Reconsidering my position about ICX. Going positive now

Stem cell; cell based hair therapy
1

Reading Monty’s posts, I have found this document about ICX which is quite interesting to see things in perspective:

http://www.intercytex.com/icx/investors/rep/otherdocs/2006-08-03/at_aim.pdf

page 41, onwards.

Maybe the main problem is money after all. Lack of money.
The document, tells ICX’s roadmap:

-in phase II, they were going to try 3 different formulations.

-Then, If some of the 3 formulations worked, they would jump to Phase III
using the best formulation.
-If none of them worked, then they would expand phase II to try new formulations.

So they covered the possibility of failure for these 3 formulations, and they planned to try more formulations.

So even if all 3 formulations failed, they didn’t plan to stop the project!!!
Why are they stopping now, even if the preestimulation seems promising?? Well, the only explanation seems that there is a severe lack of money.

But if the problem is the lack of money, and the preestimulation is working ok, then why are they hiding the number of hairs?
I don’t know.

They also say, very important,:
QUOTE:
>>>>
The proposed Phase II study strategy seems appropriate given the uncertainty about optimal formulation, the need to generate safety data for the US IND, limitations regarding number of injections possible prior to scale up and the need to find the optimal clinical setting. The timings for the proposed Phase II study seem reasonable given that this is a highly motivated patient population, though the study(ies) will require longer if further formulations need to be evaluated or if further safety data is required for the IND.
Budget estimates to mid-2007 for the first 20 patients in the THATCH II trial
(£500k) are adequate. If recruitment of further patients is required for THATCH II there will be additional costs. No budget is yet available for the pivotal Phase III trial.
Small studies have been carried out to date in model systems with human female DPs and it is too early to say what their long term fate will be.
<<<<

So this document states that ICX had budget only for 20 trialists in phase II
(500k pounds).
There was no budget for Phase III yet. And apparently no budget for an expanded phase II.

But in spite of this, they say that they had plans to set up a manufacturing facility in USA for 2009, ready for product launch.

QUOTE:
>>>
Currently the product is manufactured at the Group’s Manchester facility. In the USA a anufacturing facility will be set up at the same location as that for ICX-PRO; this is lanned to become operational in 2009 in time for product launch.
<<<

So it seems clear that they initially planned to keep investing money in the project beyond phase II.

It seems that now, they can’t afford these projects.
I would say that it is fundamentally by lack of money.

Apparently, they have money but just for the skin products.

Well, if my new guessings are right, maybe we are lucky if they find someone to pay the bills.
But of course, this is a big setback.

2

y spend money on phase iii if not needed. they didnt do phase iii on vavelta, they didnt even complete full phase ii on vavelta and still launched it. they dont want to do phase iii on ICX SKN, now they dont want to do it on TRC so 3 of their 4 products will not have phase iii

they want sell trc now because they have all data and they can make money, after all they r doing commercial work for a reason

3

» Reading Monty’s posts, I have found this document about ICX which is quite
» interesting to see things in perspective:
»
» http://www.intercytex.com/icx/investors/rep/otherdocs/2006-08-03/at_aim.pdf
»
» page 41, onwards.
»
» Maybe the main problem is money after all. Lack of money.
» The document, tells ICX’s roadmap:
»
» -in phase II, they were going to try 3 different formulations.
»
» -Then, If some of the 3 formulations worked, they would jump to Phase III
» using the best formulation.
» -If none of them worked, then they would expand phase II to try new
» formulations.
»
» So they covered the possibility of failure for these 3 formulations, and
» they planned to try more formulations.
»
» So even if all 3 formulations failed, they didn’t plan to stop the
» project!!!
» Why are they stopping now, even if the preestimulation seems promising??
» Well, the only explanation seems that there is a severe lack of money.
»
» But if the problem is the lack of money, and the preestimulation is
» working ok, then why are they hiding the number of hairs?
» I don’t know.
»
» They also say, very important,:
» QUOTE:
» >>>>
» The proposed Phase II study strategy seems appropriate given the
» uncertainty about optimal formulation, the need to generate safety data
» for the US IND, limitations regarding number of injections possible prior
» to scale up and the need to find the optimal clinical setting. The timings
» for the proposed Phase II study seem reasonable given that this is a highly
» motivated patient population, though the study(ies) will require longer if
» further formulations need to be evaluated or if further safety data is
» required for the IND.
» Budget estimates to mid-2007 for the first 20 patients in the THATCH II
» trial
» (£500k) are adequate. If recruitment of further patients is required for
» THATCH II there will be additional costs. No budget is yet available for
» the pivotal Phase III trial.
» Small studies have been carried out to date in model systems with human
» female DPs and it is too early to say what their long term fate will be.
» <<<<
»
» So this document states that ICX had budget only for 20 trialists in phase
» II
» (500k pounds).
» There was no budget for Phase III yet. And apparently no budget for an
» expanded phase II.
»
» But in spite of this, they say that they had plans to set up a
» manufacturing facility in USA for 2009, ready for product launch.
»
» QUOTE:
» >>>
» Currently the product is manufactured at the Group’s Manchester facility.
» In the USA a anufacturing facility will be set up at the same location as
» that for ICX-PRO; this is lanned to become operational in 2009 in time for
» product launch.
» <<<
»
» So it seems clear that they initially planned to keep investing money in
» the project beyond phase II.
»
» It seems that now, they can’t afford these projects.
» I would say that it is fundamentally by lack of money.
»
» Apparently, they have money but just for the skin products.
»
» Well, if my new guessings are right, maybe we are lucky and it is possible
» that TRC is not dead after all. If they find someone to pay the bills.
» But of course, this is a big setback.

