Dr Farjo answers more questions - 04 May 09

Stem cell; cell based hair therapy
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Balding Blog - Questions & Answers 04 May 09

Thank you very much for answering our questions and for having this site. Thank you Dr. Farjo for joining. These questions are for Dr. Farjo re: hair multiplication/intercytex study:

  1. Is Intercytex going to phase 3 trials with the procedure they currently have?
  2. Is the current product marketable given the current results, if it does go into phase 3? (It sounds like it is not, but that it created an enterance into another idea that may be marketable)
  3. How long do you think it will be before a marketable product exists?
  4. You mention that further studies are planned. When do you think this new Photo-hair technology will be tested on humans?
  5. Will Intercytex be doing these studies? It sounds like they are waiting for someone else to buy them out. If not Intercytex, who will be doing these studies?
  6. Intercytex has mentioned they have given Bosley the option of purchasing them or parterning. Bosley has their own theory on how to make this work, so why would Bosley buy them? (Speculating of course)
  7. Who else besides Intercytex and Bosley/Aderans seems to be doing hair multiplication testing/research?

Thank you for any or all all answers to the above questions.

The following response is by UK-based physician Dr. Bessam Farjo:

Response by:
Dr Bessam Farjo, United Kingdom
Dr Bessam Farjo
United Kingdom

  1. A decision has not been made yet on timing. One reason is that we are still waiting on the analysis of the global photos concerning the larger of the injected areas. A second reason is the more promising finding of growing hairs out of the multiplied cells in the lab in the mouse, which will hopefully lead to a new clinical trial. Finally there are financial restrictions at the moment due to the global economic situation that is affecting most biotech companies.
  2. See Q1. A product goes into market only after successful phase III.
  3. Due to all what I mentioned it would be foolish of me to predict that with any accuracy.
  4. A clinical trial should take place once the lab studies on human hair produce results reliably and predictably. We’re not at that point yet.
  5. No, that is not the case. They said they are looking for funding from outside the company for this project. Given the funds, Intercytex will continue with these studies.
  6. Bosley has an option to market Intercytex’s product should they succeed ahead of Bosley (or more accurately Aderans). I take this opportunity to confirm that I am neither a director nor a shareholder with Intercytex plc.
  7. I am not aware of anyone else.
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in summary, this aint going anywhere yet, they need $$$$$$$$

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kaput

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» in summary, this aint going anywhere yet, they need $$$$$$$$

Raising money or finding a partner with deep pockets is not a problem when you have something that works.

I have been following biotech for about 20 years. What doesn’t make sense is the phase 1 trial being done in the UK and then phase 2 being done in the USA. This doesn’t sound right.

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» » in summary, this aint going anywhere yet, they need $$$$$$$$
»
To give you an idea of the regulatory hurdles, Geron has been around for about 10 years. After finally getting a working protocol together and after submitting 25,000 pages of supporting documentation the FDA intially turned them down on their stem cell thearpy. It was only after an additional 6 months of review that the FDA is allowing limited testing. This is for a thearpy that could help people that are completely paralyzed.

I would think the bar would be much higher for something like baldness.