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Intercytex Group plc Results for year ended 31 December 2008


#1

Is this good or not.Its not really giving any time frame - What do you all think?

ICX-TRC
Product description
ICX-TRC consists of a suspension of autologous dermal papilla (DP) cells. These cells are able to
stimulate the generation of new hairs when injected into the scalp in close proximity to the epidermal cells
which generate the hair. It is intended that ICX-TRC will be used by specialists in hair transplant centres,
dermatologists and plastic surgeons to treat patients with hair thinning or hair loss.

Clinical development
We have now completed our Phase II study, which was conducted by Dr Bessam Farjo in
Manchester, to examine different ways to deliver the DP cells. DP cells naturally reside at the base of all
hair follicles and are known to control the growth and cycling of hair. It has been known by scientists for
many years that these cells can also interact with epidermal cells in the skin and induce them to form new
hairs. For this to occur however, the DP cells need to be placed close to the epidermal cells which in turn
need to be in a correct inducible state to respond to the DP signals.
This trial was designed to examine the effect of different DP delivery techniques and methods to ensure
that the epidermal cells were in the correct state to respond to the signals and produce new hairs.

In this study, subjects were injected 900 times with 1μl aliquots of DP cells in a large area which was
photographed at the end of the study. Subjects were also injected in a smaller area, divided into two
sections - counts were obtained by shaving and photographing the two small sections of scalp,
injecting them multiple times (either 1 injection of 50 μl or 50 injections of 1 μl) with living DP cell
suspension and then applying a specialised image analysis system to provide a total hair count. In
these small sections, all 19 subjects in the trial were treated using a range of injection and scalp prestimulation
techniques; the first 6 subjects were injected without stimulation of the scalp. In the
remaining 13 subjects the resident hair producing (epithelial) cells were stimulated at the time of
delivery of the DP cells in one of the two treatment sites.
13 subjects completed the 48-week trial with 6 subjects lost to follow-up. Of the 13 subjects completing
the trial the data showed that:

· 65% (11/17) of the treated sites in the non-stimulated group responded to the treatment by
increasing numbers of hairs of all sizes
· 71% (12/17) of the treated sites in the non-stimulated group responded to the treatment by
increasing numbers of hairs over 30 micron in diameter
· 78% (7/9) of the treated sites in the stimulated group responded to the treatment by
increasing numbers of hairs of all sizes
· 100% (9/9) of the treated sites in the stimulated group responded to the treatment by
increasing numbers of hairs over 30 micron in diameter
· The overall take rate (number of hairs produced per 100 injections) in the stimulated areas
was
o 40% (n=6) for hairs of all sizes
o 18% (n=6) for hairs over 30 micron in diameter

The larger (900 injection) area photographs have not yet been analysed.
These data are consistent with the interim data reported last September and further confirm 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.

Dr Bessam Farjo, the Principal Investigator for this study, said “We have learned a lot from this trial,
including the different ways in which these cells can be delivered and that it is possible to do one
thousand of these injections in a relatively short period of time and at little discomfort to the patient. I
am very encouraged by this data both in the increase in the total number of hairs in the treated site but
more importantly by the increase in thicker hairs, those over 30 micron.”
Further results of the trial will be presented later in the year.

Commercial opportunity
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 trial and 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.

SEE LINK
http://www.intercytex.com/icx/news/releases/2009/2009-03-26/2009-03-26.pdf


#2

· 78% (7/9) of the treated sites in the stimulated group responded to the treatment by
increasing numbers of hairs of all sizes
· 100% (9/9) of the treated sites in the stimulated group responded to the treatment by
increasing numbers of hairs over 30 micron in diameter

· The overall take rate (number of hairs produced per 100 injections) in the stimulated areas
was
o 40% (n=6) for hairs of all sizes
o 18% (n=6) for hairs over 30 micron in diameter

I think this works out as a lot of bloody injections to get 40% of hairs of all sizes.10,000 injections ould then give you 4000 hairs,20,000 injections would give you 8000 hairs - get the picture.

