Dia-B Achieves Major Clinical Milestone By Detecting Its Diabetes Drug Compound ISF402 In Blood

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 31 Aug 2007 - 1:00 PDT

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Dia-B Tech Limited (ASX:DIA) has achieved a major clinical milestone of its ISF402 diabetes drug development by confirming its detection in the bloodstream of trial patients. Peptides and proteins already existing in the bloodstream often mask small peptide drugs, making drug evaluation unreliable.

A robust procedure has been developed for measuring ISF402 in plasma. Development of the assay has advanced the clinical development of ISF402 by identifying a major clinically active metabolite (HTD-amide) and in animal studies determining the circulating concentrations of HTD-amide that improve insulin action. The assay can measure ISF402 and HTD-amide in plasma from humans and animals dosed orally with ISF402 and the results confirm that ISF402 enters the circulation after oral dosing.

An independently assessed analysis of interim data from the recently completed Phase Ia trial has shown pharmacologically relevant amounts of HTD-amide in plasma from trial subjects dosed orally with ISF402. The concentrations detected were similar to those achieved in rabbits given oral ISF402.

Dia-B chairman Dr Michael Wooldridge stated, "this is a major step in developing the company's ISF402 diabetes drug. There are usually difficulties in detecting small peptides in the circulation as plasma is full of small peptides and proteins that can mask the signal. It's like finding a needle in a haystack."

"Results from the assay demonstrate ISF402 absorption into human plasma after oral dosing, and allows Dia-B to pursue a drug registration strategy with the US FDA."

Professor Paul Zimmet AO, chairman of Dia-B's Scientific Advisory Board and Head of the International Diabetes Institute said, "these results add to evidence of good tolerability and safety of ISF402 which is a key competitive advantage for this drug candidate. The need for a new safe diabetes drug has been highlighted by the recent safety concerns of some other drugs used in the treatment of diabetes."

About Dia-B Tech Ltd

Dia-B is an Australian publicly listed biotechnology company (ASX:DIA) focused on the development of therapeutics for the treatment of diabetes and its associated complications. Dia-B has three compounds in development:

-- ISF402 in Phase Ia/Ib clinical trial in Australia as an orally administered diabetes treatment
-- IMO14 in preclinical development as an insulin sensitizer
-- CDA1 in preclinical development for diabetic nephropathy and atherosclerosis

Diabetes is a major metabolic disease reaching epidemic proportions in the developed world. Australia has more than I million diabetics and this number is growing by 100,000 per year. Fears about the social and economic burden of a looming epidemic have led the federal, state and territory governments to agree recently to a $200 million program to tackle the disease. In the US over 20 million people (7% of the population) have diabetes.

About ISF402 Phase Ib clinical trial

Dia-B Tech's Phase Ib trial is testing the safety of ISF402 in subjects with exercise or diet controlled type 2 diabetes. Recruiting of patients has now been finalized for the Phase 1b trial, and dosing is expected to be completed in the first two weeks of October 2007.

Trial protocol:

-- Patients are randomized to receive ISF402 or placebo on two separate occasions followed by a standard meal
-- Each period will be separated by a minimum of 14 days
-- Patients are to be dosed with 900mg of ISF402 based on the pharmacokinetic data from the Phase Ia trial

Trial end-point:

-- To evaluate the safety, tolerability and pharmacokinetics of a single oral dose of ISF402

http://www.diab-tech.com.au