ICX Phase II -- Something is going wrong

Hey all,

Okay, I know some of us tend to scrutinize what comes out of Intercytex as though it were the Holy Bible. But I noticed a discrepancy:

In September 2006 Intercytex made this statement: “If all goes as expected, phase II may be concluded in approximately 1 year.” That is, Phase II should be done in by September 2007. See here for this statement: http://www.hairsite.com/intercytex-hair-multiplication.htm

However, in the most recent report from Intecytex they plan on “preliminary” Phase II data in 2007 and “additional” phase II data in 2008. No completion in 2007, for sure. See here for this statement: Investis Digital | Trusted Digital Communications and Marketing Company

So what could be going “wrong” with Phase II? Any ideas?

All the best,
BB

Hey,

One other point. Note that in Phase II so far there have been 9 patients biopsied but only 6 have been treated. See here for this information: http://www.intercytex.com/icx/investors/rep/2007-03-23/2007-03-23.pdf

Does anyone have any ideas why only 66% of the first cohort were treated with ICX’s product?

All the best,
BB

» Hey all,
»
» Okay, I know some of us tend to scrutinize what comes out of Intercytex as
» though it were the Holy Bible. But I noticed a discrepancy:
»
» In September 2006 Intercytex made this statement: “If all goes as
» expected, phase II may be concluded in approximately 1 year.” That is,
» Phase II should be done in by September 2007. See here for this statement:
» http://www.hairsite.com/intercytex-hair-multiplication.htm
»
» However, in the most recent report from Intecytex they plan on
» “preliminary” Phase II data in 2007 and “additional” phase II data in
» 2008. No completion in 2007, for sure. See here for this statement:
» Investis Digital | Trusted Digital Communications and Marketing Company
»
» So what could be going “wrong” with Phase II? Any ideas?
»
» All the best,
» BB

:surprised::surprised::surprised:

Guys Chill out!

By the end of September Intercytex will announce preliminary data for phase II !

I think you’re over scrutinizing the Intercytex statements way too much. Note that September '06 to early '07 is still “approximately 1 year”. Also, hardly any R&D project “all goes as expected”, and when it doesn’t, it’s not necessarily because there’s anything fundamentally wrong.

It’s clear that their biggest problem is the money. If they had more money they could run the trials at quicker pace. they try to conserve as much money as possible so they changed their mind and now they run the phase II in multiple cohorts. first 9 patients - 3 probably got scared and run away, 6 got treated now they wait for the outcome (if they had money they could inject another 6 with diferent dose/formulation and see which of the two is better, but they don’t so they probably think let’s try this first and see if it is a hit or no and then we may guess what next …)

» Hey all,
»
» Okay, I know some of us tend to scrutinize what comes out of Intercytex as
» though it were the Holy Bible. But I noticed a discrepancy:
»
» In September 2006 Intercytex made this statement: “If all goes as
» expected, phase II may be concluded in approximately 1 year.” That is,
» Phase II should be done in by September 2007. See here for this statement:
» http://www.hairsite.com/intercytex-hair-multiplication.htm
»
» However, in the most recent report from Intecytex they plan on
» “preliminary” Phase II data in 2007 and “additional” phase II data in
» 2008. No completion in 2007, for sure. See here for this statement:
» Investis Digital | Trusted Digital Communications and Marketing Company
»
» So what could be going “wrong” with Phase II? Any ideas?
»
» All the best,
» BB

It is very typical for ICX to miss their time lines. We saw phase 1 get extended out for years. Now we are seeing the same extended timelines for phase II. That’s one of the many reasons why I gave up completely on the notion of a 2008 ICX-TRC release.

» Hey all,
»
» Okay, I know some of us tend to scrutinize what comes out of Intercytex as
» though it were the Holy Bible. But I noticed a discrepancy:
»
» In September 2006 Intercytex made this statement: “If all goes as
» expected, phase II may be concluded in approximately 1 year.” That is,
» Phase II should be done in by September 2007. See here for this statement:
» http://www.hairsite.com/intercytex-hair-multiplication.htm
»
» However, in the most recent report from Intecytex they plan on
» “preliminary” Phase II data in 2007 and “additional” phase II data in
» 2008. No completion in 2007, for sure. See here for this statement:
» Investis Digital | Trusted Digital Communications and Marketing Company
»
» So what could be going “wrong” with Phase II? Any ideas?
»
» All the best,
» BB

…and add the fact that i couldn’t see Kemp’s 66 replicated hair on his recent skingraft video! Something is obviously going wrong. By the way, have you noticed the temperature in Greece up to 46 degrees lately ? the correlation is clear to me : no hm in greece before 2008. Damn…

