Intercytex hair multiplication results - yr ended Dec 31, 2007

Stem cell; cell based hair therapy
21

» 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.

no dude, they said they will NOT continue the clinical trial,

where the hell they said they are searching for commercialization?

22

» where the hell they said they are searching for commercialization?

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.

23

ok but unless they continue Phase II to Phase III marketing is just fantasy, and I think that up to now we haven’t proved that the technique works so, in this extract the important thing is that they wont complete the research however read well… “We do not intend to finance the continuation of clinical AND commercial development of ICX-TRC”

24

So 2 of the 6 patients without stimulation LOST hair. It makes you wonder if there’s more value to the stimulation than the actual cell injections. It also makes you wonder if Follica is onto something.

.

25

Research is done. Is not dangerous and they can grow hair in thinning areas. This is a FACT. But they are getting different results in different people. like propecia or minox do.

I think they are saying that they want MONEY and they are not going to expend more in trials. Instead they want someone to pay and start using their tecnology. This is a smart movement IMHO that can make ICX go to the market EARLIER.

But as you can see I am not to good in speaking and reading english :smiley:

26

i think i will expect more from follica …:frowning:

27

This is what was stated last year - why they changed their tune!

ICX-TRC clinical and commercial development

Phase I clinical trials (safety) have been completed in seven volunteers at a single UK transplant centre. No safety issues have arisen and five out of seven patients have shown increased hair numbers.

A Phase II clinical efficacy trial on patients with male pattern baldness is being conducted by Dr Bessam Farjo in Manchester, to optimise the delivery of 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 total hair count. Two sub-groups of five subjects each were injected with DP cells using different delivery techniques. In the first sub-group, two out of five patients showed substantial increases in hair count at 24 weeks. In the second sub-group, all patients showed substantial and visible increased hair counts at six or twelve weeks. A further eight subjects will be treated with variations in delivery technique. 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.

28

It’s Follica or nothing.

29

Well, nobody here expected HM tomorrow.
We’ll see how the bosely/ intercytex relationship unfolds over time, and we’ll see if the Follica approach holds any real-world merit.

.

30

no text

31

» It’s Follica or nothing.

Hold your horses guys! Maybe there is some hope!

I think that they have had this agenda long before these tests. They said before that they will commerlialize (early commerlization) the TRC before phase IIb or phase III (2008-2009). They said that the Bosley has the option. Maybe the are in the point that they need the partner and it´s money and other resources and more patients with their money to treat and that way test the TRC with more people (= more results). They are looking the partner right now (Bosley or some other company) because it will be ready when these phase II trials are over (maybe late 2008 early 2009).

It´s quite difficult to explain (excuse the errors in my text!). I´m in a hurry now but hope you´ll get the point! Hope guys!

My Dream

32

the only promises now are FOLLICA and ACELL for a transplant… This report had show what i was suspecting… …

33

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.

OUTLOOK

Over the next year we expect to report sustained strong progress both
commercially and clinically:What does this mean?

See link
http://www.intercytex.com/icx/investors/rns/rnsitem?id=1205823736nRNSR3084Q&t=popup

34

OUTLOOK

Over the next year we expect to report sustained strong progress both
commercially and clinically:What does this mean?

I think they are referring to all of their products with this general statement…not specifically to TRC

35

means <>

36

Its time to interview Paul Kemp again…and ask him if he somewhat agrees with what Ken Washnik said few weeks ago about not knowing when its coming out.

I’m really surprised they didn’t release the phase-II data though!

BTW, Where’s TheGame???

37

Here’s all the TRC stuff from the press release.

ICX-TRC - hair regeneration
• Three and six month data from Phase II trial shows increase in hair count
• Larger data set available in H2 2008

All patients have now been treated in the Phase II trial of ICX-TRC, our hair regeneration product, and
the results so far are promising. We have been assessing delivery variations in the trial and we have filed
a patent application covering techniques which appear to improve the increase in hair count observed.

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

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

READ PEOPLE. intercytex says they’re getting increased hair counts so how is that bad. they also say barrier to commercial success is low which is a positive thing… it means low risk of failure if brought to market.

they also didn’t say they are quiting after phase II but looking for a partner to help fund phase III and so on. phase III is on a mass scale, most likely costly and if you remember intercytex was in need of funding before so they likely can’t finish it on their own. maybe some of you should hold out until they release actual information on how the product performs before thinking the world is over and slitting your wrists.

38

» READ PEOPLE. it doesnt say that it has failed. intercytex says they’re
» getting increased hair counts so how is that bad. they also say barrier
» to commercial success is low which is a positive thing… it means low
» risk of failure if brought to market.
»
» they also didn’t say they are quiting after phase II but looking for a
» partner to help fund phase III and so on. phase III is on a mass scale,
» most likely costly and if you remember intercytex was in need of funding
» before so they likely can’t finish it on their own. maybe some of you
» should hold out until they release actual information on how the product
» performs before thinking the world is over and slitting your wrists.

I agree. It’s not great news, but ppl. here are jumping out of windows too early. They absolutely did not say that they are quiting TRC. They said they are looking for a partner for Phase III; maybe that means- oh, I don’t know- that they ARE PLANNING FOR PHASE III AND NEED SOME HELP TO DO IT BIGGER THAN ANY OF THEIR PREVIOUS TRIALS.

39

» I agree. It’s not great news, but ppl. here are jumping out of windows
» too early. They absolutely did not say that they are quiting TRC. They
» said they are looking for a partner for Phase III; maybe that means- oh, I
» don’t know- that they ARE PLANNING FOR PHASE III AND NEED SOME HELP TO DO
» IT BIGGER THAN ANY OF THEIR PREVIOUS TRIALS.

That could mean years before they can start phase 3 and we are back to the famous “HM is 5 years away”.

40

Off the cuff, it sounds to me like they think the fundamental technique works fine. But it looks like they also expect the rest of the development to commercialization to be a challenge

Maybe they foresee the need for a much larger operation to do the gruntwork of refining the procedure. Many more patients will be needed, there will probably be some expensive shots-in-the-dark before they find the right methods of getting growth consistency, etc.