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OXFORD BIOMEDICA REPORTS FURTHER
ENCOURAGING PHASE II RESULTS WITH TROVAX IN RENAL AND PROSTATE CANCER
– Presentations at the 18th EORTC-NCI-AACR Symposium, 7-10 November 2006
in Prague, Czech Republic – |
Oxford, UK – 9 November 2006: Oxford BioMedica (LSE: OXB), a leading gene
therapy company, announced today that Dr. Robert Amato has presented further
encouraging data from three Phase II trials of TroVax, the Company’s lead cancer
immunotherapy product, in renal cell carcinoma and prostate cancer at the 18th
EORTC-NCI-AACR Symposium on "Molecular Targets and Cancer Therapeutics", which
is being held on 7-10 November 2006 in Prague, Czech Republic.
http://www.fecs.be/emc.asp?pageId=973&Type=P
Dr. Amato of the Genitourinary Oncology Centre, the Methodist Hospital in
Houston, USA, is the Principal Investigator for two ongoing Phase II trials of
TroVax in renal cell carcinoma (RCC) and a Phase II trial of TroVax in prostate
cancer.
The RCC trials are designed to evaluate the safety, immunogenicity and
effectiveness of TroVax as a single agent and in combination with standard
therapy of interleukin-2 (IL-2) or interferon-α (IFN). The regimen comprises
seven intramuscular injections of TroVax over 41 weeks. To date, the two trials
have enrolled 33 patients with progressive metastatic RCC and 18 patients are
currently receiving therapy. All patients were heavily pre-treated before
entering the trials. Dr. Amato presented data showing that TroVax was well
tolerated and has shown promising anti-tumour activity in this patient group.
One patient had a complete response (tumour eradication) and two patients
developed a partial response (tumour shrinkage). A further 15 patients showed
disease stabilisation for periods exceeding three months, including one patient
that has been stable for more than 46 weeks. Overall survival in the two studies
is too early to assess and has yet to reach a median. The immunological analysis
is ongoing but a preliminary assessment has shown that TroVax induced
5T4-specific antibody responses in more than 90% of evaluable patients.
Importantly, in patients with clear cell RCC, there was a statistically
significant correlation (p=0.028) between the immune response to 5T4 and
clinical benefit based on changes in patients’ tumour burden. This is
particularly encouraging since it supports the rationale that the 5T4-specific
immune response induced by TroVax has therapeutic benefit. Clear cell RCC is the
most common subtype of renal cancer and is the patient group for the Phase III
TRIST study.
The Phase II trial in prostate cancer is similarly designed to evaluate the
safety and immunogenicity of TroVax as a single agent and in combination with
standard therapy of GM-CSF. The regimen comprises ten intramuscular injections
of TroVax over 45 weeks. The trial has enrolled 27 patients with
hormone-refractory prostate cancer and eight patients continue to receive
therapy. TroVax was well tolerated and all patients developed a strong
5T4-specific antibody response whether or not they received GM-CSF. Analysis of
cytotoxic T-cell immune responses stimulated by TroVax in the renal and prostate
cancer trials is ongoing.
Dr Mike McDonald, Oxford BioMedica’s Chief Medical Officer, commented on the new
data: “We are very encouraged by the data emerging form these Phase II trials.
The data provide further evidence that TroVax can be administered safely and
that it induces consistent antibody responses to the target tumour antigen 5T4.
The correlation between immune and clinical responses supports our Phase III
development strategy of TroVax in renal cancer”.
Presentation abstracts are available at:
http://www.oxfordbiomedica.co.uk/news/2006-ob-23.htm
-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:
Gemma Bradley/ Susan Yu/ Katja Stout
Northbank Communications
Tel: +44 (0)20 3008 7555
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
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.
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