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March 18th?


#1

New to hear, and am wondering how it was announced that ICX would be releasing information on the 18th of March. Is this just an update on thier progress? If so what Phase are they testing now 1, 2, or 3? Also would I be wrong to assume that if they are into thier phase 3 trials that treatment would be avalible soon after?
Thanks


#2

atm they are in phase II trial, we have to wait again…


#3

So thier update is on the results of the phase 2 trials?.. Phase 2 is for safety?


#4

ICX-TRC clinical and commercial development

Phase I clinical trials (safety) have been completed in seven volunteers at a single UK transplant centre. No safety issues have arisen and five out of seven patients have shown increased hair numbers.

A Phase II clinical efficacy trial on patients with male pattern baldness is being conducted by Dr Bessam Farjo in Manchester, to optimise the delivery of 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 total hair count. Two sub-groups of five subjects each were injected with DP cells using different delivery techniques. In the first sub-group, two out of five patients showed substantial increases in hair count at 24 weeks. In the second sub-group, all patients showed substantial and visible increased hair counts at six or twelve weeks. A further eight subjects will be treated with variations in delivery technique. The full data set on all subjects at 24 weeks will be available in during 2008. This detailed analysis will form the basis of further Phase II or Phase III trials as appropriate.


#5

Thankyou for your time.


#6

they are in phase II,

this phase may still take anything from 10 months to a few years. it may also fail or be stopped and canceled. it is dose testing & efficiency phase.

phase III has some significant chance of failure as well. and if it goes to phase III it will take an aditional year (very unlikely that it would be just a year) or more before you can expect it on the market.


#7

All three of the steps are technically for both “safety and efficacy.” So theoretically the project isn’t out of danger of being abandoned all the way up until phase#3 is complete and it’s on the market.

But in reality the process works more like this:

– The biggest goal of phase #1 is basically just to make sure the stuff isn’t gonna hurt anyone.

– Phase #2 is arguably the “meat” of the trials process. At the end of phase #2 we will have a real idea about what this stuff is capable of delivering and how to do it best. Some products have made it through the end of phase#2 testing and then been ruled unsafe later, but it’s a rare occurrence. Anything that clears phase#2 is very likely to go to the commercial market without any more major setbacks to disrupt the progress.

– Phase#3 is mostly fine tuning the rougher conclusions that were gathered in phase#2. Dosages, another round of trials to experiment for efficacy, etc.


#8

» they are in phase II,
»
» this phase may still take anything from 10 months to a few years. it may
» also fail or be stopped and canceled. it is dose testing & efficiency
» phase.
»
» phase III has some significant chance of failure as well. and if it goes
» to phase III it will take an aditional year (very unlikely that it would
» be just a year) or more before you can expect it on the market.

I agree with you debris. I have finally decided that I will be going for a small FUE transplant with Dr.Cole if Intercytex decides to extend phase II.


#9

if it was to fail intercytex would not even think about releasing trc in 2008. there are too many pessimists on this board who know nothing

The DTI grant will be used to adapt this proven technology to produce autologous (i.e. sourced from and returned to the same individual) human cells in a reliable, efficient way and at a scale that can handle a large number of people.

Key word = “Proven”

Nick Higgins, Chief Executive Officer of Intercytex said: “We are delighted that the DTI has granted us this substantial funding. The large-scale production of ICX-TRC will be key to its commercial success and this collaboration will support our scale-up work. ICX-TRC is currently in Phase II clinical testing and this project should ensure we are in a position to produce cells to treat large numbers of people, both in our later stage clinical trials and when ICX-TRC is launched.”

key word = “when”

below was march 2007 results. They said 9 patients treated that means they will have a full year’s results for many of those those 9 patients in march 2008.

