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Intercytex: Year-end clinical trial update


#1

Intercytex: Year-end clinical trial update

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.


#2

» Intercytex:
» Year-end clinical trial update

»
» 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.

Phase II trials was on only 5 subjects? I would be surprised if this would qualify as a study

the increased hair counts what is this? 13 percent of what…105 percent of what? are these velous hairs? or terminal hairs>

are they telling us that on the guys with 105 percent increase that they doubled the amount of hair on their heads previous to the procedure?
to me their trials have too few participants and the results they post are given out with intentionally misleading or confusing data.


#3

» Phase II trials was on only 5 subjects? I would be surprised if this would
» qualify as a study
The patients are 26!! 5 it’s the new sub-group…
» the increased hair counts what is this? 13 percent of what…105
» percent of what? are these velous hairs? or terminal hairs>
It’ hairs
»the results they post are given out with intentionally misleading or confusing data.

Commercial politics of a trade-society…


#4

» Intercytex:
» Year-end clinical trial update

»
» 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.

Nick Higgins, CEO commented: “We have made strong progress across our clinical development pipeline during 2007 with positive clinical efficacy data being generated on all our products in the portfolio. With significant newsflow in the first half of 2008, Intercytex is well positioned to capitalise on the rapidly emerging field of regenerative medicine.”

In the Business world, this CEO is taking some risks here…I dont thnik that he would have said that without postive unreleased Data…


#5

» Phase II trials was on only 5 subjects? I would be surprised if this would
» qualify as a study
»
» the increased hair counts what is this? 13 percent of what…105
» percent of what? are these velous hairs? or terminal hairs>
»
» are they telling us that on the guys with 105 percent increase that they
» doubled the amount of hair on their heads previous to the procedure?
» to me their trials have too few participants and the results they post
» are given out with intentionally misleading or confusing data.

Phase II is a rolling trial. The first cohort involved twelve subjects; two were lost to study. These twelve subjects were divided into two groups: the first did not receive pre-epidermal stimulation; the second did. Regarding the breakdown of numbers, I have read that the first group was initially comprised of six subjects; however the subsequently published results only mentioned five. It is therefore reasonable to assume that at least one subject was lost to study at this point. Given that the first group did not achieve particularly good results (2 out of 5 showed increased hair counts, of 21 and 55%), the argument could be made that both subjects lost to study came from this test group. As stated in the most recent press release, a third cohort of five patients has received TRC using the pre-stimulation technique; two more will be treated in January. This makes a total of 17 patients. That they hope to provide preliminary 12 week data on 16 patients in March 2008 suggests they have lost one more subject from the original cohort.

As for your second point regarding percentages, I agree with you. Assuming the calculation is X + (X x 13-105 x 0.01) = Y (where X represents the original number of hairs, and Y the final number), then it all depends on how much hair you have in the test area to begin with. Then again, I failed math in high school, so I may have that wrong.

Sources:
http://www.intercytex.com/icx/news/releases/2007/2007-09-25/
http://www.intercytex.com/icx/news/releases/2007/2007-12-18/


#6

» Nick Higgins, CEO commented: “We have made strong progress across our
» clinical development pipeline during 2007 with positive clinical efficacy
» data being generated on all our products in the portfolio. With
» significant newsflow in the first half of 2008,
» Intercytex is well positioned to capitalise on the rapidly emerging field
» of regenerative medicine.”
»
» In the Business world, this CEO is taking some risks here…I dont thnik
» that he would have said that without postive unreleased Data…

They do have more than one product in their portfolio. The statement is not referring solely to TRC.


#7

ICX going full-steam ahead. Great, great news.


#8

assuming they are talking about the increase in amounts of hair in the test area to begin with…Lets assume the area is almost devoid of hair, there is a 1 sq cm area with 10 hairs there…when it should have 70 to 100 hairs…

so in the worst case there was a 13 percent increase which means there was an increase of ONE hair in that area…that could very well be phase of growth cycles and not even because of the study

same with a 100 percent increase which would mean a whopping TEN MORE HAIRS in that area, and even then, they dont tell us if these new hairs are velous or terminal, lets assume since they dont tell us , that they are velous, which is pretty worthless

this is what I mean by misleading
Unless they give actual before and after hair counts, their results are meaningless


#9

» They do have more than one product in their portfolio. The statement is
» not referring solely to TRC.

they said the phase II trial would end in 2008 so there should be an update about TRC at that time


#10

Hello HanginInthere, I have read you before lot of times and despite you seems to me not as an acceptable opinion, I have to give you the reason this time, only tell you that always behind your scepticals opinions, you should give at least one oportunity to the hoppeness, not everything is as bad as it seems for you, you forgot to mention that the process can be performed all times you want so in case of only 13% of regrowth you could repeat it till infinite.

But what if it is applied in a bald area? 100% regowth of what? becouse as it seems in the reports given by ICX, it is not strictely neccesary to apply it in a vellus area, isn´t it? so it is suppused that I could apply it my nose for example.
Dermal papila cells with previous stimulated skin produces hair, but where is the difference ( in the skin ) between a vellus and a bald area? Vasculars differences?

» assuming they are talking about the increase in amounts of hair in the
» test area to begin with…Lets assume the area is almost devoid
» of hair, there is a 1 sq cm area with 10 hairs
» there…when it should have 70 to 100 hairs…
»
» so in the worst case there was a 13 percent increase which means there was
» an increase of ONE hair in that area…that could very well be phase
» of growth cycles and not even because of the study
»
» same with a 100 percent increase which would mean a whopping TEN MORE
» HAIRS in that area, and even then, they dont tell us if these new hairs
» are velous or terminal, lets assume since they dont tell us , that they are
» velous, which is pretty worthless
»
» this is what I mean by misleading
» Unless they give actual before and after hair counts, their results are
» meaningless


#11

Who’s moneys on this thead going on and on and on,especially as HanginInThere,as put is bite in.