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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.

Regulatory notices and product safety data

Worldwide (excluding USA)

Bead Block™ is CE marked and indicated for the treatment of a variety of hypervascular tumours (including Uterine Fibroids) and arteriovenous malformations (AVMs). For full prescribing information please refer to Bead Block instructions for use.

DC Bead® is CE marked and is indicated for the treatment of malignant hypervascular tumours and loading with doxorubicin drug. DC Bead® is also indicated for loading with irinotecan for the treatment of metastatic colorectal cancer (mCRC). Both indications may not be available in your territory. For full prescribing information please refer to DC Bead instructions for use.

DC BeadM1™ is indicated for loading with irinotecan for the treatment of metastatic colorectal cancer (mCRC). For full prescribing information please refer to DC Bead M1 instructions for use.

USA

In the USA, Bead Block™ is indicated for the treatment of hypervascular tumors and arteriovenous malformations (AVMs). For full prescribing information please refer to Bead Block USA Instructions for use.

LC Bead™ is cleared by the FDA for the embolization of hypervascular tumors and arteriovenous malformations (AVMs). For full prescribing information please refer to LC Bead instructions for use.

LC Bead M1™ is cleared by the FDA for the embolization of hypervascular tumors and arteriovenous malformations (AVMs). For full prescribing information please refer to LC Bead M1 instructions for use.

DC Bead is not currently available for sale or distribution in the USA. Both indications may not be available in your territory. 

DC Bead M1 is not currently available for sale or distributions in the USA. 

Canada

DC Bead® with doxorubicin is indicated for trans-arterial chemoembolization (TACE) of unresectable hepatocellular carcinoma (HCC). DC Bead are also intended to be loaded with irinotecan for the purpose of embolization of vessels supplying malignant colorectal cancer metastasised to the liver (mCRC), and delivery of a local, controlled, sustained dose of irinotecan to the mCRC. For full prescribing information please refer to DC Bead Canada Instructions for Use 

DC BeadM1 is primarily intended as an embolic agent to treat vessels supplying malignant colorectal cancer metastasised to the liver (mCRC). DC BeadM1 is also compatible with irinotecan, which can be loaded prior to embolisation and then, as a secondary action, elute a local, controlled and sustained dose to the mCRC after embolisation. For full prescribing information please refer to DC BeadM1 Canada Instructions for Use  

Tawain

DC Bead is approved by the Department of Health and is intended to be loaded with Mayne (Hospira) doxorubicin HCI for the purpose of embolisation of vessels supplying malignant hypervascularised tumour(s), and delivery of a local, controlled, sustained dose of doxorubicin.  DC Bead is also indicated for the embolisation of nidus vessels without medication.  Approved size ranges in Taiwan are 300-500µm and 500-700µm.

Hong Kong

PRECISION Bead™ is indicated for the delivery of Doxorubicin, a chemotherapeutic agent for the treatment of malignant hypervascular tumours, where Trans Arterial Embolisation (TAE) is not contraindicated.