News
BIONOMICS PARTNERS WITH THE AUSTRALASIAN LUNG CANCER TRIALS GROUP AND NHMRC CLINICAL TRIALS CENTRE TO CONDUCT BNC105 PHASE II TRIAL FOR MESOTHELIOMA T
09-Dec-2009- 60 patients at 12 centres in Australia.
- Second Phase II clinical trial for BNC105
- Follows successful Phase I clinical trial
Adelaide, Australia: Bionomics Limited (ASX: BNO) announced today plans to conduct a Phase II clinical trial of its BNC105 anti-cancer drug on 60 mesothelioma patients at up to twelve centres in Australia.
Bionomics has contracted the Australasian Lung Cancer Trials Group (ALTG) and the NHMRC Clinical Trials Centre (CTC) to conduct the clinical trial.
The ALTG is a multi-disciplinary organisation dedicated to reducing the incidence, morbidity and mortality of lung and thoracic cancer and improving the quality of life of lung and thoracic cancer patients in Australia and New Zealand through the coordination and facilitation of high quality clinical research.
CTC, a clinical research organisation, runs large multicentre investigator-initiated clinical trials, takes part in trials of national and international collaborative trial groups and contributes expertise to trials run by others. The CTC was established in 1988 as a research unit of the National Health and Medical Research Council (NHMRC). It is affiliated with the Faculty of Medicine, University of Sydney.
This is the second planned Phase II clinical trial of the anti-cancer properties of BNC105 after the company announced a US-based Phase II renal cancer trial earlier this year.
BNC105 is a novel anti-cancer agent which is both a vascular disrupting agent (VDA) and an inhibitor of cancer cell proliferation.
This follows a successful BNC105 Phase I clinical trial in patients with advanced cancers at the Peter MacCallum Cancer Centre, the Western Hospital, Austin Health and the Royal Melbourne Hospital.
Mesothelioma is a form of cancer that is usually caused by exposure to asbestos. In this disease malignant cells develop in the protective lining that covers most of the body's internal organs. Its most common site is the outer lining of the lungs and internal chest wall.
Most people who develop mesothelioma had jobs where they have been exposed to asbestos dust fibres. There have also been cases where people washing the clothes of others have suffered mesothelioma.
Despite treatment, mainly with chemotherapy and radiation therapy, the disease usually carries a poor prognosis.
Bionomics has rapidly reached a number of clinical milestones for BNC105 including:
- Blood levels consistent with VDA and anti-tumour activity
- Evidence of VDA activity confirmed by tumour imaging
- A mesothelioma patient enrolled in the trial achieved stable disease where cancerprogression was halted
- No complicating side-effects
- Data suggests BNC105 has over 10 fold therapeutic window compared to a leading competitor in cancer patients
"This drug has been very promising so far and the company is quickly moving to Phase II trials. We are expecting to report interim results of this trial in patients with mesothelioma in early 2011," said Dr Deborah Rathjen, CEO & Managing Director of Bionomics.
"This condition has virtually no effective treatments after first line chemotherapy and patients typically have a life expectancy of less than 1 year. The long latency means that we are still to see the peak incidence of mesothelioma over the next decade."
In 2005 there were 597 new cases of mesothelioma diagnosed in Australia and in 2006 there were 486 deaths attributed to mesothelioma. It is a usually fatal cancer which typically occurs 20 to 40 years after exposure to asbestos.
The title of Bionomics' planned clinical trial is: Phase II trial of BNC105P as 2nd line chemotherapy for advanced malignant pleural mesothelioma.
It is a single arm, unblinded study for patients with mesothelioma who have progressed on platinum/pemetrexed chemotherapy. BNC105 will be administered on days 1 and 8 of 21 day cycles. Treatment will continue until disease progression.
The primary objective is to determine the tumour response rate. Secondary endpoints include progression free survival, quality of life, overall survival and treatment duration.
Further details of the clinical trial are contained in the Clinical Appendix following this announcement.
Enquiries:
Bionomics Limited
Dr Deborah Rathjen
CEO & Managing Director
+61 8 8354 6101 / 0418 160 425
drathjen@bionomics.com.au
Monsoon Communications
Rudi Michelson
+61 3 9620 3333
Clinical Appendix
| Name of Trial | Phase II trial of BNC105P as 2nd line chemotherapy for advanced malignant pleural mesothelioma |
| Primary Endpoints | Response rate as measured by modified RECIST criteria |
| Secondary Endpoints |
|
| Blinding Status | Unblinded, single arm |
| Product Development Status | Phase II |
| Treatment Method (route/frequency/dose levels) | 10 minute IV infusion, administered on days 1 & 8 of a 21 Day repeating cycle; single dose level |
| Number of Trial Subjects | 60 |
| Subject Selection Criteria | For patients who have progressed on platinum/pemetrexed chemotherapy (i.e. 2nd line chemotherapy in advanced malignant pleural mesothelioma) |
| Trial Location(s) | Australian-based. Up to 12 Australasian Lung cancer Trial Group (ALTG) sites. |
| Expected Completion | 2 year accrual period; follow-up period of 1 year after last patient is recruited |
| Trial Standard | ICH-GCP |
About Bionomics Limited
Bionomics (ASX: BNO) discovers and develops innovative therapeutics for cancer and diseases of the central nervous system. Bionomics has small molecule product development programs in the areas of cancer, anxiety, epilepsy and multiple sclerosis. Bionomics' most advanced program, BNC105 for the treatment of cancer, is based upon the identification of a novel compound that potently and selectively restricts blood flow within tumours. Bionomics' discovery and development activities are driven by its three technology platforms: Angene®, the company's angiogenesis target and drug discovery platform, incorporates a variety of genomics tools to identify and validate novel angiogenesis targets. MultiCore® is Bionomics' proprietary, diversity orientated chemistry platform for the discovery of small molecule drugs. ionX® is a set of novel technologies for the identification of drugs targeting ion channels for diseases of the central nervous system.
For more information about Bionomics, visit www.bionomics.com.au
Factors Affecting Future Performance
This announcement contains "forward-looking" statements within the meaning of the United States' Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that relate to prospective events or developments are deemed to be forward looking statements. Words such as "believes," "anticipates," "plans," "expects," "projects", "forecasts," "will" and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by these forward-looking statements, including risks related to the clinical evaluation of BNC105, our available funds or existing funding arrangements, a downturn in our customers' markets, our failure to introduce new products or technologies in a timely manner, regulatory changes, risks related to our international operations, our inability to integrate acquired businesses and technologies into our existing business and to our competitive advantages, as well as other factors. Subject to the requirements of any applicable legislation or the listing rules of any stock exchange on which our securities are quoted, we disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
