Q&A with Dr. Paul Kemp, Intercytex - April 2008

Stem cell; cell based hair therapy
1

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.

For more information about Intercytex’s research, please click Intercytex

For their March 18th press release, click Press Release

2

One month ago, the final deadline for phase-II was Fall '08 and now it’s Q2-3 2009. Plus now they need to go through phase-III…!

so Q3-2009 - Phase-II results

IF those are good, then probably

2010-2012 - Phase-III

then they turn in the results which takes about 2 years

2012-2014 - MHRA review

Then maybe commercialization in 2015 - I’d be 33 then! :frowning: We are screwed BIG TIME!

I guess time for me to start the herbal treatment now and see if works. Good luck guys with whatever you are planning…I’m not counting on TRC anymore, time to move on with my life!

3

» Then maybe commercialization in 2015 - I’d be 33 then! :frowning: We are screwed
» BIG TIME!
»
»
» I guess time for me to start the herbal treatment now and see if works.
» Good luck guys with whatever you are planning…I’m not counting on TRC
» anymore, time to move on with my life!

ROFL.

I’ve been waiting to get my hair back since before you were born.

4

End of phase 2 = Q2 or Q3 of 2009.
Phase 3 last another 1.5 years I assume
Then another 1.5 - 2 years for government to review.

Total = another 4-5 years away.

That’s too long, too long,

5

» End of phase 2 = end of 2009.
» Phase 3 last another 1.5 years I assume
» Then another 1.5 - 2 years for government to review.
»
» Total = another 4-5 years away.

if phase-II ends in fall '09, it would be full 3 years for phase-II (started sep '06). I don’t see how they can complete phase-III in 1.5 years, especially because its going to have loads more people whose, probably, entire heads they have to inject…unlike phase-II in which they only did two areas. So my relalistic assumption is phase-III will definitely take atleast 2-3 years!

6

» » Then maybe commercialization in 2015 - I’d be 33 then! :frowning: We are
» screwed
» » BIG TIME!
» »
» »
» » I guess time for me to start the herbal treatment now and see if works.
» » Good luck guys with whatever you are planning…I’m not counting on TRC
» » anymore, time to move on with my life!
»
» ROFL.
»
» I’ve been waiting to get my hair back since before you were born.

So… let’s go everybody to ALVI for a transplant… :smiley:

7

they say 3-4 years… icx seems now too long for wait…

8

» they say 3-4 years… icx seems now too long for wait…

That’s just too long. It could easily be 5 years if there are any delays. It seems that it’s always 5 years away.

9

» I’ve been waiting to get my hair back since before you were born.

I feel you man! how old and what NW are you now?

I started balding at 18 and at 26, I’ve got a shiny NW6. That’s why I am concerned about getting my hair back…the only hope I had was TRC in '08…some idiots beat that drum in '06 and got everyone excited. Its definitely a long way from commercialization and I don’t wanna waste my life anymore thinking about hairloss all the time - while people out there are living their lives.

10

» » they say 3-4 years… icx seems now too long for wait…
»
» That’s just too long. It could easily be 5 years if there are any delays.
» It seems that it’s always 5 years away.

Wishful thinking.Why believe in ICX-TRC at all at this point,they have been changing dates for a long time now.

Shave your head and join the crew over at www.baldrus.com and get on with life,alternatively have a hair transplant,these are the only real choices for the near future.

Hair transplant are scary,a bit of a gamble,if they fu*k up - you can always spend more money on using body hair - how bloody stupid does that sound.

16 months ago I was lucky enough to actually talk to the person who’s dealing with trials at the Farjo Clinic - she was very convincing,but it all amounted to a big nothing - I must of been on something at the time to be taken in,by it.

Yes life is a big …

11

It will take 2 years just to the regulators to review it AFTER the phase III trial!

» 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.
»
» For more information about Intercytex’s research, please click
» Intercytex
»
» For their March 18th press release, click
» Press
» Release

12

I see these answers are quite contradictory.

He says that the TRC’s progress is “on target” (ie. 2010) but later, his comments point to 2013 the earliest.

Dr. Kemp says he can’t comment on the characteristics of the new hair because this would violate regulatory authorities. This is exactly the same excuse Bazan argued in the past. Sorry Dr. Kemp, why don’t you comment, at least, on the Phase I hair’s characteristics? Or why don’t you post Vavelta photos, as the product has already been launched?

Instead of telling us that Vavelta rendered “some exceptional results” why don’t you post a photo, to see how exceptional they are.

Why don’t you tell us the meaning of these photos you posted here on page 19:
http://www.vavelta.com/vavelta/mp/story/vaveltaface/cell02.pdf
If you can’t post TRC photos, why did you post these photos?

Although I still have faith on ICX, I am certainly quite dissapointed. :frowning:

13

i believe in them… ICX seems to be toooooo far away…

14

I agree that ICX is disappointing and now does seem very far away. Unfortunately they seem further along than both ACell and Follica, neither of which has done Phase I trials on humans, let alone Phase II.