ICX-TRC march 2007
We started a Phase II trial of ICX-TRC, our cell therapy product for hair regeneration in male-pattern baldness, in September. The process involves taking a biopsy from the subject, separating out the relevant cells, and growing them in our facility using our proprietary process. All biopsies from the first cohort of 9 patients have been taken and most of these patients have been treated. Further cohorts will follow investigating variations in delivery technique. We expect to report preliminary data from this trial around the middle of the year


#10

ssssss:
if it was to fail intercytex would not even think about releasing trc in
2008. there are too many pessimists on this board who know nothing

I agree… although I can understand why some people feel demoralized; they’ve been on this forum for ages, and they have yet to see a legitimate cure. That said, times change, consumer demands evolve and so does technology. I think we’re in a better position today than ever before. FUE is replacing FUT, the internet is weeding out unscrupulous doctors, and more companies than ever before are focusing efforts on a legitimate HM treatment. All-in-all we’ve gone a long way from plugs and medieval scalp reductions. There’s no need for pessimism.

.


#11

Majority of phase II products never reach the market because they fail phase II or phase III tests. You may call it a pessimism, but for me it’s just statistics and ignoring these high phase II/phase III failure ratios I call dreaming.

I do believe that it will work in the end but I won’t do anything I’d regret in case it failed.

Also:

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.

That means that phase II will not end before January 2009 when the last guys reach 12 month mark.

The second cohort will need aditional 9 months to reach full year (== december 2008).

Now whose the pessimist here dude?


#12

debris:
Now whose the pessimist here dude?
short answer: you

Nobody said we’ll be sporting full heads of hair by the end of 2008.
I simply find the progress encouraging.

.


#13

» debris:
» Now whose the pessimist here dude?
» short answer: you
»
» Nobody said we’ll be sporting full heads of hair by the end of 2008.
» I simply find the progress encouraging.
»
»
»
» .

ssssss said that in march they will have full 12 month data which is just delusion or possibly a typo


#14

ssssss said that in march they will have full 12 month data which is just
delusion or possibly a typo
I suppose ssssss assumes intercytex will re-examine whomever they treated (during Phase I back in March 2007) in March 2008 to acquire some degree of annual data. Again, I’m just guessing.

.


#15

Debris said 2009 for end of phase II. I’d say another 4 years for end of phase III and approval. Which bring us to 2013.

And if we count from the start: 2008 + 5 = 2013 :smiley:


#16

That means that phase II will not end before January 2009 when the last guys reach 12 month mark.
The second cohort will need aditional 9 months to reach full year (== december 2008).
Now whose the pessimist here dude?

Where is write that a patient need one year to have a complete test phase??
Remember, or know, if you don’t know this, that the complete circle of life death and regeneration of an hair follicle is 6 MONTHS, not one year, so 6 months it’s the time that show you how a follicle born grow and die, so why you are speaking about 1 year??


#17

Average hair cycle of healthy hair takes 2 years or more, so I kinda don’t agree with what you saying at all but this is completely irrelevant.

What is relevant is what ICX say on their web page:

At the end of the trial, photographic data will be analysed from a much larger area of treated scalp on all subject at 12 months

This means that if the january cohort was the last one (and it probably is not), the trial could end 12 months later as the earliest.

all this information comes from their web page:
http://www.intercytex.com/icx/products/aesthetic/icxtrc/
http://www.intercytex.com/icx/investors/rns/rnsitem?id=1197961285nRNSR1153K&t=popup


#18

I’d be even more realistic than Debris, I’d say 2015 before the most common guy can afford and be able to have it done. Because the technology takes time to settle down.

You guys talk with your feeling not with the science, the mathematics and the statistics which is Debris does.


#19

» I’d be even more realistic than Debris, I’d say 2015 before the most common
» guy can afford and be able to have it done. Because the technology takes
» time to settle down.
»
» You guys talk with your feeling not with the science, the mathematics and
» the statistics which is Debris does.

Yup; I’d say 2012-2015 if trials are successful. Of course, we’ll know if we’ll be lucky enough to only have to wait that long in about a year and a half. By then, it will be clear whether or not either ICX or Folica have something commercially viable.


#20

» Yup; I’d say 2012-2015 if trials are successful. Of course, we’ll know if
» we’ll be lucky enough to only have to wait that long in about a year and a
» half. By then, it will be clear whether or not either ICX or Folica have
» something commercially viable.

the next 8 years without hair? NO PLEASE