Note as expected from Intercytex - NO PHOTOS

Also did you note this:
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 trial and 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

My opinion,we’ve along time to wait!


#3

» · 78% (7/9) of the treated sites in the stimulated group responded to the
» treatment by
» increasing numbers of hairs of all sizes
» · 100% (9/9) of the treated sites in the stimulated group responded to the
» treatment by
» increasing numbers of hairs over 30 micron in diameter
»
» · The overall take rate (number of hairs produced per 100 injections) in
» the stimulated areas
» was
» o 40% (n=6) for hairs of all sizes
» o 18% (n=6) for hairs over 30 micron in diameter
»
» I think this works out as a lot of bloody injections to get 40% of hairs
» of all sizes.10,000 injections ould then give you 4000 hairs,20,000
» injections would give you 8000 hairs - get the picture.
»
» Note as expected from Intercytex - NO PHOTOS
»
» Also did you note this:
» 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 trial and 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
»
» My opinion,we’ve along time to wait!

6 people dropping out in such a small study seems high, no? Does any one know what an acceptable attrition rate is? Also, I’m curious why they’re so keen on selling to Bosley. Bosley has their own thing with Aderans, which uses slightly different technology. Does anyone know?


#4

» · 78% (7/9) of the treated sites in the stimulated group responded to the
» treatment by
» increasing numbers of hairs of all sizes
» · 100% (9/9) of the treated sites in the stimulated group responded to the
» treatment by
» increasing numbers of hairs over 30 micron in diameter
»
» · The overall take rate (number of hairs produced per 100 injections) in
» the stimulated areas
» was
» o 40% (n=6) for hairs of all sizes
» o 18% (n=6) for hairs over 30 micron in diameter
»
» I think this works out as a lot of bloody injections to get 40% of hairs
» of all sizes.10,000 injections ould then give you 4000 hairs,20,000
» injections would give you 8000 hairs - get the picture.
»
» Note as expected from Intercytex - NO PHOTOS
»
» Also did you note this:
» 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 trial and 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
»
» My opinion,we’ve along time to wait!


#5

These are excellent results :slight_smile: We now know that they have seen massive hair growth. We also now know that rejuvination is also an option -

"I am very encouraged by this data both in the increase in the total number of hairs in the treated site but more importantly by the increase in thicker hairs, those over 30 micron.”

we already knew the following as they had posted it 12 months ago -
“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 trial and 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”

The results were upto 31st dec 2008 and thats when the trial offiacially concluded so who knows what they have been attempting to do over the last 3 months :slight_smile:


#6

» These are excellent results :slight_smile: We now know that they have seen massive hair
» growth. We also now know that rejuvination is also an option -
»
» "I am very encouraged by this data both in the increase in the total
» number of hairs in the treated site but more importantly by the increase in
» thicker hairs, those over 30 micron.”
»
» we already knew the following as they had posted it 12 months ago -
» “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 trial and 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”
»
» The results were upto 31st dec 2008 and thats when the trial offiacially
» concluded so who knows what they have been attempting to do over the last 3
» months :slight_smile:

They have probally been trying sell the business or part of,before creditors start calling in debt


#7

» · The overall take rate (number of hairs produced per 100 injections) in
» the stimulated areas
» was
» o 40% (n=6) for hairs of all sizes
» o 18% (n=6) for hairs over 30 micron in diameter

That’s NOT encouraging at all! The average hair diameter is 60-90 microns. So basically those 18% of injections that they are counting, a good number of those aren’t even producing Normal hair. So if we slash this figure in half, you’d get only 9 hairs from 100 injections :expressionless:


#8

No trial 3 mentioned until they find interested partner/buyer.So this means everything is on hold.

In other words they are not telling/giving you nothing.