Wow that was a very informative read.

It was written some time ago though so things could have changed since then.

                                                                       "At launch the

product will be positioned as a ‘filler’ in the early stages of hair loss, or for use in
combination with follicular transplantation in males, to provide a hair thickening effect.
Longer term plans include use as a stand alone treatment in younger males and females."

“Intercytex plans to launch the product initially for use in combination with follicular
transplantation in males, to provide a thickening effect. This will fit with its commercial
strategy of partnering with a company already active in the follicular transplantation
business e.g. Bosley Medical. The ‘hair thickening’ usage of ICX-TRC will be expanded
as a stand alone treatment for younger males with early male pattern baldness for whom
follicular transplantation would not be recommended. In this sector, additional revenues
could be derived from storage of cultures for future implantation. The ‘‘hair thickening’’
concept should also play well in the female market where all-over hair thinning is the
issue of concern.”

4

Yes, and regarding hair direction look at this part:

In the longer term Intercytex is evaluating whether the optimal setting for a pivotal
clinical study, and hence first marketing approval, is as a ‘filler’ in the early stages of hair
loss or as as an adjunct to transplantation. This seems reasonable given the absence of
information on the cosmetic acceptability of the hair produced.
<<

So they are saying that they don’t know if the direction will be correct, and that is why they are considering the worst-case scenario, and that is why they will only use it as “thickener”.

But also note that in this document they already mention that in phase I, 5/7 regrew new hair.
So they know how this new hair looks, and if the direction is good or not.

Then, if they are planning to use it as thickener, its because the initial results have bad direction, and they need to solve it. That is why they are considering to use it as thickener only at the beginning.

This document is very useful, although it is a bit old.

5

» y spend money on phase iii if not needed. they didnt do phase iii on
» vavelta, they didnt even complete full phase ii on vavelta and still
» launched it. they dont want to do phase iii on ICX SKN, now they dont
» want to do it on TRC so 3 of their 4 products will not have phase iii
»
» they want sell trc now because they have all data and they can make money,
» after all they r doing commercial work for a reason

no, the situation with Vavelta is different.
They are doing more phase II trials with Vavelta, even if they have “launched”. This launch is not a definitive launch. This is only small-scale. But they keep doing trials.
In the case of TRC, unless they find new money, everything will stop.

6

well y waste more money on carrying completing phase ii clinical amc commercial work, y not end it now ? if they have to do clinical work then y do commercial work with it if there is nothing to commercialise

7

» well y waste more money on carrying completing phase ii clinical amc
» commercial work, y not end it now ? if they have to do clinical work then
» y do commercial work with it if there is nothing to commercialise

what?? I don’t understand anything.

8

another website is saying they r looking 4 some1 to do the procedures

9

» another website is saying they r looking 4 some1 to do the procedures.

We have talked about all this in this forum. Read all the posts and you have all the info available.

They have no money to keep going. That is why they need a partner.
They need more research. TRC is not ready for market yet as Vavelta is.
Even unregulated, TRC would not be ready, and they have no money left.

this is what we can deduce from the very limited info.

10

» » another website is saying they r looking 4 some1 to do the procedures.
»
» We have talked about all this in this forum. Read all the posts and you
» have all the info available.
»
» They have no money to keep going. That is why they need a partner.
» They need more research. TRC is not ready for market yet as Vavelta is.
» Even unregulated, TRC would not be ready, and they have no money left.
»
» this is what we can deduce from the very limited info.

