I am no authority on the matter, but I'll take a shot at answering these questions. (They are good questions, though some of them have been asked before on this site.)
1. In the Phase I study, why did only 5/7 regrow hair? What happened to the remaining 2? This can perhaps shed light on what hurdles they are currently facing.
A few explanations as to why only 5/7 regrew hair that I can think of, though these are just my thoughts:
Like the second part to this first question suggests, perhaps there are other hurdles that they have to overcome. There are many theories as to the source of male pattern baldness, and maybe it isn't just one thing, but many contributing factors. For example, maybe the unfortunate 2/7 men have a "dried out" vasculature - not enough blood vessels to support the regrowth. Or maybe (my own theory) hair grows in cycles due to the migration of growth-triggering cells which move from one follicle to the next, and those 2/7 either lost the pathway of migration, or lost the cells, or whatever. Again, just my ideas. Another reason could be related to the next question - those 2/7 require a higher dosage for regrowth to occur. Maybe there is some sort of "threshold" of needed cells to begin regrowth, or the dosage or procedure of the intermediate "proprietary" step needs to be tweaked.
2. Why is it taking so long to start Phase II? The first time I heard about Intercytex (early 2005) they had written on their website that the Phase I was successful and they were planning on starting Phase II later that year (2005). Any ideas?
As I understand it, the goal of Phase II is to find the ideal dosage. In the case of a drug administration, for example finasteride, they did studies on multiple dosages, and found that 1mg / day is the best on average. But there is a lot of data on other dosages. If you do a search you'll find it on this site. In this case, however, there are multiple steps. They might be fine-tuning the cell culturing procedure, and/or it could be that there are a certain number of cells that must be injected into a given area for regrowth to occur. But they are also going to continue to evaluate the safety of the procedure in this phase as well. But it is an exciting phase, in my opinion. I certainly hope that they figure out what it takes to make this work for 7/7 patients.
Phase II will also involve more patients, say 20 instead of 7. And as willing as both doctors and patients are to jump in, they have to abide by a protocol and a great deal of logistics. It all takes time.
I was in a clinical trial for something unrelated. It was slated to last for just 1 month, with 5 visits within that month. But I had to wait until 2 months from the time I called to apply, because my schedule and the doctor's schedule had too many conflicts.
3. How many months/years will Phase II take, and any ideas when Phase III will start after that?
I can only guess on this one. 2 years maybe? Hopefully. Maybe somebody could search for other trials and compare the 3 phases for each given trial, to see how long phase II was compared to phase I on average.
4. Most importantly: don't they have to wait for at least one hair cycle to complete (which can take several years from my understanding) to know if indeed the HM is viable for more than one implantation? And if so, wouldn't that mean they should wait the several years between each of the Phases to make sure the procedure is ok, and then move on?
Yes, they do. I didn't think of this before I read it on this site, maybe for the same reason that they are going ahead with phase II. The reason is that they can probably do phase II dosage studies in parellel with verifying that the next hair cycle continues to grow. They might find out that of those lucky 5/7, only 3/5 continued to grow hair with the next cycle, because the other 2 were given a different dosage, or the culturing process was different, or whatever.
So the answer is that yes this has to be verified. But they can assume that the injected cells will act as their parent cells, and continue to regenerate cycle after cycle. And based on that assumption, they can procede to tweak the protocol with Phase II.
And maybe they already verified that the next cycle of growth is just as good as the first, who knows?
I'm pretty excited about this. This could put an end to a lot of stress for all of us. Can you imagine?[/u]
