Prelim Phase II Results
Oxford Biomedica PLC
06 October 2005
FOR IMMEDIATE RELEASE 6 OCTOBER 2005
OXFORD BIOMEDICA ANNOUNCES ENCOURAGING PRELIMINARY PHASE II
RESULTS WITH TROVAX IN RENAL CELL CARCINOMA
Oxford, UK: 6 October 2005 - Oxford BioMedica (LSE:OXB.L), the leading gene
therapy company, today announces preliminary data from the Phase II trial of
TroVax in renal cell carcinoma (RCC). The data show that TroVax is safe and well
tolerated in this patient group and that the product induces a strong
anti-tumour immune response against the 5T4 tumour antigen. Some of these data
were referred to in a presentation made by the principal investigator for this
Phase II trial at the World Vaccine Congress on 5 October 2005.
The Phase II trial in RCC is being conducted at the New York-Presbyterian
Hospital in New York, USA, under an approved Investigational New Drug protocol.
The principal investigator for the trial is Dr Howard Kaufmann of the New
York-Presbyterian Hospital. Dr Kaufmann is a leading expert in clinical
immunotherapy and is an advisor on TroVax.
The Phase II trial is an open label study of TroVax in combination with
interleukin-2 (IL-2) therapy, which is an FDA-approved treatment for RCC.
Patients receive five immunisations of TroVax over 12 weeks and up to four
cycles of high dose IL-2. Patients that show an anti-tumour immune response to
TroVax will be offered an additional three vaccinations. The primary endpoints
of the trial are safety and immunogenicity. Secondary efficacy endpoints include
tumour responses, time to disease progression and overall survival.
The trial is intended to recruit up to 25 patients, in order to gather
information on the safety of TroVax in this setting and also the ability of
TroVax to elicit immune responses to the tumour antigen 5T4. To date, seven
patients have been recruited. There have been no serious adverse events related
to TroVax, which is consistent with the safety profile of the product across all
trials, and TroVax treatment has been well tolerated. Five patients have reached
the preliminary analysis point for immune responses. This preliminary time point
is after two immunisations with TroVax. All five patients have shown high
anti-tumour antibody responses to 5T4. The antibody levels were at the top end
of the range reported from the Phase II trials with TroVax in patients with
colorectal cancer undergoing chemotherapy. Anti-tumour cellular responses
against the 5T4 antigen will be analysed and reported in due course.
Dr Howard Kaufmann gave a presentation on 5 October 2005 at the World Vaccine
Congress in Lyon, France, in a session on Vaccines in Clinical Development. In
his presentation, titled 'Poxvirus Vaccine Strategies for the Treatment of
Cancer', Dr Kaufmann referred to the Phase II trial with TroVax in RCC and
highlighted the potential of the product.
Independently, there has been a recent publication on the prevalence of 5T4
expression in renal cancer. This was authored by Robert Hawkins of the Christie
Hospital in Manchester (see Griffiths et al., British Journal of Cancer 2005).
In this publication, most RCC tumours were found to have high levels of 5T4
expression, both on primary and metastatic sites. This suggests that the
majority of patients with RCC could benefit from a 5T4-targeted product such as
TroVax.
Commenting on the TroVax results in renal cell carcinoma, Oxford BioMedica's
Chief Executive, Professor Alan Kingsman said: 'It is very encouraging that the
results with TroVax in renal cell carcinoma are consistent with our data set in
colorectal cancer. We are also grateful for the strong support of TroVax shown
by Dr Kaufmann. Renal cell carcinoma is an aggressive disease with an unmet need
for effective treatments. The high levels of 5T4 in renal cancer and the paucity
of treatment options make this an ideal setting for further development of
TroVax'.
-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 7886 8150
Sue Charles/ Katja Stout/ Ashley Lilly
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 the areas of
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 an immunotherapy and a gene therapy in multiple Phase II trials, and a
preclinical targeted antibody therapy in collaboration with Wyeth. In
neurotherapy, the Company's lead product is a gene therapy for Parkinson's
disease, which is expected to enter clinical trials 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 65 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, Viragen,
MolMed and Kiadis; and has licensed technology to a number of companies
including Merck & Co, Biogen Idec and Pfizer.
Further information is available at http://www.oxfordbiomedica.co.uk
2. TroVax(R) cancer immunotherapy
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 protein.
In over 70 patients treated, TroVax has been safe and well tolerated, and
induced a strong anti-5T4 immune response. In the completed Phase I/II trials,
the immune response correlated, with high significance, to time to disease
progression, which translated into a correlation with improved overall survival.
Four Phase II trials are underway and data to date have been encouraging.
Further trials including Phase III trials are planned.
This information is provided by RNS
The company news service from the London Stock Exchange