What i dont understand is this people saying that phase III costs 100 million for the testing. How in the world is it possible even if it was 500 test subjects, for a clinical trial to cost 100 million dollars? I understand they have to pay staff salaries etc, but lets say you have 100 scientists at 50k per year, for one year is 5 million dollars, and you know they do not have that many scientists, well maybe they do. I still cant see where they come up with 100 million dollars

11

» What i dont understand is this people saying that phase III costs 100
» million for the testing. How in the world is it possible even if it was
» 500 test subjects, for a clinical trial to cost 100 million dollars? I
» understand they have to pay staff salaries etc, but lets say you have 100
» scientists at 50k per year, for one year is 5 million dollars, and you
» know they do not have that many scientists, well maybe they do. I still
» cant see where they come up with 100 million dollars

the pdf says:

Budget estimates to mid-2007 for the first 20 patients in the THATCH II trial
(£500k) are adequate.
<<

So this is 1 million USD for 20 test subjects in Phase II.
This would be 25 million USD for 500 subjects.
But probably PhaseIII is more expensive per trialist than PhaseII.

12

» the pdf says:
» >>
» Budget estimates to mid-2007 for the first 20 patients in the THATCH II
» trial
» (£500k) are adequate.
» <<
»
» So this is 1 million USD for 20 test subjects in Phase II.
» This would be 25 million USD for 500 subjects.
» But probably PhaseIII is more expensive per trialist than PhaseII.

And I think in Phase III, the trialists will be studied for a much longer period.
Then cost would easily reach the 100 million USD you said.

13

» » the pdf says:
» » >>
» » Budget estimates to mid-2007 for the first 20 patients in the THATCH II
» » trial
» » (£500k) are adequate.
» » <<
» »
» » So this is 1 million USD for 20 test subjects in Phase II.
» » This would be 25 million USD for 500 subjects.
» » But probably PhaseIII is more expensive per trialist than PhaseII.
»
» And I think in Phase III, the trialists will be studied for a much longer
» period.
» Then cost would easily reach the 100 million USD you said.

as far as I read phase 2 only had less than 20 test subjects and a lot of them dropped out on top of that. i seriously doubt that phase 3 would have 500 test subjects

I still would like to see breakdown on where they spend 100 million dollars thats A HELL OF A LOT OF MONEY for a study

14

» as far as I read phase 2 only had less than 20 test subjects and a lot of
» them dropped out on top of that. i seriously doubt that phase 3 would have
» 500 test subjects
»
» I still would like to see breakdown on where they spend 100 million
» dollars thats A HELL OF A LOT OF MONEY for a study

phase2 has treated 19 subjects.
1 has been lost to follow up.
5+5 have been already evaluated for several weeks
8 are going to be evaluated next.

I think that lack of money is forcing ICX to use reduced cohorts.

I also doubt that phase III will have as much as 500 subjects, but if ICX gets money, maybe the number of trialists will be a decent one.

btw, who said phase III will cost 100million USD?

15

» » as far as I read phase 2 only had less than 20 test subjects and a lot
» of
» » them dropped out on top of that. i seriously doubt that phase 3 would
» have
» » 500 test subjects
» »
» » I still would like to see breakdown on where they spend 100 million
» » dollars thats A HELL OF A LOT OF MONEY for a study
»
» phase2 has treated 19 subjects.
» 1 has been lost to follow up.
» 5+5 have been already evaluated for several weeks
» 8 are going to be evaluated next.
»
» I think that lack of money is forcing ICX to use reduced cohorts.
»
» I also doubt that phase III will have as much as 500 subjects, but if ICX
» gets money, maybe the number of trialists will be a decent one.
»
»
» btw, who said phase III will cost 100million USD?

i saw that number thrown around not sure by whom

if its not accurate what do you think the amount would be

16

Neuren, a new drug, had a mere 10 million dollars budgeted for its phase 3 FDA trial US FDA approves Phase 3 IND for Glypromate | Scoop News

"…Neuren has engaged a US-based, international contract research organisation to manage the global trial of 520 patients which will be carried out in the US, Australia and New Zealand. This Phase 3 trial is double-blind, multi-centred, placebo controlled and is based on endpoints that have been well-established in previous FDA-approved studies using validated measurement techniques. The trial is estimated to take 18 months.

