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 patients 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.