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Oxford BioMedica Announces Publication of TroVax® Phase II
Analyses in Peer-Reviewed Medical Journal
-- Results from Phase II trial in prostate cancer published in Cancer
Immunology, Immunotherapy --- Favourable tolerability and biomarker results -Oxford, UK – 29 July 2013: Oxford BioMedica (“Oxford BioMedica” or “the Company”) (LSE: OXB),
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the leading gene-based biopharmaceutical company, today announces that analyses of a TroVax
Phase II study in patients with castration-resistant prostate cancer (CRPC) have been accepted for
publication in the peer-reviewed medical journal Cancer Immunology, Immunotherapy, the official
journal of the Association for Cancer Immunotherapy.
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TroVax (MVA-5T4) is a therapeutic cancer vaccine designed to stimulate the immune system to
destroy cancerous cells expressing the 5T4 tumour antigen, which is broadly distributed throughout a
wide range of solid tumours. The paper, entitled “Vaccination of castration-resistant prostate cancer
patients with TroVax (MVA-5T4) in combination with docetaxel: a randomized phase II trial” will be
published in Cancer Immunology, Immunotherapy later this year. Previews of the clinical manuscript
can be accessed online at: http://link.springer.com/article/10.1007%2Fs00262-013-1457-z.
The randomised, open-label Phase II study in the United States aimed to assess the activity of
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TroVax plus chemotherapy drug docetaxel (Taxotere ) versus docetaxel alone. With an initial target
enrolment of 80 patients, recruitment was challenging and the study enrolled 25 patients with
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metastatic CRPC; 12 were treated with TroVax plus docetaxel and 13 were treated with docetaxel
alone. In October 2012, Oxford BioMedica made a strategic decision to close the US trial in order to
focus on investigator-led Phase II studies.
Highlights from the Phase II CRPC study
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 TroVax was well-tolerated in all patients.
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 Patients treated with TroVax plus docetaxel showed a greater median progression-free survival
of 9.67 months compared with 5.10 months for patients on the docetaxel alone arm (P = 0.097;
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HR = 0.31; 95 % CI 0.08-1.24) .
 Importantly, a pre-treatment biomarker previously demonstrated to predict 5T4 immune response
and treatment benefit showed a strong association with 5T4 antibody response and a statistically
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significant association with progression-free survival in patients treated with TroVax plus
docetaxel, but not docetaxel alone.
 The results demonstrate, for the first time, the prospective validation of a pre-treatment
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biomarker which is predictive of both 5T4 immune response and treatment benefit in cancer
patients.
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P = p-value, HR = hazard ratio, CI = confidence interval.
The biomarker is a combination of three pre-treatment blood parameters: 5T4 antibody levels; haemoglobin; and
haematocrit (proportion of blood volume occupied by red blood cells) which can all be measured using a simple blood test.
The biomarker is being used in ongoing investigator-led Phase II studies.
John Dawson, Chief Executive Officer of Oxford BioMedica, said: “Oxford BioMedica has a
strong track record of publishing articles in well-respected medical journals. Peer-reviewed by
experts, this paper demonstrates that our novel biomarker can identify patients most likely to benefit
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from treatment with TroVax . The use of biomarkers in cancer immunotherapy is becoming
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increasingly important, which further underlines the attractiveness of TroVax as a cancer vaccine.”
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-EndsFor further information, please contact:
Oxford BioMedica plc:
Lara Mott, Head of Investor Relations and Corporate Communications
Media Enquiries:
Mary-Jane Elliott/Matthew Neal
Consilium Strategic Communications
Tel: +44 (0)1865 783 000
Tel: +44 (0)20 7920 2345
Notes to editors
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1. About Oxford BioMedica
Oxford BioMedica plc (LSE: OXB) is a biopharmaceutical company developing innovative gene-based
medicines and therapeutic vaccines that aim to improve the lives of patients with high unmet medical
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needs. The Company’s technology platform includes a highly efficient LentiVector gene delivery
system, which has specific advantages for targeting diseases of the central nervous system and the
eye; and a unique tumour antigen (5T4), which is an ideal target for anti-cancer therapy. Through inhouse and collaborative research, Oxford BioMedica has a broad pipeline with current partners and
licensees including Sanofi, Pfizer, Novartis, GlaxoSmithKline, MolMed, Sigma-Aldrich, Biogen Idec,
Emergent BioSolutions, ImaginAb and Immune Design Corp. Further information is available at
www.oxfordbiomedica.co.uk and www.oxbsolutions.co.uk.
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2. TroVax
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TroVax is a therapeutic vaccine that stimulates the immune system to destroy cancerous cells
expressing the 5T4 tumour antigen which is present on most solid tumours. The product comprises a
modified vaccinia virus Ankara (MVA) vector, encoding the 5T4 antigen. Vaccinia viruses are
commonly used as delivery systems for the development of antigen-specific vaccines. Results from
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10 previous clinical trials in colorectal, renal and prostate cancer have shown that TroVax is safe and
well tolerated in over 500 patients; can be administered in combination with various other treatments
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and show clear indication of efficacy. Approximately 90% of patients treated with TroVax mounted
an anti-cancer immune response to the 5T4 antigen.