Positive Safety Data From Precision Clinical Trial For Drug Eluting Bead

Biocompatibles

150 MGS OF DOXORUBICIN SAFELY DELIVERED

Biocompatibles International plc., the medical device company focused on the treatment of cardiovascular disease, cancer and benign tumours, is pleased to announce positive safety data from the PRECISION clinical trials for the evaluation of the Drug Eluting Bead.

The data will be presented on Sunday 26th September at CIRSE 2004, the Cardiovascular and Interventional Radiological Society of Europe, by Dr. Ronnie Poon, Associate Professor at the Centre for the Study of Liver Disease, University of Hong Kong, the trial’s principal co-investigator.

Low Levels of Plasma Doxorubicin

Data for the levels of plasma doxorubicin over the first 72 hours have been reviewed for the 15 patients in the dose escalation phase of PRECISION Asia. They have then been compared with published data for the TACE (Trans Arterial Chemo Embolisation) technique that is at present the standard therapy for the group of Hepatocellular Carcinoma (HCC) patients studied in PRECISION.

The Drug Eluting Bead demonstrated a significant reduction in systemic exposure compared with the TACE procedure (p: <0.001). Peak doxorubicin levels were reduced by more than 99%. 1

Patients continue to be recruited into the trial at the highest dose available

Low Complication Rate for First 30 Patients

High plasma levels of chemotherapeutic drugs, like doxorubicin, are often associated with toxicity related complications.

Analyses of the first 30 patients in Hong Kong and Barcelona have shown that only three patients experienced treatment related complications, a 10% event rate. This compares with a 27.5% complication rate in the most recently published trial for the TACE technique.2 Previous TACE studies have shown considerably higher event rates. 3

Positive Trend in Tumour Response

A small number of patients have had their scheduled three month MRI follow up. The tumour response in these patients is consistent with achievement of the study’s goal of an improvement in the 35% response rate observed in recently published trials for the TACE technique. Further data from PRECISION trials will be published during the balance of 2004 and 2005.

Dr Poon commented, “The Drug Eluting Bead is a promising option. Our patients have tolerated the treatment well”.

The Drug Eluting Bead used in the high-dose, current, phase of PRECISION is designed to deliver 150 mgs of doxorubicin at each treatment. A typical TACE treatment delivers 60-100mgs and patients typically have only four treatments because of the cumulative cardio-toxic effect of high levels of plasma doxorubicin. The investigators expect that PRECISION patients will be able to receive further Drug Eluting Bead treatments after the completion of the two treatments prescribed in the trial.

The Drug Eluting Bead was CE Marked earlier this year and has been made available for physician evaluation in Europe and certain other countries.

Dr Peter Stratford, Managing Director of Biocompatibles’ Drug Delivery Division commented, “We are delighted with these results. We now have clinical data demonstrating the viability of our Drug Eluting Bead concept.”

  • Johnson PJ et al. J Hepatology 13;120:1990
  • Llovet JM et al. The Lancet 359; 1734: 2002
  • Groupe d’Etude et de Traitement du Carcinome Hepatocellulaire. The New England Journal of Medicine 332; 1256: 1995
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