-----Original Message-----
From: David Irving <david_irving@bioaust.com.au>
Date: Thursday, September 09, 1999 5:51 PM
Subject: Re: PAI-2
Reply to: Re: PAI-2 Hello Walter,
Thanks for your email. I am not sure why you did not receive the information that you requested from us about PAI-2 since our program leader did reply to you and copied me in. I will include a copy of that email below. I trust this will provide you with the information that you require. Please do not hesitate to contact me again if you need any clarification or further information either relating specifically to PAI-2 or to our company in general which, as you will notice below, is in the process of seeking new investment.
Best regards
David
>>Dr David O. Irving
>>Head of Development
>>Biotech Australia Pty Ltd
>>28 Barcoo Street
>>Roseville NSW 2069
>>Australia
>>
>>Phone: +61 2 9928 8829
>>Fax: +61 2 9928 8899
>>E-mail: David_Irving@bioaust.com.au
>>
_____________________________________________________
Dear Mr Morton
I apologise for not replying to you sooner, but things are rather hectic around here, as I am sure you will understand from the following.
PAI-2 is currently in Phase 2 clinical trials for both Chronic Venous Leg Ulceration ( CVLU) and Psoriasis. These trials have taken longer than we anticipated, as our inclusion criteria are very rigorous, and hence patient recruitment has been a bit slow. We believe such rigour is essential if we are to get reliable results. The current estimate is that the results of the trials will come about July, 2000.
Having said that, our "Phase1" trials were more like small Phase 2 trials in design, as we treated actual patients, not healthy volunteers with PAI-2, and obtained results which indicated PAI-2 was beneficial with 94% certainty (CVLU) or 98% certainty (PSOR). Consequently we are justifiably optimistic about the phase 2 results. The phase 1 trials were on 20 patients, while the phase 2 trials will test 130 -140 lesions.
We are well placed in other essential parts of the project. Our manufacturing process is very efficient, and we are licenced to produce clinical grade (GMP) material for the trials and beyond, to the market. We have developed and patented a gel formulation for topical application of PAI-2 to the skin. In addition, we have extensive world-wide patents on PAI-2, both for the original isolation of the molecule and for specific disease applications. There are other disease applications which we are investigating, which I cannot divulge at the moment, to follow after CVLU and psoriasis.
Biotech Australia is currently on the market, and we are looking for investors, as well as for pharmaceutical partners for later stage development and marketing of PAI-2.
I hope this answers some of your questions. Please do not hesitate to ask if you need more information. I will be in Europe for the next 2 weeks at a conference, but will be back here on the 6th September.
Best Wishes,
Clive Bunn, PhD,
Project Manager, PAI-2. |
