announcement today

This is a hell of a lot more positive than the other day. 84 % chance of success to me is statistically significant, especially with only 11 type 2 patients. If 9 succeeded out of 11 then that is 84%. Can someone shed some light .
ann. below.

cheers




Dear Shareholder,
I am delighted to have the opportunity to write to you at this pivotal and
exciting time in the short history of Dia-B Tech Limited. The Company’s recent
announcements position the business for a period of consolidation and further
growth. Dia-B aims to lead the world by delivering the first oral by mouth
diabetes drug without significant adverse side effects in the last 25 years.
Why do Board and Management maintain this confidence regarding the future
for the Company and its ability to achieve such an ambitious goal? The
Company’s lead product, ISF402 now has a compelling set of data indicating
the compound will be active in humans, and this is a major step forward as we
move to Phase II human trials.
- Clinical data: The Phase I trial delivered results that ISF402 has an
excellent safety and tolerability profile. There was a clear indication of
a biological effect in humans that was consistent with data from animal
models. The dose-dependent trends in insulin and C-peptide seen in
healthy people were also apparent when administered to type 2
diabetes patients. What these results showed was that ISF402 caused
a reduction in baseline insulin secretion from the pancreas without
reducing insulin release after a meal. Both effects would be beneficial,
and in the type 2 diabetes patients there was an 84% chance that the
difference was due to the drug. This result is enormously promising in
the context of a small sample size of patients.
These results delivered more than what the Company set out to
achieve
- Mechanism of Action: The animal model work in the preclinical
studies suggests that ISF402 acts by increasing the amount of insulin
available in the circulation without increasing insulin release from the
pancreas. An animated version of how ISF402 works and a short video
statement by me as to the importance of the Phase I results can be
seen at www.dia-btech.com.au
- Oral bioavailability: Dia-B has been able to show that ISF402 is
detectable in meaningful levels in animal and human plasma which
confirms the safety and early efficacy data in the Phase I trial for the
compound.
This data allows Dia–B to join a very small and elite number of Australian
biotech companies with a drug compound proceeding to Phase II human
trials. This is quite an achievement in such a short time.
The next step for developing ISF402 is to seek approval from the US Federal
Drug Authority (FDA) to conduct the Phase II trials. This will allow Dia-B to
build a clinical package that will gain the confidence of the global medical
community. This approval can be a difficult process and may take some
months. However, the extra effort is worthwhile as it delivers a clear path to
accessing the world’s largest healthcare market, the United States and deliver
strong returns for our shareholders. Furthermore, by performing Phase II
trials under the guidance of the FDA, it also provides Dia-B with greatest
value should we seek to license ISF402 in the future.
I want to congratulate the members of the Scientific Advisory Board and the
research team for all their hard work in bringing Phase I for ISF402 to a
successful and very encouraging conclusion.
Dia-B is focused on metabolic disorders by firstly developing new treatments
for type 2 diabetes. As such, we are not a single product Company but retain
a portfolio approach to managing the business. As shareholders, you will be
aware of two other projects under active development. The other compounds
are:
- IMO14: an alternative type 2 diabetic drug extracted from plants and
used for generations as a treatment in Pacific Island communities; and
- CDA1: a potential treatment for diabetic kidney disease and
atherosclerosis which affects a very large proportion of people with
diabetes.
Both these compounds continue to show promise in the preclinical
development being undertaken with our collaboration partners.
As a Doctor, I have seen first-hand how devastating diabetes and its
complications can be. There have been very few new treatments for diabetes
in the last fifty years in spite of diabetes now being a worldwide epidemic. I
have great faith that our current projects will place Dia-B at the forefront of
new diabetes treatments. The work being done by Dia-B will be crucially
important in the fight to curb this debilitating disease and to improve the lives
of many people around the world.
Biotechnology is an endeavour of patience and resolve. We have made
substantial progress and I very much thank you for showing such patience
and for continuing to support our efforts. We will keep you updated
throughout 2008. In the meantime, I wish you all a happy and safe festive
season.
Yours sincerely
Hon Dr Michael Wooldridge
Chairman
13 December, 2007