Bionomics (ASX:BNO) has initiated a new Phase I clinical study for its anti-cancer stem cell drug candidate known as BNC101.
Adelaide-based Bionomics is a biopharmaceutical company focused on the discovery and development of innovative therapeutics for the treatment of diseases of the central nervous system (CNS) and cancer.
The new trial follows acceptance of an investigational new drug (IND) application by the US FDA in August 2015.
Pre-clinical studies to support the IND application showed that BNC101 was well tolerated with no adverse dose identified.
According to Bionomics CEO and Managing Director, Dr Deborah Rathjen, "This is an important milestone for the business as we continue to build on our proven strengths and capabilities as a drug discoverer and early stage developer of important new therapies with significant clinical and commercial potential.
“It is another step forward as we build a globally competitive Australian business with integrated drug discovery and development expertise to support strategic partnerships and clinical development of multiple promising drug candidates.”
The open label, multi-centre clinical trial in patients with metastatic colorectal cancer will aim to demonstrate that BNC101 is safe and well tolerated and that it is able to delay disease relapse in treated patients.
The trial will be conducted at specialist centres across Australia and have two arms, firstly with BNC101 alone and then in combination with standard of care chemotherapy.