The US Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application to evaluate TroVax, a proprietary cancer vaccine, in patients with metastatic renal cancer
TroVax will be tested in combination with the standard treatment interleukin-2 (IL-2), an immune stimulator, in patients whose median survival is approximately 13 months.
Safety and immunogenicity will be the primary goals, but patients will be monitored for clinical benefit including increased survival.
The trial will be conducted at the Columbia Presbyterian Medical Center in New York and patient recruitment is expected to start in Q3 2004.
The study should be complete, as far as the primary end-points are concerned, within approximately twelve months of initiation.
There were an estimated 31,900 new cases of renal cancer in the USA in 2003 (source: American Cancer Society, Cancer Facts and Figures for 2003).
More than half of these patients have metastatic disease (secondary cancer).
After surgical removal of the primary tumour, treatment with IL-2 has been shown to have some benefit, suggesting that the tumours may be responsive to immunological strategies.
The rationale for this trial is that the immune response induced by TroVax may halt or delay the progression of metastases so increasing survival beyond the estimated median of 13 months.
Using TroVax in combination with IL-2 may enhance that response.
There is a great need for additional therapies for renal cancer as the prognosis for patients is poor with current treatments.
The regulatory strategy for the development of TroVax will involve seeking fast track approval and opening discussions about product registration if early data are encouraging.
Commenting on the approval Oxford BioMedica's chief executive, professor Alan Kingsman, said: "We are delighted to be able to take TroVax into the USA in an indication that has real unmet medical need".
"We expect patient recruitment to be faster than we have seen in previous trials and we are excited about testing TroVax with an immune stimulator such as IL2."
