I think AEZS has little control over this trial. In any case they are not spending any money over this. From their website "Phase 2 portion of the trial is supported by a three-year US$1.6 million grant from the National Institutes of Health to the lead investigator, Jacek Pinski, MD, PhD, of the USC Norris Comprehensive Cancer Center".
That sounds quite accurate. In fact, if the results are as good as the phase 2 indicates, patients in the dox arm may even demand for AEZS 108. In any case, we should get an idea before the interim results where the trial is headed.
FDA has approved open-label phase 3 for AEZS108 under SPA. From what I read, open-label studies have the opposite of placebo effect (called hawthorne effect). Is this a positive for this phase 3? Does anyone have any input on this?
Why is this bad news? They already have a completed Phase 2 for Ovarian Cancer waiting for resources to go into Phase 3 for about 4 years. Is there any point in wasting money in additional phase 2 studies? In fact, this is pretty good news.