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€6.2m Grant for the development of CellBeads in Cardiovascular Diseases

Farnham, UK, 30 March 2010: Biocompatibles International plc (LSE:BII) is pleased to announce the award of a €6.2M grant for the development of CellBeadsTM for the treatment of Cardiovascular Diseases.

The award has been made by the BioMedical Materials program (BMM), a public-private partnership subsidised by the Dutch government. The project was one of seven selected by BMM joint International Scientific Advisory Board. The Chair of the Board, Professor Bob Löwenberg, MD said, "it was a delight to be involved in the selection of such an excellent portfolio of research".

The grant recognises the collaboration between the four parties to the agreement - The Molecular Cardiology Laboratory at the Erasmus Medical Centre, Rotterdam; the University Medical Centre, Utrecht; CellMed, who developed the CellBeads products, and Biocompatibles UK who designed the cardiovascular programmes, the latter two being subsidiaries of Biocompatibles.

A comprehensive programme encompassing both AMI (acute myocardial infarction, or heart attack) and CHF (congestive heart failure) will determine optimal dose and optimal technique of bead delivery; long-term cell viability; GLP-1 expression; safety; bead distribution measured by imaging; and evaluation of additional cardioprotective therapeutic proteins. The project aims to deliver the data package to then enable First-In-Man studies in AMI and CHF.

The Principal Investigator for the CellBead Project, Professor Henricus Duckers of the Erasmus Medical Centre commented:

"The use of the CellBeads technology has great potential for the treatment of patients suffering from an acute myocardial infarction or congestive heart failure, due to the expression of potent cardioprotective factors over a sustained period of time. The administration of the CellBeads, as an off-the-shelf product, immediately following an AMI and the retention of significant numbers of encapsulated stem cells in the infarct zone, offers a practical treatment regime not currently available from other technologies."

Early work has already demonstrated the technical feasibility of the approach and the improvement in cardiac performance that is possible.

This grant builds upon the award of MRC1 research within the Cardiovascular Biology Group at the University of Manchester; and Technology Strategy Board funding at the Bristol Heart Institute, both aimed at evaluating the feasibility of CellBead technology in cardiovascular applications2.

Managing Director of Biocompatibles UK, Dr Peter Stratford, added:

"We congratulate our colleagues at CellMed on this endorsement of their technology. This grant enables us to build on the promising clinical progress we have made with CellBeads in the treatment of Stroke. This is a radical treatment for a major disease area and it is the aim of the project team that the first patient will be treated before the end of 2013."

Biocompatibles is providing support for the programme over the next three years, which will be reflected in the annual financial guidance, for which there is no change in respect of the current year.

1Medical Research Council

2An article on the CellBead technology is featured the March issue of the journal Regenerative Medicine, following its presentation late last year to the stem-cell community at the London Regenerative Medicine Network meeting, University College London.

Ends

Contact:

Biocompatibles
Crispin Simon, Chief Executive
Ian Ardill, Finance Director

+44 (0)1252 732706

Anna Keeble

+44 (0)7879 818876

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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.