Update on Hepatic Colorectal Cancer Metastases Programme, DEBIRI
10/09/2007
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Update on Hepatic Colorectal Cancer Metastases Programme, DEBIRI
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Positive Preliminary Results in DEBIRI v FOLFIRI trial
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DEBIRI Cost significantly lower than conventional Chemotherapy Regimen
Biocompatibles International plc, a medical technology company focused on drug-device Combination Products principally for use in oncology, is pleased to provide an update on the metastatic colorectal cancer (mCRC) clinical trials conducted at Empoli/Ferrara, Italy, where the DC Bead loaded with irinotecan (DEBIRI) has been extensively evaluated in patients with liver metastases from colorectal cancer.
At the 2007 Meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) on September 9th, Dr Camillo Aliberti, Department of Interventional Radiology, Delta Hospital, Azienda Unità Sanitaria Locale, Ferrara and Professor Giammaria Fiorentini, Department of Oncology, San Giuseppe Hospital, Empoli, Florence, presented an update on two clinical trials that enrolled a combined total of 52 patients.
In the First, Registry, trial, whose earlier data had been presented at CIRSE 2006 and ASCO GI 2007, twenty patients with liver metastases whose disease had progressed from prior systemic chemotherapy, were treated with 38 cycles of DEBIRI with a dose of 100mgs of irinotecan. At the new reporting date, 15 patients (75%) were alive, with a median survival of 210 days (range: 90 to 380 days).
The procedure was well tolerated by most patients with median duration of hospitalization of three days (range 1-10 days). Additional quality of life data demonstrated that 90% of the patients reported an improvement.
On the basis of the data from the Registry trial, the investigators designed a second trial, DEBIRI v FOLFIRI, in which Dr Aliberti and Professor Fiorentini treated 32 patients whose disease had progressed from prior systemic chemotherapy. 14 patients were treated with 27 procedures of DEBIRI and 18 patients with 144 doses of FOLFIRI - an approved systemic chemotherapy regimen incorporating irinotecan.
In the DEBIRI arm the response rate was 80% and in the FOLFIRI arm the response rate was 10%. The eight week quality of life improvement was 70% and 30% respectively. Preliminary survival data was favourable for the DEBIRI arm.
The cost per patient of the DEBIRI and FOLFIRI treatments was €4,000 and €12,000 respectively.
Professor Fiorentini commented “The survival data is beginning to look very interesting and I look forward to further randomised studies. It is certainly good to have alternatives to expensive new drugs.”
Crispin Simon, Chief Executive of Biocompatibles, commented "People are concerned about the cost of new cancer drugs. We believe that DEBIRI can offer a safe, effective and affordable treatment option and are progressing the clinical programme accordingly."
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Notes to Editors:
DEBIRI Drug-Eluting Bead with Irinotecan
FOLFIRI Chemotherapy regimen for the treatment of colorectal cancer, made up of the drugs FOLinic Acid (Leucovorin), Fluorouracil (5-FU) and IRInotecan (Camptosar).
Biocompatibles International plc is a leading medical technology company in the field of drug-device Combination Products, operating through two businesses. Biocompatibles supplies Bead and Drug-Eluting Bead products – primarily for use in Oncology; and supplies polymer for Medtronic’s Endeavor Drug-Eluting Stent product. CellMed is developing a Bead product for Cosmetic Dermatology and a Drug-Eluting Bead product for the treatment of stroke, based on proprietary stem cell technology. Our strategic partners include Angiodynamics Inc, Medtronic Inc, Merz AG and Terumo Corporation.