Intercytex Phase II hair multiplication COMPLETED trial results
This post is outdated. For new information, see: Intercytex and regenerative hair therapy: what are they waiting for?
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| He only looks sad still; he died while waiting for hair |
Intercytex, the UK-based biotechnology company and hair multiplication darlings of the moment, have released the final results from their Phase II trials for their flagship hair product, ICX-TRC.
The last results were in September, leaving us with extremely promising results and the impression that they were ironing out the kinks.
They appear to have found more consistency this time around, but are oddly backing out of further development and commercial production, saying only that they’ve left the option open for a hair transplant specialist company to swoop in and take over, with Bosley getting first crack.
Hot off the press:
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.
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.
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.
What does this mean?
- With pre-stimulation, all subjects grew hair.
- No hair counts were disclosed, which is questionable.
- Intercytex is waiting until September of this year for the final follow-up.
- They are ceasing further testing and looking to license the technology to a hair transplant company.
The big question now is their motivation for stopping further trials and cashing out. We’re left with some ambivalent phrasing: they are ceasing “clinical and commercial development” and cutting in-company financing, but are seeking a very large partner to carry out “distribution”.
It could be a sign of failure: that the technology was not successful enough to turn the profits they had hoped for without further trials, and are rats trying to sell the proverbial ship before it goes under. On the other hand, it may be that no further trials are genuinely necessary, and armed with the successful data, they are looking to pass the baton to someone with the infrastructure to carry out the procedures.
Unless a partnership forms in the meantime, we’ll have to wait until September to see how successful ICX-TRC has been.
Previously: Intercytex phase II hair multiplication trial update
Read more about Intercytex and Hair Multiplication on the Tressless Wiki
