FDA Approval of Drug-Eluting Bead Clinical Trial

06/03/2008

  • Randomised Phase II Trial in Patients with Hepatic Colo-rectal Metastases

  • DEBIRI Treatment to be combined with systemic Irinotecan

  • Eligible Patients will have failed first line chemotherapy

First US Trial of Novel Cancer Treatment

Farnham UK: 6th March 2008 - Biocompatibles is pleased to announce approval by the US Food and Drug Administration (FDA) of a Phase II trial for the evaluation of the Drug-Eluting Bead delivering irinotecan - (DEBIRI), in patients with hepatic colo-rectal metastases.

The plan is that 70 patients will be recruited in ten US hospitals under the leadership of Dr Wells Messersmith, Director, GI Medical Oncology Program, University of Colorado Cancer Center; with an investigator group that includes physicians from Johns Hopkins Hospital in Baltimore and North Western Memorial Hospital in Chicago. Eligible patients will have failed first line chemotherapy which, in the US, is the oxaliplatin-based FOLFOX regimen, combined with Avastin (bevacizumab). Patients will be randomized either to DEBIRI combined with systemic irinotecan, or to a control arm of systemic irinotecan only. The trial has been conditionally approved under an FDA Investigational Device Exemption (IDE).

The primary end point of the trial is progression free survival with secondary end-points that include safety, tumour response and overall survival. The investigational product is PARAGON Bead ™, a Drug-Eluting Bead pre-loaded with irinotecan. The Company has previously announced promising data from Europe on the use of the Drug-Eluting Bead with irinotecan using the DC Bead product .

Irinotecan is widely used in the treatment of hepatic colorectal metastases, with an estimated 200,000 patients per annum treated.

Dr Messersmith commented “I believe that combining a high dose of locally delivered irinotecan, together with systemic administration of the same drug, could be of significant benefit to colorectal cancer patients. This trial will enable us to evaluate this novel strategy.”

It is expected that the first patient will be recruited into the trial around the middle of 2008. The trial is part of a programme that is designed to deliver US regulatory approval of the Paragon Bead.

Colorectal cancer that has metastasised to the liver (mCRC) represents one of the largest opportunities currently addressed by Biocompatibles’ Drug-Eluting Bead programme. Each year there are more than 400,000 new cases of colorectal cancer in the US and EU-15 of which up to 50% develop liver metastases within five years of diagnosis. In around 80% of cases these tumours are unresectable and the two year survival rate of these patients is around 20%.

The PARAGON Bead Programme for mCRC is one of two of Biocompatibles’ Drug-Eluting Bead programmes. The first product into clinical trials was the Drug-Eluting Bead, delivering doxorubicin for the treatment of Hepatocellular Carcinoma (HCC). Biocompatibles estimates that the market opportunity for this product is up to $400m; and that the potential market opportunity for the PARAGON Bead is larger.

Crispin Simon, Chief Executive of Biocompatibles, commented “I am delighted with this approval. An approved IDE in the second-line setting is a big step forward. Our Drug-Eluting Bead technology has stood up to significant scrutiny.”

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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.