15

Hey,

2 things:

  1. Thanks, David, for taking the time to do the interview with Kemp.
  2. How can ICX-TRC be “on target” in terms of progress when commercialization will begin well beyond 2010?

Best,
BB

16

I always believed that most on this board were too optimistic.

I questioned many who were acting as if HM was a done deal already and that trials were just some kind of formality.

I also cautioned that it may need to go through an approval process, and again I was ignored or shouted down.

Likewise, when I suggested that it might go to the end of the line for the approval process, because baldness is not considered serious (even by many here, who are in denial).

But no one listens to Ahab the wise.

Anyway, I’m not dissapointed that HM is taking longer (or even, if ever) than many here thought, because I did not hear only what I wanted to believe.

17

I don´t understand the marketing of Intercitex, couse After all this info from Mr.Kemp, Everybody will turn their hopes to Follica, that it is suppused to be the competence.
I have read in this forum that follica won´t have to go through all the regulatory process that ICX has to go throught ( in case I am wrong please tell me ) , so it would be at the market before ICX ? And understanding the process more or less as we know, wouldn´t be possible a " Do it at home"? , just like some members of this ofrum has tried.

If Follica process is “as simple as it seems”, it is just time that someone who experiment the process will achieve grow hair, only in case he process would work.
Don´t you believe?

18

“Small scale” commercialization in 2008!!!

Does anybody else remember Intercytex mentioning that on their website. I DO

We have been “led along” for a while now folks. Always keep in mind that by purchasing rights to TRC, Bosley has some communication with ICX,

He wouldn’t even come out and say whether or not we get to see one measley before-and-after photo after phase two trials are completed and “all the data are analyzed”—which could be another year (quick, has it ever taken you a year to analyze results of anything you have done? Me either)

Guys, Im not saying HM will never happen. Im not saying that at all, but what I will say is this: We WERE GIVEN SOME INFORMATION AFTER PHASE ONE, AND EVEN ONE SMALL PHOTO. Kemp is claiming that they can release no information until phase two is finished, but wont even DESCRIBE whether the new hair growth looks pretty good or not. Its beyond evasive. I cannot stress enough that if YOU ARE NOT A GOOD CANDIDATE FOR A HAIR TRANSPLANT WITHOUT HM, DO NOT GET ONE. HM IS NOT A GIVEN IN TEN YEARS. IT MAY NEVER HAPPEN. I think somebody will get something down that is acceptable personally be it the Japanese, Aderans, or ICX, or that Indian Clinic, but this truly may be several years-----like 2015 or something. I’d encourage all of you to make a decision “up there” and quite frankly forget about ICX until September’s end. Follica might warrant our attention in the near term, but beyond that…its nothing and apparently will be nothing for some time. One year after phase two, then phase three, then about two years…we’d be looking at 5 YEARS at the best case scenario. This contradicts the living hell out of “2008 small scale commercialization” and makes ICX look like they were blindsided with TRX being regulated as a medicine. Not good. Go live your lives

19

I think Acell is releasing their human grade product this year…but remember, they are not saying it will regrow hair…I dont think anybody will know till its tried…we are the ones who are hoping it will regrow hair (based on the many pics of tissue regrowth (along with fur regrowth) on the animals on their website)

here are some links …

http://www.acell.com/news_updates.php

http://www.acell.com/vetcases/chadwick.html

http://www.acell.com/vetcases/lucille.html

http://www.acell.com/vetcases/twinkie.html

20

HairSite: Is the progress of the ICX-TRC project on target at this point?
Dr. Paul Kemp: Yes it is. We were once told of a “small scale” commercialization in 2008 being possible, now we are being told that ICX always intended to partner with a larger company (below) for a phase three trial. Contradiction.

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. Does anybody else think “the ultimate solution for baldness” would honestly need any marketing help that one trip to the TODAY show wouldn’t provide? Me either

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. The phase two trialees will be finished in September, but he has just pushed back any results until the last few months of 2009, a year later than September

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. He isn’t even going to tell you if they have new baby hair, or decent hair, what color, or ANYTHING, but he WOULD tell you the growth was “SIGNIFIGANT” and that there were “INCREASES” in every trialee----but wont say if it even looked “pretty good” or “dark” or “light”. Uh-huh[/color]

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. Wont say if anyone else has expressed interest…

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. If the data is GOOD, could we expect a small scale commercialization in 2009?

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. Wont even tell us if one can get multiple treatments of HM spaced out over the years. Wont even speculate.

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. At least one year after phase two before phase three begins…then phase three for at least one year and then a review of that data for another year. Time is slipping away isn’t it?

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.

Im sick of the mushroom treatment. Go out and live your lives and forget about hair. If something good comes down the pike, NBC news will speak of it----but until then its all speculation. We used to make fun of people on this board who said 2010 back in 2002…well now 2010 seems pitifully optimistic. 2012 looks like the EARLIEST we could HOPE for HM.