The company has announced enrollment of the first patient in the Phase III clinical programme for olaparib.
The company’s oral poly ADP ribose polymerase (PARP) inhibitor is being investigated for the treatment of BRCA mutated ovarian cancer. The SOLO (Study of OLaparib in Ovarian cancer) programme is designed to determine the benefit, by progression free survival, of olaparib as a maintenance monotherapy in BRCA mutated ovarian cancer patients who are in complete or partial response following platinum-based chemotherapy in the first line setting (SOLO 1), and in the relapsed setting (SOLO 2). Both trials are randomised, double blind, placebo controlled studies that utilise the tablet formulation of olaparib at a dose of 300mg twice daily.
As a result of the initiation of this programme, the pre-tax impairment charge of $285 million, which was incurred in December 2011 following the decision not to progress olaparib into phase III development, will be reversed in the third quarter of 2013. The reversal of this impairment charge will be excluded from Core earnings per share.
“This is a significant milestone for olaparib, and further evidence of AstraZeneca’s commitment to invest in distinctive science in our core therapy areas, with a particular focus on high unmet need. We feel olaparib has real potential to significantly improve treatment decisions for this group of patients who currently have limited options, and to become the next important product in our growing oncology portfolio,” said Antoine Yver, Vice President and Head of Oncology in AstraZeneca’s Global Medicines Development in the press release.