Acquisition of novel biodegradable bead technology
PRECISION I clinical trials positive data
Category: Biocompatibles Company News
Biocompatibles International plc., the medical device company focused on the treatment of cancer, cardiovascular disease and benign tumours, is pleased to announce further positive data from the PRECISION I clinical trials for the evaluation of the Drug Eluting Bead in the treatment of patients with intermediate stage hepatocellular carcinoma (primary liver cancer).
At a presentation to the British Society of Gastroenterology at Birmingham, on 16th March 2005, Dr Jordi Bruix, Head of the Barcelona Clinic Liver Cancer Group within the Liver Unit at the Hospital Clinic in Barcelona and the principal investigator for PRECISIONI (Barcelona), presented further preliminary data from the PRECISION trials.
Fifteen patients in Hong Kong have now been evaluated for tumour response at three months and 61% have been found to have responded to the treatment (objective response by EASL criteria). The tumour response by the RECIST criteria was 53%. These data compare with data from a reference study of 35% using similar criteria.1
Dr Bruix also presented data on complications for the same patient group where an event rate of 13% was recorded. A complication rate of 27% was recorded in the reference trial using similar criteria at a different time point.
Dr Bruix commented “These data from our colleagues in Hong Kong are very promising and I look forward to seeing the first results from Barcelona.”
It is expected that the final data on all 30 patients from PRECISION II (Hong Kong) will be presented in the fourth quarter of 2005; and from PRECISION I (Barcelona) in the first half of 2006.
Biocompatibles is in the process of planning a randomised controlled trial (PRECISION IV) that is designed to establish the Drug Eluting Bead as the definitive treatment for patients with intermediate stage primary liver cancer. It is intended that the first patient be recruited during the course of 2005. The company believes that the United States FDA will require data from PRECISION IV before granting marketing approval in the US.
Crispin Simon, Biocompatibles’ Chief Executive, commented: “We are delighted with these preliminary results. With the Drug Eluting Bead technology, we know that there is more drug going into the tumours and less going into the patient’s circulating blood. And these results suggest that the patients are seeing the benefits that were intended.”
“Chemo-embolisation improves survival of stringently selected patients with unresectable hepatocellular carcinoma” The Lancet Vol 359. May 18 2002