Drug-Eluting Bead Cancer Trials: Update on US Activities
27/04/2009
• Primary Liver Cancer Trials at Johns Hopkins
• Liver Metastases Trials at sites in Denver, Chicago, Louisville , Atlanta, Knoxville, Milwaukee
Biocompatibles is pleased to provide an update of Drug-Eluting Bead clinical trials in the United States. All but one1 of these trials are approved by the FDA under Investigational Device Exemptions (IDE) and are registered at http://clinicaltrials.gov – the database that permits public scrutiny of clinical trials.
At the Johns Hopkins University School of Medicine in Baltimore, MD, Professor Jean-Francois Geschwind, Professor of Radiology, Surgery and Oncology, has completed a trial in which the Drug-Eluting Bead was used to treat 20 patients with primary liver cancer (HCC or hepatocellular carcinoma) in a single arm trial. Professor Geschwind, presenting the results of the trial at the Annual Meeting of the Society of Interventional Radiology (SIR) in March, reported a tumour response rate of 90% at six months and adverse events within expected limits. This is a high response rate – especially in view of the fact that about half of the patients had higher risk co-morbidities, according to the current guidelines of the American Association for the Study of Liver Disease2 .
Professor Geschwind is now recruiting patients in a single arm Phase II trial evaluating the potential usefulness of sorafenib in conjunction with treatment with Drug-Eluting Bead in 50 patients with HCC. Four patients have been treated and it is expected that preliminary data will be presented during the course of 2009. This trial is part of a clinical collaboration agreement between Biocompatibles and Bayer Pharmaceuticals Inc. (announced on 26 September 2008).
Professor Geschwind is also recruiting patients in a 30 patient single arm trial evaluating the potential usefulness of the Drug-Eluting Beads in patients with Neuroendocrine Metastases in the liver.
Professor Robert Martin, Associate Professor of Surgery in the Division of Surgical Oncology at the University of Louisville, has initiated a randomised trial for the evaluation of the Drug-Eluting Beads in hepatic colorectal metastases for patients who are not eligible for surgical resection (first line patients) (announced on 17 April 2009). This trial is known as PARAGON Louisville. Patients will be randomised either to the regimen of FOLFOX + Avastin with all drugs delivered intra-venously, or to the same FOLFOX + Avastin regimen but with the dose of Irinotecan delivered by Drug-Eluting Beads. Other hospitals involved in this trial are: The Emory Clinic, Atlanta, GA; The University of Tennessee Medical Centre, Knoxville, TN; The Medical College of Wisconsin/ Froedtert Memorial Lutheran Hospital, Milwaukee, WI and Piedmont Healthcare Research Institute, Atlanta, GA.
Professor Wells Messersmith, Associate Professor, Division of Medical Oncology, University of Colorado Cancer Center, Denver, CO, is recruiting patients with hepatic colorectal metastases who have failed one line of drug therapy (second line patients). This trial is known as PARAGON 1. Patients will be randomised to a regimen either of intra-venous Irinotecan only or of intra-venous Irinotecan + Drug-Eluting Beads delivering irinotecan. The first patient in this trial has been treated at Northwestern Memorial Hospital, Chicago, IL. (announced on 17 April 2009). It is intended that the Lahey Clinic, near Boston, MA, also joins the trial in the next few weeks.
Crispin Simon, Chief Executive of Biocompatibles, commented "The US is a key focus for us and we appreciate the commitment of the investigators and their support staff. Our Drug-Eluting Bead products are now routinely used in more than 35 countries; but we are maintaining our commitment to assembling definitive evidence in support of this evolution in clinical practice."
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1The exception is the Paragon Louisville trial for which conditional IDE approval has been granted by FDA, as a result of which no filing has yet been made with clinicaltrials.gov. It is intended that the trial be granted full IDE approval status and registered with clinicaltrials.gov, in the next few weeks.
2 Bruix and Sherman HEPATOLOGY 2005; 42: 1208-1235
Contact:
Biocompatibles +44 (0)1252 732712
Crispin Simon, Chief Executive
Ian Ardill, Finance Director
Biocompatibles International plc
Biocompatibles International plc is a leading medical technology company in the field of drug-device combination products.
The Oncology Products Division conducts the marketing of Biocompatibles’ approved oncology products, supplied from facilities in Farnham, UK and Oxford, CT. These include Drug-Eluting Bead products which are used in more than 35 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.
Our R&D Facilities are engaged in licensing and in new product development, based on the company’s core drug delivery technologies. The Drug Delivery Division, in Farnham, UK is developing new products for oncology. CellMed, in Alzenau, Germany, is developing a Drug-Eluting Bead product for the treatment of stroke, based on proprietary stem cell technology; and a GLP-1 analogue for the treatment of diabetes and obesity partnered with AstraZeneca. We also have collaborative agreements with Bayer Healthcare Pharmaceuticals Inc., Medtronic Inc. and Merz Pharmaceuticals GmbH.
Further information is available at www.biocompatibles.com
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.