PBT2 as it is called has shown positive improvements in the cognitive ability and has reduced brain deteriation in some of the animal models that were used. So, the purpose of Phase II is to conduct studies on actual people during period of at least one year. This particular study has been going on since 2011. This has been done on 109 people with early and mid-stage symptoms of HD. According to Prana Biotechnology Limited (PBT) who conducted the study, the results were very promising and they plan to move on to Phase III to obtain approval from the FDA and make the drug avaialble to HD patients.
Another exciting factor about this potential new drug is that it has also shown improvements on study animals infected with Alzheimer's Disease as well. If the results continue to be as promising as they have thus far, there may be treatment for not one, but two diseases that affect the brain. I like the sound of that.
I was so excited when I first read this. Surely that must mean we can have this drug available to the public very soon, right? Well, as I learned today, that all depends on your defintion of soon. Phase III, which looks fro 1000 - 3000 people to test normally takes THREE years! Yes, three. And then, when the application is filed with the FDA, they may take two years or longer to approve the applicaitons.
But, still even five years doesn't sound so bad. After all, as early as 2010 when Robert's mother passed away, there wasn't even a Phase II being conducted. News like this gives me hope for Robert, Debbie, Chrissy and many of the people we have met in our Support Group.
PBT2 will not cure HD or Alzhiemer's, but it could stop the effects that the two diseases have on the brain. While that is wonderful news, research is still needed and being done to find a way to stop them both before they even begin.
Parana Biotechnology Limited plans to release the official results of the Phase II studies in October. I eargerly look forward to that to seeing the full details of those results and seeing what the potential for this promising drug really are. I am sure I will have another blog posting then to share it with you.
