BerGenBio announces first patient dosed in BGB324 AML trial

BerGenBio AS (“BerGenBio” or the “Company”), an oncology biopharmaceutical company, today announces that the first patient has been dosed in its multi-centre Phase 1b trial (BGBC003) of BGB324, a selective inhibitor of Axl, in patients with acute myeloid leukaemia (AML) at Haukeland University Hospital in Bergen, Norway.

The two part Phase 1b trial will primarily investigate the safety and tolerability of BGB324 when administered as a single agent and in combination with standard of care drug (cytarabine) in patients with AML; secondary endpoints will also explore evidence of clinical response and assess novel biomarkers. The study will be conducted at six sites in Norway, Germany and the United States. The Company expects data to be available from this trial in 2015.

Professor Bjørn Tore Gjertsen, Principal Investigator at Haukeland University Hospital said:
“BGB324 is a potential breakthrough treatment for patients with aggressive AML, and it is particularly encouraging that a forward-thinking biotech company like BerGenBio prioritised a trial for patients with this aggressive blood cancer. I am delighted that I am able to offer this experimental drug to my patients and to allow us to test a novel therapeutic concept in patients that have limited treatment options.”

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:
“We continue to progress BGB324, our first-in-class selective Axl inhibitor, through early clinical development; recently we also received FDA clearance and this trial will open imminently in the United States and at sites in Germany. The novel mechanism of action of this class of drugs holds great potential as a treatment for many aggressive drug resistant cancers; we will also investigate BGB324 in non-small cell lung cancer (NSCLC). Therefore we see successful completion of this study as a key value inflection point for the Company. We expect preliminary data from these studies in 2015.”