Bionomics Limited
Bionomics (ASX: BNO) is a productive drug discovery and development engine room focused on new treatments for cancer and serious disorders of the central nervous system (CNS). Through application of its proprietary technology platforms, MultiCore®, Angene® and ionX®.
The company has generated multiple drug candidates and targets in the therapeutic areas of Cancer, Anxiety, Multiple Sclerosis and Epilepsy. The company has a strong out-license record in conjunction with its in-house development program which has seen two highly promising drugs enter clinical trials in the past two years.
Bionomics BNC105 renal cancer trial commences in USA with Hoosier Oncology Group
Leading Australian drug developer Bionomics (ASX: BNO) and its partner, the Hoosier Oncology Group have commenced the widely anticipated clinical trial of BNC105 in patients with renal cell carcinoma in three clinical sites in the US.
The company now has two major drugs in clinical development as well as an important partnership with Merck Serono for the discovery of new drugs to treat Multiple Sclerosis.
Dr Deborah Rathjen, Bionomics’ managing director said she was pleased to be working with such an experienced clinical consortium as the Hoosier Oncology Group to conduct this trial across multiple sites throughout the US.
The Hoosier Oncology Group, Inc. based in Indianapolis, Indiana consists of a working association of over 400 dedicated community and research center physicians and clinical research practitioners in the US.
"Metastatic renal cancer has a poor prognosis and there exists a real need for new therapies despite relatively recent advances in treatment. It is encouraging that a renal cancer patient enrolled in the Phase I study of BNC105 conducted in Australia under an IND application to the US FDA showed clinical benefit," Dr Rathjen said.
Renal cancer accounts for 2-3% of human malignancies and accounts for over 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.
Renal cell cancer offers a strong market opportunity for Bionomics and BNC105 if successfully developed. Current leading drugs used to fight renal cancer indicate upside potential for BNC105.
Worldwide sales of Sutent® were US$847 million in 2008, whilst reported sales of Nexavar® in 2008 were US$677.8 million.
Sales projections for Afinitor®, which gained marketing approval in the US and Europe in 2009 for the treatment of renal cancer, exceed US$500 million.
The BNC105 trial is now open to enrolment at the Baylor Sammons Cancer Centre, Dallas, Texas; Indiana University Melvin and Bren Simon Cancer Centre, Indianapolis; and the Cancer Treatment and Research Centre, University of Texas, San Antonio, Texas.
Up to 12 sites are anticipated to become involved in the trial across the US and a total of 152 patients are anticipated to be enrolled in the trial.
The trial will determine whether BNC105 is effective in the treatment of progressive metastatic renal cell carcinoma, either in combination with or following Afinitor® (also known as Everolimus) treatment in patients who have disease progression following treatment with tyrosine kinase inhibitors such as Sutent® or Nexavar®.
Trial Principal Investigator Dr Thomas E Hutson of the Baylor Sammons Cancer Centre/Texas Oncology commented “The mechanism of action of BNC105 provides an innovative approach to the treatment of solid tumours, including metastatic renal carcinoma, by attacking established tumour vasculature. It is particularly exciting to be conducting a trial which has the potential of creating a new paradigm for the treatment of renal cancer”.
Bionomics completed a major $15 million capital raising in 2009.
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Other Bionomics Limited articles
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25/02/10 Europe's Edison Investment Research values Bionomics at twice current valuation
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09/12/09 Bionomics to conduct Phase II clinical trial on its BNC105 anti-cancer drug
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04/11/09 Bionomics CEO confident anti cancer and anxiety clinical milestones can be reached in 2010
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27/10/09 Bionomics anxiety drug BNC210 succesfully completes first stage, Phase 1 clinical trial
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16/10/09 Bionomics clinical trials for anxiety drug BNC210, show superiority to Valium, Prozac
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08/09/09 Bionomics raises $5.8m, total of $15m in funding to progress anti-cancer and anxiety drugs
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28/08/09 Bionomics' underlying revenues increase 115%, costs down, positioned in cancer and anxiety trials
Other Bionomics Limited news
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02/03/10 Bionomics makes strides with clinical trial of anxiety compound
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02/02/10 Bionomics makes further gains with anti-anxiety drug compound BNC210
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08/10/09 Australian drug developer Bionomics SPP closes oversubscribed
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16/09/09 Bionomics to complete $2.2 million capital raising via share purchase plan
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07/09/09 Bionomics completing capital raising
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03/09/09 Bionomics turns up the heat on cancer, with planned $7 million capital raising
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25/06/09 Bionomics commences clinical trial for anti anxiety drug BNC210 - with less side effects
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10/02/09 Bionomics adds $4 million cash from biotech investor
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