Intercytex Report is out.. Ouch, are you guys going to be disappointed

Stem cell; cell based hair therapy
41

» » You are wrong, this thing works. They make hair in every head they
» » inject. Only difference is that, at that dose, some people grow
» +13%
» » hair and some +100% hair. Thats only mean that you need to increase the
» » dosage in people that doesnt build enough hair, not that system doesn´t
» » work.
»
» In the first sub-group 2 patients out of 5 showed substantial increases in
» hair count (21 & 55%) at 24 weeks.
»
» buy some glasses

weren’t they all given different dosages though??

42

» My culture is having a dialectical confrontation with who thinks
» different by me. For understanding. is it clear now?

No, it’s not clear. We were discussing whether or not one statement by ICX was valid or not. I was right, you were wrong. Your “argument” was full of irrelevant, pretentious nonsense about syllogisms.

Don’t take any of that in the wrong way; those are just my opinions. I don’t know you, and I’m sure you’re a great guy.

By the way, I love Italy and Italians (in general, they’re much nicer, more honest, and more intellectually serious and well-grounded than Americans).

In fact, I’m going to Italy TOMORROW.

43

» There is one pdf and one powerpoint.
» The following can be downloaded from the following address.
»
» http://www.intercytex.com/icx/news/releases/2007/2007-09-25/2007-09-25.pdf
» and
» http://www.intercytex.com/icx/investors/rep/rep2007/2007-09-25/2007-09-25.pdf
»
» This is the key point mentioned about ICX-TRC.
»
» “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.”

Does anyone know if they plan on re-injecting the previous trial members as well as new patients?
That would be very valuable to see not only if new delivery techniques can improve the initial results on new patients, but also if more treatments on the same patient equals more results.
If the injections can only give 105% results, but that 105% result is achieved every time you inject (once every six months) then that wouldn’t be so bad.

44

» ICX+TRC “results encouraging”; ALL patients showed significant regrowth; up
» to 103%.
»
» Their product VAVELTA is not yet in Phase III clinical trials, yet it’s
» already been placed on the market for patients. This shows that this CAN
» be done. This coincides with their prediction of possible limited
» commercialization in 2008.

JTR,
I think there are two elements to a 2008 limited commercialization.

  1. If ICX wants to do it,
  2. If MHRA lets them do it.

From what I remember from an earlier ICX release, ICX was going to look into whether TRC could receive the approval that Valveta did regarding some new UK or European legislation. I don’t think (or at least nothing has been publicized about it) that ICX-TRC has been granted that classification, yet.

45

» JTR,
» I think there are two elements to a 2008 limited commercialization.
» 1. If ICX wants to do it,
» 2. If MHRA lets them do it.

You’re absolutely right. It all depends on what MHRA decides. However, I think that ICX think that it’s reasonable to expect that MHRA might grant them authorization to do this, otherwise they wouldn’t have mentioned it publicly.

46

» » » » you guys need to get real , and realize that HM is just a pipe dream
» » at
» » » » this time
» » »
» » » NO. It is working right now.
» »
» »
» » yes and little green men landed behind my house last night
» »
» » its working, where? can you access it? nope, its in some lab somewhere
» » with a bunch of guys running around trying to figure out what to say,
» to
» » make people think its " jusr around the corner" and to just be patient
» »
» » this , another few years always turns out to be more than they predict
» »
» » so if they say 2 or 3 yrs count on 10 yrs
» » if they say 10 yrs it means they have no idea what they are doing and
» the
» » technology has not yet been invented
»
» oh yea thas right, your super vitamins are the cure we forgot, lol.

HM is a pipedream and you guys swallow all the …just wait, soon it will be out…crap

keep waiting
suckers

47

I’m as disappointed as the next guy by ICX’s release but this is ridiculous.

If this reminds you of Lawrence Cutslinger then I have to say, your notion of ‘realism’ is as far from reality as that of the Grungistas themselves. We’re following a legitimate company, engaging in legitimate, well-founded science. It seems likely that HM DOES work in principle, although at this point nobody is sure how well. We therefore duly await press-releases by said legitimate company, who are pursuing clinical trials as we speak, to follow progress. At times, naturally, these reports of progress will be slower and less substantial than we might have hoped.

And you are telling us that this reminds you of Lawrence Cutslinger? Your qualifications as a representative of ‘we realists’ seems to be a bit suspect, no. I won’t even begin to go into the hair vitamin regimen… A realist, I think not.

