Singapore, Jul 2, 2009: Bionomics Limited, an Australian biotech company involved in discovery and development of innovative therapeutics for cancer and diseases of the central nervous system announced a key milestone about its the clinical development of BNC105, its novel vascular disrupting agent (VDA) for the treatment of solid tumour types: a dose of 12.6 mg/m2 has been selected for the next clinical trial of BNC105.  

 

The Phase I clinical trial of BNC105 has been conducted in patients with advanced cancers at four Melbourne hospitals under the umbrella of Cancer Trials Australia.  The objectives of the trial were to evaluate the safety, tolerability, and pharmacokinetics of BNC105 in cancer patients and to identify a dose level of BNC105 to be used in future clinical trials of BNC105. Following evaluation of the clinical trial information gathered to date a dose of 12.6 mg/m2 has been selected for the next clinical trial of BNC105.

 

“This dose level was well tolerated by patients and rapidly achieved plasma drug levels required for VDA activity after a single intravenous dose. In the Phase I trial, it was very encouraging to see a patient suffering from renal cell cancer who was treated at the 12.6 mg/m² dose level had stable disease for 9 weeks and we hope to further demonstrate efficacy in the Phase II trial,” said Dr Deborah Rathjen, Chief Executive Officer and Managing Director of Bionomics,.

 

For the next stage of development of BNC105, Bionomics intends to utilize the expertise of Hoosier Oncology Group, Inc. headquartered in Indianapolis, to evaluate the efficacy of the compound in renal cell carcinoma. The HOG consists of a working association of over 400 dedicated community and research centre physicians and clinical research practitioners across the United States.  It has successfully leveraged this network to conduct cancer clinical trials since its creation in 1984.

 

Dr. Nasser Hanna, Chairman of the HOG, said, “The Hoosier Oncology Group is enthusiastic to bring potentially innovative treatments to its members and patients, and Bionomics’ is a welcomed partner in that pursuit with its novel compound.”

 

Quake Pletcher, Executive Director of the HOG stated, “We welcome the opportunity to work with Bionomics in developing this novel VDA.  The HOG has consulted with a number of leading genitourinary oncologists within its extensive network and there is a sense of excitement about the use of this agent for treating renal cancer.”

 

Renal cancer accounts for 2-3% of human malignancies and accounts for 85% of kidney cancers. Every year, approximately 200,000 cases are diagnosed worldwide, with 55,000 people diagnosed in the USA. The five year survival rate for patients with metastatic disease is less than 2%. Kidney cancer is asymptomatic, and in 40% of cases is diagnosed at an advanced stage.

 

Dr Rathjen said, “The success of Bionomics’ first clinical trial of BNC105 would not have been possible without the efforts of Cancer Trials Australia and the investigators and supporting staff at each of the clinical sites.”