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You Know Whats Weird To Me


#1

Is how hair multiplication has been classified as a medicine and therefore must go through all the stages and trials as a drug, but hair transplants arent.
Everyone stay in Intercytex’s ear about releasing the preliminary data from the phase 2 trials.
Should be soon now


#2

» Is how hair multiplication has been classified as a medicine and therefore
» must go through all the stages and trials as a drug, but hair transplants
» arent.
» Everyone stay in Intercytex’s ear about releasing the preliminary data
» from the phase 2 trials.
» Should be soon now

Don’t count on the results till the fall Intercytex have at least a one or two months of lag.


#3

Actually with the new EU legislation that’s currently pending it will most likely be classified as a tissue engineered mediciation (not sure if thats the exact language they use but it’s something along those lines).

Remember that ICX posted that the possible 2008 limited release is dependent on good Phase 2 results and potential legislative developments. So it’s not a drug and not a surgical procedure but something new and wonderful:) I presume theres some similar ruling in America?


#4

» Actually with the new EU legislation that’s currently pending it will most
» likely be classified as a tissue engineered mediciation (not sure if thats
» the exact language they use but it’s something along those lines).
»
» Remember that ICX posted that the possible 2008 limited release is
» dependent on good Phase 2 results and potential legislative developments.
» So it’s not a drug and not a surgical procedure but something new and
» wonderful:) I presume theres some similar ruling in America?

It’s not true, as gottabelieve wrote, that HM is being classified AS a medicine. It is being treated LIKE a medicine, because currently the MHRA has no other category to put it in.

In the US, cell-based therapies are classified as “biologics” and are regulated by the FDA’s Office for Biologics.


#5

» Actually with the new EU legislation that’s currently pending it will most
» likely be classified as a tissue engineered mediciation (not sure if thats
» the exact language they use but it’s something along those lines).
»
» Remember that ICX posted that the possible 2008 limited release is
» dependent on good Phase 2 results and potential legislative developments.
» So it’s not a drug and not a surgical procedure but something new and
» wonderful:) I presume theres some similar ruling in America?

Is there any idea as to when the MHRA will decide how TRC will be regulated?
Thanks.


#6

» Is there any idea as to when the MHRA will decide how TRC will be
» regulated?
» Thanks.

I actually found the draft legislation PDF and had a look at it, there should be a link for it in the old forum.

IIRC once the legislation comes into effect there is a ‘grace period’ for companies to catch up (severals as I remember). So a company, like ICX can choose to submit their products under the new legislation or the old UK only laws depending on condition. And since the EU regs are specifically aimed cell basted therapies (and also gene therapy) it appears to have streamlined the process. This I believe is how Intercytex are able to release Valveta this year even though it’s also only in Phase 2 (also since it’s allogenic as opposed to autologous).


#7

» » Is there any idea as to when the MHRA will decide how TRC will be
» » regulated?
» » Thanks.
»
» I actually found the draft legislation PDF and had a look at it, there
» should be a link for it in the old forum.
»
» IIRC once the legislation comes into effect there is a ‘grace period’ for
» companies to catch up (severals as I remember). So a company, like ICX
» can choose to submit their products under the new legislation or the old
» UK only laws depending on condition. And since the EU regs are
» specifically aimed cell basted therapies (and also gene therapy) it
» appears to have streamlined the process. This I believe is how Intercytex
» are able to release Valveta this year even though it’s also only in Phase 2
» (also since it’s allogenic as opposed to autologous).

Ok, thanks. So, it looks like, right now, we’re waiting for the regulation to be finally passed.


#8

well this puts a whole new paint job on things.
assuming phase 2 goes well, with new reason to believe it wouldnt
this makes small scale Commercialization in 2008 very viable

» IIRC once the legislation comes into effect there is a ‘grace period’ for
» companies to catch up (severals as I remember). So a company, like ICX
» can choose to submit their products under the new legislation or the old
» UK only laws depending on condition. And since the EU regs are
» specifically aimed cell basted therapies (and also gene therapy) it
» appears to have streamlined the process. This I believe is how Intercytex
» are able to release Valveta this year even though it’s also only in Phase 2
» (also since it’s allogenic as opposed to autologous).


