Oxford BioMedica says the first patient has been treated in Trist, a multi-centre Phase III trial of cancer immunotherapy TroVax in patients with advanced or metastatic renal cell carcinoma (RCC)
Mike McDonald, Oxford BioMedica's chief medical officer, commented on the start of the study: "The Phase III Trist study is designed to demonstrate definitively that TroVax is effective as a treatment for this aggressive form of kidney cancer".
"The clinical experience with TroVax in over 150 patients has shown indications of its therapeutic potential as well as its excellent safety profile".
Trist (TroVax renal immunotherapy survival trial) is a Phase III trial that is designed to evaluate whether TroVax immunotherapy, added to first-line standard of care therapy, prolongs the survival of patients with locally advanced or metastatic clear cell renal carcinoma.
The trial is a randomised, placebo-controlled, two-arm study that will compare TroVax in combination with standard of care to placebo with standard of care.
The standard of care therapies will be interleukin-2, interferon-alpha or Sutent (sunitinib).
The protocol stratifies treatment between the standard of care options to ensure that the allocation of TroVax and placebo is rigorously balanced.
Approximately 700 patients will be recruited from about 120 centres in the USA, European Union and Eastern Europe.
The primary endpoint for the trial is survival improvement and secondary endpoints include progression-free survival, tumour response rates and quality of life scores.
The protocol includes the appointment of a Safety and Efficacy Monitoring Board (SEMB) to assess the safety and potential efficacy of the drug combinations at various time points during the trial.
In May 2006, Oxford BioMedica received a special protocol assessment (SPA) agreement for the Trist study from the US Food and Drug Administration (FDA).
The SPA process enables FDA evaluation of a trial protocol that is intended to form the primary basis of an efficacy claim for product registration.
The SPA agreement ensures that the design, conduct, analysis and endpoints of the trial are all acceptable to the FDA.
Oxford BioMedica anticipates rapid patient recruitment.
Median survival for patients with advanced or metastatic renal cell carcinoma is approximately 11 months.
The duration of the trial will be determined by the number of survival events (deaths) in the study group.
The trial is expected to reach a conclusion in 2008-09, which would support the company's objective of reaching product registration in 2009.
Commenting on the news, Oxford BioMedica's chief executive, professor Alan Kingsman said: "The start of our first Phase III trial is an important milestone for Oxford BioMedica and ensures that the TroVax programme is on track for potential product registration in 2009.
"In addition, starting the Phase III trial further emphasises the value of the product to potential partners".
The company remains committed to securing a major corporate partner for the ongoing development and commercialisation of TroVax.
As reported in September, discussions with lead prospective partners have progressed to development strategies and deal terms.
The most advanced prospect is a major pharmaceutical company with a leading oncology franchise that completed its due diligence on the TroVax programme recently.
Oxford BioMedica is working expeditiously with three other global pharmaceutical companies to bring all four companies to the same stage of discussions.
