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Intercytex Phase II hair multiplication COMPLETED trial results

17 March 2008 27,181 views 36 Comments
Img_icxtrc_large.jpg
He only looks sad still; he died while waiting for hair

Intercytex, the UK-based biotechnology company and hair multiplication darlings of the moment, have released the final results from their Phase II trials for their flagship hair product, ICX-TRC.

The last results were in September, leaving us with extremely promising results and the impression that they were ironing out the kinks.

They appear to have found more consistency this time around, but are oddly backing out of further development and commercial production, saying only that they’ve left the option open for a hair transplant specialist company to swoop in and take over, with Bosley getting first crack.

Hot off the press:

We have now completed the treatment phase of our Phase II study, being conducted by Dr Bessam Farjo in Manchester, to optimise the delivery of the 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 a total hair count. All 19 subjects in the trial have now been treated using a range of injection and scalp pre-stimulation techniques; the first 6 subjects were injected without stimulation of the scalp. In the remaining 13 the resident hair producing (epithelial) cells were stimulated at the time of delivery of the DP cells.

11 subjects have now passed the 24-week time point since treatment and specialised image analysis at this time point showed:

• Of the group of 6 patients without stimulation of the scalp, 3 had an increased hair count and
two had a reduced hair count; one has been lost to follow-up.

• Of the 5 subjects with pre-treatment scalp stimulation, all had increased hair count at 12 weeks and the 3 who were evaluable at 24 weeks all had an increased hair count at that time point.

These data are consistent with the earlier data reported last September and the hypothesis that new hair production is improved by pre-stimulation of the scalp, leading to an interaction between the injected cells and the resident hair producing cells.

24 week data on all subjects in the trial will be available in September 2008 and at the end of the trial photographic data will be analysed from a much larger area of treated scalp on all subjects at 48 weeks.

ICX-TRC overcomes one of the principal drawbacks of conventional transplants which is that the outcome is limited by the amount of donor hair available. By using the Intercytex cell therapy technique almost limitless hair regeneration is possible in a less invasive procedure. Furthermore, treatment can commence early on in the hair loss process with retreatment available in subsequent years. The barrier to commercial success for ICX-TRC is relatively low, being the ability to increase hair count in transplanted or thinning areas.

We believe the continued development of ICX-TRC would best be carried out in partnership with a specialist in the aesthetics field. We do not intend to finance the continuation of clinical and commercial development of ICX-TRC beyond the current Phase II trialand shall seek to sign a partner when we have the complete data package from this trial. Intercytex has granted Bosley, the largest chain of hair transplant clinics in the US, an option to negotiate distribution rights to the product.

Intellectual Property
We have split our cell delivery patent application into three separate applications in the US reflecting additional techniques that are being developed. We have also filed a patent application relating to our
observation that epidermal stimulation pre-treatment appears to enhance hair follicle formation.

Two other previously filed patent applications relating to the method of culturing the dermal papilla cells have been published and are undergoing international examination.

 

What does this mean?

  • With pre-stimulation, all subjects grew hair.
  • No hair counts were disclosed, which is questionable.
  • Intercytex is waiting until September of this year for the final follow-up.
  • They are ceasing further testing and looking to license the technology to a hair transplant company.

 

The big question now is their motivation for stopping further trials and cashing out. We’re left with some ambivalent phrasing: they are ceasing “clinical and commercial development” and cutting in-company financing, but are seeking a very large partner to carry out “distribution”.

It could be a sign of failure: that the technology was not successful enough to turn the profits they had hoped for without further trials, and are rats trying to sell the proverbial ship before it goes under. On the other hand, it may be that no further trials are genuinely necessary, and armed with the successful data, they are looking to pass the baton to someone with the infrastructure to carry out the procedures.

Unless a partnership forms in the meantime, we’ll have to wait until September to see how successful ICX-TRC has been.

Previously: Intercytex phase II hair multiplication trial update

36 Comments »

  • Intercytex phase II hair multiplication trial update - Tressless said:

    [...] Note: there are new results in this trial. See the March ‘08 Intercytex update here [...]

