Oxford, UK – 23 May 2006:
Oxford BioMedica (LSE: OXB), a leading
gene therapy company, announced today that
a Phase II trial of TroVax in patients
with prostate cancer that is unresponsive
to hormone therapy is open for
recruitment. This is the first clinical
trial of TroVax in this cancer type.
The Phase II trial in prostate cancer is
being conducted at the Methodist Hospital
in Houston, Texas, USA. The Principal
Investigator for the trial is Dr Robert
Amato. The trial is designed to enrol 24
men with hormone-refractory prostate
cancer who have previously received
chemotherapy or have refused chemotherapy
and have progressive disease. The trial is
open label and will have two arms (12
patients each) to assess the activity of
TroVax alone versus TroVax alongside an
approved treatment for prostate cancer,
granulocyte macrophage-colony stimulating
factor (GM-CSF).
The primary objectives of the trial are to
evaluate the safety and synergies of the
combination treatment, and to assess
whether GM-CSF, which is known to increase
white blood cell count and hence boost the
immune system, increases the anti-cancer
immune response stimulated by TroVax.
Efficacy endpoints include objective
response rate, progression-free survival,
overall survival and changes in
prostate-specific antigen (PSA) level,
which is a recognised marker of disease
status.
Prostate cancer is the leading cause of
cancer in men. Localised radiotherapy or
surgery is potentially curative for
early-stage disease although many patients
relapse and require hormone therapy.
However, therapeutic options are limited
when the cancer has progressed and no
longer responds to hormone therapy, which
is the setting for the Phase II trial of
TroVax. Initial data from this trial are
expected in the first half of 2007.
According to Datamonitor, treatments for
prostate cancer generated worldwide sales
of $2.7 billion in 2004.
Commenting on the start of the Phase II
trial in prostate cancer, Oxford
BioMedica’s Chief Medical Officer, Dr Mike
McDonald, said:
“We are
delighted that Dr Amato is supporting a
Phase II trial of TroVax in prostate
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
provide a new therapeutic option for
patients with prostate cancer who have
progressed despite hormone therapy and for
whom there are few available treatments.”
Dr Robert Amato, Director of the
Genitourinary Oncology Center at the
Methodist Hospital said:
“TroVax could provide a significant
benefit to patients with
hormone-refractory prostate cancer,
particularly when administered with an
effective immunostimulant such as GM-CSF.
Our team at the Methodist Hospital has
seen some intriguing clinical responses
with TroVax from our trial in renal cell
carcinoma and we are delighted to expand
our collaboration with Oxford BioMedica
into prostate cancer.”
Oxford BioMedica’s Chief Executive
Officer, Professor Alan Kingsman added:
“As we broaden and deepen the clinical
development of TroVax, the value of our
lead product candidate increases for
potential partners.”
Clinical evaluation of TroVax is ongoing
in renal cell carcinoma, colorectal cancer
and now prostate cancer. Oxford BioMedica
plans to start a Phase III trial in renal
cell carcinoma in the second half of 2006.
The Company recently secured a Special
Protocol Assessment agreement with the FDA
for this Phase III trial. An update on the
clinical trials and development plan for
TroVax will be released to coincide with
TroVax presentations at the American
Society of Clinical Oncology (ASCO) Annual
Meeting, to be held on 2-6 June in
Atlanta, Georgia, USA.
-Ends-
|
For further information, please
contact: |
|
|
Oxford BioMedica plc:
Professor Alan Kingsman, Chief
Executive |
Tel: +44 (0)1865 783 000 |
|
City/Financial Enquiries:
Lisa Baderoon/ Mark Court/ Mary-Jane
Johnson
Buchanan Communications |
Tel: +44 (0)20 7466 5000 |
|
Scientific/Trade Press Enquiries:
Katja Stout/ Gemma Bradley
Northbank Communications |
Tel: +44 (0)20 7886 8150 |
Notes to editors
1. Oxford BioMedica
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.
Further information
is available at
www.oxfordbiomedica.co.uk
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 100 patients have
now been treated with TroVax in six
clinical trials (collectively over 400
doses). The Company is targeting
colorectal cancer and renal cell carcinoma
(RCC) as lead indications for the
development of TroVax. Renal cell
carcinoma is an indication where TroVax
might achieve a rapid route to product
registration.
3. Prostate cancer
Prostate cancer is the leading cause of
cancer in men. According to the American
Cancer Society, an estimated 232,090 new
cases of prostate cancer were diagnosed in
the USA in 2005 and approximately 29,900
men die of this disease annually. The
five-year survival rate of men with
prostate cancer is 98%, although this
falls to 34% for metastatic disease.
Localised radiotherapy or surgery is
potentially curative for early-stage
disease although many patients relapse and
require hormone therapy. According to
Datamonitor, treatments for prostate
cancer generated worldwide sales of $2.7
billion in 2004. However, therapeutic
options are limited when the cancer has
progressed and no longer responds to
hormone therapy. Early detection is
important, and it is recommended that men
over the age of 50 have a
prostate-specific antigen (PSA) blood test
every year.