Interesting point, JB. Still I find it totally bizarre that companies like Intercytex can’t get the funding needed for finding a baldness cure. After all, billions of dollars is in the pockets of those who find a moderately acceptable “cure”… Perhaps there’s still the widespread perception that only women are willing to pay $$ to improve their looks?? I also know that propecia wasn’t the big money-maker Merck was hoping for…

» » Hey all,
» »
» » Okay, I know some of us tend to scrutinize what comes out of Intercytex
» as
» » though it were the Holy Bible. But I noticed a discrepancy:
» »
» » In September 2006 Intercytex made this statement: “If all goes as
» » expected, phase II may be concluded in approximately 1 year.” That is,
» » Phase II should be done in by September 2007. See here for this
» statement:
» » http://www.hairsite.com/intercytex-hair-multiplication.htm
» »
» » However, in the most recent report from Intecytex they plan on
» » “preliminary” Phase II data in 2007 and “additional” phase II data in
» » 2008. No completion in 2007, for sure. See here for this statement:
» » Investis Digital | Trusted Digital Communications and Marketing Company
» »
» » So what could be going “wrong” with Phase II? Any ideas?
» »
» » All the best,
» » BB
»
» It is very typical for ICX to miss their time lines. We saw phase 1 get
» extended out for years. Now we are seeing the same extended timelines for
» phase II. That’s one of the many reasons why I gave up completely on the
» notion of a 2008 ICX-TRC release.

when they “data available” they mean when the data from the trial will be made public. It doesnt mean when the trial will finish. They will know their results way before we do.

So the trial may well finish in sept 2007 but we will only get to know the results in jan 2008 etc

» So the trial may well finish in sept 2007 but we will only get to know the
» results in jan 2008 etc

in thought you said hm 2007 ? snif, i had put all my hopes in you nathan!! now i can only throw myself out of …my bed ?..waaaaaaa…

» Interesting point, JB. Still I find it totally bizarre that companies like
» Intercytex can’t get the funding needed for finding a baldness cure. After
» all, billions of dollars is in the pockets of those who find a moderately
» acceptable “cure”… Perhaps there’s still the widespread perception that
» only women are willing to pay $$ to improve their looks?? I also know that
» propecia wasn’t the big money-maker Merck was hoping for…

I think it is critical that their other products are successful, which seems to be the case so far. If they can generate cash from the other products, this is going to be a big help for ICX, so even their other products are not related to hair, it is just as important for them to be successful on these other product lines.

I’m still sticking with Q4 2007

Over the course of the summer i bet u we see loads of presentations and hear loads of news from aderans and Intercytex.

» Hey,
»
» One other point. Note that in Phase II so far there have been 9 patients
» biopsied but only 6 have been treated. See here for this information:
» http://www.intercytex.com/icx/investors/rep/2007-03-23/2007-03-23.pdf
»
» Does anyone have any ideas why only 66% of the first cohort were treated
» with ICX’s product?
»
» All the best,
» BB

They take the biopsy and then they culture the cells for THREE WEEKS.
Then they inject.
So, the remaining 3 trialists were just waiting for the cells to be cultured.

» I think it is critical that their other products are successful, which
» seems to be the case so far. If they can generate cash from the other
» products, this is going to be a big help for ICX, so even their other
» products are not related to hair, it is just as important for them to be
» successful on these other product lines.

I agree. It will be a boost to investors confidence and money will not be a problem. See what they say about Vavelta, it’s coming out later this year.

“In March 2006, Intercytex received confirmation from the MHRA (Medicines and Healthcare products Regulatory Agency) that ICX-RHY was outside the scope of the current legislation covering the marketing of medicines and devices in the UK. Intercytex plans to make ICX-RHY available in the UK market once additional clinical data are available, at the end of 2007, under the trade name VAVELTA™.”

» I’m still sticking with Q4 2007
»
» Over the course of the summer i bet u we see loads of presentations and
» hear loads of news from aderans and Intercytex.

We will hear loads of news from Intercytex about their other products, not about ICX. Their new product for skin is supposed to be available later this year.

» I agree. It will be a boost to investors confidence and money will not be
» a problem. See what they say about Vavelta, it’s coming out later this
» year.

Personally, I’m a little concerned about Vavelta. Mostly because it is allogenic (freaks people out a litte) and Isolagen’s similar procedure has had a rough time in phase III, thus sales aren’t what they had hoped.

If it bombs, the stocks will tumble, and that will make it tough for TRC. IMO, they should be pushing TRC as their #1 product, but that’s just me. :slight_smile:

» I’m still sticking with Q4 2007
»
» Over the course of the summer i bet u we see loads of presentations and
» hear loads of news from aderans and Intercytex.

hi nathan,
have you had any news from your insider lately ?

cheers