The Phase 3 trial is budgeted to cost Neuren A$10 million, which is substantially less than many other Phase 3 trial"

Ive looked at the Motley Fools website and they pointed out that some drugs have taken 350 million dollars to get through the entire three phases of FDA trials and to be approved for sale. Sometimes FDA phase 3 trials cost over 100 million. Ive read that in the past.

However, chances are slim something like a few injections on your noggin’ would make it that expensive

Here is why Im not so enthusiastic however…SCID mice.

Aderans and ICX have had SEVERAL YEARS to graft human skin on SCID mice and practice HM. There is no telling how many little lab animals they have shot up in this way, and if they haven’t they are fools as they are the best test method we have to “practice” an indication like this before moving to human beings, which is expensive and requires a hell of alot more precaution. How many lab mice have ICX and Aderans shot up? I’d bet its a bunch by now. They already had their favorite mixes before phase two in all likelihood, one gets those ducks in a row before phase 2. You can test on these mice before PHASE 1.

My idea, which I still think is the best, is to do the HM protocol that makes the most hair…and inject the “hair seeds” (Ken Washenik’s one time description of them) into a man’s thigh after he has had hair removal there. Any hairs that grow would obviously be HM hairs. An FUE doc would then transplant the hair growing from the thigh to the head as a fully differentiated hair. If he got no growth down there, he wouldn’t be getting his head shot up a bazillion times with needles for nothing. I’d do this until better results were had in HM testing. They could start making money in the NOW this way. A man would merely pay an increased amount per graft (probably more than 10 bucks) instead of 5 or 6 dollars per graft. One BHT doc, Umar, was doing BHT’s for 5 bucks in the past.Its the only way to have a hair surgery in the NOW that would put MORE hair on your head than what you had before. If a man got both his upper thights shot up with HM, and moderate hair growth ensued (head hair wont grow long in length on the body), he could have a few thousand real differentiated hairs moved to his head in this way. Most men on finasteride dont need 60,000 hairs, just 10,000 or so. In conjunction with a regular transplant, this would be “enough” to meet most mens needs up there.

If one is cueball bald with only 10,000 hairs on their entire head…they’d be needing too much to do in this way.

Waiting for conventional HM to really work good in human heads is obviously going to be a few years away in my opinion based on their phase two results. This is a tough nut to crack apparently. If Aderans buys what ICX has after September…it still might be several years, as in five or more as Bosley would be distributing it and they’d have to get with the FDA and see if the FDA would accept the phase 2 trials that ICX did before having a phase 3 and then the review process EVEN IF IT WORKED GOOD ENOUGH TO GO FORWARD WITH… Aderans will have money for this if they think they have a winner.

17

okay, Benji, then lets assume 100 million USD for phase III with a decent set of trialists.

Regarding your suggested method of preseeding the upper thigh, could be a solution. Although maybe the characteristics of the hair are altered. Maybe it is better to put the seeds on the scalp, and then replant the hairs with the correct direction.
They could even use mice to pregrow the hairs, although this is an unpleasant idea.

For me it is clear that the direction problem is not yet solved, and maybe that is why ICX lately mentioned about growing the hairs outside the body and then planting on the scalp.

If the direction is bad as I suspect, I don’t see how these hairs can be used as “filler”, unless the hairs are replanted. If the new hairs are chaotic, you will have a strange mixture of correct+chaotic hairs in the head, and the result will be pretty bad.

Also, lets remember that ARI has researched a lot in scaffolds, so they could join ICX and reach a viable solution.

18

ok, 100 million USD then. Benji has convinced me.

19

There is alot wrong in your post here»
» Regarding your suggested method of preseeding the upper thigh, could be a
» solution. Although maybe the characteristics of the hair are altered.
Donor dominance Spanish Dude…the hair retains its characteristics wherever its moved. The only thing that has been shown to change is the length sometimes that it will grow in the recipient location. Some body hair has grown longer on the head than it does on the body, but in many cases it does not. Body hair moved to the head will be kinky if it is on the body, or will be curly if it was curly on the body. Head hair moved to the body will have the exact color and texture that it did on your head, except that it will not grow long. Jahoda proved this many years ago.

