Bionomics Limited, an international biotech based in Thebarton, Australia, has gained approval from the FDA to proceed with its clinical trial of BNC105 in women with ovarian cancer.

Bionomics anticipated the approval and has already prepared much of the trial, with expected initiation in the next quarter. The phase I/II trial will evaluate BNC105 in combination with carboplatin and gemcitabine in a multi-centre trial in Australia and the U.S.

BNC105 is a Vascular Disruption Agent (VDA) that rapidly shuts down existing and new tumor blood vessels with no effect on normal blood vessels. Preclinical data has indicated that all solid tumor types, including breast, prostate and lung cancers, are susceptible to the VDA effect of BNC105 and that the compound also potently inhibits the growth of a broad range of cancer cells in culture.

In addition, BNC105 is currently under evaluation in combination with the mTOR inhibitor Everolimus (Afinitor), in a U.S. multi-center phase II clinical trial in patients with metastatic renal cell carcinoma (kidney cancer). More than 21 U.S.-based trial sites have been activated to date and the combination of BNC105 and Afinitor has been shown to be safe and well tolerated. Enrollment in the trial is due for completion at the end of 2012.