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Interesting Website


#1

http://tressless.com/blog/2007/09/25/intercytex-phase-ii-hair-multiplication-trial-results/


#2

» http://tressless.com/blog/2007/09/25/intercytex-phase-ii-hair-multiplication-trial-results/

So when will this thing come to market?

Depends on how the next leg of the trials go, but Intercytex already has a market-released cosmetic product called ICX-RHY which was greenlit by MHRA, the medical regulatory agency in the UK. It’s quite possible that our beloved hair multiplication technology will receive the same push to market after Phase II.

I like that bit - Sounds good.


#3

Good find, but I disagree with this statement:

“There may or may not be more Phase II or Phase III testing after this.”

That statement implies that Phase II, Phase III, or abandonment may occur after the next round of Phase II data. But I interpret Intercytex as saying that Phase II OR Phase III will occur next. If the results are really bad then they’ll no doubt just still be in Phase II trials, not abandon the whole project. They’ve invested a lot already and know that Trichocyte has a high level of interest.

Best,
BB


#4

» http://tressless.com/blog/2007/09/25/intercytex-phase-ii-hair-multiplication-trial-results/

He forgot the most important question of all: Will the new hair cycle normally . . .

Will it last as long as the original donor hair?

(I sure hope so–but I have forebodings.)

The other questions the website lists, pale in comparision.


#5

» http://tressless.com/blog/2007/09/25/intercytex-phase-ii-hair-multiplication-trial-results/

The one solid piece of really good news in all this is that all subjects grew hair.

Think how much worse we’d be feeling if, for example, only half the subjects grew hair.

So . . .

So far, so good.


#6

"Intercytex released the results from their ongoing ICX-TRC Phase II trial hair multiplication technology today.

To be clear: permanent hair is being grown on bald scalps. No drugs or further treatment is needed to keep the hair. This is the beginning of an absolute cure for hairloss.

From the PDF information sheet:

ICX-TRC consists of a suspension of autologous dermal papilla (DP) cells. These cells are able to stimulate the generation of new hairs when injected into the scalp in close proximity to the epithelial cells which generate the hair. The purpose of the ongoing Phase II study being conducted by Dr Bessam Farjo in Manchester is to optimise the delivery of the DP cells. In this study, hair counts are obtained by shaving and photographing a small section of scalp, injecting it and then applying a specialised image analysis system to provide a total hair count. Two sub-groups were each injected with autologous DP cells using different delivery techniques. The first group focussed on delivery of the hair inductive DP cells, and in the second group resident hair producing (epithelial) cells were also stimulated at the time of delivery. Although it is too early to determine fully the differences between the sub-groups, the preliminary data are encouraging. In the first sub-group 2 patients out of 5 showed substantial increases in hair count (21 & 55%) at 24 weeks. In the second sub-group (5 patients in total) injected more recently, all patients showed substantial and visible increased hair counts at 6 and/or 12 weeks (13-105%). We believe this increased hair production is attributable to the interaction between the injected DP cells and the stimulated resident hair producing cells. A further 8 subjects will be treated with variations in delivery technique. The full data set on all subjects at 24 weeks will be available in the middle of 2008. This detailed analysis will form the basis of further Phase II or Phase III trials as appropriate. At the end of the trial photographic data will be analysed from a much larger area of treated scalp on all subjects at 12 months. Currently 2 patients have been lost to follow up.

What this means:

There was a large variation in result quality, coinciding with Intercytex refining their technique.
Everyone that completed the trial grew hair.
Some patients doubled their hair count in the test area (105%). Other patients, not so much (13%).
A new trial with 8 patients will begin soon, the delivery technique will be further refined.
New results will be released in 24 weeks (mid 2008), with images.
There may or may not be more Phase II or Phase III testing after this.
What we still don’t know:

The quality of the new hair
If repeat injections in the same area would yield continual improvement
What “pre-stimulation” means, which by their account improves efficacy and is the basis of the second leg of their Phase II trial.
If this new hair is definitely DHT resistant and cycles normally (Likely, but not proven).
"So when will this thing come to market?

Depends on how the next leg of the trials go, but Intercytex already has a market-released cosmetic product called ICX-RHY which was greenlit by MHRA, the medical regulatory agency in the UK. It’s quite possible that our beloved hair multiplication technology will receive the same push to market after Phase II.

