INTERCYTEX Year-end clinical trial update

Stem cell; cell based hair therapy
1

ICX-TRC is a novel hair regeneration product. It 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.

In September this year we announced the first results from the current Phase II trial. In the sub-group of subjects (5 in total) whose scalp was pre-stimulated at the time of injection all subjects 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 5 subjects have now been treated with ICX-TRC using the pre-stimulation technique with 2 more expected in January. By the end of March 2008 we expect to announce preliminary 12 week data on up to 16 subjects in total and preliminary 24 week data on up to 10 subjects.
WE WILL HAVE THAT TO WAIT 24 WEEKS MORE IT The FINAL RESULT Of PHASE 2?:frowning:

2

BL,

There will probably be a few more trials of “phase 2” before they are willing to move onto phase 3. ICX probably wants to find the best A)Inject depth, B)Inject numbers of cells 3)Best cell mixture of DP cells and other cells and D)cultivation methods and storage methods for these cells.

There are alot of variables in mixing the different five stages of the entire process above. They want to find the best for each in order to optimize the product. They would want a very successful phase three trial. Remember, this is just a company researching and testing a product. They aren’t going to behave like a 25 year old man who wants his hair back so he can go out clubbin’ with style. They will process this science and this product like a company processing a new artifical heart or renal dialysis machine…slowly and methodically. Im impatient too, but I realize that isn’t going to make it go faster. But it is on its way.

3

I just wonder what TRC will really be capable of right out of the gate after phase#3 is done and it hits the market.

ICX has been careful to keep calling this a boost to traditional HT work rather than a stand alone deal, and I wonder why. Aside from the artistic hairline creation issue, I don’t see what the limitation on TRC would really be.

To my mind, it seems like a patient could just keep throwing TRC sessions at his head indefinitely until he more or less got his original density back.

Of course I know the efficacy of each TRC session is important in the big picture of HM. But I don’t see the harm in letting patients overspend for a bunch of sessions at the early days of HM and get more hair back as soon as possible. Plenty of guys would be willing to roll the dice on efficacy a few extra times, waste some money, and ultimately get most of their hair back sooner.

Any thoughts?

4

»
»
»
» To my mind, it seems like a patient could just keep throwing TRC sessions
» at his head indefinitely until he more or less got his original density
» back.
»
»
»?

 I have had this thought myself, and privately wished they would go ahead and release when they have a ----pretty good---- working protocol of new permanent (or better stated, donor-area characteristic) hair. One could get top ups over the years.
5

» I have had this thought myself, and privately wished they
» would go ahead and release when they have a ----pretty good---- working
» protocol of new permanent (or better stated, donor-area characteristic)
» hair. One could get top ups over the years.

but then again how many of us would be able to keep flying over to the UK in order to constantly keep getting “top ups” or whatever third world country they end up releasing it in first because i dont expect it to come out in the US anytime soon.

6

I would fly anywhere, multiple times per year if necessary. I really don’t care, as long as it works. But I am not getting a HT. My hairline, while not perfect, is close enough for now. And I want to get HM to start filling in all the thinness. I would only consider a HT after seeing the HM results and knowing that it is just a minor procedure to finish up the job.

7

» Plenty of guys would be willing to roll the dice on efficacy
» a few extra times, waste some money, and ultimately get most of their hair
» back sooner.
»
»
» Any thoughts?

IMO, any procedure that can give a man his hair back is going to be a smash hit. It won’t matter if it costs 100 grand and takes 15 sessions. As long as it can consistently restore a man and/or woman’s hair, people are going to sit in the chair.

The potential downsides here are regrowth limitations and inconsistency. But that will not IMO stop the procedure from being marketed as long as some men can get their hair back.

I see in the HT industry, one guy gets a good looking hairline, one guy gets a crappy looking hairline, and 3 guys get marginal looking hairlines. Yet, people still flock to the HT clinics and get their hairlines worked on. We will see the same thing in HM as long as some guys do in fact get their heads restored.

Men have been purchasing expensive snake-oil, ingesting potentially dangerous medications, etc. for ages in hopes of getting their hair back. If something comes along that works well in 25% of men and leaves the rest screwed, men will still flock to the chairs in order to roll the dice. It will cost 3 thousand dollars or less to find out if you are a good candidate for the procedure. Huge numbers of people will lay down that kind of cash as long as at least 25% of patients are getting a wow response.

The main catch here for patient satisfaction is that patients must be informed of the odds up front and this must be backed by trial data.

8

Yeah, I’m 100% convinced of the core demand for HM even if it’s inconsistent.

But what concerns me a little bit is that ICX itself doesn’t seem to be acting like the initial TRC is gonna be used to this degree.

Why not?

Don’t they realize that millions of men don’t give a sh*t about the costs if something actually works AT ALL to leave them with any more total scalp hairs than they started the procedure with?

Don’t they realize that their consistency & efficacy concerns sound like a joke compared to spending $100K to REALLY roll the dice on strip HTs, problematic/weak medications, and BHTs?

Don’t they realize that a decent percentage of men would be willing to pay for extra TRC sessions just to free themselves of existing MPB medication regimens?

It just seems like either ICX still doesn’t truly understand the enormity of the demand for a better MPB option, or else they’re trying to caution us that this stuff is not gonna be as infinitely-repeatable as we all assume it will be.

9

if it’s not going to be used to give a man full head of hair, then it’s simply because it was not possible to do so.

and this is probably the most probable outcome.