Last week the organization that is overseeing the ICT-107 clinical trial recommended that ImmunoCellular continue the ICT-107 trial. Just a quick refresher, I am currently enrolled in the ICT-107 clinical trial and ImmunoCellular is the company behind ICT-107.
So the fact that they are continuing the trial is great news! If they would have canceled the trial that would probably mean they think it’s doing more harm than good. The somewhat sobering part of the news is the criteria that had to be met for this announcement to occur. The way the study was designed, an interim analysis was to be released once 32 “events” have occurred. In this study an event is defined as a patient death. This really speaks to just how deadly glioblastoma is. In the vast majority of clinical trials for other ailments if 25% of the patients die before the trial is even complete, they would probably stop the trial pretty quickly. Glioblastoma is a beast though, and in the clinical trials for it the main goal is extending the life of the patient.
Nobody knows how many of those patients were on active drug or placebo and the final results of the phase II of the ICT-107 probably won’t be out until later this year or early next year. If the results are good it will likely go onto a Phase III trial and then go to the FDA for approval. I found this chart which goes through the typical stages.
So assuming everything goes well with the ICT-107 trial it will probably be somewhere around 2020 before the drug would come to market and be available to everyone. Seems a bit crazy that the process takes so long. You would think if a drug for such a deadly disease shows good results in phase I and Phase II, Phase III could be skipped or the placebo removed, but I don’t think that’s how it works. Maybe they are worried about a scenario from the movie, “I Am Legend”, where a virus created for the purpose of battling cancer mutates in a plague that kills everyone. There do seem to be a lot of zombie movies out lately, so maybe the government really is just trying to prevent a zombie apocalypse 🙂
Nothing much else to report, still feeling great overall and have been enjoying the summer with my family. Below is family picture from our recent trip to Isle of Palms.