That said, ICX-RHY may have only made it to market because it’s a new technology that isn’t adequately regulated. There’s a big party-crashing cloud coming in the form of new European legislation called Advanced Therapies Medicinal Products Regulation (ATMP) , which may become law in 2008. This could be seen as either an extra hurdle or as incentive for Intercytex to get to market fast, as any existing approvals will not face the new regulation. (source)

Regardless of any setbacks, when the doors do finally open to a renewable source of hair, you can count on a stampede of bald man-mastodons rattling windows and flattening all life in a mad dash to the lab, wherever that may be. I’ll be the third formerly wooly mammoth from the front."

Even this guy feels the same, “there is a large variation in result quality”, I hope I am wrong but all the signs are pointing to another minoxidil like product. It is done differently but results may very well be just like Rogaine, it works for some and not everyone gets the same results.


#7

that would suck.


#8

» Even this guy feels the same, “there is a large variation in result
» quality”, I hope I am wrong but all the signs are pointing to another
» minoxidil like product. It is done differently but results may very well
» be just like Rogaine, it works for some and not everyone gets the same
» results.

This is better than Rogaine, no doubt in my mind. The efficacy rates of Rogaine are actually astonishingly low. I just hope Phase IIc are pormising enough to begin Phase III after that – with commercialization on the horizon.


#9

» This is better than Rogaine, no doubt in my mind. The efficacy rates of
» Rogaine are actually astonishingly low. I just hope Phase IIc are
» pormising enough to begin Phase III after that – with commercialization
» on the horizon.

Mind you, Rogaine 5% actually claims to have 75% success rate. The recent ICX update doesn’t sound that much better than Rogaine, their success rate range is actually quite alarming, too wide to be meaningful.


#10

tressless says “New results will be released in 24 weeks (mid 2008), with images.”

ICX does not promise that. the pdf says merely, “At the end of the trial photographic data will be analysed …”

there is nothing about releasing images. If they were inclined to do that, they would have and could have with the current trial.


#11

Without actual before and after hair counts, it’s impossible to know whether it is just another Rogaine. But even if it is just another Rogaine now, there is a difference. Rogaine will always be Rogaine. Oh, they might up the percentage from 2% to 5%, but it’s still Rogaine. It will never be more than that. Even if this first release of HM is no better than Rogaine, that doesn’t mean future iterations won’t be better, once the technical hurdles are overcome. That’s the rub though. How long is it going to take? I certainly hope it’s not 20 years, and I don’t think it will be, but I also cannot discount it either.


#12

And don’t forget that even if Rogaine’s hair count percentages are similar, ICX has the leg up even now.

Assuming that ICX is producing terminal hairs (and that’s a big if of course at this point), Rogaine for the most part produces soft, downy hairs of little cosmetic use.

Most importantly, assuming ICX is producing hairs that cycle normally, they won’t require daily application like rogaine does.

What are Rogaine’s numbers anyway? Are they really as good as 13-105 percent?


#13

» And don’t forget that even if Rogaine’s hair count percentages are similar,
» ICX has the leg up even now.
»
» Assuming that ICX is producing terminal hairs (and that’s a big if of
» course at this point), Rogaine for the most part produces soft, downy
» hairs of little cosmetic use.
»
» Most importantly, assuming ICX is producing hairs that cycle normally,
» they won’t require daily application like rogaine does.
»
» What are Rogaine’s numbers anyway? Are they really as good as 13-105
» percent?

I’ve been using Rogaine for a long time.

I would estimate that at best you get a 20% increase in terminal hair growth–but IT IS ONLY TEMPOARARY.

Rogaine wears off after about 18 months, and it’s downhill again.

This is because Rogaine does not grow new hair.

It just wakes up those follicles in resting phase, so that all follicles grow hair and none are in resting phase—

Until after about 18 months, when the follicles begin to cycle and rest again.


#14

New hairs that grow terminal w/o daily support once created = major league progress on curing MPB.


#15

I want to say that this medications (Rogain and Propecia) could not be compared in this way with HM.
Because if you have response lets say 25% after HM then you can go back again after 3 months and do second HM
and again have response 25%, and then again if you need … that could mean that you will have option of unlimited number of hairs AND that is real cure for baldness (if it is true).
Rogaine however will give you some response (15% or even 70%) but you will lose that in 2 -3 years and that is - No More Nothing.


#16

Email me please: 4ltkfi702@sneakemail.com


#17

» Email me please: 4ltkfi702@sneakemail.com

Here we go again, please share with the board or can I email you too ?