#9

» 6 people dropping out in such a small study seems high, no?

Maybe the product makes people disappear, they have just found another indication for it, they are amazing !!


#10

» … so who knows what they have been attempting to do over the last 3
» months :slight_smile:

Maybe they have been trying to take pics ?


#11

» » … so who knows what they have been attempting to do over the last 3
» » months :slight_smile:
»
» Maybe they have been trying to take pics ?

They have no money to buy a camara;-)


#12

Hair of 30 microns or less will eventually be deactivated by DHT. If a patient has, say, 10 hairs of over 50 microns per 100 injections, it would take 15 sessions of 1,000 injections each session to get any kind of coverage.

A bit more work to do yet.


#13

I think this sounds good. Sure, its nothing near perfect results, but before, we thought TRC is dead. If they can sell it, it could be out in 3-4 years.

So either TRC actually is dead because ICX doesnt have the money to develope it any further or they can sell it to bosley or someone else. If that happens, then TRC remains an option for us.


#14

Hahahahahahaha!
hahahahahahaha!

i can always say the day ago,what we can read in the new update from TRC at the next Morning!!!

Iam a prophet and can look in the future!You can ask me some question!
You can get the answer for 78$
78%

:wink:


#15

years ago hair transplants weren’t as good as today,that’s the same for HM.these are just the first experiments with these type of procedures,it’s all relatively new so experience would bring in better ways of using HM and thus better results,the simple fact that they are able to see some new growth and hair improvement with this procedure is already a good sign


#16

I agree. A phase 2 clinical trial is to continue to assess safety and efficacy. Were the results perfect? No. But does this mean that it can work? Yea, there’s hope. Let’s hope that they continue to perfect their work and move on to phase 3 or that a company works with them to further advance the product. We gotta be optimistic… I can see why they may not want to reveal pictures right now, as even with growth, some people may look at the results and completely blow the company off even if they are still in phase 2. I do want to see pictures eventually though. Am I saying this is the real deal? No. But it’s better to be hopeful than to not be.


#17

» I agree. A phase 2 clinical trial is to continue to assess safety and
» efficacy. Were the results perfect? No. But does this mean that it can
» work? Yea, there’s hope. Let’s hope that they continue to perfect their
» work and move on to phase 3 or that a company works with them to further
» advance the product. We gotta be optimistic… I can see why they may not
» want to reveal pictures right now, as even with growth, some people may
» look at the results and completely blow the company off even if they are
» still in phase 2. I do want to see pictures eventually though. Am I saying
» this is the real deal? No. But it’s better to be hopeful than to not be.

I agree 100%, this is encouraging news even though they did not present any pictures, I hope when the financial crisis is over, they will be able to partner with someone who is willing to fund phase 3 trial.


#18

Intercytex ICX-TRC FAQ & product pages updated today

FAQ page - See link
http://www.intercytex.com/icx/products/aesthetic/icxtrc/faqsicxtrc/

Product page - See link
http://www.intercytex.com/icx/products/aesthetic/icxtrc/


#19

Further results of the trial will be presented later in the year.This is stated on the Farjo Clinics website.

See link
http://www.farjo.net/news.asp?action=view&id=657


#20

At the bottom it says that they’re looking for a patner to move into the next trial phase. I don’t think they would’ve said that had they not been optimistic about their product’s potential. The fact of the matter is that their work shows that new hairs can be produced. They do need to perfect their technique and work with a much larger sample group, but for that, they obviously will need more money. In the end, even if ICX-TRC ends up not being the “cure” to baldness, it at least gives us hope that we’re getting closer to finding something that will work. I know we’ve always heard the 5-10 years thing, and we may continue to hear 5-10 years… but I don’t think we’ve ever had anything up until now that proved that this can work. Maybe I’m wrong, but I think we’ll eventually see something out in the market that will work for us balding men :). Smart hair surgeons would support research in HM and look for ways to make it a profitable business.