The last thing we need, anyway, is an “I don’t you so” by someone who claims to be a so called “realist”, simply because he was vaguely right about the fact that ICX’s news would be disappointing. Your job as a perpetual negativist is not difficult. You simply attack HM as unrealistic, a ‘pipe dream’ over and over, as the press releases out of ICX go by, ranging from hope-giving and positive to inscrutable, to negative like this one. The old adage: a broken clock is right twice a day…

» you guys need to get real , and realize that HM is just a pipe dream at
» this time

I think this sums it up. You like to use this board to spread the gospel of your pet theories and unscientific views, and above all, you love to tell people what they need to do.

Next we’re going to have to take a multi-chelated-super-atomic-mineral hair pill in our ‘regimens’. Right?

48

“The full data set on all subjects at 24 weeks will be available in the middle of 2008”

Ok, so they will finish phase 2 middle of 2008 and probably not start phase 3 till late 2008. If they need another year to 2 years for phase 3, that means it will be at least 2010 , bad news fellow, I don’t know if I can wait that long :frowning:

49

» ICX+TRC “results encouraging”; ALL patients showed significant regrowth; up
» to 103%.
»
» Their product VAVELTA is not yet in Phase III clinical trials, yet it’s
» already been placed on the market for patients. This shows that this CAN
» be done. This coincides with their prediction of possible limited
» commercialization in 2008.

What really gets me down about this release is that, this being their financial report, they’re likely to put the best spin on anything they write. Yet the Phase II results seemed decidedly mediocre.

It’s nice that the second cohort had higher regrowth than the first cohort (though I didn’t quite understand the reason the suggested for it), but there is still a very large range, what it 13%-103%. Also, unless I missed something, did they ever define what they consider viable growth, or let us know what types of hairs were being grown (ie, cosmetically acceptable hairs).

I think the spin one is likely to put on this article is directly tied to how desperate you are for a reasonably quick HM. The results here were not bad in themselves, but I think we are mostly disappointed because it seems like it is moving so slowly, and that a viable procedure seems further away than it did two days ago. They’re not even sure whether, at mid-2008, they’ll be ready for phase three trials or not. And honestly, to me, call it a hunch but I think it is VERY unlikely that there will be some level of commercialization in 2008, as much as I would hope it to be true.

If you don’t really care when HM comes out, or are here for a more academic interest in HM as some are, then you’re doing great. HM is improving, even if at a snail’s pace, and it seems like we can now say without a doubt that HM is a real, legitimate science.

That doesn’t make the desperate waiters much happier though.

50

» » ICX+TRC “results encouraging”; ALL patients showed significant regrowth;
» up
» » to 103%.
» »
» » Their product VAVELTA is not yet in Phase III clinical trials, yet it’s
» » already been placed on the market for patients. This shows that this
» CAN
» » be done. This coincides with their prediction of possible limited
» » commercialization in 2008.
»
» JTR how would you interpret the 103% regrowth? How would you understand
» it?
»
» Does it mean that they had like 100% percent regrowth for the treatment
» received?

This is unclear to me as well. It might mean that the subject regrew 100% of hair that stopped cycling, and actually experienced follicular neogenesis to a very small extent as well, thereby giving him slightly more hair than he originally started out with in the test area.

51

» » My culture is having a dialectical confrontation with who thinks
» » different by me. For understanding. is it clear now?
»
» No, it’s not clear. We were discussing whether or not one
» statement by ICX was valid or not. I was right, you were wrong.
» Your “argument” was full of irrelevant, pretentious nonsense about
» syllogisms.
»
» Don’t take any of that in the wrong way; those are just my opinions. I
» don’t know you, and I’m sure you’re a great guy.
»
» By the way, I love Italy and Italians (in general, they’re much nicer,
» more honest, and more intellectually serious and well-grounded than
» Americans).
»
» In fact, I’m going to Italy TOMORROW.

Different way to interpret things!!
I was sure I am rigth, and you no. And your argues were an an empty dialectical exercsise.

I was sure you read the post on this forum which shows the different versions on icx web site of the sentences about the date of the phase II results.

I was sure you agree -at least now- that the results are poor and for this reason we will have -maybe- a definitive result in 2008.

BUT we agree on mediterranean culture. You will be welcome!

52

»
» Different way to interpret things!!
» I was sure I am rigth, and you no. And your argues were an an empty
» dialectical exercsise.
»
» I was sure you read the post on this forum which shows the different
» versions on icx web site of the sentences about the date of the phase II
» results.
»
» I was sure you agree -at least now- that the results are poor and for this
» reason we will have -maybe- a definitive result in 2008.
»
»
» BUT we agree on mediterranean culture. You will be welcome!

