Dave/Jim/All:
a fast update on what I have ascertained so far, re WF-10 in Thailand.
first news to really surprise me was to discover that there has been a test under way in Canada for the past 2 years, under the SAP program of HC. I can find absolutely zilch, about it, on the HC SAP site. Am I the only one who was unaware of this?
This is an open-label study, being conducted in Canada, with the express approval of HC. The purpose of the study is to allow patients to be treated with WF10 through Health Canada's controlled Special Access Programme (SAP). Dimethaid is conducting the program. Health Canada has approved this study as a compassionate use protocol. As of May 22, 2001, 36 patients (22 males and 14 females) have been enrolled. The study is ongoing.
THAILAND:
the drug is used here in only one official capacity, for
treatment of chronic complications after cancer radiotherapy.
it was approved by the Thai Food and Drug Administration (Thai FDA) in 1997.
It has been studied in clinical trials with HIV/AIDS
patients in Thailand. I suspect that "Off label" use may be limited by the fact that it is used for only the one area (oncology) rather than several (immunology). But, I will not have a definitive answer as to the sales picture, until I get some information from the Thai distributor. That is proving to be tuff sledding, as the distributor's website is still under construction.
There have been safety studies completed here, but the main one is yet to be announced. It is referenced as <the WF10-98-THAI-01CYS study>. My Thai doctor tells me that her oncology specialist friend has told her the results of this study are known but will only be formally announced 'soon', i.e. in 2003... or, if things go according to the Thai way, sometime before the Second Coming...This may very well be after the Phase III's are published.
That's all for now. Fox. |