  • R said:

    Don’t hold your breath when Bosley Reps are involved. The whole system was a quick investment scam and nothing Bosley does or will do reputable. I knew that this would fail due to the relationship with Bosely. You are best to wait for Follica and other real scientist where a lay person with skin wounds can regrow hair without special formulas. Follica’s technigue will just enhance the delivery. Bosley reps have again shown futile neglect for real science. The five year mark should be kept silient to avoid overstatign ones standing and forecast. Science will catch up but not with these weasels.

  • hutiy said:

    looks like they armed with everything they need, After all why say things positive data and “ICX-TRC overcomes one of the principal drawbacks of conventional transplants which is that the outcome is limited by the amount of donor hair available. By using the Intercytex cell therapy technique almost limitless hair regeneration is possible in a less invasive procedure. Furthermore, treatment can commence early on in the hair loss process with retreatment available in subsequent years. The barrier to commercial success for ICX-TRC is relatively low, being the ability to increase hair count in transplanted or thinning areas”

    and then say “Low market risk of TRC”

    and then contradict the above and dump the product, does not make sense does it ????? They also said they commercialising right now so why carry out commerial work if there is nothing to commercialise ???

    we already had an inkling that they would launch this product after phase 2 as they have done with vavelta and r looking to do with ICX-SKN. They have a sellable product and feel there is no need to go to phase III.

  • action said:

    yes all this speculation and mystery is to keep us intrigued and interested, but realy lets get to the point that we all are looking for, when can we expect this product to launch to the public and moreover when will it be available to the us market. We all know the technology works, infact its not just ICX-TRC that has had sucess with hair clonin, there have been major breakthroughs all around the world. Stop with the games and get us what we need.

  • Lapse Midronakis said:

    This terrible news for mes. My hair falls out every days and soon nothing but shiny pink patch. Can a some smart person make some science hair growth advance so this Greek man can become handsomes again?

  • Chris said:

    This is what I believe.

    I believe the hair multiplication works and can regrow as much hair as you want, but I think the quality of the hair is very poor and probably grows in all diferent directions. It would seem to me that if the quality of the hair is really good and it grows the same as your original hair, then they would have mentioned this and would not be looking to unload this technology on to someone like Bosley. Furthermore, I believe the problem with the quality of the hair may be something that is not easily fixed if it can be fixed at all. Afterall there has to be a reason why there being so vague as to the results. I mean no mention of quality, hair count, or if the hair is DHT resistant has ever been throughly disclosed.

  • Hamid Reza Kh said:

    I am agree with Chris!
    Why don’t they show us only 1 picture from ICX-TRC??

  • j.dill said:

    this is not meant to offend anyone .. the fact that you want to close your ears to …is….. it does not work…
    consider this.. how many multi billionaires are there in the entire world ?..do you not think for one moment that one person with that kind of money would not pay to have his or hair
    regrown if it were possible.!! we have walked on the moon. and computer science, and yet theres no cure for baldness except. the word itself ..EXCEPT the fact that you are bald, and move forward.
    life is short and not enough time to worry over hair,…i am bald and not happy.but trying to cope with it the human way……………………..hope.

  • dave said:

    I have news for you j.dill, just because you feel like that train of logic works, doesn’t make it true. I’m a scientist who works on novel cancer treatments and I know first hand that even though there are billionaires who still die from that disease, it doesn’t mean that the new treatments that we’re working on are useless and worth ignoring. Quite the opposite, there are incredible things in the pipeline that are really worth holding out hope for, and honestly if I got cancer today I would do just that. Similarly with hair loss, treatments such as cell therapy are going to be just as real as sequencing the human genome is now - it’s not about IF, just WHEN. Obviously don’t put your life on hold for it, but it’s ok to believe beyond any doubt now that within the next 20 years and likely much less, this problem will be readily solvable. The only thing that irritates me about it is that it’s not nearly as tough as some of the other problems life scientists work on - however most academic labs won’t touch it due to the bad shadow it casts on the reputation of those involved. Which is funny considering how many people suffer from it, and how much money is waiting for a really great treatment. Nevertheless, money tends to motivate , and for every intercytex there will be other groups around the world who you won’t know about that are going at this problem from many similar and diverse directions. Just a decade or two ago we really were far away from being about to solve problems like this, but the tools we have now make it amazingly unlikely that we won’t.

