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Liver Metastases Clinical Trial referenced by Cancer Research UK

Farnham, UK, 13 August 2010: Biocompatibles (LSE:BII), the medical technology company, is pleased to announce that the Paragon II clinical trial now appears on the database of CancerHelp UK – the patient information arm of Cancer Research UK.

Paragon II is an MHRA1-approved, Phase II clinical trial for the evaluation of Drug-Eluting Beads delivering irinotecan (DEBIRI), for the treatment of liver metastases from colorectal cancer, in patients who are eligible for surgical resection. The treatment combines giving irinotecan straight to the cancer with a way of blocking the blood vessels that supply the tumour with nutrients. Patients are treated - initially with DEBIRI and then, approximately one month later, by surgical resection of the liver tumour.

The Cancer Research UK reference is at http://www.cancerhelp.org.uk/trials/a-trial-looking-irinotecan-beads-bowel-cancer-spread-liver-PARAGON-II.

Each year there are more than 36,000 new cases of colorectal cancer in the UK, in which 50% develop liver metastases within five years of diagnosis. In around 20% of cases, these liver tumours can be surgically resected - a patient's best chance of longer-term survival – the five year survival rate being around 25%.

Mr Graeme Poston, Chairman, and Chairman of Surgery, of the Liverpool, Mersey and North Cheshire Hepatobiliary Cancer Network and principal investigator of the trial recently presented promising results on an initial cohort of 18 patients recruited in the Paragon II trial at the World Congress for Gastro-Intestinal Cancer (Barcelona, Spain: July 1-3, 2010)].

UK participating hospitals include, University Hospital, Aintree, Liverpool and Basingstoke and North Hampshire Hospital, Basingstoke.

Crispin Simon, CEO of Biocompatibles, commented;

"CancerHelp UK offers patients a wealth of information that is clear, reliable and easy to understand. We are delighted that they have recognised the potential value of treating Liver Metastases with DEBIRI and look forward to reporting results of the trial."

PARAGON II is a trial within a clinical programme studying DEBIRI in the treatment of liver metastases from colo-rectal cancer. PARAGON Louisville is the next most advanced trial within this programme, and is studying DEBIRI in a first line setting in the US in combination with the standard of care chemotherapy regimen, FOLFOX plus Avastin.

-Ends-

1Medicines and Healthcare products Regulatory Agency

Contact:

Biocompatibles +44 (0) 1252 732732
Crispin Simon, Chief Executive  
Ian Ardill, Finance Director  
   
Anna Keeble +44 (0) 7879 818876

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.