Oxford BioMedica reports that the first patient has been treated in a second Phase II trial with TroVax in combination with interleukin-2 (IL-2) in patients with metastatic renal cell carcinoma (RCC)
There are now five Phase II trials ongoing with TroVax in RCC and colorectal cancer.
The first patient was treated in a second Phase II trial in RCC at the Methodist Hospital in Texas, USA, on 14 November 2005.
This open label trial is expected to recruit up to 25 patients.
The Principal Investigator for the trial is Robert Amato, who is an internationally recognised opinion leader in the treatment of RCC.
The trial is designed to evaluate the safety and immunogenicity of TroVax in conjunction with low dose IL-2, which is commonly used in the treatment of RCC.
Initial data from this trial are expected in the first half of 2006.
The company is targeting RCC as a lead indication for the development of TroVax, in addition to colorectal cancer.
As reported on 2 November 2005, the company believes that RCC is an indication where TroVax might achieve a rapid route to product registration.
The company aims to initiate a Phase III trial of TroVax in RCC in 2006 and is targeting product registration in 2009.
In parallel, the Company is conducting negotiations with potential partners for TroVax.
The current treatment market for RCC is approximately US$600 million according to Datamonitor.
Commenting on the news, Oxford BioMedica's chief medical officer, Mike McDonald, said: "We are delighted to have Dr Amato's support for the TroVax programme as we also prepare to begin a large randomised Phase III registration trial in mid 2006.
"The Phase III trial will assess the impact of TroVax in prolonging survival of patients with this rapidly progressive disease."