  • people.... icx-trc said:

    people… this method has to work… i have now been waiting for this for wery long time…

    In year 1998— was my dream clone hair… and i think they have been working for long time with hair cloning to not create SOMETHING fo curing hair loss…

    I thrust in this guys… and its our only hope…

    So please, dont be negativ…

  • Ad said:

    It seems to me like you only ever get pessimists posting on sites like this, for some reason they become so gutted by their hair loss that they protect themselves by being so negative about any up coming treatments so’s not to get their hopes up and be disappointed.

  • stallone said:

    will there ever be treatment for this baldness, except discussing that there would be hope someday.

  • martin said:

    I think they filed here. Only 66 more hairs?, they can get you 2000 hairs in one session in today´s hair transplants. The only serious people these days are follica. Our best shot is that the army of US (which created recenly an agency for regnerating skin in veterans injured) can take this a step forward and then take it to the market

  • martin said:

    I think they failed here. Only 66 more hairs?, they can get you 2000 hairs in one session in today´s hair transplants. The only serious people these days are follica. Our best shot is that the army of US (which created recenly an agency for regnerating skin in veterans injured) can take this a step forward and then take it to the market

  • rp said:

    im pretty sure they are just trying to cash out because there are more lucrative deals out there. after all, they just got that military contract for $85 million. its time for them to pass on phase three clinicals to others and then get fda approval, no need for them to sit on the golden egg when they have other things going on. they would never take this thing all the way through, its obvious. they never had the infrastructure to do this themselves.

  • d'andre said:

    i am very disappointed about this report. if this was successful in any meaningful way there would be pictures, hair counts, you name it and there is no way they would be trying to sell out to anyone else. they would develop their own infrastructure to distribute and market HM. they would have plenty of time to do this while going through phase III trails and during the time they would need to develop the procedures to where they were affordable to a mass market. if this worked, it would be one of the surest bets in history. do you think they just said ” this is going to make billions of dollars, but we just dont feel like messing with it, so we’re going to sell it to someone else and let them make all the money on our hard work and investment”, i dont think so. i hope im wrong.

  • Parsa Mohebi, M.D. said:

    I was hoping to see more documented evidence of the details of the study. Although I know there are some concerns with releasing details of the procedures, the principles of the research project could be and should be announced so all hair restoration centers have a more accurate answer for their patients when they are planning for long term planning for the treatment of individual patients.

    Dr. Parsa Mohebi
    Medical Director
    US Hair Restoration - A LA hair transplant center
    http://www.ushairrestoration.com

  • KL said:

    I am convinced hair cloning is possible and Intercytex and other organizations are doing it right now. However, it is very suspect why Intercytex is not showing pictures, there is definitely some kind of card gaming going on. This is a multi, multi billion dollar industry we are talking about here gentlemen!

    I believe what Intercytex is now working on is a way to prevent cloned hair from regenerating forever. They are intentionally developing hair cells that will only last for, say 180 to 365 days and then die out. The reason for this to ensure you continually need reinjection’s; a monthly/yearly reoccurring cost, no different from Rogaine or Propecia, just a hell of lot better. The question is how much it will cost and how much are you willing to pay.

    Think about it, we NEVER really cure ANYTHING; more money is made treating symptoms….

  • keon said:

    Guys guys… Why they will sell it to Bosley is simple… Intercytex is not a Hair transplant company. They are scients, who knows how to split the cell from each other, transplant physician can not do that.
    Can we please read the different.

    I believe on this product guys… just wait until september… i can not guaranty them any god results… but i guaranty them that they got something…

    Will see what they got in september.

    Untill then guys.. please, write positiv…who i am, trust me, im one of them…:)

  • John Doe said:

    Why would they sell or partner to Bosely? Simple, they do not have enough money to launch and market this product worldwide. Is Intercynex going to build a clinics across America/Europe/Asia so people can have the procedure? It is kind of like saying a big food company should go build a bunch of supermarkets to sell their products in. They are two competly different business. Bosely= Marketing, Distribution, Customer Service and Intercynex= company that focues on innovative medicine/manufactuering or selling the use for royality payments.

  • A G said:

    If you guys read their financial statements from 2006 they state in their that Bosley had been granted an option for rights to distribution…meaning that if/when ever it came to market, Bosley would always have had a major role in distribution anyways, so this announcement doesnt change anything.

