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Published on 15 April 2008

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Studies show benefit of drug-eluting beads

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Biocompatibles International plc is pleased to announce the results of a study presented by Professor Pierre Goffette, of the Saint-Luc University Hospital, Louvain Medical School, Brussels at the European Conference on Interventional Oncology in Florence, Italy.

Liver Transplant is one of three classes of treatment for Hepatocellular carcinoma (HCC) that offer the possibility of long-term survival. It is therefore described as a treatment prescribed “with curative intent”. Patients with HCC are assessed for their suitability for transplant according to the “Milan Criteria”. The five-year survival rate in patients who meet the Milan criteria is around 85%, and around 45% in patients who do not.

Approximately 40% of patients who are initially placed on the transplant list are eventually taken off it before receiving a transplant, due to tumour progression or worsening underlying liver disease.

Professor Goffette’s study included patients who both met, and fell outside, the Milan Criteria.

Professor Goffette prescribed 42 treatments of Drug-Eluting Bead therapy for eighteen patients. Eight patients met the Milan criteria and were awaiting liver transplant. Ten did not and were not on the transplant list at the time of treatment with Drug-Eluting Bead therapy.

Of the ten who initially did not meet the Milan Criteria, eight were down-staged and placed on the transplant list. Of the eighteen patients treated with Drug-Eluting Beads, twelve patients have now received a transplant.

In all eighteen patients the tumours treated with the Drug-Eluting Beads were assessed by radiological imaging and the Objective Response was in line with previous Drug-Eluting Bead studies. Imaging is, however, an imperfect assessment of biological activity, which is a major factor in determining patient outcomes.

A biological examination of the tumours in the explanted liver was therefore also made, by histological analysis, where the Objective Response was 92% and the Complete Response was 46%. Complete histological response from any treatment is rare; and is believed to correlate with long term survival. Professor Goffette commented on the higher anti-tumoral response compared with conventional TACE and remarked that complete necrosis had been achieved even in large tumours.

Professor Goffette’s data is consistent with data presented by Professor Antonio Nicolini of the Ospedale Maggiore Policlinico di Milano at the Society of Interventional Radiology Scientific Meeting in March this year. Professor Nicolini reported a complete response by histology in 71% of eight HCC patients who had been given a liver transplant. Crispin Simon, Chief Executive of Biocompatibles, commented: “Oncologists
who have seen the complete response data have been impressed; and the down-staging of patients onto the transplant list is obviously an important milestone.

“Of course we need to validate these findings in further trials but doctors are now telling their patients that Biocompatibles’ Drug-Eluting Bead therapy is a step on the way to a possible cure for their cancer. Drug therapy rarely offers that chance.”

Biocompatibles International plc



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