» Maybe it is better to put the seeds on the scalp, and then replant the
» hairs with the correct direction.
Direction probably isn’t the foremost of their concerns, lack of hair growth is. When have they said direction was a problem? 13% increases in the first phase two trial would be much more of a problem. If they are having both direction issues and lack of growth, it really is bad news.
» They could even use mice to pregrow the hairs, although this is an
» unpleasant idea.
Immunodeficient mice are available, but these creatures dont live very long. PETA would have an absolute fit for a gazillion lab mice to be used this way. Growing an ear in a lab mice’s back to transplant to someone who has been born without an ear or has lost one is one thing, but utilizing them for things like hair would set off a firestorm of controversy. It will never happen.
»
» For me it is clear that the direction problem is not yet solved, and maybe
» that is why ICX lately mentioned about growing the hairs outside the body
» and then planting on the scalp.
Aderans is who is using biodegradable tissue matrixes in the body and creating cultures to where hair can grow outside of it for re-implantation (or trying to anyway), not Intercytex. Intercytex has said nothing about direction being a problem. ICX has mentioned nothing about growing hairs outside the body.
»

» If the direction is bad as I suspect, I don’t see how these hairs can be
» used as “filler”, unless the hairs are replanted. If the new hairs are
» chaotic, you will have a strange mixture of correct+chaotic hairs in the
» head, and the result will be pretty bad.

Its been mentioned on this forum that over time stromal tissue just might correct bad direction anyway. Notice alot of bad old transplants from the eighties when direction wasn’t so good get better direction as the years go on alog with the grain of the other scalp hair. Its the plugginess that is an issue with them. I think you have talked yourself into thinking that direction is their problem at ICX. Its almost certainly the lack of thick growing hair that its the problem. They’d have happily given everyone a haircount if the hair had grown in thickly but haphazardly, but they didn’t. One can keep their hair cut short if direction is a problem, but its almost assuredly not their problem as they havent mentioned it. Its growth.
»
» Also, lets remember that ARI has researched a lot in scaffolds, so they
» could join ICX and reach a viable solution.
This is true, if direction is a big problem. We’d know if one of them would release a photograph, or if Aderans would mention anything. But they dont…and hence why the forum is becoming pointless. We just aren’t given much information on continuing trial results. These entities have tests, but aren’t willing to tell us how the tests are coming out. That is not a good thing. Indications that actually work, like finasteride…give you all kinds of stats and numbers on how much bigger the hairs get, how many more of them per square inch there are, show you pictures, etc. The more I think about how they didn’t include even any statistical increases after this latest trial, the more I think that the improvements over the first phase two trial weren’t very much. Maybe 5 out of 5 men grew hair, but it really does take 200 hairs per square inch to look pretty thick and 120 to even look “thinnish”. People without MPB often have 400 or more hairs per square inch. When they say 13% increase in thinning areas, do you realize that might mean somebody who had a thin 50 hairs per square inch might have went to 57 hairs per square inch? Are the new hairs circumference thick or are they “thinnish” intermediate looking hairs?

WE dont know because they wont tell us. Thats why just checking up on ICX’s and Aderans website about once a year is the only rational thing left to do. If they get into phase 2 at Aderans, maybe they put something up…but other than David procuring an interview with them, we just aren’t getting any answers at all anymore. It makes speculation pointless.

20

-About Donor Dominance: I have to refresh my memory here, but I think this is not completely true when you inject only DP cells. For example, the color of the hair is that of the receptor site. This is on Intercytex FAQs.

-Yes, direction is a concern for ICX. Its in this pdf. That is why they plan to use it as a filler at launch. Also, you can see in the FAQs that they are ellusive about the subject: “there should not be a problem because you are injecting cells” LOL.

-Yes, ICX is considering to grow hairs outside the body, or at least “protohairs”: they have filed a patent.
http://www.hairsite.com/hair-loss/forum_entry.php?id=14113&page=0&category=1&order=last_answer

Also, I think it was Jerry Cooley who talked about it in a conference?

-It is true that ICX didn’t tell us numbers, and this could indicate that they are having growth problems. But as I said, this was planned. If all the three formulations failed, they planned to keep trying new formulations. I am sure there are many variables to play with.
And we cannot say that these formulations failed, because the preestimulated patients all of them had increased numbers.

-I don’t know if over time direction will correct by itself, but even in that case, it is a big problem if your hair looks horrible for years. In any event, I don’t like the idea of using it as a filler. Mixing good hairs with slanted hairs is not a good idea. If that was acceptable, then using 100% HM will also be acceptable.

quote:

WE dont know because they wont tell us. Thats why just checking up on ICX’s and Aderans website about once a year is the only rational thing left to do. If they get into phase 2 at Aderans, maybe they put something up…but other than David procuring an interview with them, we just aren’t getting any answers at all anymore. It makes speculation pointless.
<<

I agree with this. With so little information that they are giving us, we can speculate and speculate, for nothing.
Paul Kemp interviews are quite informative, though.