UK-based AstraZeneca has started a Phase III clinical trial of olaparib, an oral poly ADP ribose polymerase (PARP) inhibitor being developed for the treatment of BRCA mutated ovarian cancer.
As a result of the initiation of the trial, the company will reverse a previous pre-tax impairment charge of $285m in the third quarter of 2013.
The Phase III study of olaparib in ovarian cancer (SOLO) is aimed at showing the benefits of olaparib as a maintenance monotherapy in BRCA mutated ovarian cancer patients who are in complete or partial response following treatment with platinum-based chemotherapy in the first line setting (SOLO 1) and in the relapsed setting (SOLO 2).
The SOLO 1 study will assess olaparib as a maintenance monotherapy in patients with BRCA mutated ovarian cancer following first line platinum based chemotherapy.
The SOLO 2 study will look into the development of olaparib as a maintenance monotherapy in patients with BRCA mutated platinum sensitive relapsed ovarian cancer.
The company is carrying out the SOLO 1 and SOLO 2 study in collaboration with the Gynecologic Oncology Group and the European Network of Gynaecological Oncological Trial Groups respectively.
Both SOLO 1 and SOLO 2 trials, which are randomised, double blind and placebo controlled, use the tablet formulation of olaparib at a dose of 300mg twice per day.
The successful results from the subgroup analysis by BRCA mutation status of the Phase II maintenance study in relapsed ovarian cancer were earlier presented at the American Society of Clinical Oncology 2013 Congress.
AstraZeneca Global Medicines Development unit vice-president and head of Oncology Antoine Yver said: "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."
Olaparib exploits DNA repair pathway deficiencies to destroy tumour cells and as such has the potential to be developed as a potent drug for a range of cancer types with DNA repair deficiencies.
According to the new analysis, the drug is expected to help certain patients with a particular mutation of BRCA gene.
Human genes BRCA1 and BRCA2 belong to a type of genes called tumour suppressors and their mutation has been connected to hereditary breast and ovarian cancer.
According to the company, only 15% of ovarian cancers are found before the cancer has spread outside the ovary and the five-year survival rate is well below 50% in spite of advances in treatment and diagnosis.
Image: Intermediate magnification micrograph of a low malignant potential (LMP) mucinous ovarian tumour. Photo: courtesy of Nephron.