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View the ICX-TRC
animation |
 ICX-TRC is
an autologous hair regeneration therapy, a
suspension of human
dermal papilla (DP) cells, for the
treatment of
male pattern baldness and
female diffuse alopecia. DP cells
stimulate the generation of new hairs when injected into the
scalp in close proximity to the epithelial cells which
generate new 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.
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.
A Phase II study, which was
conducted by Dr Bessam Farjo in Manchester, is now
complete.
This trial was designed to examine the effect of different DP
delivery techniques and methods to ensure that the epidermal cells
were in the correct state to respond to the signals and produce new
hairs.
In this study, subjects
were injected 900 times with 1µl aliquots of DP cells in a
large area which was photographed at the end of the study. Subjects
were also injected in a smaller area, divided into two sections
- counts were obtained by shaving and photographing the two
small sections of scalp, injecting them multiple times (either 1
injection of 50 µl or 50 injections of 1 µl) with
living DP cell suspension and then applying a specialised image
analysis system to provide a total hair count. In these small
sections, all 19 subjects in the trial were 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 subjects the resident hair producing (epithelial)
cells were stimulated at the time of delivery of the DP cells in
one of the two treatment sites.
13 subjects completed the
48-week trial with 6 subjects lost to follow-up. Of the 13 subjects
completing the trial the data showed that:
· 65%
(11/17) of the treated sites in the non-stimulated group
responded to the treatment by increasing numbers of hairs of all
sizes
· 71%
(12/17) of the treated sites in the non-stimulated group
responded to the treatment by increasing numbers of hairs over 30
micron in diameter
· 78% (7/9)
of the treated sites in the stimulated group responded to
the treatment by increasing numbers of hairs of all sizes
· 100% (9/9)
of the treated sites in the stimulated group responded to
the treatment by increasing numbers of hairs over 30 micron in
diameter
· The
overall take rate (number of hairs produced per 100 injections) in
the stimulated areas was
o 40% (n=6) for hairs of all sizes
o 18% (n=6) for hairs over 30 micron in
diameter
The larger (900
injection) area photographs have not yet been analysed.
These data are consistent
with the interim data reported last September and further confirm
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.
Dr Bessam Farjo,
the Principal Investigator for this study, said “We have
learned a lot from this trial, including the different ways in
which these cells can be delivered and that it is possible to do
one thousand of these injections in a relatively short period of
time and at little discomfort to the patient. I am very
encouraged by this data both in the increase in the total number of
hairs in the treated site but more importantly by the increase in
thicker hairs, those over 30 micron.”
Further results of the
trial will be presented later in the year.
Intercytex is exploring
partnering opportunities to continue the next clinical phase of
development of ICX-TRC.
*Source:
Coldwater (Market Research)
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