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Interesting Histogen info


#1

http://www.ishrs.org/PDF/F4-2009.pdf
Good interview, starts at p 8.

“In our initial human trial,
these injections were done at the baseline time point with
evaluations performed at subsequent visits. We will look at
different concentrations or injections at multiple time points
,
to determine a dose ranging within future studies. In addition,
we are working with formulations that will allow us to
test topical application of the product.”

“Our best current prediction
for market availability in the U.S., based on the time line
for clinical trials and regulatory approval, is 2015. We will
be conducting an additional concurrent pivotal clinical trial
outside of the U.S. and will seek market approval in other
countries where availability is possible prior to 2015
.”


#2

» http://www.ishrs.org/PDF/F4-2009.pdf
» Good interview, starts at p 8.
»
» “In our initial human trial,
» these injections were done at the baseline time point with
» evaluations performed at subsequent visits. We will look at
» different concentrations or injections at multiple time points
,
» to determine a dose ranging within future studies. In addition,
» we are working with formulations that will allow us to
» test topical application of the product.”
»
» “Our best current prediction
» for market availability in the U.S., based on the time line
» for clinical trials and regulatory approval, is 2015. We will
» be conducting an additional concurrent pivotal clinical trial
» outside of the U.S. and will seek market approval in other
» countries where availability is possible prior to 2015
.”

prior to 2015…nice!


#3

ja, the same old tale. You people never learn. Remember that ICX was also saying they would try to launch TRC outside UK to avoid regulations and speed up the launch. Now we have nothing, and the impression that this has been a total fiasco.
So please, ignore these foolish predictions. Just ask for hard proof that they have something working now.


#4

True. But the problem with ICX was that it didn´t work that well. Histogen doesn´t seem to work that well either (the pictures are unimpressive,you would not even notice that the guys grew hair if you saw them irl imo), but we dont know how good it is with multiple injections yet.


#5

Has Histogen been proven to be more effective than the drugs that have already been approved by the FDA to treat hairloss, i.e., Propecia and Rogaine?

I mean, are we talking about a drug which is QUALITIATIVELY better here, or are we talking about just more of the same, something that can keep your hair growing for a while, but which ultimately will not “cure” hairloss or make a big cosmetic difference?

Are we just getting excited about “more of the same”?

Where is the hard evidence, apart from just claims made verbally by Histogen?


#6

» Has Histogen been proven to be more effective than the drugs that have
» already been approved by the FDA to treat hairloss, i.e., Propecia and
» Rogaine?
»
» I mean, are we talking about a drug which is QUALITIATIVELY better here,
» or are we talking about just more of the same, something that can keep your
» hair growing for a while, but which ultimately will not “cure” hairloss or
» make a big cosmetic difference?
»
» Are we just getting excited about “more of the same”?
»
» Where is the hard evidence, apart from just claims made verbally by
» Histogen?

Histogen uses WNT signalling, which is the ‘newest thing’ in hair loss research. We do not have concrete proof that this will be better than rogaine/propecia, but we have a pretty good idea that it will be.


#7

» Has Histogen been proven to be more effective than the drugs that have
» already been approved by the FDA to treat hairloss, i.e., Propecia and
» Rogaine?
»
» I mean, are we talking about a drug which is QUALITIATIVELY better
» here,
» or are we talking about just more of the same, something that can keep
» your
» hair growing for a while, but which ultimately will not “cure” hairloss
» or make a big cosmetic difference?
»
» Are we just getting excited about “more of the same”?
»
» Where is the hard evidence, apart from just claims made verbally by
» Histogen?

» Histogen uses WNT signalling, which is the ‘newest thing’ in hair loss
» research. We do not have concrete proof that this will be better than
» rogaine/propecia, but we have a pretty good idea that it will be.

Their core WNT-signalling science is WAY more powerful than anything in the past, but the Histogen research itself is not showing signs of major improvements.

Aderans & Folica are liable to make medium-term gains of real significance. Histogen is more of a coin-toss IMHO.


#8

» “Our best current prediction
» for market availability in the U.S., based on the time line
» for clinical trials and regulatory approval, is 2015. We will
» be conducting an additional concurrent pivotal clinical trial
» outside of the U.S. and will seek market approval in other
» countries where availability is possible prior to 2015
.”

FIve years? Really? They couldn’t have gone with something original like, say, 7 years? That’s why I have more faith in Aderans or Follica - they don’t say a word. The only time you don’t hype is when you’re trying to keep a valuable secret.


#9

http://www.ishrs.org/PDF/F4-2009.pdf
Good interview, starts at p 8.

“In our initial human trial,
these injections were done at the baseline time point with
evaluations performed at subsequent visits. We will look at
different concentrations or injections at multiple time points,
to determine a dose ranging within future studies. In addition,
we are working with formulations that will allow us to
test topical application of the product.”

“Our best current prediction
for market availability in the U.S., based on the time line
for clinical trials and regulatory approval, is 2015. We will
be conducting an additional concurrent pivotal clinical trial
outside of the U.S. and will seek market approval in other
countries where availability is possible prior to 2015
.”

You have to love America’s priorities.
You can have a gun today, but your medicine is always 5+ years away.


