The clinical trial was carried out at Fremantle Hospital, Western Australia, under the
direction of Dr. Michael C. Stacey of the department of surgery. Based on the
results of this small pilot study, a larger clinical trial is now underway.
Message 11483143
In response to: <<Biotech Australia is still in pre-clins, and the research you reported is apparently in-vitro.>>
Cistron granted a sublicense to the PAI-2 DNA Patents to Biotech to make, use and sell PAI-2 protein for therapeutic products in the U.S. Cistron has been advised by Biotech that it opened an Australian manufacturing facility in October 1994, concluded a preliminary safety study using PAI-2 to treat leg ulcers, initiated a 20 patient clinical trial on patients with leg ulcers, which was co-funded by the Australian government, and is currently in a 130-140 patient Phase II trial. Phase III involves wide-scale studies on patients with the same disease in order to provide comparison with currently available drugs or biologics. Data from Phase I, II and III trials are submitted in an NDA. The NDA involves considerable data collection, verification and analysis, as well as the preparation of summaries of the manufacturing and testing processes, pre- clinical and clinical trials. The FDA must approve the NDA before the drug may be marketed.
ALSO
"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."
( Message 11204892 ) |
