BerGenBio AS ("BerGenBio" or the "Company"), an oncology biopharmaceutical company, today announces that its multi-centre open label Phase 1b trial (BGBC004) of BGB324, a selective inhibitor of Axl, in patients with Stage IIIb and Stage IV non-small cell lung cancer (NSCLC) in erlotinib-sensitive and refractory patients who have an activating EGFR mutation, is now underway at the University of Texas MD Anderson Cancer Center, Houston, Oncology Partners, Houston, and at UT Southwestern Medical Center, Dallas, Texas, USA.
This multi-centre trial, which will enrol 66 patients, is designed to: determine the maximum dose of BGB324 that can be safely administered in combination with erlotinib; identify the recommended Phase 2 dose of BGB324; and evaluate the safety, pharmacokinetics and clinical activity of BGB324 in combination with erlotinib.
Professor John V. Heymach, MD, PhD, Professor and Chair, Thoracic/Head & Neck Medical Oncology at University of Texas MD Anderson Cancer Center said:
"Acquired resistance to erlotinib curtails the clinical utility of this drug in the treatment of NSCLC. BGB324's novel mechanism holds tremendous potential for improving the treatment outcomes in this setting and I am excited to be able to offer my patients the drug in this clinical trial and look forward to reporting the outcomes in due course."
Richard Godfrey, Chief Executive Officer of BerGenBio, commented:
"The initiation of the NSCLC trial demonstrates our continuing clinical progress with BGB324, our first-in-class selective Axl inhibitor. This is our second Phase 1b trial following the initiation of the acute myeloid leukaemia trial in November 2014 and we look forward to reporting results from these studies later in 2015."