Singapore: Bionomics Limited launched a phase I/II clinical trial of its vascular disrupting agent BNC105 in women with ovarian cancer. Around 134 women are expected to be enrolled at 18 sites spread across the US, Australia and New Zealand.

The trial will evaluate BNC105 in combination with current standard therapies carboplatin and gemcitabine. The trial would be conducted by the Australian and New Zealand Gynaecological Oncology Group (ANZGOG) in collaboration with the National Health and Medical Research Council Clinical Trials Center (NH&MRC CTC) in Australia and the Hoosier Oncology Group in the US. BNC105 is a vascular disruption agent (VDA) that rapidly shuts down existing and new tumour blood vessels with no effect on normal blood vessels.

Dr Deborah Rathjen, CEO and managing director, Bionomics, said that, "The design of this clinical trial is based on robust preclinical data demonstrating synergy between BNC105 and platinum-based therapies in improving survival rates of animals with solid tumours. There is extremely promising data around this compound and we anticipate this trial will establish further potential of BNC105 in this new indication - to help women suffering ovarian cancer."

Although modest improvements have been made in patient outcomes as a result of surgery or chemotherapy, a relapse is seen in majority of ovarian cancer patients, who eventually succumb to the disease. There is a clear unmet medical need for more effective systemic therapies. Drugs used to treat ovarian cancer had reported sales over $2 billion in 2011.

In addition to the phase I/II ovarian cancer trial, BNC105 is currently under evaluation, in combination with the mTOR inhibitor Everolimus (Afinitor), in a US multi-center phase II clinical trial in patients with metastatic renal cell carcinoma (RCC). Presently, there are over 30 US-based clinical trial sites actively recruiting patients to participate in the trial. Five patients received at least 10 cycles of the combination.

Enrolment in the RCC trial is due for completion at the end of the year. Data from the RCC trial and the BNC105 clinical trial in women with ovarian cancer may enable consideration by the FDA of fast track designation for BNC105 adding substantial value to the BNC105 licensing package.