this is from page 16 of the AGM CEO report of 30 November 2006:
"Following the FDA'S guidance we decided not to execute the second stage of this study and proceed with the design and execution of a phase III trial using the dose with the best profile from this trial and designing the phase III trial with disease-free survival as the accelerated registration end point."
On page 14 it is mentioned that the FDA said to Progen, "accelerated approval was possible for disease-free survival as the primary endpoint." So, I think the shortest time to registration is important to everyone as their is currently no effective treatment for this disease after resection.
the issue now at this critical stage, is the emphasis on the safety profile of the drug at an effective level, given the number of drugs that the FDA has recently taken off the market for adverse side effects. Why risk those benefits any longer, by using the dosage at the higher level. The drug has been shown to work at 160mg with outstanding results. Remember, we preventing tumours from forming in a higly vascular organ where our drug properties are more significant as an anti-metastatic agent. So effective dosages might be much lower than with a high tumour burden where highly toxic chemo is used.
Additionally, the FDA has been involved with this study as a colaborative partner via the SPA, and their input was probably considered in using just the 160mg.dose. It is always better to work closely with the FDA in these efforts
They published the results of the higher dose, the study group as smaller and it seems the drug less effective at high levels.13 people dropped out there were still improvement at the 250mg level, but they were far less pronounced and came with some serious side effect.
PGL Price at posting:
0.0¢ Sentiment: Buy Disclosure: Not Held
