very bad news from Intercytex

[michael barry]

I'll just post the interview. This sucks and I feel lied to. Those a-holes were talking 2008 "small scale commercialization" a year ago----and now they are talking one year to review phase two data, and phase 3 will have to be performed, then a long review of that data-----and they aren't really even releasing the results. My take: Its just not very effective---only small increases in hair. Thats my take



HairSite: Is the progress of the ICX-TRC project on target at this point?
Dr. Paul Kemp: Yes it is.


HairSite: Has it always been Intercytex's intention to partner with a larger company for the phase III trial?
Dr. Paul Kemp: Yes, partly to help finance the trial but also to provide marketing help. We are not in the hair transplant business and are primarily a research, clinical and manufacturing organisation.


HairSite: When will phase II trial officially end and when can the public expect the official trial data (including before and after photos) to be released?
Dr. Paul Kemp: The trial will be completed Q2-3 2009.


HairSite: Have you seen any of the phase II test subjects? Can you describe the characteristics of the new hair growth?
Dr. Paul Kemp: We will provide data at the end of the trial. It is not appropriate to make information available during the trial. We are a public company and have legal obligations to the various regulatory authorities.


HairSite: Will Intercytex consider partnering with Bosley for phase III trials? Any other suitors besides Bosley for phase III trial?
Dr. Paul Kemp: Bosley have an exclusive option to the negotiate an agreement at the end of the Phase II.


HairSite: Can we still expect a small scale commercialization in 2009 for TRC?
Dr. Paul Kemp: Can't be answered until phase II data is in.


HairSite: Intercytex has another product called Vavelta which has gone commercialization without phase III trial. Can the same apply to ICX-TRC ?
Dr. Paul Kemp: No. ICX-TRC will be regulated by the UK’s MHRA as a medicine


HairSite: Can a patient come back for repeat treatment until the desired density is achieved? Do you still think that ICX-TRC will work better in conjunction with a hair transplant for some people?
Dr. Paul Kemp: Can't be answered until the phase II data is in.


HairSite: How long do you expect phase III will last?
Dr. Paul Kemp: We can better understand the follow up period for phase III after the phase II data is in. Phase II is scheduled to be a one year follow up. We don’t yet know if this is too long or not long enough.


HairSite: What is the next step after the conclusion of phase III trial and approximately how long will it take before commercialization in the UK assuming everything goes well with phase III?
Dr. Paul Kemp: The data will need to be compiled and then submitted to the regulators and they will need to review it. This process typically takes 18-24 months.

 

[elguapo]

18 - 24 MONTHS!!! to compile, submit, and review the data? What a crock of $hit!!! Talk about sitting on your @$$es doing nothing!!!!!

 

[khali]

I think they are waiting for baby boomers to retire and slow down the economy. Then they will speed up the process.

 

[Lucky_UK]

Very dissapointing comments by the founder of Intercytex plc, not very encouraging at all, and the option for allowing Bosley the rights (if it ever does come into fruitation) puts me off the idea all together.

 

[michael barry]

all this from a company that once had verbiage on its website pertaining to "small-scale commercialization in 2008" being possible.

Bullshiiiit!!!!!!!!!!!!!!!!

They are talking about not even releasing any phase two data until the third quarter of 09' (roughly September of next year), and then having to do an entire phase three trial.......................another year (10'), and then 18-24 (11'-12')months of review of that trial by themselves and England's governing medical body to see if it could be relased. Hell, it looks like 2013 if everything went well. But they wont even tell us or show us one pic of the "substantial" regrowth----claimnig that they "cant" because of whatever shiiity excuse.


Know what I think? .............................Its only "so-so" at best. It thickens existing areas --some---, but does not grow much hair on areas that already have hair.




Whats the point? The point is DO NOT GET AN hair transplant thinking this will come and save you. Bosley et al are trying to milk this for all its worth, getting men in chairs for surgery thinking HM will eventually bail them out----but that may not be the case. They simply dont know if they can improve it a great deal over what they have now.

 

[Pereira]

seems to be a lack of good results

 

[sphlanx2006]

They are talking about not even releasing any phase two data until the third quarter of 09' (roughly September of next year), and then having to do an entire phase three trial.......................another year (10'), and then 18-24 (11'-12')months of review of that trial by themselves and England's governing medical body to see if it could be relased. Hell, it looks like 2013 if everything went well. But they wont even tell us or show us one pic of the "substantial" regrowth----claimnig that they "cant" because of whatever shiiity excuse

v

And not even 2013 because phase III trial is not going to end in just one year. Hell, phase II will last 2+half years, phase III is supposed to be bigger. My opinion: Lack of results. Its sad but true. If this thing was working very good, they would run as fast as they can to have it out as soon as possible.

There are still some chances that this will work. Still, if you told me that by the year 2014 you will have a solid HM out, i would be pleased. But i am not counting so much on ICX anymore. sh*t the last two months have been really bad in the hair loss front. Lets hope Follica will find a way to combat the problems with their procedure...

 

[1750]

this from their latest report

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
six subjects were injected without stimulation of the scalp. In the
remaining thirteen the resident hair producing (epithelial) cells
were stimulated at the time of delivery of the DP cells.
Eleven subjects have now passed the 24?week time point
since treatment and specialised image analysis at this time
point showed:
// of the group of six patients without stimulation of the scalp,
three had an increased hair count and two had a reduced hair
count; one has been lost to follow?up.
// of the five subjects with pre?treatment scalp stimulation,
all had increased hair count at twelve weeks and the three
who were evaluated 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.

IMO they're taking their sweet time with this and results are quite obviously minimal.... I wonder if in September the 24 week data will be released with pics

 

[jakeb]

"The barrier to commercial success for ICX?TRC is relatively low"

to me, means...

"The results weren't that good but we know people will still pay for it"

 

[sphlanx2006]

//Edit

In english when you say that barrier of success is relatively low do you mean that
there is a good market potential or that there is a bad market potential?

Just want to clear this out because I dont understand what they mean. (english is not my mother language)

 

[harold]

good market potential.
hh

 

[sammo]

The human race are hopeless... we need like an Einstein for hairloss. I do like the ONE thing he said about it being treated as a 'medicine' because hairloss is not purely cosmetic in my opinion, like a pair of fake breasts. I think all these bosleys and corporate fucks will do their best to make sure hairloss treatments are not seen as medicines / treatments for a severely impacting event on both men / women, but look at it like a form of disease. If instead of hairs (that you cant feel) dropping off our heads, if it was our limbs or toes, im sure there would be a completely different take on hairloss being purely a cosmetic problem, and mabye more people would be trying to develop on a market to potentially make millions.

Sammo

 

[Eureka]

Bosley should just die..Whenever I get hyped about HM I think about bosley being in control of it, It's total sh*t. If I have to go into a bosley building to get any type of hair work done I'm talking a lawyer with me, And whatever hairloss hair transplant expert I can find. I wonder if they rent those out

Intercytex will take it's time going through the motions, remember some of the estimates where 5-15 years. I just hope it comes out, I don't want to see another supposed hairloss tretment blink out of existence. I'd rather it take 10 years then come out on time and be bollocks.