MELBOURNE, Australia, Feb. 26 /PRNewswire/ -- Bionomics Limited (ASX: BNO) today announced the initiation of treatment for the first patient in the Phase I trial of its anti-cancer drug, BNC105.
The BNC105 Phase I clinical trial involves treatment of patients with advanced cancer. Patients will be treated with BNC105 on days 1 and 8 of a 21 day cycle, over two cycles. The trial will be conducted at clinical sites within the Cancer Trials Australia network at the Royal Melbourne Hospital, the Peter MaCallum Cancer Centre and the Western Hospital in Melbourne.
Dr. Deborah Rathjen, CEO and Managing Director of Bionomics hailed the commencement of the Phase I trial as a significant milestone for the Company.
"We are excited to commence our trial of BNC105 and to announce our first patient has begun treatment," Dr Rathjen commented. "We will provide regular updates as we move through the trial, and I look forward to updating shareholders on our progress."
The primary objective for this trial is the evaluation of the safety and tolerability of BNC105. The results obtained from this trial will enable the identification of an appropriate dose of BNC105 for subsequent trials. Further objectives include, the evaluation of BNC105 pharmacokinetics and its activity against tumour vasculature and tumour growth.
BNC105 is a new type of anti-cancer drug called a Vascular Disruption Agent (VDA) which blocks the blood supply to a solid tumour, effectively "starving" the tumour of nutrients. Pre-clinical data indicates that BNC105 has a dual mechanism of action with the ability to not only block the supply of nutrients to the tumour but also to directly destroy cancer cells. In addition, BNC105 is retained in the tumour at high levels for an extended period of time, enhancing its' anti-cancer effect.
Although VDAs have strong potential for use in combination with traditional cancer treatment options, including chemotherapy, preclinical data obtained with BNC105 to date suggest that its dual action is likely to enable its use as a single agent treatment. A large number of animals with BNC105 were cleared of their tumour burden after two cycles of treatment.
The US Food and Drug Administration (FDA) accepted Bionomics'
Investigational New Drug (IND) application for BNC105 in November 2007. The
trial design is in accordance with FDA guidelines and the results will
support the future clinical development of BNC105.
FOR FURTHER INFORMATION PLEASE CONTACT:
Dr. Deborah Rathjen
CEO & Managing Director
+618 8354 6101 / +61 418 160 425
+612 9237 2800 / +61 408 465 800
Trial Title: A Phase I, Two-Stage, Dose-Escalation Study of BNC105P, a
Novel Vascular Disrupting Agent, In Patients with Advanced Solid Tumors
Protocol Abbreviated Name: BNC105P.001
Primary Objective: To determine the safety and maximum tolerated dose
(MTD) in patients with advanced solid tumors.
* To determine the pharmacokinetics of BNC105 and BNC105P (the pro-drug
form of BNC105).
* To demonstrate modulation of kinetic parameters directly related to
tumour vascular characteristics using DCE-MRI.
* To show evidence for a dose-response relationship between either dose
administered or pharmacokinetic parameters and DCE-MRI kinetic
* To identify a therapeutic window.
* To obtain preliminary data on the suppression of tumour growth using
* To evaluate prospective biomarkers of anti-tumour response.
Method: Two-stage dose escalation study involving intravenous
administration of BNC105P on days 1 and 8 of a 21 day cycle for 2 cycles
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(R), the company's angiogenesis target and drug discovery platform, incorporates a variety of genomics tools to identify and validate novel angiogenesis targets. MultiCore(R) is Bionomics' proprietary, diversity orientated chemistry platform for the discovery of small molecule drugs. ionX(R) 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 http://www.bionomics.com.au
BNC105 is a new type of drug called a Vascular Disruption Agent (VDA) that acts to rapidly shut down the blood supply within a tumour. It thereby "starves" the tumour of the oxygen and nutrients it needs to survive.
VDAs (Vascular Disruption Agents) have significant clinical potential in the treatment of cancer, as they may potentially be applied across a very wide variety of cancer types, including colon, lung and breast cancers. The market potential for VDAs has been estimated at approximately US $5 billion annually (ASInsights, 2003)
|SOURCE Bionomics Limited|
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