BiPar Sciences, Inc. has announced the expansion of phase II clinical trial programmes for its lead product, BSI-201, in ovarian cancer. This is the third major clinical trial of BSI-201 that BiPar has launched in the past six months, expanding on on-going trials in breast and brain cancer.

The company is evaluating BSI-201, the first poly ADP-ribose polymerase (PARP) inhibitor in its DNA repair portfolio, as a monotherapy for patients whose ovarian cancer is linked to a hereditary genetic defect. Clinicians at Memorial Sloan-Kettering Cancer Center will enrol patients who have a mutation in their BRCA1 or BRCA2 genes.

"We believe BSI-201 holds great promise as a targeted therapy in this difficult-to-treat type of ovarian cancer," said Carol Aghajanian, MD, co-principal investigator and chief of the gynaecologic medical oncology service at Memorial Sloan-Kettering Cancer Center. "BRCA-negative patients are at higher risk of breast and ovarian cancer because BRCA plays a key role in repairing DNA errors that lead to tumour formation".

Ovarian cancer strikes more than 21,000 women a year in the United States and is one of the most common causes of cancer death in women, killing more than 15,000 annually in the United States. Patients with the hereditable BRCA-negative form of the disease account for about 15 per cent of the patient population. Women with defective BRCA genes are also at considerably higher risk of breast cancer.

"We have identified a number of important types of cancer where PARP plays a crucial role in tumour growth, and we believe that BRCA-negative ovarian cancer represents another excellent target for BSI-201," said Barry Sherman, MD, BiPar's executive vice president of development. "We will soon have patients enrolled in four separate phase II trials of BSI-201, reflecting the breadth of tumour types that could be sensitive to the drug."

The company is currently conducting a phase II trial of BSI-201 in triple-negative breast cancer and is collaborating with the New Approaches to Brain Tumour Therapy (NABTT) consortium, a National Cancer Institute-funded research group, to test BSI-201 in glioblastoma multiforme (GBM), the most common brain cancer in adults. An additional trial in uterine cancer is expected to begin enrolment in the coming weeks. The company also plans to present data from its phase I trials of BSI-201 in solid tumours at the American Society of Clinical Oncology Annual Meeting that begins later this month in Chicago.