded by
the US National Cancer Institute (NCI), part
of the National Institutes of Health, to prevent
and treat cancer in adults. Among the Group’s
institutions are 17 of the NCI’s 61
designated cancer centres. The Group enrols
nearly 7,200 patients each year and has about
120 clinical trials underway at any given
time. SWOG has its headquarters at the University
of Michigan in Ann Arbor, Michigan. |
| |
|
|
|
|
|
|
Top
of page
Website by College Hill - Life Sciences
|
| |
|
|
