Promising Data in Liver Metastases Clinical Trial
First Line Combination FOLFOX + DEBIRI
FDA Approval of Phase IIb Trial in the United States
Farnham UK, 26 August 2010: Biocompatibles International plc (LSE:BII), the medical technology company, is pleased to announce the presentation of promising Phase I/II data in a clinical trial evaluating DEBIRI (Drug-Eluting Beads loaded with irinotecan) in liver metastases from colo-rectal cancer; and FDA approval for continuing the clinical trial into a randomised Phase IIb.
Robert Martin MD PhD, Associate Professor of Surgery in the Division of Surgical Oncology at the University of Louisville presented data at the World Congress for Gastro-Intestinal Cancer (Barcelona, Spain: 30 Jun-3 Jul, 2010) for ten patients with unresectable liver metastases who had received no prior treatment (first line) and who had been treated with the combination of FOLFOX1 + DEBIRI2.
Five of the ten patients were down-staged to a potentially curative surgical treatment3 and Dr. Martin described the treatment regime as "safe and effective with superior surgical downstaging."
The Chairman of the session, Dr. Eric Van Cutsem MD PhD, Professor of Internal Medicine at the University of Leuven in Belgium concluded that DEBIRI is a "…new and promising technique."
With FDA approval for the randomised Phase IIb, the following hospitals will now join the trial – Emory University, Atlanta, GA; Piedmont Hospital, Atlanta, GA and Clearwater Cancer Center, Huntsville, AL. 60 patients will be randomised to FOLFOX or FOLFOX + DEBIRI4. The primary end-point is tumour response with secondary end-points that include safety, progression free survival and overall survival. Results are expected in 2012.
DEBIRI with DC Bead is approved for use in the UK and 30 other countries.
Crispin Simon, Chief Executive, commented:
"The FOLFOX regimen is a standard of care because it has been shown to extend survival. But the liver metastases will still typically progress with systemic chemotherapy unless they can be surgically removed.
And while FOLFOX is a systemic treatment, DEBIRI is a catheter-targeted local treatment - so there is a good rationale to explain the increase in the number of patients in this trial who were down-staged to resection and a potential cure.
These are very promising results.
And following the NICE rejection of Avastin this week, patients do now have another option to discuss with their doctor."
-Ends-
1 FOLFOX is a chemotherapy regimen made up of 5-fluorouracil, leucovorin and oxaliplatin
2 Six patients were also treated with Avastin (bevacizumab), as clinically indicated. Avastin is a registered trademark of Genentech, part of the Roche group
3 Four patients were treated with surgical resection and one with radio-frequency ablation
4 Patients will also be treated with Avastin where clinically indicated.
Contact:
| Biocompatibles | +44 (0) 1252 732706 |
| Crispin Simon, Chief Executive | |
| Ian Ardill, Finance Director | |
| Anna Keeble | +44 (0) 7879 818876 |
Biocompatibles International plc (www.biocompatibles.com)
Biocompatibles International plc
Biocompatibles International plc is a leading medical technology company in the field of drug-device combination products.
The Oncology Products Division supplies medical devices from facilities in Farnham, UK and Oxford, CT. These include Drug-Eluting Bead Products which are used in more than 40 countries for the treatment of primary liver cancer (HCC), liver metastases from colorectal cancer, and other cancers; and Brachytherapy products (Radiation-Delivering Seeds) which are used in the treatment of prostate cancer. Our distribution partners include AngioDynamics Inc., Terumo Corporation and Eisai Co. Ltd. We have a clinical collaboration agreement with Bayer Healthcare Pharmaceuticals Inc.
Our Licensing Division includes CellMed, in Alzenau, Germany, which is developing a Drug-Eluting Bead product for the treatment of stroke, based on proprietary stem cell technology; a GLP-1 analogue for the treatment of diabetes and obesity partnered with AstraZeneca; and a cosmetic Dermatology Bead partnered with Merz Pharmaceuticals GmbH. We also have a PC Licensing agreement with Medtronic Inc. in the field of Drug-Eluting Stents.
This news release contains forward-looking statements that reflect Biocompatibles' current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of Biocompatibles' research strategy, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory and commercialisation processes.