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Hairsite\'s explanation

#1

Can hairsite clarify any of this? How does this report affect the release of hm?

#2

» Can hairsite clarify any of this? How does this report affect the release
» of hm?

I’d rather not speculate at this point. I just want to say I am thankful that we are dealing with a public company. Everything is more transparent and out in the open. No more secrecy and mysteries like we used to have in the Gho-era.

#3

Intercytex CLEARLY stated the following:

“We do not intend to finance the continuation of clinical and commercial development of ICX-TRC beyond the current Phase II trial and shall seek to sign a partner when we have the complete data package from this trial.”

Unless they get a partner, this technology is frozen – no further development, no commercialization after Phase 2. Essenatially, this technology will stay off the market until further notice. And even with ‘further notice’, there will still need to be more work done before their product is ready to go.

#4

it just shows they dont need to do phase III , we knew this almost 2 years ago

phase III is quite long so y pay 4 it when u dont need it, they want money ASAP

#5

» Intercytex CLEARLY stated the following:
»
» “We do not intend to finance the continuation of clinical
» and commercial development of ICX-TRC beyond the current Phase
» II trial and shall seek to sign a partner when we have the complete
» data package from this trial.”
»
» Unless they get a partner, this technology is frozen – no further
» development, no commercialization after Phase 2. Essenatially, this
» technology will stay off the market until further notice. And even with
» ‘further notice’, there will still need to be more work done before their
» product is ready to go.

I am still digesting the info as we speak. It is NOT clear why they discontinued the trial. Is that because of funding issues or because the trial results are not satisfactory?

#6

» I am still digesting the info as we speak. It is NOT clear why they
» discontinued the trial. Is that because of funding issues or because the
» trial results are not satisfactory?

I’m leaning towards bad results because they’ve been saying since last year that they would release 24 week data in March '08 and they didn’t. The only reason for that is poor/unreliable results - still they should have at least given us an idea of what the results were after 24 weeks.

#7

Some points:

  1. IMO, it appears that Intercytex has hit the wall with HM, just like previous researchers have. It seems that getting a few hairs to grow - a proof of concept - is relatively straightforward (there have now been multiple research groups that have done it). But turning that proof of concept into a comcercially viable product seems to be very difficult. In other words, consistently and reliably reproducing cosmetically acceptable hair has not been achieved yet. Long is the road from idea to fruition.

  2. If ICX-TRC was close to being ready for the market (i.e., the technology issues have been solved), Intercytex would bring it to market ASAP and reap the profits. My read into their latest statement is this: the basis for the technology is there, but it needs more work, and in the meantime, we’re focusing our resources on our other products.

#8

» » Intercytex CLEARLY stated the following:
» »
» » “We do not intend to finance the continuation of clinical
» » and commercial development of ICX-TRC beyond the current
» Phase
» » II trial and shall seek to sign a partner when we have the complete
» » data package from this trial.”
» »
» » Unless they get a partner, this technology is frozen – no further
» » development, no commercialization after Phase 2. Essenatially, this
» » technology will stay off the market until further notice. And even with
» » ‘further notice’, there will still need to be more work done before
» their
» » product is ready to go.
»
» I am still digesting the info as we speak. It is NOT clear why they
» discontinued the trial. Is that because of funding issues or because the
» trial results are not satisfactory?

Maybe both. It does look like a simple cost/benefit analysis. According to ICX, they’ve grown hair. However, can they recoup the research costs based on the quality of their results? And even if you build a great product, can you get it to market? Plenty of inventions have missed their time the first go round b/c they didn’t get put on the right shelves to sell. What they’d like is someone with a business structure (preferably in aesthetic medicine) to share the risk and possible reward.

#9

TAGHL,

Everybody grew hair…with prestimulation.

Phase three trials cost about 100 million (FDA ones anyway). ICX is broke, and cannot borrow that kind of money. They stated that they think its commercially viable. In my opinion they think they have something that will sell now.

IF the “increases” in haircount are meager…then we are being lied to. This is why I want photographs. Im going to Email them.

HAIRSITE--------------getting photos of these trialess (the three available at 24 weeks) should be a priority for YOU. If ICX gives you the run-around…that is all we will need to know. It will have been a small increase and thus ICX really has hit the wall as TAGHL has profferred. Other than pre-stimulation…I really cant think of many ways that they can improve the procedure.

