Intercytex ICX-TRC interim results

[ginner]

http://www.intercytex.com/icx/investors ... -09-25.pdf

ICX-TRC – Phase II trial status
• Efficacy trials designed to look for new hair growth
• Rolling programme to optimise delivery technique
• 12 patients treated (2 lost to study), preliminary data encouraging
• 2 main variations on delivery technique assessed;
– Group 1 (no pre-stimulation of epidermis) - at 24 weeks 2 out of 5 patients
showed significant increase in hair counts (21 & 55%)
– Group 2 (pre-stimulation of epidermis) - all 5 patients showed significant hair
increase (13 – 105%) [6 and 12 week data]
• Stimulation of epidermis prior to injection appears to improve results
• Further improvements in delivery technique planned for next 8 patients
• New IP being generated

http://www.intercytex.com/icx/news/rele ... 007-09-25/

Hair regeneration – first 12 patients treated in Phase II trial of ICX-TRC
Preliminary data from Phase II trial of ICX-TRC for hair regeneration shows increased hair counts and good safety profile

 

[joe32]

not bad...some patients showed "significant hair
increase " it seems that now it is just a matter of patterning this to get consistant results . id say thats excellent news?

 

[FabioM]

Interesting the part where they say "significant hair increase.

It looks like they have to pré-stimulate the epidermis for results to show up in every tested person.

I think it´s good news but i still want to see some pics, to see if the hair looks tick or not unk:

Anyway hopefully hairloss will be a thing of the past :hairy:

 

[elguapo]

What do the numbers mean? When they say "13% - 105% hair increase (6 and 12 week data)", does this mean that at 6 weeks, only 13% of the injections turn into growing hairs on some of the guys, and 105% turn into growing hairs for others, which would mean that 5% of hairs around the injections start to grow anew!? And the "6 and 12 week data" part, does that mean that at 6 weeks, all the hairs that are going to grow start growing at 6 weeks, and are there still at 12 weeks?

All good news, though I agree that it would be nice to see photos as well. But the numbers are confusing to me. I'm trying to think of a way to get to the bottom of it... maybe emailing them would help.?

I think the best part is that 5 out of 5 patients showed increase in hair growth with the pre-stimulation technique. That's better than hearing that only 5 out of 7 showed increase in hair growth, as in the first clinical trial.

 

[jambri]

With pre-stimulation of the epidermis, a 13% to 105% increase in haircount was seen in the injected area. It is not referring to the % of cells that survived.

What is most irritating to me, is that phase II looks like it is continuing until september 2008 with additional patients, but there is no mention of phase III (yet). Looks like this won't be released until 2010 or 2011 at least then.

You have to wonder why no pictures have been shown for this product, whereas pictures have been shown for their skin product.

 

[elguapo]

HM is a pretty cool and new technology. Personally, I wasn't expecting it to come out by 2010.

I'm still confused about the numbers, 13 - 105% increased hair growth. Even Norwood 7's have hairs on the side of the head. If they have 105% hair increase, does that mean that if they have 50,000 hairs on the sides of their head, then they now have 52,500 + 50,000 = 102,500 hairs on their heads now?

 

[AussieExperiment]

HM is a pretty cool and new technology. Personally, I wasn't expecting it to come out by 2010.

I'm still confused about the numbers, 13 - 105% increased hair growth. Even Norwood 7's have hairs on the side of the head. If they have 105% hair increase, does that mean that if they have 50,000 hairs on the sides of their head, then they now have 52,500 + 50,000 = 102,500 hairs on their heads now?

No they are referring to the treated area. So if you say have 1000 hairs around the crown, post treatment you will have between 1130 and 2050 hairs. So not overly impressive really. The good responders to finasteride and dutasteride are probably getting similar results for alot less money.

These results also support not going off finasteride or dutasteride and counting on HM. Obviously the more hair you have saved before you get HM the better the results will be. It does not sound like slick areas will respond very well.

 

[sphlanx2006]

I am preety confused about these numbers. In fact it is preety unclear and i see this in many hairloss studies. If it is 105% increase in the total numbers of area treated, then a VERY diffuse thinning guy would get no cosmeticaly acceptable difference. If he had 10hair/sq.cm now he is going to have 20 which is still preety diffuse.

 

[smartsang]

You have to wonder why no pictures have been shown for this product, whereas pictures have been shown for their skin product.

"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.



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."

 

[FabioM]

You have to wonder why no pictures have been shown for this product, whereas pictures have been shown for their skin product.

"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.



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."

Then i guess only next year will they show new images from the trials

 

[FabioM]

HM is a pretty cool and new technology. Personally, I wasn't expecting it to come out by 2010.

I'm still confused about the numbers, 13 - 105% increased hair growth. Even Norwood 7's have hairs on the side of the head. If they have 105% hair increase, does that mean that if they have 50,000 hairs on the sides of their head, then they now have 52,500 + 50,000 = 102,500 hairs on their heads now?

No they are referring to the treated area. So if you say have 1000 hairs around the crown, post treatment you will have between 1130 and 2050 hairs. So not overly impressive really. The good responders to finasteride and dutasteride are probably getting similar results for alot less money.

How do you know that the increase in hair count doesn´t give good results?

 

[smartsang]

From what I read (if anyone wants link, i'll give) The 2n'd trials where done like this :

i. Completely bald area, of 1cm square, injected 100.
ii. Much larger area with thinning hair, given 900 injections.

