Publication in Clinical Cance
OXFORD BIOMEDICA ANNOUNCES PUBLICATION OF TROVAX® PHASE III RESULTS IN METASTATIC RENAL CANCER IN CLINICAL CANCER RESEARCH
-- TRIST Results Published in Peer-Reviewed Journal --
Oxford, UK - 14 October 2010: Oxford BioMedica plc ("Oxford BioMedica" or "the Company") (LSE: OXB), a leading gene therapy company, today announces that the results from the TroVax® Renal Immunotherapy Survival Trial ("TRIST"), a randomised, double-blind, placebo-controlled Phase III study, have been accepted for publication in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR).
TroVax® (MVA-5T4) is Oxford BioMedica's 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 article, entitled "Vaccination of Metastatic Renal Cancer Patients with MVA-5T4: A Randomized, Double Blind, Placebo Controlled Phase III Study", will be published in Clinical Cancer Research on 15 November 2010. Previews of the clinical manuscript can be accessed online at http://clincancerres.aacrjournals.org.
As previously announced, the TRIST results demonstrated that TroVax® was well tolerated but did not result in enhanced survival relative to placebo controls. However, exploratory analyses have identified sub-groups of patients where TroVax® may be of significant benefit. To date, the exploratory analyses have identified three key factors for consideration:
i. Patients with a good prognosis who received TroVax® plus interleukin-2 ("IL-2") (a cytokine with anti-tumour activity) showed a significant survival advantage vs. good prognosis patients who received placebo plus IL-2;
ii. The Phase III TRIST results confirm the association between a 5T4 (but not the MVA vector) antibody response and enhanced patient survival seen in Phase II; and
iii. Survival was prolonged in patients who had normal haematology prior to receiving TroVax® i.e. normal levels of platelets, monocytes and haemoglobin in their blood profile.
There are a number of upcoming development initiatives for TroVax®; the first patient in the current Phase II study in progressive hormone refractory prostate cancer has been treated and the Company also anticipates two studies in mesothelioma and ovarian cancer, sponsored by external parties, to start in Q1 2011.
Stuart Naylor, Chief Scientific Officer of Oxford BioMedica, said: "The publication of the TRIST results in the Clinical Cancer Research journal supports the potential for TroVax® to bring significant benefit to cancer patients worldwide. It is important for the cancer vaccine community to learn as much as possible from the data available and, as such, these continuing analyses may help identify those patients who are more likely to benefit from this class of therapy.
"The fact that patients who are likely to respond well to TroVax® can be identified by a simple blood test is pivotal for the planning of all future studies; we have applied this to our current Phase II study and look forward to seeing the next results from our TroVax® clinical programme."
-Ends-
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For further information, please contact: |
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Oxford BioMedica plc: Lara Mott, Head of Corporate Communications |
Tel: +44 (0)1865 783 000 |
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Media/Financial Enquiries: Emma Thompson/Rob Newman/Ben Simons M:Communications |
Tel: +44 (0)20 7920 2345
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US Enquiries: Thomas Fechtner The Trout Group LLC |
Tel: +1 (646) 378 2900 |
Notes to editors
1. 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 needs. The Company's technology platform includes a highly efficient gene delivery system (LentiVector®), 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 in-house and collaborative research, Oxford BioMedica has a broad pipeline and its partners include sanofi-aventis, Sigma-Aldrich and Pfizer. Further information is available at www.oxfordbiomedica.co.uk.
2. TroVax®
TroVax® is Oxford BioMedica's therapeutic cancer vaccine which is designed 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 Modified Vaccinia Ankara vector, 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 antigen.
3. Clinical Cancer Research
Clinical Cancer Research is a journal of the American Association for Cancer Research whose focus is to publish innovative clinical and translational cancer research studies that bridge the laboratory and the clinic. Clinical Cancer Research is especially interested in clinical trials evaluating new treatments, accompanied by research on pharmacology and molecular alterations or biomarkers that predict response or resistance to treatment. The journal also prioritises laboratory and animal studies of new drugs and molecule-targeted agents with the potential to lead to clinical trials, and studies of targetable mechanisms of oncogenesis, progression of the malignant phenotype, and metastatic disease.
Clinical Cancer Research will publish articles that provide the reader with knowledge and information to impact the natural history of malignant disease by providing better care for patients with cancer.
This information is provided by RNS
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