    The 2 things which are worrying are their lack of results and that theyre stopping development. Lack of results I suppose I can overlook for now, simply because by September this year or March next year we will know for sure what is going on. But that they’re stopping development is of course not encouraging. Its possible they just don’t have the resources to do the large-scale trials in Phase 3 and to work out the kinks in their system, such as direction of growth, etc. Which would be nice, but I think I am a bit too pessimistic for that.

    I think the most likely scenario is that they’ve had a bit of success with it, but not enough for them to keep going with it so they will be trying to pass it on for someone else to try and make workable.

    There’s others out there though so don’t lose hope!

  • lost hope said:

    Ive been waiting for a cure since the 80’s and have been hearing 5 more years ..10 more years for almost 30 years ..so ive resigned to the fact that I will die a balding man ..Maybe my son will have a chance for a full head of hair since hes only 8 yrs old and has the bald gene from both of his grandfathers ..I’d say they will have a cure when he’s about 25 so just be thankful for being healthy and alive cause they wont ever find a cure

  • lost soul said:

    I believe what Intercytex is now working on is a way to prevent cloned hair from regenerating forever. They are intentionally developing hair cells that will only last for, say 180 to 365 days and then die out. The reason for this to ensure you continually need reinjection’s; a monthly/yearly reoccurring cost, no different from Rogaine or Propecia, just a hell of lot better. The question is how much it will cost and how much are you willing to pay.

    Think about it, we NEVER really cure ANYTHING; more money is made treating symptoms

  • justwondering said:

    yeah, the succint press release seems suspicious. perhaps the issue is that the hair grows in all sorts of directions. To some extent, transplanted hair would still be necessary, and if this is the case, most of the personnel trained to place the hair and the cloned cells in the correct direction is under Bosley’s payroll. but it seems that the time is coming!!! LOST SOUL, I disagree with you, free market and fierce competition will guarantee better and improved techniques developed by rival firms, not now but in the future. it sounds unreasonable to expect firms developing partially successful treatments just for the sake of keeping the clientele.

  • Kubrick said:

    Just thought I’d correct j.dill & point out that yes you are right in saying that there is no cure for baldness but that you are wrong in saying that man has walked on the moon.Most people know it was a hoax and that it is impossible - hence the reason nobody has “returned” to the moon in 36 years !

  • omg said:

    All balding men are doomed to be bald, and im one of them. Im only 23 years old ;( why did god give me this curse? I dont want to be ugly, I will lose my good looks as soon as i go bald. I really cant take it, im at the end of the line with my hair, ffs. I really do hope that this technique is available for me when I really need it, probably a couple more years, HT’s will not work for me I am a destined norwood fucking 7 the way things are fucking going. Fuck sake, just get this HM done so we can all be happy :’(.

  • Hannibal said:

    Hurry up with that technique, what is taking so long?? These researchers are incompetent, they need 1 billion years to multiply some hair, they are pathetic.

    Put someone that knows what is doing in charge of the research not some amateurs because they’ll find something in at least 100 years.

    We are going bald here so hurry up!!!! And it’s because of the man made chemicals so it’s your fault ,now fix it.

  • blh said:

    will it happen in 2009?

  • A.K said:

    I also believe that the product is finished, it’s already a proven science back form 97′. quite possibly the only reason photos and real data are not shown is because it worked so well public demand would cause riots. They can increase the cost of the final product by delaying the procedure to “recoup” their “research” funds. An odd thing a bosley rep told me when i first went for my consul. although he didn’t word it that way.

  • jimflex said:

    im 17 going bald….and i neeeeeeed there to be a miracle hair cure in
    2 YEARS MINIMUM!!!!!!!!!

    everyone is counting on this technique to work but the BIG PROB is that at the moment things are seemingly all a mystery.fuck i hope that they do something about this before i kill myself!,

    hair=youthfull looks-happiness:P
    no hair=sadness-u feel old-uglinesss-which all leads to depression..(aka me atm)

    fareplay for all of those who “look good bald”i unfortunatly do not come under that category……..

    ANOTHER 5 YEARS!!!!?SOME PEOPLE DONT HAVE 5-10-15-20 YEARS THEY NEED HAIR NOW OK NOWWWWW!!!!!!im sure id spend a year of all of my hard earned money for this miracle “full head of hair”treatment IFF IT WORKED FOR G SAKES…

  • Reuben said:

    Here are two products that grow hair and does not require you to use them in order to maintain your hair. I understand what you’re going thru man. Dr. Zhannguang 101 series @ http://www.tcmhospital.com and Thymuskin @ http://www.thymusking.com (gel and shampoo is all that is needed). They will not work on you if you have put minoxidil on your scalp. Something about it that causes the hair follicle to depend on it and which will eventually kill it off.
    About the intercytex looking for a deal with a major company. I hope to god that it is not with Bosley or Medical Hair Restoration because I have seen their work and feel sorry their victims (People who’s hair transplant came out looking like Chucky). It will be a big let down if they do get it.