#9

» well this puts a whole new paint job on things.
» assuming phase 2 goes well, with new reason to believe it wouldnt
» this makes small scale Commercialization in 2008 very viable
»
»
» » IIRC once the legislation comes into effect there is a ‘grace period’
» for
» » companies to catch up (severals as I remember). So a company, like ICX
» » can choose to submit their products under the new legislation or the
» old
» » UK only laws depending on condition. And since the EU regs are
» » specifically aimed cell basted therapies (and also gene therapy) it
» » appears to have streamlined the process. This I believe is how
» Intercytex
» » are able to release Valveta this year even though it’s also only in
» Phase 2
» » (also since it’s allogenic as opposed to autologous).

Your dreaming buddy, this wont be out to the public for years.


#10

» So it’s not a drug and not a surgical procedure but something new and
» wonderful:) I presume theres some similar ruling in America?

It’s nothing.

You’ve seen nothing. They’ve presented nothing. They haven’t even claimed to do anything, really. “Increased hair counts”–meaningless.

There will be no HM in 2008. There will be no HM in 2010. I’d bet money that there won’t be any HM by 2020 either.


#11

» Your dreaming buddy, this wont be out to the public for years.

Possibly even decades.

Science views baldness as trivial. Nobody really cares and no regulatory agency is going to approve any treatment for baldness that has even a slight risk of adverse side effects.

I started balding in 1988. Even back then there were “cure for baldness right around the corner” articles in magazines and occasionally in newspapers. Minoxidil was heavily hyped and that is certainly no cure.

Now, nearly 20 years later, we are no closer to a cure today than we were when I was 14 years old. NO CLOSER!


#12

» » So it’s not a drug and not a surgical procedure but something new and
» » wonderful:) I presume theres some similar ruling in America?
»
» It’s nothing.
»
» You’ve seen nothing. They’ve presented nothing. They haven’t even
» claimed to do anything, really. “Increased hair counts”–meaningless.
»
» Intercytex is a cruel joke that does nothing but build false hope.
»
» There will be no HM in 2008. There will be no HM in 2010. I’d bet money
» that there won’t be any HM by 2020 either.

Hairboy,

    They are IN PHASE TWO TRIALS right NOW. Obviously they believe they can clone dermal papilla cells from donor hair, and re-inject them. What are you, one of those hairtransplantmill trolls attempting to get everyone here to give up and just go out and get a HT now (because you know a newer, better procedure will be available within the next handfull of years). The info from phase 2, which I expect in roughly October, may reveal a man whose stem cell transplants from donor hair grew a great deal of hair, just like a transplant x10, giving a guy a pretty full head of hair with only 120 donor follicles used up. Could that be it?

     Or are you one of those "no hopers" who is broke financially and does not want HM to come out until you can afford it? :-(

#13

» » » So it’s not a drug and not a surgical procedure but something new and
» » » wonderful:) I presume theres some similar ruling in America?
» »
» » It’s nothing.
» »
» » You’ve seen nothing. They’ve presented nothing. They haven’t even
» » claimed to do anything, really. “Increased hair counts”–meaningless.
» »
» » Intercytex is a cruel joke that does nothing but build false hope.
» »
» » There will be no HM in 2008. There will be no HM in 2010. I’d bet
» money
» » that there won’t be any HM by 2020 either.
»
»
»
» Hairboy,
»
» They are IN PHASE TWO TRIALS right NOW. Obviously they believe
» they can clone dermal papilla cells from donor hair, and re-inject them.
» What are you, one of those hairtransplantmill trolls attempting to get
» everyone here to give up and just go out and get a HT now (because you
» know a newer, better procedure will be available within the next handfull
» of years). The info from phase 2, which I expect in roughly October, may
» reveal a man whose stem cell transplants from donor hair grew a great deal
» of hair, just like a transplant x10, giving a guy a pretty full head of
» hair with only 120 donor follicles used up. Could that be it?
»
» Or are you one of those “no hopers” who is broke financially and
» does not want HM to come out until you can afford it? :frowning:

I am a “no hoper”, but not for financial reasons. I have no hope because I’ve seen NO PROGRESS.