Okay, Pat, the fact of the matter is I was wrong on an important point: I said there was no delay, and it turned out there WAS indeed a delay. The forum member BostonBaldy showed us that when he displayed results from the “WayBack Machine” showing that ICX had changed the last sentence on their ICX information page multiple times in the past year. They had actually changed their own deadline several times!

If you looked at ONLY the last iteration of what they said, i.e. that Phase II results were expected in the first half of 2007, then by my reading, I was 100% correct in interpreting that as no delay.

The reason is because that was an announcement of when results were EXPECTED, not when results were going to be announced. If it were about when results would be announced, they would have said that. (We really had no right to expect otherwise, or to read our own interpretation into that statement.)

However, we were not really debating over whether there was a delay or not (although I did say, incorrectly, that there was no delay). What we were really debating was the truth of their last statement. In other words, taken by itself and given the fact that no results had been released at that point (when we were having this debate), was that statement valid or not?

The fact is that, at that point in time, the statement was entirely valid. It was a correct, and truthful, statement about the then-current state of affairs.

What I had not noticed was that ICX had changed the website multiple times.

53

» » » ICX+TRC “results encouraging”; ALL patients showed significant
» regrowth;
» » up
» » » to 103%.
» » »
» » » Their product VAVELTA is not yet in Phase III clinical trials, yet
» it’s
» » » already been placed on the market for patients. This shows that
» this
» » CAN
» » » be done. This coincides with their prediction of possible limited
» » » commercialization in 2008.
» »
» » JTR how would you interpret the 103% regrowth? How would you understand
» » it?
» »
» » Does it mean that they had like 100% percent regrowth for the treatment
» » received?
»
»
» This is unclear to me as well. It might mean that the subject regrew 100%
» of hair that stopped cycling, and actually experienced follicular
» neogenesis to a very small extent as well, thereby giving him slightly
» more hair than he originally started out with in the test area.

It probably means that if, for example, there were 100 existing hairs in the area injected, then after the trial there were 103 more hairs, for a total of 203.

54

i dont even think there will be phase 3

look at vavelta, even phase 2 isnt fuly complete and its on market in england

see intercytex did not delay preliminary results people here were worried about march 2008 premiminary results but like they said before the prelimnary results were available this summer for them

it look like the whole trial will finish spring 2008 and then we might see trc in some country

after just 6 weeks they saw significant new hair :slight_smile:

55

» i dont even think there will be phase 3
»
» look at vavelta, even phase 2 isnt fuly complete and its on market in
» england
»
» see intercytex did not delay preliminary results people here were
» worried about march 2008 premiminary results but like they said before the
» prelimnary results were available this summer for them
»
» it look like the whole trial will finish spring 2008 and then we might see
» trc in some country
»
» after just 6 weeks they saw significant new hair :slight_smile:

REALLY ? I haven’t read everything in the forum, that s good news :slight_smile: :slight_smile:

56

» “The full data set on all subjects at 24 weeks will be available in the
» middle of 2008”
»
» Ok, so they will finish phase 2 middle of 2008 and probably not start
» phase 3 till late 2008. If they need another year to 2 years for phase 3,
» that means it will be at least 2010 , bad news fellow, I don’t know if I
» can wait that long :frowning:

so are you going to get a FUE in the meantime? i’d still like to wait to see what the results in mid 2008 would be because if its like this then i dont know if FUE is worth it.

57

HELL NO! That was before I found out that they can skip phase 3 and go straight to the market. It changes everything now, I will wait for HM, it may come as early as 2009. :slight_smile:

58

» HELL NO! That was before I found out that they can skip phase 3 and go
» straight to the market. It changes everything now, I will wait for HM, it
» may come as early as 2009. :slight_smile:

Yeah it may still be possible for them to skip phase III. The UK medical regulatory body let them skip phase III of Valveta lol they haven’t even finished phase II and they already launched in the UK. So hopefully with a little luck ICX-TRC does really well in this last part of phase II and they skip ahead to market.

59

» » HELL NO! That was before I found out that they can skip phase 3 and go
» » straight to the market. It changes everything now, I will wait for HM,
» it
» » may come as early as 2009. :slight_smile:
»
» Yeah it may still be possible for them to skip phase III. The UK medical
» regulatory body let them skip phase III of Valveta lol they haven’t even
» finished phase II and they already launched in the UK. So hopefully with a
» little luck ICX-TRC does really well in this last part of phase II and they
» skip ahead to market.

You don’t think they would have mentioned that in the release if they were planning it?

60

» You don’t think they would have mentioned that in the release if they were
» planning it?

They have mentioned it in ealier releases. Just because they haven’t mentioned it now doesn’t mean they have given up on it.