#10

» TAGHL,
»
» Everybody grew hair…with prestimulation.
»
»
» Phase three trials cost about 100 million (FDA ones anyway). ICX is broke,
» and cannot borrow that kind of money. They stated that they think its
» commercially viable. In my opinion they think they have something that
» will sell now.
»
»
»
» IF the “increases” in haircount are meager…then we are being
» lied to. This is why I want photographs. Im going to Email them.
»
»
»
»
» HAIRSITE--------------getting photos of these trialess (the three
» available at 24 weeks) should be a priority for YOU. If ICX gives you the
» run-around…that is all we will need to know. It will have been
» a small increase and thus ICX really has hit the wall as TAGHL has
» profferred. Other than pre-stimulation…I really cant
» think of many ways that they can improve the procedure.

I am not sure if they will share anything until they have complete data package from this trial.

#11

if the results were poor y would they say this

"We now have a maturing portfolio of assets focused on skin and hair all demonstrating exciting clinical efficacy in large and growing markets. As the data continues to be reported for each of our products with highly encouraging results, it underscores the potential of our technology and the value of Intercytex in the rapidly developing field of regenerative medicine.”

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.

they r creating patents

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.

#12

» Some points:
»
» 1) IMO, it appears that Intercytex has hit the wall with HM, just like
» previous researchers have. It seems that getting a few hairs to grow - a
» proof of concept - is relatively straightforward (there have now been
» multiple research groups that have done it). But turning that proof of
» concept into a comcercially viable product seems to be very difficult. In
» other words, consistently and reliably reproducing cosmetically acceptable
» hair has not been achieved yet. Long is the road from idea to fruition.
»
» 2) If ICX-TRC was close to being ready for the market (i.e., the
» technology issues have been solved), Intercytex would bring it to market
» ASAP and reap the profits. My read into their latest statement is this:
» the basis for the technology is there, but it needs more work, and in the
» meantime, we’re focusing our resources on our other products.

I definitly agree with your points here.

I think Intercytex has come to a head in their research with ICX-TRC. They have had some success but obviously not enough to warrant a real winner and so they don’t want to sink anymore money into it after phase II.

I imagine Bosely will probably buy Intercytex’s Technology at basement prices and combine it with their own. That is only speculative though. I really feel that this whole thing is probably due more to lack of funds then results. They just can’t spend anymore resources on ICX-TRC and need to get their other products out and into market. So unfortunately for us ICX-TRC is cut out from the list.

I think I will be heading over to the Hair Transplant part of the website as my time waiting for a HM cure has run out. Guess if you can’t beat them might as well join them.

#13

» Everybody grew hair…with prestimulation.

Yes, 5 out of 5 did. As you kind of pointed out, we don’t know Intercytex’s definition of ‘hair growth’, which is the key to this whole discussion. Lots of things can grow hair…minoxidil, finasteride, laser comb, etc, but we all know that these don’t produce much hair growth. So claims of being able to grow hair don’t impress me…at least until I see the hard data. Bottom-line: it’s impossible to say from the limited data how good ICX-TRX really is.

The only thing we really know from this report is that Intercytex is halting development of ICX-TRC at the conclusion of Phase 2, and that they are looking for a partner.

Personally, I don’t think this technology is a bust, but it sounds like it needs more work and/or testing.

#14

Its obviously a failure.

  1. The promised data and produced NOTHING. That right there is a huge red flag. In science, this behavior would get you dismissed out of hand.

  2. If they had a product that worked, they wouldn’t be worried about funds - they’d have a gaggle of angle VCs banging down their door begging to let them lend the money necessary to get it to market.

Lets be realistic here and move on. There is a far more reputable company (i.e., attached to the American university system) that is working on what appears to be a far more simpler and effective form of hair stimulation: Follica. Lets see what they can do and not pay anymore attention to ICX. Their behavior (missed deadlines, intentionally enegmatic releases intended to mislead) is more than a little bit dishonest. They’ll be gone in a year or so.

#15

» Its obviously a failure.
»
» 1) The promised data and produced NOTHING. That right there is a huge red
» flag. In science, this behavior would get you dismissed out of hand.
»
» 2) If they had a product that worked, they wouldn’t be worried about funds
» - they’d have a gaggle of angle VCs banging down their door begging to let
» them lend the money necessary to get it to market.