It has been two years since Intercytex finished Phase I of the HM trials. Now? How many patients have ACTUALLY had cells extracted and reinjected? Have any?

My understanding, and please correct me if I am wrong, is that the first iteration of the Phase II trial is only going to involve a handful of volunteers. Is that correct?

Before HM hits the market it will have to be tested on hundreds of patients. At the rate Intercytex is moving that will take a lifetime.

Nobody wants HM more than I do. I just shaved my head slick bald a few minutes ago.


#14

» Nobody wants HM more than I do. I just shaved my head slick bald a few
» minutes ago.

Total pain in the backside,having to shave head all the time.I shave mine every 2 days.


#15

Intercytex has gone farther than Gho Bazan and Aderans combined. They are the only one in phase 2. I bet if they decide to start phase 3, then it’s almost like a sure thing that HM will hit the market. If they keep postponing phase 3, then it’s bad news.

Whether they start Phase 3 or not is the most crucial.


#16

hairboy2008 wrote:

  " am a "no hoper", but not for financial reasons. I have no hope because I've seen NO PROGRESS.

It has been two years since Intercytex finished Phase I of the HM trials. Now? How many patients have ACTUALLY had cells extracted and reinjected? Have any?

My understanding, and please correct me if I am wrong, is that the first iteration of the Phase II trial is only going to involve a handful of volunteers. Is that correct?

Before HM hits the market it will have to be tested on hundreds of patients. At the rate Intercytex is moving that will take a lifetime"

Its actually been closer to three years since ICX got new hair growth on 5 of 7 men. They shot up 20 men last October as their FIRST PHASE 2 A trial. Based upon results in the first phase 2, they will try different culturing protocols in the phase 2 B trial, and from that different culturing (and probably inject amounts and depths) in their phase 2 C trials. Getting the right mix of stem cells and growth factors on the scalp to recreate the fetal environment in an attempt to get as thick hairgrowth as possible.

ICX has moved slow, but not as slow as Aderans has. THey may have a great response to just these 20 guys. Perhaps all of them will grow alot of hair, and we will have a winner right off. Or perhaps only 3 or 4 will grow a good deal of hair and the rest “so-so”. However, with just 120 donor follicles sacrificed, one could have a “so-so” procedure done 3-4 times until they get what they want without really denting the donor supply.

We will know ALOT more about where we stand when the phase 2 results are released. Its the first real attempt to grow a great deal of hair from stem cells.


#17

Actually, if you check the Prelimiary result presentation of Intercytex dated 23 march 2007, you’ll see that they just treated 6 patients so far and I don’t think they treated them in october as you said, later than that. They are moving way slower than you think… Sorry

I’d be surprised to have results in september, will be much later than that. And they are very far from your Phase IIb you are talking.


#18

» Actually, if you check the Prelimiary result presentation of Intercytex
» dated 23 march 2007, you’ll see that they just treated 6 patients so far
» and I don’t think they treated them in october as you said, later than
» that. They are moving way slower than you think… Sorry
»
» I’d be surprised to have results in september, will be much later than
» that. And they are very far from your Phase IIb you are talking.

Im going to paste what was on ICX’s website,

"Phase II - the Design

Phase II has officially started in September 2006. Up to 20 test subjects may be enrolled for phase II. Only local subjects will be recruited. Not all test subjects are scheduled to begin the trial at the same time. There will be fine-tuning and adjustments to the protocol as the trial progresses. Dr. Kemp described phase II as a “rolling or staggering” trial in the sense that the protocol may evolve over the duration of the trial. More than 1 protocol may be tested in phase II depending on the initial results.

