Postive Data from Combination Therapy Trial in Primary Liver Cancer
03/11/2009
Farnham UK: 3rd November 2009. Biocompatibles is pleased to announce the first presentation of data from the Company’s clinical collaboration agreement with Bayer HealthCare Pharmaceuticals Inc, first announced on 25th September 2008.
At the 60th meeting of the American Association for the Study of Liver Diseases (AASLD) Professor Jean-Francois Geschwind MD, Professor of Radiology, Surgery and Oncology at the Johns Hopkins University School of Medicine in Baltimore, has presented interim data from 11 patients with liver cancer (HCC) treated with Biocompatibles’ Doxorubicin-Eluting Bead (DEB-DOX) in combination with Bayer’s systemic agent, Nexavar® (sorafenib) tablets. Nexavar is co-developed by Bayer and Onyx Pharmaceuticals Inc. Dr Geschwind observed a 45% Tumour Response rate1 and 100% Disease Control 2 . The trial is planned to recruit 50 patients in a single arm Phase II study design.
Dr Geschwind concluded, “Preliminary analysis reveals that the combination appears to be safe as it did not result in any greater toxicities than with either therapy alone. Additionally, the preliminary efficacy analysis is promising”.
The principal focus of Biocompatibles’ Clinical Collaboration with Bayer is a randomised Phase IIb trial, sponsored by Bayer. Three hundred patients are being randomised either to DEB-DOX plus placebo, or to DEB-DOX plus Nexavar. The primary end-point of the trial is time to progression, with secondary end-points that include safety and survival. The trial is recruiting patients from approximately 90 hospitals in Europe, Asia and the United States. Biocompatibles expects that a positive trial result would establish the combined therapy as the standard of care in the developed world for HCC patients in the target indication. The trial is not designed as a registration study for either product.
“We are encouraged by the preliminary results of this clinical trial and look forward to further evaluating the safety and efficacy of Nexavar in combination with Biocompatibles’ DEB-DOX,” said Dimitris Voliotis, Vice President, Nexavar Clinical Development, Bayer HealthCare Pharmaceuticals.
Crispin Simon, Chief Executive of Biocompatibles, commented:
“Cancer is a systemic and a local disease. So it makes sense to combine the systemic treatments developed by drug companies with our local Drug-Eluting Bead therapies.
Our vision is to be in the mainstream of Oncology and the data from combination therapy trials will demonstrate the progress that we are making in the months and years ahead. Today’s results with Nexavar are a great start.”
-ends-
1 EASL (European Association for the Study of Liver Diseases) basis
2 Includes Tumour Response and Stable Disease
Contact:
Biocompatibles +44 (0)1252 732732
Crispin Simon, Chief Executive
Ian Ardill, Finance Director
Anna Keeble +44 (0)7879 818876
Julian Walker +44 (0)20 7357 9477
Biocompatibles International plc (www.biocompatibles.com)
Biocompatibles International plc is a leading medical technology company in the field of drug-device combination products.
The Oncology Products Division supplies medical devices 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. We have a clinical collaboration agreement with Bayer Healthcare Pharmaceuticals Inc.
Our Licensing Division includes CellMed, in Alzenau, Germany, which is developing a Drug-Eluting Bead product for the treatment of stroke, based on proprietary stem cell technology; a GLP-1 analogue for the treatment of diabetes and obesity partnered with AstraZeneca; and a cosmetic Dermatology Bead partnered with Merz Pharmaceuticals GmbH. We also have a PC Licensing agreement with Medtronic Inc. in the field of Drug-Eluting Stents.
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.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world’s leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units: Women’s Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
Notes to Editors
Nexavar is currently approved in more than 80 countries for the treatment of patients with liver cancer and in more than 90 countries for the treatment of patients with advanced kidney cancer. Nexavar is being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of other cancers, including non-small cell lung cancer, breast cancer, ovarian cancer and as an adjuvant therapy for kidney cancer and liver cancer.
Essential Information
Name of the medicinal product : Nexavar® 200 mg film-coated tablets.
Qualitative and quantitative composition: 200 mg sorafenib (as tosylate)
Indication: 1. Treatment of hepatocellular carcinoma. 2. Treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Contraindications: Hypersensitivity to sorafenib or to any of the excipients. Warnings and Precautions:Hand-foot skin reaction and rash, usually CTC grade 1 and 2. Increased incidence of arterial hypertension (usually mild to moderate, early in the course of treatment). Blood pressure should be monitored regularly and treated as appropriate. Increased risk of bleeding. Increased incidence of cardiac ischaemia/infarction. Gastrointestinal perforation in less than 1%; sorafenib to be discontinued. Levels of sorafenib may be increased in patients with severe hepatic impairment. Infrequent bleeding events or elevations in INR have been reported in some patients taking warfarin concomitantly. Patients on such therapy should be monitored. Temporary treatment interruption and/or dose modification or discontinuation may be considered, depending on the severity of the observed adverse reactions. No formal studies on wound healing have been conducted. Temporary interruption of sorafenib therapy is recommended in patients undergoing major surgical procedures. Experience of use in the elderly is limited and cases of renal failure have been reported. High risk patients according to MSKCC prognostic group were not included in the phase III study in renal cell carcinoma and benefit-risk has not been evaluated in these patients. Caution is recommended when administering sorafenib with compounds that are metabolised/eliminated predominantly by the UGT1A1 (e.g. irinotecan) or UGT1A9 pathways. Caution is recommended when sorafenib is co-administered with docetaxel. The risk of reduced plasma concentrations of sorafenib should be considered before starting a treatment course with antibiotics. Undesirable effects: Very common: lymphopenia, hypophosphataemia, haemorrhage (incl. gastrointestinal, respiratory tract, cerebral), hypertension, diarrhoea, nausea, vomiting, rash, alopecia, hand-foot syndrome (palmar plantar erythrodysaesthesia syndrome), erythema, pruritus, fatigue, pain (mouth, abdominal, bone, tumour, headache), increased amylase and lipase. Common: leucopenia, neutropenia, anaemia, thrombocytopenia, anorexia, depression, peripheral sensory neuropathy, tinnitus, hoarseness, constipation, stomatitis (including dry mouth and glossodynia), dyspepsia, dysphagia, dry skin, dermatitis exfoliative, acne, skin desquamation, arthralgia, myalgia, renal failure, erectile dysfunction, asthenia, fever, influenza like illness, weight decrease, transient increase in transaminases. Uncommon: folliculitis, infection, hypersensitivity reactions (including skin reactions and urticaria), hypothyroidism, hyperthyroidism, hyponatraemia, dehydration, reversible posterior leukoencephalopathy, myocardial ischaemia and infarction, congestive heart failure, hypertensive crisis, rhinorrhea, gastro oesophageal reflux disease, pancreatitis, gastritis, gastrointestinal perforations, increase in bilirubin, jaundice, cholecystitis, cholangitis, eczema, erythema multiforme, keratoacanthoma / squamous cell cancer of the skin, Stevens-Johnson syndrome, gynaecomastia, increase in alkaline phosphatase, INR abnormality, prothrombin level abnormality. On prescription only.
Date of Revision of the Text: July 2009. Please note! For current prescribing information refer to the package insert and /or contact your local Bayer Schering Pharma Organisation. Bayer Schering Pharma AG, 13342 Berlin, Germany.