It is possible that a phase II could be completed

It is possible that a phase II could be completed by end of 2014. Ctix has ingenious plan to start a phII/III retinblastoma trial after completing this phI. That will give them orphan drug status opportunity, fast track and breakthru status opportunities. Things will move quickly - more so than usual. They will not complete a combined phII/III in a year, but could complete a single phII.

The Phase 1B trial by U Bologna  is surely ready to go - just waiting to fill in the dose in their (most likely) prepared application. If they receive approval quickly - they'll be on their way. Recruiting won't be a problem for them. Facilities are already chosen. The PR says this will be combo study with cytarabine - but the beauty of a phase 1B is that the primary agent being tested, in this case Kevetrin, can be combo-tested in multiple arms at the same time. So one group of patients get Kevetrin/Cytarabine combo if their cancer deems that most appropriate, another gets Kevetrin/multikinase inhibitor, etc...Advantages of this kind of study are ability to study multiple combos in single trial, ability to have healthier, earlier staged patients participate since the new agent is just being piggybacked onto their primary chosen treatment - just adding to their standard therapy, and the time saving is immense. A multicombo ph IB can be completed start to finish in 6 months.