In phase II, there will be TWO test sites on each volunteer’s scalp. The first test site is on a completely bald area measuring about 1 sq cm. This site will be subject to100 injections of the cultured suspension. Unlike the first test site that resides on a completely bald area, the second test site is on a much larger area containing thinning hair. The second site will be subject to 900 injections. In other words, each volunteer will receive 1,000 injections divided between two test sites on his scalp. Both test sites will be administered and monitored simultaneously.

Evaluation of the 900-injections test site will be done primarily through photographic assessment of the before and after changes. A more detailed graft-by-graft hair count assessment will be performed on the smaller 100-injections test site.

If all goes as expected, phase II may be concluded in approximately 1 year.

Here are the first four questions on ICX’s FAQ’s page:

  1. How can I receive ICX-TRC?
    ICX-TRC is currently in Phase II clinical trials in the UK, so it is not yet widely available.

  2. When will ICX-TRC be on the market?
    ICX-TRC is classified as a medicine by the regulatory authorities and hence has to undergo a series of clinical trials before it can be offered on the market. We currently estimate that the earliest that ICX-TRC would be available on the market is 2010 although we don’t know in which country it will be launched first.

  3. How can I stay in touch with ICX-TRC’s progress?
    Please watch our website for news and announcements about ICX-TRC and sign up via the news alert so you can stay up-to-date with our progress.

  4. When will the Phase II trial be completed?
    It is a rolling trial which will optimise the formulation and delivery as well as studying safety and efficacy. We expect some data will become available during 2007. We anticipate the current trial will complete during 2008.

<<<<

I haven’t heard anything about them only using 6 guys for phase one, I thought it was 20, I also thought Kemp told that to Hairsite, but I could be wrong about that (its been a while since I read that interview).
At any rate, they claimed to be in Phase 2 last October. I’d expect there to be growth a little slower than with a traditional transplant whose full results aren’t usually achieved for one year, so this October to December should seemingly be about right to guage any successes or failures outright. I assume they will at least say if one or two guys grew some hair. If they dont, I’ll assume that it failed, but I’ll email Katherine Harris every day until she tells me whether anybody grew anything or not. This is a publically traded company, and they should be forthright about the progress in their trials for potential investors (like me). However, Frankhair, I’d be dissapointed if they only shot up 6 guys with the protocol (culturing and injecting) that they had the most confidence in to start with. As you say, that would be indicative of them not being all to confident.

ICX, and cloning in general, are the only real potential solutions to hairloss period until genetic therapy (decades away) can nullify certain genes in our scalp, or androgen receptor agonist can end receptor expression in targeted tissues (which wont help if one has already lost hair in an area). Its either ICX, Aderans, Phoenixbio, or Shishedo or bust for all of us to be truthful in my opinion. I just dont thing any hypertrichotics like Osh-101, or re-invigoration of stem cells (oh boy, a new head full of MPB hairs with the same genetics), or fooling with neural pathways is going to do the trick.

Im mindful of that old guy years ago who had to take oral spiro for six years and started regrowing all his hair after being bald for forty years, but for the most part, I think miniaturized hairs ain’t gonna come back for long no matter what the treatment, and thus cloning is our only chance to get something done and pretty much be able to have hair with no more worries about it.

We have a right to be a little impatient, due to the promises that were made back in the early 00’s. Hell the way they were talking back then (especially Washenik), I’d have expected cloning to be de riguer by NOW. It has been dissapointing hansn’t it?


#19

ICX-TRC

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.

See link

http://www.intercytex.com/icx/investors/rns/rnsitem?id=1174633281nRNSW5680T&t=popup


#20

» ICX-TRC
»
» 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.
»
»
» See link
»
» http://www.intercytex.com/icx/investors/rns/rnsitem?id=1174633281nRNSW5680T&t=popup

I understand what you are saying, but if you look more closely in their report, you’ll see as Baldie42 said that there are only 9 patients so far and only 6 has been treated back in end of march.

Go and give a peek at their report.