PRECISION V Results
15/08/2008
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Drug-Eluting Bead Arm has a higher Tumour Response (51.6%) than the Control Arm (43.5%), (not significant: p=0.1135)
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Drug-Eluting Bead Arm has a lower rate of drug-related adverse events (13%) than the control arm (37%), (significant: p=0.0001)
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Safety profile between the two groups is otherwise similar
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Principal Investigator Panel: “We believe that these results show that DC Bead is a better treatment than conventional TACE”
Biocompatibles is pleased to announce the headline results from the PRECISION V clinical trial. A more complete presentation of the results will take place as planned at CIRSE (Cardiovascular and Interventional Radiological Society of Europe) 2008, September 13-17, 2008, Copenhagen. A further announcement will be made at that time.
PRECISION V is a prospective, single blind, Phase II randomised controlled trial evaluating Biocompatibles’ Drug-Eluting Bead against a control arm of conventional TACE (cTACE) in HCC. 212 patients were recruited at 23 European hospitals. 201 patients received at least one treatment and are the basis for this primary analysis.
The Principal Investigator Panel – composed of Professor Johannes Lammer1, Professor Anthony Watkinson2 and Professor Riccardo Lencioni3 – concluded that the PRECISION V results “… show that DC Bead is a better treatment than conventional TACE. An improved response with significantly lower toxicity is unusual for a new cancer therapy.”
The primary end point of the trial is Tumour Response at six months. The Drug-Eluting Bead Arm has a higher Tumour Response (51.6%) than the Control Arm (43.5%) – a 19% improvement (not statistically significant, p=0.1135).
The Drug-Eluting Bead Arm has a lower rate of drug-related adverse events (13%) than the control arm (37%) – a statistically significant difference (p=0.0001). The data for drug-related adverse events is important in the context of the planned evaluation of the Drug-Eluting Beads in combination with new systemic drug therapies. More news on this programme is expected in the next few weeks.
Crispin Simon, the Chief Executive of Biocompatibles, commented “We are pleased with the results of PRECISION V which we expect to support the continued growth of the Drug-Eluting Bead products; where the next significant news is expected to be approval in China.”
1 Principal Investigator and Professor of Radiology, Medical University, Vienna, Austria.
2 Chairman of the Data Monitoring Committee and Professor of Radiology, Peninsular Medical School, Royal Devon & Exeter Hospital. UK.
3 Adjudicator for the independent central imaging and Professor of Radiology, University Hospital, Pisa, Italy.