Phase III Trial in Trovax
Oxford Biomedica PLC
07 November 2006
For Immediate Release 7 NOVEMBER 2006
OXFORD BIOMEDICA commences PHASE III trial OF TROVAX IN RENAL cancer
Oxford, UK - 7 November 2006: Oxford BioMedica (LSE: OXB), a leading gene
therapy company, announced today that the first patient has been treated in
TRIST, a pivotal multi-centre Phase III trial of TroVax, the Company's novel
cancer immunotherapy, in patients with advanced or metastatic renal cell
carcinoma (RCC).
Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on the
start of the study: 'The Phase III TRIST study is designed to demonstrate
definitively that TroVax is effective as a treatment for this aggressive form of
kidney cancer. The clinical experience with TroVax in over 150 patients has
shown indications of its therapeutic potential as well as its excellent safety
profile.'
TRIST (TroVax Renal Immunotherapy Survival Trial) is a Phase III trial that is
designed to evaluate whether TroVax immunotherapy, added to first-line standard
of care therapy, prolongs the survival of patients with locally advanced or
metastatic clear cell renal carcinoma. The trial is a randomised,
placebo-controlled, two-arm study that will compare TroVax in combination with
standard of care to placebo with standard of care. The standard of care
therapies will be interleukin-2, interferon-alpha or Sutent(R) (sunitinib). The
protocol stratifies treatment between the standard of care options to ensure
that the allocation of TroVax and placebo is rigorously balanced.
Approximately 700 patients will be recruited from about 120 centres in the USA,
European Union and Eastern Europe. The primary endpoint for the trial is
survival improvement and secondary endpoints include progression-free survival,
tumour response rates and quality of life scores. The protocol includes the
appointment of a Safety and Efficacy Monitoring Board (SEMB) to assess the
safety and potential efficacy of the drug combinations at various time points
during the trial.
In May 2006, Oxford BioMedica received a Special Protocol Assessment (SPA)
agreement for the TRIST study from the US Food and Drug Administration (FDA).
The SPA process enables FDA evaluation of a trial protocol that is intended to
form the primary basis of an efficacy claim for product registration. The SPA
agreement ensures that the design, conduct, analysis and endpoints of the trial
are all acceptable to the FDA.
Oxford BioMedica anticipates rapid patient recruitment. Median survival for
patients with advanced or metastatic renal cell carcinoma is approximately 11
months. The duration of the trial will be determined by the number of survival
events (deaths) in the study group. The trial is expected to reach a conclusion
in 2008-09, which would support the Company's objective of reaching product
registration in 2009.
Commenting on the news, Oxford BioMedica's Chief Executive, Professor Alan
Kingsman said: 'The start of our first Phase III trial is an important milestone
for Oxford BioMedica and ensures that the TroVax programme is on track for
potential product registration in 2009. In addition, starting the Phase III
trial further emphasises the value of the product to potential partners.'
The Company remains committed to securing a major corporate partner for the
ongoing development and commercialisation of TroVax. As reported in September,
discussions with lead prospective partners have progressed to development
strategies and deal terms. The most advanced prospect is a major pharmaceutical
company with a leading oncology franchise that completed its due diligence on
the TroVax programme recently. Oxford BioMedica is working expeditiously with
three other global pharmaceutical companies to bring all four companies to the
same stage of discussions.
-Ends-
For further information, please contact:
Oxford BioMedica plc: Tel: +44 (0)1865 783 000
Professor Alan Kingsman, Chief Executive
City/Financial Enquiries: Tel: +44 (0)20 7466 5000
Lisa Baderoon/ Mark Court/ Mary-Jane Johnson
Buchanan Communications
Scientific/Trade Press Enquiries: Tel: +44 (0)20 3008 7555
Gemma Bradley/ Susan Yu/ Katja Stout
Northbank Communications
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 clinical candidates and a preclinical targeted antibody therapy,
which is being developed in collaboration with Wyeth. The Company has started
Phase III development of its lead cancer immunotherapy product, TroVax, in renal
cancer and multiple Phase II trials in various cancer settings are ongoing or
planned. In neurotherapy, the Company's lead product, ProSavin, is expected to
enter clinical trials in Parkinson's disease in 2007. The preclinical pipeline
includes gene-based products for vision loss, motor neuron disease and nerve
repair.
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(R)
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. 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. Oxford BioMedica has started a
Phase III trial (TRIST - TroVax Renal Immunotherapy Survival Trial) in 700
patients with advanced renal cell carcinoma. The TRIST study received a Special
Protocol Assessment from the US Food and Drug Administration in May 2006. A
Phase II trial in prostate cancer is ongoing and a trial in breast cancer is due
to start under the auspices of the US Southwest Oncology Group.
To date, over 150 patients with colorectal, renal or prostate cancer
(collectively over 500 doses) have been treated with TroVax. The product has
attracted support from Cancer Research UK, the US National Cancer Institute, and
the UK clinical trials network, QUASAR. These organisations are already
conducting or plan to conduct clinical trials with TroVax.
At the Annual Meeting of the American Society of Clinical Oncology in June 2006,
Oxford BioMedica's scientists and external clinical investigators presented
promising clinical data from five open-label Phase II studies of TroVax, which
included tumour response rates and median survival for patients receiving TroVax
alongside standard therapy. In August 2006, a follow-up analysis of patient
survival in two Phase II trials in colorectal cancer suggested that TroVax may
provide a long-term therapeutic effect after treatment has halted. In all trials
to date, the endpoints of safety and anti-tumour immunological responses have
been achieved with no serious adverse events being attributed to TroVax.
3. Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common form of kidney cancer in the USA.
More than 150,000 people are newly diagnosed with RCC worldwide each year.
Prognosis is very poor. If RCC has metastasised to other organs at the time of
first diagnosis, the five-year survival rate is less than 5%. In the USA and
Europe, RCC accounts for more than 33,000 deaths each year. Data from IMS
suggest that over 5,000 patients in the UK received treatment for metastatic RCC
in 2005.
The most common form of RCC is known as clear cell, which is evident in
approximately 80% of cases. The other main category is papillary, which is found
in 15-20% of cases. Commonly used treatments for patients with metastatic RCC
include cytokines such as interferon-alpha, which has limited efficacy, and
interleukin-2, which is associated with severe side effects at high dose levels.
In the last 12 months, two novel kinase inhibitor drugs have been approved for
the treatment of metastatic RCC, Nexavar(R) and Sutent(R), based on progression
free survival and overall response rate data, respectively, rather than
improvement in survival.
There are several reasons why a cancer vaccine such as TroVax might have
therapeutic potential as a novel treatment for RCC. There is circumstantial
evidence that immune responses may be important in dictating the outcome for RCC
patients and a vaccine could potentiate this immune response. TroVax, in
particular, may be the vaccine of choice since the expression of 5T4, the
antigenic component of TroVax, is more prevalent in RCC than any other solid
cancer analysed by Oxford BioMedica: the antigen is present at high levels on a
high proportion of cells in approximately 90% of RCC tumours.
Treatments for RCC generated annual sales of approximately US$600 million
according to Datamonitor.
This information is provided by RNS
The company news service from the London Stock Exchange
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