Aderans Research Treats One-Hundredth Subject in Clinical Study

» » I hate to speak of timelines, but are we looking at three years if all
» goes
» » to plan?
»
» Till commercialization? Try double that. Phase II will be done “later
» this year”, then the data has to be analyzed, the decision made to whether
» or not to go forward, then Phase III begun, completed, and submitted to the
» FDA. Then it has to be approved, and the protocol and its associated
» equipment has to be mass-produced and taught.

OR if phase-II goes fine…then you can just enroll in phase-III and get it for free before everyone else.

Can we please not start with the fantasy time lines again. None of us know how long it will take to bring these things to market.

» Can we please not start with the fantasy time lines again. None of us know
» how long it will take to bring these things to market.

As it has been pointed out many times, we have a very good idea of how long it takes to bring things to market. The average time from Phase 1 to commercial is 10 years. Aderans is in the middle of Phase II, which would suggest they are in the middle (i.e. 5 years) of that timeline (if it works).

» » Can we please not start with the fantasy time lines again. None of us
» know
» » how long it will take to bring these things to market.
»
» As it has been pointed out many times, we have a very good idea of how
» long it takes to bring things to market. The average time from Phase 1 to
» commercial is 10 years. Aderans is in the middle of Phase II, which would
» suggest they are in the middle (i.e. 5 years) of that timeline (if it
» works).

One thing that I always wondered about is what if this procedure works acceptably well (increases 5-6k new follicles) in 50% of people, but the cost of implementation would be upwards of $10k. How would they be able to market a product that would cost five figures, but only have a 50% success rate? To run a business like that, the company would have to guarantee growth or give your money back. However, for them to be profitable, they’d then have to charge everyone $20k to cover the 50% that don’t get growth. I’m not sure how big a market they’ll have for people willing to pay 20k for 5-6k worth of follicles.

I think if this was the case, they would simply try to sell the technology to some other enthusiastic startup that thinks they can crack the HM case. And the process starts all over again.

» » Can we please not start with the fantasy time lines again. None of us
» know
» » how long it will take to bring these things to market.
»
» As it has been pointed out many times, we have a very good idea of how
» long it takes to bring things to market. The average time from Phase 1 to
» commercial is 10 years. Aderans is in the middle of Phase II, which would
» suggest they are in the middle (i.e. 5 years) of that timeline (if it
» works).

Not five years again! (just joking :slight_smile: )

As Spanish Dude said these are exactly the type of trials that are needed if a cure is to be found.

I only started coming to this website in the past year and it amazes me that these types of trials are occurring. I find it promising. Whilst there is no guarantee it will work, you need to buy a ticket before you can win the lottery.

» » » Can we please not start with the fantasy time lines again. None of us
» » know
» » » how long it will take to bring these things to market.
» »
» » As it has been pointed out many times, we have a very good idea of how
» » long it takes to bring things to market. The average time from Phase 1
» to
» » commercial is 10 years. Aderans is in the middle of Phase II, which
» would
» » suggest they are in the middle (i.e. 5 years) of that timeline (if it
» » works).
»
» One thing that I always wondered about is what if this procedure works
» acceptably well (increases 5-6k new follicles) in 50% of people, but the
» cost of implementation would be upwards of $10k. How would they be able to
» market a product that would cost five figures, but only have a 50% success
» rate?
To run a business like that, the company would have to guarantee
» growth or give your money back. However, for them to be profitable, they’d
» then have to charge everyone $20k to cover the 50% that don’t get growth.
» I’m not sure how big a market they’ll have for people willing to pay 20k
» for 5-6k worth of follicles.
»
» I think if this was the case, they would simply try to sell the technology
» to some other enthusiastic startup that thinks they can crack the HM case.
» And the process starts all over again.

This is a good point. Personaly I dont believe that any cure will have a 100% success rate due to human variability. You only have to look at skin conditions like excema and psoriasis and the number of different treatments which are used on an individual trial and error basis in patients to realise skin and hair does not behave in a predictable fashion for everyone.

Mass production.

Raw materials can’t be cheapened past a certain point but almost any construction processes can be cheapened to an astonishing degree. I don’t see HM calling for any huge demands in raw materials.

» » What?? Only 30% showed a viable response? “Viable response” must mean
» more
» » than any response, or else I really can’t see them proceeding with phase
» II
» » trials.
»
» I think the 30% figure is referring to Phase I. In Phase I they were only
» looking whether there were any safety issues. We won’t know whether this is
» a viable treatment before we know the results of phase II.
» I actually think this is the most exciting article I have read for a very
» long time. Clearly they are on to something here: Trials are expensive
» (especially if they are as big as this), and they wouldn’t spend all that
» money if they didn’t think that they were close to finding the cure. This
» is great news!!!

It can’t be 30%, 30% is even worse than Rogaine. Rogaine claims about 75% success rate and we all know that that it doesn’t mean all that much and it varies so much from one person to the next, they would be a fool to roll this thing out if there is only 30% success rate.

» It can’t be 30%, 30% is even worse than Rogaine. Rogaine claims about 75%
» success rate and we all know that that it doesn’t mean all that much and it
» varies so much from one person to the next, they would be a fool to roll
» this thing out if there is only 30% success rate.

Rogaine does not have a practical 75% success rate. It all depends on how you measure “success”. Yes, Rogaine may grow at least 1 hair in 75% of people.

And as was stated before, the 30% success rate refers to phase I, which is primarily designed to test safety.

»
» Rogaine does not have a practical 75% success rate. It all depends on how
» you measure “success”. Yes, Rogaine may grow at least 1 hair in 75% of
» people.
»
» And as was stated before, the 30% success rate refers to phase I, which is
» primarily designed to test safety.

Exactly.