So, the percentages depend on how much hair was their in the beginning.

 

[newguy23]

i think this is good news! it shows that HM does work. right now they are trying to find out the correct dosages thats why there is such a difference in growth from 13%-103% the guy that got a 13% probably means that he needs a greater does of injections while the guy who got 103% probably got just the right dose. once they find the correct dose of hm then it should work for everyone and should be able to regrow hair all over someones head without limit, but that is when they find the exact dose. i cant wait for the next round of trials because now they know more about which dosages are more effective and the results will be even more impressive. the question here is not whether or not HM works, because this proves that it does, the question is rather when will it be available. i personally think that 2010 is the magic number here, u figure they finish up phase II next year, they then know which dosages are ideal, then they will move on to phase three then commercialization, which is probably gonna be around 2010. now i remember they talked about small scale commercialization in 2008, but who knows maybe that will be if they decide to market it right after phase II without phase III, which is probably possible in europe because that they are not as strict as the US. But today was a great day, we learned it does work and that it is safe, once they perfect the dosage we will be golden.

 

[nomen]

According to me this report was pretty much the same as the previous one, not much new to report? (okey so they managed to "clone" some hair in a safe way... old news?) what about quality etc.
To me the report is very diffuse and unprofessionell, cant even make out the numbers, what they refer to etc....

Anyway I think the %numbers refers to the amount of hair that has survived. For instance I think that 13% means that out of 100injections 13 turned in to hair. And thus 103% implies that the injections have had rejuvenating and "follicle neogenesis" effects on the hairgrowth!

 

[hairwegoagain]

Nothing incrementally substantive, in my view. The market reacted negatively to the interim announcement, penalizing the stock 4%. At this point there is little hope from the greater market of these treatments being commercially viable within a reasonable investment horizon. The company's market cap has marched steadily downhill since it was listed.

2010 is unrealistic and naive. I would not look for this technology's availability for another 10+ years, if then. However, I'm sure there will be better treatments than what we have now introduced in the interim.

 

[elguapo]

I agree that it wasn't the best presentation. The numbers are confusing, hopefully unintentionally. I'd hate to think that they are trying to play with the numbers to make the outcome look better than it really is. If it works, it works. If it doesn't it doesn't. But don't lie to us.

Anyway, my additional thoughts are:

1) They grew hair *to some extent* in 5 out of 5 participants with the pre-stimulation technique. This is better than hearing that 2 out of 7 men didn't show any improvement at all in the Phase I trial, even if that was just a low-dosage safety trial. THEN AGAIN!, they never did say which technique/group the 2 men who were "lost" were in. They could have both been in the pre-stimulation group, and they might have quit because they didn't show any signs of new hair growth, meaning that only 5 out of 7 showed signs of hair growth, just as in Phase I studies.

2) If they are presenting data for weeks 6 and 12 using the more effective pre-stimulation technique, my guess is they tried the other non-stimulation technique first, and it didn't work so well, so they tried the pre-stimulation technique later in the game, but only 12 weeks or so ago. In other words, maybe the numbers (percentage hair increase) will improve even more for the 5 men who participated in the pre-stimulation technique, with additional time (more than 12 weeks).

3) This is new technology. In theory, it should work. But they still have their work cut out for them, having to find the optimum dosages. Hopefully now they know to press on with the pre-stimulation technique (whatever that might be) as the baseline, and improve on that. They also make it sound like the procedure works well. Remember, along with the theory of HM, they also had to develop and/or refine the procedure for cell extraction, cultivation, and control, as well as the actual method of injection. Perhaps now they can focus on the dosage and the delivery techinique with the new batch of 8 patients.

 

[smartsang]

I believe the update wasn't really meant to be substantive, just a minor update really. I'm sure we can look forward to more news sometime in 2008. 5 out of 5 people growing hair sounds good to me, though admittedly I've not clue how much really.

 

[jakeb]

I think you guys are reading the results wrong. The percentages are percent increase in hair in the test area... not the percentage of injections that worked.

HM doesn't work like a hair transplant. It's not like each injection becomes a hair. They're just using lots of tiny injections to spread the hair cells all over the scalp. Once they're in there, they cells that "take" just act like normal hair cells and start growing hair.

So the results were 13% more hair -- 105% more hair (aka, more than double the hair) that was currently there. Not bad for this stage of the game. Also note that this is cloned from the back of the head... so it's better than meds. This new hair is DHT resistant.

 

[DaSand]

I think you guys are reading the results wrong. The percentages are percent increase in hair in the test area... not the percentage of injections that worked.

HM doesn't work like a hair transplant. It's not like each injection becomes a hair. They're just using lots of tiny injections to spread the hair cells all over the scalp. Once they're in there, they cells that "take" just act like normal hair cells and start growing hair.

So the results were 13% more hair -- 105% more hair (aka, more than double the hair) that was currently there. Not bad for this stage of the game. Also note that this is cloned from the back of the head... so it's better than meds. This new hair is DHT resistant.

I was confused by the report. Thanks for clearing that up. Well, let them take their time.

 

[elguapo]

Good comments, DaSand. What you said makes a lot of sense. I didn't read your take on what he numbers meant until just now, after I chipped in a few more comments of my own.

Good point about the fact that the new hair cells are theoretically DHT resistant, and therefore better than meds by default.

Hell, we lived with hair loss for a year befor this news came out, we can live another year for hopefully even better news.