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So far, so good

Preliminary findings of two phase II trials of TroVax show that the immunotherapy is effective

Oxford BioMedica's cancer immunotherapy product in renal cell carcinoma (RCC) and prostate cancer, TroVax, has been dubbed effective by cancer experts after encouraging data from two phase III clinical trials.

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-a (IFN). The regimen comprises seven intramuscular injections for TroVax over 41 weeks.

Results of the trials, which have so far enrolled 33 patients with progressive metastatic RCC, 18 of which are currently receiving therapy, revealed that one patient had a complete response (tumour eradication) and two patients developed a partial response (tumour shrinkage). The remaining 15 patients showed disease stabilisation for periods of more than three months, including one patient that has been stable for a over 46 weeks.

The patient who had a complete response to TroVax received the drug in combination with IL-2.

Although it is too early to assess survival rates in the two studies and immunological analysis is ongoing, preliminary assessment has shown that TroVax induced 5T4-specific antibody responses in more than 90 per cent of patients evaluated.

In patients with clear cell RCC, there was a statistically significant correlation between the immune response to 5T4 and clinical benefits based on changes to individual patients' tumours. These data support the rationale that the 5T4-specific immune response offers therapeutic benefits to patients.

Oxford BioMedica has started a phase III trial - TroVax Renal Immunotherapy Survival Trial (TRIST) - in 700 patients with advanced RCC from 120 centres in the US, European Union and Eastern Europe. The randomised, placebo-controlled, two-arm study will compare TroVax in combination with standard of care to placebo with standard care. The standard care therapies will be IL-2, interferon-a or Sutent

Prostate cancer
The phase II trial in prostate cancer is also designed to evaluate the safety and immunogenicity of TroVax as a single agent and in combination with standard therapy GM-CSF. The regimen comprises 10 intramuscular injections of TroVax over 45 weeks.

Some 27 patients with hormone-refractory prostate cancer have enrolled in the trial and eight are 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.

To date, 150 patients with colorectal, renal or prostate cancer have been treated with TroVax. Colorectal cancer and RCC are lead indications for Oxford BioMedica in the development of TroVax.

30th September 2008

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