Oxford BioMedica has received a Special Protocol Assessment (SPA) agreement from the US Food and Drug Administration (FDA) for a Phase III trial of TroVax in renal cell carcinoma
The written agreement from the FDA specifies the design, conduct, analysis and endpoints of the trial, which, if successful, will support an efficacy claim in a regulatory submission for product registration.
The SPA was received at the end of the FDA's first review period following Oxford BioMedica's application in March 2006.
Oxford BioMedica plans to start the trial in the second half of 2006.
The Phase III trial, referred to as Trist (TroVax renal immunotherapy survival trial), will 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 adenocarcinoma.
The trial will be a randomised, placebo-controlled, two-arm study of TroVax in combination with standard of care versus placebo with standard of care.
Standard of care will be interleukin-2, interferon-alpha or Sutent (sunitinib).
Study treatment will be stratified between the standard of care options to ensure that the allocation of TroVax and placebo is rigorously balanced.
Recruitment will be approximately 700 patients in about 120 centres in the USA, European Union and Eastern Europe.
The primary endpoint will be survival improvement and secondary endpoints will 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.
Oxford BioMedica is also discussing the Trist trial with regulatory authorities in Europe.
In addition, the company plans to seek 'orphan drug' designation for TroVax in both the USA and Europe for renal cell carcinoma.
The granting of orphan drug status would provide Oxford BioMedica and any prospective commercial partner with various benefits in terms of regulatory exclusivity, assistance with clinical development and a waiver of filing fees.
Oxford BioMedica's chief medical officer, Mike McDonald, said: "We are delighted to have secured the SPA within such a short time period.
"We have worked closely with the FDA on the design of the TRIST study and they have been extremely supportive.
"We look forward to starting this pivotal trial of TroVax in a cancer setting where there are few treatment options and there is a need for new approaches that are both safe and effective." Commenting on the SPA, Oxford BioMedica's chief executive, Alan Kingsman, said: "This is a significant milestone for the company.
"It represents the successful achievement of the first of our major goals for 2006."