» (ARI) recently achieved a significant milestone in its Phase 2 clinical
» study of cell-based hair regeneration, treating the trial’s 100th subject.
» With clinical sites expected to double in the coming months, the study will
» likely add dozens of additional subjects to its enrollment.
[…]
» “This is leading edge research in our industry,” said Vern Liebmann, Vice
» President, Operations. “We’ve been able to conduct this study largely due
» to the generous financial backing of Aderans Co. LTD of Japan, and we’re
» collectively very excited to see the results beginning later this year.”

“Excited to see the results BEGINNING later this year”?
WHICH results??

As most of you guys already know, ARI started the Phase II trail in April 24, 2009. They mention “recently achieved a significant milestone”. Right, because there has been enough time to SEE already “significant” results during this Phase II trail - because how long it takes time to SEE hair “significant” growing - hello??? (means, to see whether such a procedure works, or not works)

It seems - as ARI mentionted that some time ago - that they recently finished their Phase II trail . So it’s time to prepare a LARGER Phase III trial (“to double test persons in the coming months” ) - and about THOSE results, ARI is “collectively very exited to see later this year” - which actually means, by the end of 2010.

In fact, “by the end of this DECADE” - you remember? :wink:

Regarding “Understanding Clinical Trails”:
http://clinicaltrials.gov/ct2/info/understand

Beginning of 2010, end of 2010, whatever. I just want them to get the sh*t working well enough to grow something impressive.

» Beginning of 2010, end of 2010, whatever. I just want them to get the sh*t
» working well enough to grow something impressive.

:ok:

your scepticism would be welcome, if we saw the same level of scepticism against Gho.
You are right, ARI, by now, should know if it works or not.

But where are Gho’s clinical trials?
Why Gho got bankrupt and no investors wanted to save him? If he had such a wonderful technology?
At least ARI has money, and plenty of trialists. Not bad, considering they are “copying Gho”.

Gho is not making any trials. Because:
-1. Noone would fund him
-2. He would fail and would have to admit his failure. It is much better to sell promises indefinitely.

» your scepticism would be welcome, if we saw the same level of scepticism
» against Gho.
» You are right, ARI, by now, should know if it works or not.
»
» But where are Gho’s clinical trials?
» Why Gho got bankrupt and no investors wanted to save him? If he had such a
» wonderful technology?
» At least ARI has money, and plenty of trialists. Not bad, considering they
» are “copying Gho”.
»
» Gho is not making any trials. Because:
» -1. Noone would fund him
» -2. He would fail and would have to admit his failure. It is much better
» to sell promises indefinitely.

And if ARI knows whether or not its product works, then the mere fact that it’s proceeding with Phase II means that it does indeed work. Unless, of course, something’s afoul here.

» And if ARI knows whether or not its product works, then the mere fact that
» it’s proceeding with Phase II means that it does indeed work. Unless, of
» course, something’s afoul here.

well, maybe it doesn’t work, but they want to try more variations of the technique to see if they finally get it to work.

Everything is possible.

Also, I have to remind you that ICX completed apparently successfuly Phase II trials for ICX-Pro, but later they failed Phase III and went bankrupt.

» And if ARI knows whether or not its product works, then the mere fact that
» it’s proceeding with Phase II means that it does indeed work. Unless, of
» course, something’s afoul here.

Just because they proceed with Phase II trials does not mean it works. It means they THINK it WILL work. Phase I trials are safety trials - they are to test the safety profile of the protocol. Phase II is a continuation of that safety profile, and the beginning of efficacy trials. Phase II determines whether or not the protocol works, and to what degree. If it works well enough, then Phase III trials are begun, and you can assume that it will reach the market as long as something doesn’t go awry. That is why Phase II trials are so important - they basically determine whether or not the protocol works.

We can say this about Aderans: this is the first real, professionally-conducted trials of a true HM protocol. ICX was a sham, and its trials were a joke. If Aderans works, the ramifications will be significantly greater than simple hair restoration - it will basically be the beginning of organ replication.

» Everything is possible.

Correct. E.g. manned spaceflight is possible too.

» Also, I have to remind you that ICX completed apparently successfuly Phase
» II trials for ICX-Pro, but later they failed Phase III and went bankrupt.

Also, I have to remind you, that Spanish Dude is telling you bull****:

Intercytex did NOT “fail” in Phase III, because Phase III couldn’t exist:

October 16 2009
The following response [extract] is by UK-based physician Dr. Bessam Farjo:

Thirdly, money aside, Intercytex agreed that the future probably lies in their ongoing lab research of making fully formed hairs from the cloned cells before taking them back to the donor. At this point, I dont know when this work will result in a clinical trial [which means again Phase I, Phase II and finally Phase III - in fact, YEARS!].

Accurate Source: Did Intercytex Fail? – WRassman,M.D. BaldingBlog

In fact, Intercytex did not have anything. All what they just did in their crappy “clinical trails” has been, what e.g. Dr. Gho (later Aderans etc) TRIED to accomplish since 1996. For example Dr. Jerry Cooley (former head U.S. consultant for Intercytex), knows the TRUTH behind Intercytex and their “clinical trails”.

:expressionless:

»
» In fact, Intercytex did not have anything. All what they just did in their
» crappy “clinical trails” has been, what e.g. Dr. Gho (later Aderans etc)
» TRIED to accomplish since 1996. For example Dr. Jerry Cooley (former head
» U.S. consultant for Intercytex), knows the TRUTH behind Intercytex and
» their “clinical trails”.
»

I didn’t know that the good doctor Jerry “hair cloning breakthrough” Cooley was an ICX advisor. Makes sense.

» I didn’t know that the good doctor Jerry “hair cloning breakthrough”
» Cooley was an ICX advisor. Makes sense.

Here you can find Cooleys’ career:
http://www.haircenter.com/about.html