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 ICX-TRC is
an autologous hair regeneration therapy, a
suspension of human
dermal papilla cells, for the
treatment of
male pattern baldness and
female diffuse alopecia. 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.
Background
Both male
pattern baldness and female diffuse alopecia result in hair-loss or
slowing of hair growth. They may be caused by physical damage
to the hair itself or to the hair follicles, but commonly arise as
a consequence of changes in the natural growth cycle of hair
generally resulting in fewer dermal papilla cells.
Approximately 95% of all cases are of genetic origin.
Market
opportunity
Hair loss
affects approximately 40% of men and 20% of women aged 50 and
over. In the US there are an estimated 40 million men and 12
million women suffering from some degree of baldness. The
estimated market size for hair regeneration products and treatments
is over $1 billion for both men and women but only 2% of patients
suffering hair loss currently seek any treatment indicating a
potentially far higher market size*.
 Existing conventional
treatments, involving the transplant of whole hairs, represent the
only means of regenerating bald or thinning areas. This is a
highly costly ($10,000 - $20,000) specialist procedure.
Extensive tissue is required, obtained by the removal of a
large section of scalp leaving a significant scar at the donor
site. Individual follicles are removed from the dissected
scalp by specialised technicians and then individually re-implanted
into surgical incisions created in the scalp. This procedure
usually takes place during two, eight-hour implant sessions
performed under a local anaesthetic. A lengthy recovery
period may be required during which time the patient may suffer
from pain, bleeding and swelling of the scalp. In general the
cosmetic effect is excellent, however in all cases, the quality of
outcome is limited by the amount of donor hair available. Moreover,
many individuals electing to undergo this procedure do not progress
to transplant surgery as they have insufficient transplantable hair
follicles to benefit from the technique as between 2,000 - 5,000
follicles are often needed for this procedure.
The ICX-TRC
procedure is significantly less problematic than conventional hair
transplants. In terms of the amount of tissue taken from the
patient, only a small sample of approximately 120 follicles is
needed. As a consequence, trauma suffered by the patient
during the procedure may be dramatically reduced.
Furthermore, as dermal papilla (DP)cells can be derived from a very
small area of hair-bearing scalp, a much higher population of
patients will be able to benefit from ICX-TRC than conventional
transplantation. Superficial injection of cultured cells into
the scalp causes far less tissue damage than implanting multiple
hair follicles and is a considerably simpler, shorter and less
painful process.
The ICX-TRC procedure
A small sample of hair follicles is taken from the patient
during a simple 30 minute operation carried out under local
anaesthetic at a hair or skin clinic. The clinic sends the
biopsy to Intercytex’
GMP compliant manufacturing facility where
the DP cells are dissociated from the rest of the
follicle. These cells are cultured and expanded in proprietary
media over three weeks and subsequently returned to the clinic
in a sterile suspension.
Using a specialised delivery system, the DP cells are
microinjected intradermally into the
patient’s scalp. The treatment is performed under local
anaesthetic and comprises a single procedure of superficial
injections, each injection delivering a minute volume of media
containing DP cells. These cells are able to stimulate the
generation of new hairs when injected in close proximity to
the epidermal cells which generate the hair. Following the
procedure, new hair growth should become evident after
approximately three months.
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.
The treatment phase of
a Phase
II trial, being
conducted by Dr Bessam Farjo in
Manchester, to optimise the delivery of the DP cells,
has been completed.
In this study, hair
counts were 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 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 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 12
weeks and the three 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.
Manufacturing
Intercytex will manufacture ICX-TRC for Europe and the US from its
own manufacturing facilities. In October 2006, Intercytex was
awarded a grant from the DTI to develop a robotic system with The
Automation Partnership for the commercial scale production of
patients’ autologous DP cells. The robotic system has an
established track record in processing many different cell samples
simultaneously, so that at this scale, in which large numbers of
different patients’ cells are handled, all samples remain
isolated throughout the multiplication process.
*Source:
Coldwater (Market Research)
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