Oxford Biomedica annouces results from three phase II trails

04-Mar-2005

Oxford BioMedica announced encouraging results from three ongoing Phase II trials of TroVax, its lead cancer immunotherapy, in the treatment of metastatic colorectal cancer. New data from two trials in first line treatment of metastatic colorectal cancer with concomitant chemotherapy have confirmed previous indications that the primary endpoints of safety and immunological responses have been achieved. All patients that have reached the interim stage of the trial have shown an immune response to the 5T4 tumour antigen.

The Company also reported that, in the two trials, the secondary endpoint of clinical benefit has exceeded expectation. Eighteen of 19 evaluable patients responded to treatment. Whilst five patients had disease stabilisation following treatment, 13 of the 19 patients were defined as clinical responders according to industry standard criteria. These comprised three complete (total tumour shrinkage) responders and ten partial (more than 30 per cent tumour shrinkage) responders.

Data emerging from the Phase II trials suggest that the magnitude and duration of immune responses may be even greater in first line treatment with concomitant chemotherapy and in the (neo) adjuvant setting with surgery. The new data provide further evidence that TroVax may offer potential benefit to patients with colorectal cancer.

More than 65 patients with colorectal cancer have been treated with TroVax to date in four clinical trials. Across all the trials, the safety profile of TroVax has been excellent and the majority (98 per cent) of assessable patients (50 patients) have mounted immune responses following treatment with TroVax. This is an exceptionally high response rate in the context of clinical studies with other cancer vaccines (Mocellin et al., Lancet Oncology 2004; vol 5: 681-9). TroVax has been investigated in different settings in these trials - first line treatment with chemotherapy, second line treatment and the (neo) adjuvant setting with surgery - and achieved its primary endpoints in each setting.

These data suggest that TroVax has therapeutic potential across all stages of colorectal cancer, supporting the notion that the product may reach large markets in this indication.

https://www.bionity.com/en/news/43960/oxford-biomedica-annouces-results-from-three-phase-ii-trails.html