Transcripts from the April 2008 Q&A with Dr. Paul Kemp.
HairSite: Is the progress of the ICX-TRC project on target at this point?
Dr. Paul Kemp: Yes it is.
HairSite: Has it always been Intercytex’s intention to partner with a larger company for the phase III trial?
Dr. Paul Kemp: Yes, partly to help finance the trial but also to provide marketing help. We are not in the hair transplant business and are primarily a research, clinical and manufacturing organisation.
HairSite: When will phase II trial officially end and when can the public expect the official trial data (including before and after photos) to be released?
Dr. Paul Kemp: The trial will be completed Q2-3 2009.
HairSite: Have you seen any of the phase II test subjects? Can you describe the characteristics of the new hair growth?
Dr. Paul Kemp: We will provide data at the end of the trial. It is not appropriate to make information available during the trial. We are a public company and have legal obligations to the various regulatory authorities.
HairSite: Will Intercytex consider partnering with Bosley for phase III trials? Any other suitors besides Bosley for phase III trial?
Dr. Paul Kemp: Bosley have an exclusive option to the negotiate an agreement at the end of the Phase II.
HairSite: Can we still expect a small scale commercialization in 2009 for TRC?
Dr. Paul Kemp: Can’t be answered until phase II data is in.
HairSite: Intercytex has another product called Vavelta which has gone commercialization without phase III trial. Can the same apply to ICX-TRC ?
Dr. Paul Kemp: No. ICX-TRC will be regulated by the UK’s MHRA as a medicine
HairSite: Can a patient come back for repeat treatment until the desired density is achieved? Do you still think that ICX-TRC will work better in conjunction with a hair transplant for some people?
Dr. Paul Kemp: Can’t be answered until the phase II data is in.
HairSite: How long do you expect phase III will last?
Dr. Paul Kemp: We can better understand the follow up period for phase III after the phase II data is in. Phase II is scheduled to be a one year follow up. We don’t yet know if this is too long or not long enough.
HairSite: What is the next step after the conclusion of phase III trial and approximately how long will it take before commercialization in the UK assuming everything goes well with phase III?
Dr. Paul Kemp: The data will need to be compiled and then submitted to the regulators and they will need to review it. This process typically takes 18-24 months.
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For their March 18th press release, click Press Release