The data show that TroVax is safe and well tolerated in this patient group and that the product induces a strong anti-tumour immune response against the 5T4 tumour antigen
Oxford BioMedica announces preliminary data from the Phase II trial of TroVax in renal cell carcinoma (RCC).
The data show that TroVax is safe and well tolerated in this patient group and that the product induces a strong anti-tumour immune response against the 5T4 tumour antigen.
Some of these data were referred to in a presentation made by the principal investigator for this Phase II trial at the World Vaccine Congress on 5 October 2005.
The Phase II trial in RCC is being conducted at the New York-Presbyterian Hospital in New York, USA, under an approved Investigational New Drug protocol.
The principal investigator for the trial is Dr Howard Kaufmann of the New York-Presbyterian Hospital.
Dr Kaufmann is a leading expert in clinical immunotherapy and is an advisor on TroVax.
The Phase II trial is an open label study of TroVax in combination with interleukin-2 (IL-2) therapy, which is an FDA-approved treatment for RCC.
Patients receive five immunisations of TroVax over 12 weeks and up to four cycles of high dose IL-2.
Patients that show an anti-tumour immune response to TroVax will be offered an additional three vaccinations.
The primary endpoints of the trial are safety and immunogenicity.
Secondary efficacy endpoints include tumour responses, time to disease progression and overall survival.
The trial is intended to recruit up to 25 patients, in order to gather information on the safety of TroVax in this setting and also the ability of TroVax to elicit immune responses to the tumour antigen 5T4.
To date, seven patients have been recruited.
There have been no serious adverse events related to TroVax, which is consistent with the safety profile of the product across all trials, and TroVax treatment has been well tolerated.
Five patients have reached the preliminary analysis point for immune responses.
This preliminary time point is after two immunisations with TroVax.
All five patients have shown high anti-tumour antibody responses to 5T4.
The antibody levels were at the top end of the range reported from the Phase II trials with TroVax in patients with colorectal cancer undergoing chemotherapy.
Anti-tumour cellular responses against the 5T4 antigen will be analysed and reported in due course.
Dr Howard Kaufmann gave a presentation on 5 October 2005 at the World Vaccine Congress in Lyon, France, in a session on Vaccines in Clinical Development.
In his presentation, titled "Poxvirus Vaccine Strategies for the Treatment of Cancer", Dr Kaufmann referred to the Phase II trial with TroVax in RCC and highlighted the potential of the product.
Independently, there has been a recent publication on the prevalence of 5T4 expression in renal cancer.
This was authored by Robert Hawkins of the Christie Hospital in Manchester (see Griffiths et al., British Journal of Cancer 2005).
In this publication, most RCC tumours were found to have high levels of 5T4 expression, both on primary and metastatic sites.
This suggests that the majority of patients with RCC could benefit from a 5T4-targeted product such as TroVax.
Commenting on the TroVax results in renal cell carcinoma, Oxford BioMedica's Chief Executive, Professor Alan Kingsman said: "It is very encouraging that the results with TroVax in renal cell carcinoma are consistent with our data set in colorectal cancer".
"We are also grateful for the strong support of TroVax shown by Dr Kaufmann".
"Renal cell carcinoma is an aggressive disease with an unmet need for effective treatments".
"The high levels of 5T4 in renal cancer and the paucity of treatment options make this an ideal setting for further development of TroVax".
