DIA dia-b tech limited

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  1. 689 Posts.
    just to correct you they have completed phase 1b trials and phase 2a is next. Assuming successful phase 1b then from what I know ( i am no expert in this feild) phase 2 is a similar trial but with a larger group of people. ( say 30 for phase 1 and 250 for phase 2 ) This gives a larger sample and if results go the same then phase 3 is all about ensuring no adverse affects on humans. Then they can move towards commercialising the drug.

    Three massive acheivements previously announced are:
    No adverse affects proven to date, this was expected as the drug comes from a natural occurring substance in Human urine that has been synthesized.
    They have found the mechanism of action in the blood( this can sometimes take years)
    THE DRUG IS IN TABLET FORM , NO NEEDLES.

    If they now show the same results of insulin uptake in humans as they did with the rats , then their is no stopping in my view. They have already applied for FDA registration as IND AS per ann. attached below. IND investigational new drug with no safety concerns means that the drug could be fastracked ( 2 to 3 years instead of 5 years)
    I have been following Dia-b since 2001 when it commenced via Cardia technologies CNN and was eventually spun out. So really it has been 6 years and drugs normally take 10 years to develop. Coming into the home straight now with a potential drug to treat the biggest growing disease known to mankind. That really excites me.

    Dia- b announcement below.

    Dia-B confirms no adverse events for lead diabetes drug
    in Phase 1b trial
    3 October 2007: Dia-B Tech Limited (ASX:DIA) confirms that there are no safety
    concerns after a safety review of the first cohort of eight patients in its Phase 1b
    human clinical trial of its lead type 2 diabetes drug compound ISF402. This
    reaffirms a similar outcome from the Phase 1a trial completed in April.
    The Phase I b trial in subjects with Type 2 diabetes is nearing completion and will
    soon be unblinded to determine any biological effects. The Phase 1a trial was
    suggestive of a biological effect in healthy volunteers.
    With the recent confirmation that a derivative of ISF was orally absorbed into
    animal and human plasma, Dia-B now envisages no impediments to proceeding
    to Phase 2 clinical trials in 2008.
    Data from the Phase 1b trial will be available in the fourth quarter of 2007.
    A priority for Dia-B is to finalise an FDA registration strategy for ISF402 so that
    the Phase 2 trial can be conducted as part of an IND (Investigational New Drug)
    registration.
    Enquiries:
    Ken Smith





 
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