Ocata Therapeutics Inc fka OCAT

[rocky301]

a couple Phase1/2 definitions that may help,


1) Phase 1-2 includes both phase 1 and phase 2 procedures into a single trial. These studies are initiated when there is an expectation of less than usual short-term side effects and risks associated with the drug or biologic such as vaccine trials. Once the metabolic and pharmacologic actions of the drug and the side effects are determined then the trial moves directly into determining the effectiveness of the agent. As with Phase I and II studies, the participants are closely monitored and as with phase II trials involve several hundred participants.
http://www.genome.gov/Pages/Research...review_app.pdf

2) Phase I/II Trials: Phase I/II trials combine a Phase I and a Phase II trial of the same treatment into a single protocol. First the Phase I part of the trial is done, to determine the MTD. Then, more patients are treated at the MTD in the Phase II part, which follows immediately afterwards. The Phase I and Phase II parts are basically ordinary Phase I or Phase II trials, so you can analyze the trial as either a simple Phase I or Phase II trial, depending whether they've reached the Phase II part of the trial or are still in the Phase I part. The only way to find out is to talk to the investigators.
http://cancerguide.org/trials_phase1.html