+ + data and comment + +, page-10

re: + + phase iib to start at end of this month + 1. From:
http://www.hotcopper.com.au/post_thread.asp?fid=1&tid=52191&sym=MBP#156542

Extract:
1. AOD9604 Obesity Drug
"Preparations are on track for commencement of the Company’s 300 patient Phase 2b human clinical trial of AOD9604 obesity drug, with the first patients expected to commence treatment in late-October.

The double-blind placebo-controlled trial involves the participation of five leading Australian hospitals. The primary aim of the study is to assess weight loss after three months daily dosing in male and female obese subjects".

2. Previous history:
http://stocknessmonster.com/news-item?S=MBP&E=ASX&N=201482

Extract: "The principle of AOD9604, already proven in animal studies, is to mimic the natural fat reducing properties of human growth hormone without producing any effects on blood sugar control or growth. In the 10 mg dose group, the overall weight loss was 1.0 kg compared to 0.4 kg in the placebo group, and in the 20 older volunteers the weight loss was 0.8 kg compared to a weight gain of 0.1 kg in the placebo group".

" MBP believes that the drug has a favourable side effect profile when compared with existing drugs on the market which mostly act on the brain to affect appetite and have many side effects".

3. Intentions:
From the Annual Report:
"Phase 3, the final step in the clinical trial process, is expected to require about 1500 patients treated for up to two years, and in tandem there is a requirement for manufacturing plant construction to meet the expected worldwide market demand on obtaining marketing approval.

It is common practice for biotech companies such as Metabolic to negotiate an exclusive marketing and distribution deal with a major pharmaceutical company that pays for these more expensive stages, in return for upfront and milestone payments together with royalties on sales.

Metabolic expects to follow the partnering path in some form, and will continue to engage in discussions with several potential partners over the next year.

The Company’s policy is to assess partnering opportunities on the basis of the maximum long-term value to be gained by shareholders, the importance of exercising control over the further development of projects and the practicalities of further self-financing.

Joint venture deal structures which involve cost sharing with the partner in exchange for sharing of the worldwide marketing rights are of particular interest to the Company".

Comment:
At this stage it is difficult to say if the FDA will grant Accelerated Approval (the subject of obesity rates is being rated very highly by the new FDA boss).

Gerry