I was going to say the same thing. If the results are really effective, they don’t have to worry about getting $$$$$. There are enough bald men in this planet to pay for the trials.

#16

Looks like Intercytex will finish phase II and then they will look for another company to distribute and if necessary pay for the final phase of developement.I am interested to see who is actually going to buy TRC.

#17

If nobody steps up to the plate and buys TRC in three or four months…thats all the answer anybody needs. A buyer will DEMAND to see the before and after pics and the data from the trials. If what ICX has isn’t much (or any) better than what Aderans has in their private research, dont look for them to buy it, even dirt cheap.

Phoenixbio and Shishedo, the Japanese companies looking into HM are a distant possibility, but who knows what their private testing looks like thusfar and how far they have or have not come. They also would demand to actually see pictures and the associated numbers measuring increases in real hair density. If they aren’t impressive, there will be no purchase.

None of these companies are going to plainly buy it before seeing efficacy data. I have a feeling they are stuck and are only getting “so-so” regrowth. Hell if regrowth was quite good, I’d put pictures up all over the place and call a news conference and show the whole world. Thats why I think its achingly average, and hence Follica becomes the only viable option left.

#18

Hi Guys,

New to forum but old’ reader. Firstly thanks to all of you involved in posting interesting stuff on this website!

2ndly just to mention I was involved in a R&D company years ago in the UK (unfortunately nothing to do with hair loss:-( ). Things work differently in any part of the world: e.g. here you get research grant, then after each research stage/step/etc you get a larger company/investment group to pay for the next one, but usually NOT BEFORE YOU HAVE ENOUGH GROUND/RESULTS TO SHOW TO POTENTIAL INVESTOR. And that’s the point I want to make here: bad news? maybe. Good news? maybe. But too early for sure.

@ skiploss: Man, research in Europe is not bad… as a proof it’s actually in an European country that you hav more Nobel’s price/millions inhabitants (Switzerland). And I can tell u if major universities in the US get always 1st positions in any worldwide list, it’s partly because these rankings are based on … US universities! So I wouldn’t trust more an American university than an European one, by my own experience. We just have a different way to do things.

#19

» If nobody steps up to the plate and buys TRC in three or four
» months…thats all the answer anybody needs. A buyer will DEMAND
» to see the before and after pics and the data from the trials. If what ICX
» has isn’t much (or any) better than what Aderans has in their private
» research, dont look for them to buy it, even dirt cheap.
»
»
» Phoenixbio and Shishedo, the Japanese companies looking into HM are a
» distant possibility, but who knows what their private testing looks like
» thusfar and how far they have or have not come. They also would demand to
» actually see pictures and the associated numbers measuring increases in
» real hair density. If they aren’t impressive, there will be no purchase.
»
»
» None of these companies are going to plainly buy it before seeing efficacy
» data. I have a feeling they are stuck and are only getting “so-so”
» regrowth. Hell if regrowth was quite good, I’d put pictures up all over
» the place and call a news conference and show the whole world. Thats why I
» think its achingly average, and hence Follica becomes the only viable
» option left.

Thank God … another sensible post!

#20

» @ skiploss: Man, research in Europe is not bad… as a proof it’s actually
» in an European country that you hav more Nobel’s price/millions inhabitants
» (Switzerland). And I can tell u if major universities in the US get always
» 1st positions in any worldwide list, it’s partly because these rankings
» are based on … US universities! So I wouldn’t trust more an American
» university than an European one, by my own experience. We just have a
» different way to do things.

Didn’t mean to bruise your fragile European ego.

I’ve studied at both top US and claimed top European (UK) universities and there is no comparison. The difference? Money. Any of the great European universities (and really, there are only a few, and most of them are in the UK) are publicly funded, which means they have limited resources. Any of the top 10 US universities have multi-billion dollar endowments (Harvard’s alone is nearly 40 billion). As to Nobels, I don’t know if your statistic is correct, and it certainly isn’t a proper gauge of one nation’s scientific industrial capabilities, but what does the location of a Nobel’s domicile mean? The question is, where were they educated. They may have been born elsewhere, and they may be living someplace else now, but the great majority did their studies and their research in the States.