Biocompatibles International PLC (LSE: BII) reported positive interim results from the ongoing combination therapy trial in primary liver cancer with Bayer healthcare Pharmaceuticals.
The interim data, presented from 11 patients with liver cancer (HCC) treated with the company’s Doxorubicin-Eluting Bead (DEB-DOX) in combination with Bayer’s systemic agent Nexavar tablets, showed a 45% response rate and 100% disease control.
“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,” said professor of radiology, surgery and oncology at the Johns Hopkins University School of Medicine in Baltimore, who presented the interim results at the 60th meeting of the American Association for the Study of Liver Diseases (AASLD).
Three hundred patients are currently being randomised either to DEB-DOX plus placebo, or to DEB-DOX plus Nexavar for the Bayer-sponsored randomised Phase IIb trial, its primary end-point being time to progression, while secondary end-points include safety and survival. Biocompatibles expects a positive trial result to establish the combined therapy as the standard of care in the developed world for HCC patients in the target indication.
“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,” said Chief Executive of Biocompatibles Crispin Simon.
Bayer, Onyx Pharmaceuticals and Biocompatibles established a clinical collaboration agreement in September 2008.
Broker Edison Investment Research said back in September that strong sales of Biocompatibles’ DC Beads products could give rise to profitability as soon as in 2011 with a further boost expected form the outcome of the ongoing trials, which are due to report in 2011-12.