Dia-B Updates Human Clinical Trial Progress For ISF 402
April 21, 2007 – 11:52 am | posted in DiabetesMelbourne-based biotech company Dia-B Tech Limited is pleased to update its progress of the Phase 1 human clinical trial of its lead type 2 diabetes drug compound ISF402 after the trial reached a critical milestone.
Stage A of the Phase 1 trial has been completed with the dosing of 32 healthy male volunteers, of which 24 received ISF402, and there were no clinical adverse events in the human subjects. Therefore, Dia-B Tech is proceeding immediately to Stage B of the Phase 1 trial.
Dia-B Tech Chief Executive Ken Smith said, “It is timely that the Coalition of Australian Governments, only last Friday, announced $200m would be directed toward a new initiative on diabetes. This confirms that new treatments are an imperative in this national and international fight against this ballooning epidemic. The next progressive step for Dia-B Tech, as we further test the safety of ISF402, will be in people with type 2 diabetes. We expect to have full results of the Phase 1 human trial available around mid-year.
“The interim data available to Dia-B is suggestive of a biological effect of ISF402, similar to that found in the previously conducted animal trials. This is enormously encouraging for Dia-B as we move forward,” said Mr Smith.
Stage B will involve testing ISF402 on a further 16 volunteers with type 2 diabetes. Active recruitment is currently underway to enable the next two groups of 8 to commence testing as soon as possible.
Prof Paul Zimmet AO, Director of Melbourne’s International Diabetes Institute, a co-inventor of ISF402 and a member of the Dia-B Scientific Advisory Board said, “We are very pleased with the progress and results of the Phase 1 trial to date. It is a very exciting time and given the earlier positive results in animals, we look forward to the outcomes from the next stage of the Phase 1 trial.”
Dia-B Tech Chairman, and former Federal Health Minister, Dr Michael Wooldridge noted, “Type 2 diabetes is now a significant international health issue warranting a unanimous vote at the UN General Assembly in December 2006 which called for united global action. It is gratifying that an Australian biotech company focusing solely on diabetes’ solutions is so far advanced in the fight against this costly and devastating disease.”
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