#10

Has Histogen been proven to be more effective than the drugs that have already been approved by the FDA to treat hairloss, i.e., Propecia and Rogaine?

I mean, are we talking about a drug which is QUALITIATIVELY better here, or are we talking about just more of the same, something that can keep your hair growing for a while, but which ultimately will not “cure” hairloss or make a big cosmetic difference?

Are we just getting excited about “more of the same”?

Where is the hard evidence, apart from just claims made verbally by Histogen?

Hard evidence?.. you mean aside from the WNT research, the photographic proof, and the diligent reports assembled by Histogen? None really, so I guess you’re right. It’s time to go see Dr Rassman for a hair transplant.


#11

It’s not all bad, at least they are willing to try other countries so there is hope that it will come sooner.


#12

» True. But the problem with ICX was that it didn´t work that well. Histogen
» doesn´t seem to work that well either (the pictures are unimpressive,you
» would not even notice that the guys grew hair if you saw them irl imo), but
» we dont know how good it is with multiple injections yet.

multiple injections? well, we also asked this question about TRC. We hoped that maybe repeated treatment with TRC would add more density. HAHA! if it was so easy, ICX would be right now testing that and plenty of investors putting money into it.
Remember that TRC phase I was a “safety”, “low dose” test, where hair was not expected. And they said that they grew some hair. We were enthusiastic, thinking that Phase II, with a higher dose, would produce tons of hair!! but Phase II gave no much better results than Phase I.

Vavelta high-dose gave poorer results than low-dose.

Its not so easy. More dosing doesn’t always mean more results.

It seems that Histogen is repeating ICX’ steps to disaster. I hope I am wrong.
But lack of investors speaks for itself.


#13

» » “Our best current prediction
» » for market availability in the U.S., based on the time line
» » for clinical trials and regulatory approval, is 2015. We will
» » be conducting an additional concurrent pivotal clinical trial
» » outside of the U.S. and will seek market approval in other
» » countries where availability is possible prior to 2015
.”
»
» FIve years? Really? They couldn’t have gone with something original
» like, say, 7 years? That’s why I have more faith in Aderans or Follica -
» they don’t say a word. The only time you don’t hype is when you’re trying
» to keep a valuable secret.

Exactly my opinion.


#14

» You have to love America’s priorities.
» You can have a gun today, but your medicine is always 5+ years away.

In Europe we do better. Medicines will be 50+ years away.


#15

» » “Our best current prediction
» » for market availability in the U.S., based on the time line
» » for clinical trials and regulatory approval, is 2015. We will
» » be conducting an additional concurrent pivotal clinical trial
» » outside of the U.S. and will seek market approval in other
» » countries where availability is possible prior to 2015
.”
»
» FIve years? Really? They couldn’t have gone with something original
» like, say, 7 years? That’s why I have more faith in Aderans or Follica -
» they don’t say a word. The only time you don’t hype is when you’re trying
» to keep a valuable secret.

They are not saying 5 years. They are targeting 2015 and have been for the last several years.


#16

» FIve years? Really? They couldn’t have gone with something original
» like, say, 7 years? That’s why I have more faith in Aderans or Follica -
» they don’t say a word. The only time you don’t hype is when you’re trying
» to keep a valuable secret.

Exactly, fckhrls. It seems in hairloss research, there’s a reliable inverse relationship between the amount of hype surrounding a product and its chance of failure.


#17

» » FIve years? Really? They couldn’t have gone with something original
» » like, say, 7 years? That’s why I have more faith in Aderans or Follica
» -
» » they don’t say a word. The only time you don’t hype is when you’re
» trying
» » to keep a valuable secret.
»
» Exactly, fckhrls. It seems in hairloss research, there’s a reliable
» inverse relationship between the amount of hype surrounding a product and
» its chance of failure.

Not necessarily, remember Washenik said in 2002/03 that they will have something in about 5 years, well it’s been 7 years already.


#18

»
» Not necessarily, remember Washenik said in 2002/03 that they will have
» something in about 5 years, well it’s been 7 years already.

In 2002/03 there was nothing far enough into clinical trials to be out in 5 years. That timeline was illogical from the start regardless of who said it.


#19

» Hard evidence?.. you mean aside from the WNT research, the photographic
» proof, and the diligent reports assembled by Histogen? None really, so I
» guess you’re right. It’s time to go see Dr Rassman for a hair transplant.

You’re calling a set of unimpressive pictures “photographic proof”?

That’s some pretty good spin! If you’re not already on Histogen’s payroll, you should be!!


#20

» » “Our best current prediction
» » for market availability in the U.S., based on the time line
» » for clinical trials and regulatory approval, is 2015. We will
» » be conducting an additional concurrent pivotal clinical trial
» » outside of the U.S. and will seek market approval in other
» » countries where availability is possible prior to 2015
.”
»
» FIve years? Really? They couldn’t have gone with something original
» like, say, 7 years? That’s why I have more faith in Aderans or Follica -
» they don’t say a word. The only time you don’t hype is when you’re trying
» to keep a valuable secret.

Um, 2015 is within 6 years at this point, not five.