CX-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.
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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.
OUTLOOK
Over the next year we expect to report sustained strong progress both commercially and clinically:
VAVELTA – we expect to start generating revenues from around the middle of the current year
and we will report on our sales progress as the product is rolled out. We will also report on our
progress in obtaining permission to market the product in other European territories. We will report final data on the facial rejuvenation and acne scar trials, and initial data from the
burns contracture study. ICX-PRO – full details of the data from the diabetic foot ulcer trial will be presented at relevant
conferences. Recruitment to the pivotal Phase III venous leg ulcer trial will be completed and
the outcome will be announced in H1 2009. ICX-SKN – full details of the current Phase I extension trial will be reported in H2 2008 and the
Phase II trial in basal-cell carcinoma excisions commenced ICX-TRC – final data on all evaluable subjects in the current Phase II trial will be announced in
H1 2009
We have seen strong efficacy evidence across our product portfolio during 2007. Continuation of the
efficacy profile that our pipeline has demonstrated to date will emphasise the value of the regenerative
medicine assets that we are creating.