  • Hamid Taravati said:

    I am a medical doctor. In our Skin & hair & laser clinic, We are following your progress with much interest. 5 year is very long for some. I have already talked to some of our hair transplant clients in our dermatology clinic. This news has created a wave of excitement. They are waiting. Would yo please keep us osted.

  • Pete said:

    I would gladly pay say 50,000 dollars to get a natrual, full head of hair. I imagine that there are at least 10 million other men on earth who would and could do the same. So consider this to be a 1/2 Trillion Dollar Market. It’s hard to beleieve that the only Company that would be intrested in a legitimate cure would be a rinky-dink company like Bosley. There must be some extremely complicated and expensive medical hurdles that have to be overcome until we see a honest cure. A real cure for Baldness could make the wealth of Saudi Princes seem like Trailer Park children’s Lunch Money by comparison.

  • George said:

    I’m only 19 and losing hair.. I can’t tell you how badly this is affecting me. This is ruining me. People have known me for being good looking, and in a sense, it was my redeeming quality, and now my hair is going, I am losing my confidence in myself. Slowly I am losing my confident personality. Slowly i am no longer feeling attractive to anyone.

    Although it is hard to know what exactly is going on, and how successful heard-about companies like intercytex and follica are, the possible market for this will be enormous. This factor is the greatest hope we have.

    Even if certain companies fail, I am sure right now, around the world, many different companies and organisations are working on a a similar method, and the potential profit to be made for this so called ’silver bullet’ will be phenomenal.

    So I think we should all stay quietly confident and resolute. The infomation at the moment suggests that companies have already found some type of ’success’, so it can only be a matter of time, how long I don’t know. Optimistically, from the infomation so far, perhaps a few more years. Perhaps five. I wouldn’t mind waiting ten years for this, that would make me 30. I think I would draw the line after 20 years, if there is nothing by this time, which would make me 40, then I think I would just let go of any hope. With all this in mind - from looking at varoius sources, companies seem to be close, a few years close at least to developing a product to save us from this injust and indiscriminate infliction.

    Along with all fellow sufferers, I pray and hope that Sceince may finally overcome nature in this long process of suffering, and that at last, in the 21st century, we will have a long awaited cure.

  • Dr Jack said:

    Being a physician, I can certainly say that follicular hair multiplication will certainly be a fantastic remedy in the near future. I am bothered by Intercytex on several different levels however… The results of phase 2 are outstanding and promising, so how could they not be already diligently working on phase 3 right now!!! I find it hard to believe that funding would be a problem, considering the huge potential market base for this. Second, by partnering with Bosley Medical, this is very discouraging. The Bosley group is a 100million dollar industry and their only motivation is profit. They do not care about individuals. This is equivalent to someone building an engine that runs on water, then wanting to partner with Exxon. I smell a rat here… and that rat’s name is Bosley. Beward.

  • Carl said:

    George, I feel ya.
    I’m 20 and I started noticing hair-loss at the age of 15.. It got serious at 16 and It made me convinced that I wasn’t good looking enough to get girls or be very popular. I ignored the problem and didn’t admit it to myself before I was 19.. then I used rogaine, it was relatively effective on me and I got some hair back.. It was the spark I needed to get back on track, finding the person I really have been all the time.. Now I definitely have relatively thin hair at my crown-area, but I realized how little it actually matter. I talked about it with a class-mate a couple of months ago and he didn’t know what I was talking about first and then he accepted my view but he claimed he really hadn’t thought about it.
    As for girls, hair, or even physical looks in general is not seen as the primary sexual thing in a man. I recommend you to read “The Game” by Neil Strauss if you haven’t already, it can become a social revolution for you, as it has for me. Now I am popular, good with girls, AND balding. I’m gonna use the hair cloning treatment when it becomes public (and affordable), but until then I certainly wont worry about my hair anymore =)

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