The bellow text is copy paste from the Intercytex report TRC section.
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 prestimulation 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 24th 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 pretreatment 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 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.