Programmes

Our most advanced development programmes for cancer are listed below.

PRECISION Bead^®

Target Indication: Primary liver cancer (HCC)

Status: Phase II

PRECISION Bead^® is a drug-eluting bead in development for the treatment of primary liver cancer or Hepatocellular Carcinoma (HCC). It consists of a bead embolisation system pre-loaded with the chemotherapeutic drug doxorubicin, an intercalating agent which inhibits DNA replication in rapidly growing cancer cells. The highly engineered beads are locally administered via the hepatic artery to physically block blood flow to the liver tumour, starving it of oxygen. In addition, doxorubicin elutes from the beads, providing a local, controlled and sustained dose of drug directly to the tumour.

Approximately 350,000 patients per annum will develop HCC in the US, EU5 and Asia-Pacific countries, with by far the majority being in the latter because of the higher incidence of viral hepatitis in these countries.¹ The current global market for loco-regional therapies for HCC is $80-90m.²

In June 2012, the US Food and Drug Administration (FDA) granted humanitarian use device designation for BTG’s PRECISION Bead^® for the treatment of patients with uveal melanoma with hypervascularised hepatic metastases. A Humanitarian Device Exemption (HDE) seeking authority to sell the product in this indication is now planned for submission in H1 2013.

References:

1. Approximate incidence. Patients per annum based on Globocan 2002, ACS 2009 and Biocompatibles data
2. Biocompatibles data on file

 

PARAGON Bead^®

Target Indication: Metastatic colorectal cancer (mCRC)

Status: Phase II

PARAGON Bead^® is a drug-eluting bead in development for the treatment of colorectal cancer which has metastasized to the liver (mCRC). It consists of a bead embolisation system pre-loaded with the chemotherapeutic drug irinotecan, which prevents DNA replication and transcription in rapidly growing cancer cells by inhibition of the enzyme topoisomerase I. The highly engineered beads are locally administered via the hepatic artery to physically block blood flow to the liver tumour, starving it of oxygen. In addition, irinotecan elutes from the beads, providing a local, controlled and sustained dose of drug directly to the tumour.

Up to a half of all colorectal cancer patients develop secondary hepatic metastases, giving an annual incidence of approximately 200,000 patients in the US and EU5.¹ The current global market for liver directed loco-regional therapies for mCRC is $90-100m.²

BTG plans to request an HUD for PARAGON Bead^®, loaded with irinotecan, to treat patients with intrahepatic cholangiocarcinoma (ICC). If granted, an HDE submission is anticipated in H1 2013.

References:

1. Approximate incidence. Patients per annum based on Globocan 2002, ACS 2009 and Biocompatibles data
2. Biocompatibles data on file