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Intercytex hair multiplication results - yr ended Dec 31, 2007


#1

http://www.intercytex.com/icx/news/releases/2008/2008-03-18/

Just checking it out now.

This is from their website:

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 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.

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.


#2

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.

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.

ICX-TRC – final data on all evaluable subjects in the current Phase II trial will be announced in H1 2009

In other words get used to being bald - no trial 3,unless they can partner with someone else = WHY?


#3

» 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.
»
» 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.
»
» ICX-TRC – final data on all evaluable subjects in the current Phase II
» trial will be announced in
» H1 2009
»
»
» In other words get used to being bald

Yeah, but what does this mean… “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”…

Does this mean after Phase II data they roll product?


#4

» » 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.
» »
» » 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.
» »
» » ICX-TRC – final data on all evaluable subjects in the current Phase II
» » trial will be announced in
» » H1 2009
» »
» »
» » In other words get used to being bald
»
»
» Yeah, but what does this mean… “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”…
» Does this mean after Phase II data they roll product?

yes why?


#5

»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.

we are set back a couple of years. They will START seeking a partner when they have all phase 2 data at the end of the year and then their will be a phase 3 before launching. :frowning:


#6

continuation of clinical development can only mean that there is a need for phase 3. If we start speculating about an early release once again people will be very disapointed. Let´s stay realistic for once.


#7

,


#8

Lets see what Follica can do.


#9

No no. Be back in exactly one year to read what you wanted to hear today lol…

ICX-TRC – final data on all evaluable subjects in the current Phase II trial will be announced in H1 2009


#10

» Lets see what Follica can do.

They’ve shown increased hair. The release specifically mentioned “We believe the continued development of ICX-TRC would best be carried out in partnership with a specialist in the aesthetics field.”


#11

scalpt… In the last report (sept 2007) they have provided data “really hard to understand” and in this (march 2008) absolutely nothing, oh yes, !!!


#12

,


#13

If they had something that could produce acceptable results, would they have announced that they aren’t going to fund it?


#14

Milestone payment of US$200,000 received from Bosley under ICX-TRC option…

That means they have achieved their goal so far ( maybe in % of regrowth)

That is not bad at all !!


#15

» That is not bad at all !!

that is:


#16

There was only bit of odd information:
“Milestone payment of US$200,000 received from Bosley under ICX-TRC
option”

.


#17

» Milestone payment of US$200,000 received from Bosley under ICX-TRC
» option…
»
» That means they have achieved their goal so far ( maybe in % of regrowth)
»
» That is not bad at all !!

To a company like Bosley’s thats just a little gamble.It was also paid a few years ago.


#18

A Hair Transplant Doctor can make $200.000 in 1 month only using the forums and internet. There are thousands of people ready to go anywere in the world to be injected. They can make the$200.000 in a day selling the injections to us.

They said that they are not going to continue trials, but wait for 2009 to release the data :smiley: WTF


#19

» They said that they are not going to continue trials, but wait for 2009 to
» release the data :smiley: WTF

yes wait wait and wait again, what do u expect from the 2009 full data release?


#20

» » They said that they are not going to continue trials, but wait for 2009
» to
» » release the data :smiley: WTF
»
» yes wait wait and wait again, what do u expect from the 2009 full data
» release?

mmm well…

I am reading the pdf and I now think that there are not bad news. They said they are going to SEARCH FOR COMERCIALIZATION IN 2009. And I think this is big news.