Histogen Update - Spencer Kobren Speaks With Dr. Craig L. Ziering

[534623]

Some hairs have even had considerable change while not even having circles around them (ie. the two hair follicle between 34 and 35 has thinned).

Correct. I couldn't make circles around ALL follicular units, because ...

What’s going on here? It’s certainly not classic androgenic alopecia where the affects are more diffuse. One does not see something like this in an area affected by androgenic alopecia.

That means, the observation area (treated area) has too dense hair in BOTH pics in general - something one indeed does not see like this "in an area affected by androgenetic alopecia". In fact, the pics just show a completely normal circulating (anagen-catagen-telogen-anagen etc) observation area - nothing more nothing less!

And even there is a way to encircle ALL follicular units (you guys can do this anyhow and use the existing circles and numbers as orientation!) - you simply CAN'T see "statistically significant improvement". I mean, idiots can always see improvement if they WANT (or need) to see "improvement".

[The Alchemist]

What do you mean random? The only random about it is that he's being a bit selective about the distinctions, for example, 9, 28, and 56 appear to have improved while 18, 37, and 38 appear to have weakened, even though all of these targets were marked as "unchanged". Also, his analysis doesn't take into account hairs per follicle; we see, for instance, that 55 has progressed from slick bald to 2 hairs, while 41 has still hair growing out of it albeit one less than before. Some hairs have even had considerable change while not even having circles around them (ie. the two hair follicle between 34 and 35 has thinned).

But in the end, that's just hair-splitting; I don't see what the improvement is in s2018, and we are confused as to what Histogen wants to prove by publishing such an image, or how the measurements relate to the image. Oh well, I think I'm getting a hair transplant!

Look at the area surronding circle 13, it looks nothing like the early photo.

There is a follicle between 20 and 21 that he didn't even bother to count
which is substantially thicker than before.

9 is thicker yet buttmunch counted it as unchanged

19 appears entirely different

To the left of 26 there are 3 follicles that have all increased dramatically in size and were completely ignored.

Over circle 25 there are hairs that are substantially larger which he didn't bother to count.

There are hairs to the upper left of circle 76 which are much larger

Etc.. Etc.. Etc..

His analysis is piss poor.

[hellouser]

The only random about it is that he's being a bit selective about the distinctions, for example, 9, 28, and 56 appear to have improved while 18, 37, and 38 appear to have weakened, even though all of these targets were marked as "unchanged".

Perhaps it has something to do with growth stages for those hairs that have weakened? As in, maybe those hair recently shed and are in the early stages of growing back?

Just throwing it out there, although it is an interesting observation that some weakened... but if the overall effect is greater thickness, density but especially regrowth, it shouldnt matter TOO much.

[clarence]

WTF is this? You throw a bunch of random circles around some of the hairs and then declare the analysis no good? You're a joke. Take your unscientific analysis and go back hairsite, Ironman.

What do you mean random? The only random about it is that he's being a bit selective about the distinctions, for example, 9, 28, and 56 appear to have improved while 18, 37, and 38 appear to have weakened, even though all of these targets were marked as "unchanged". Also, his analysis doesn't take into account hairs per follicle; we see, for instance, that 55 has progressed from slick bald to 2 hairs, while 41 has still hair growing out of it albeit one less than before. Some hairs have even had considerable change while not even having circles around them (ie. the two hair follicle between 34 and 35 has thinned).

But in the end, that's just hair-splitting; I don't see what the improvement is in s2018, and we are confused as to what Histogen wants to prove by publishing such an image, or how the measurements relate to the image. Oh well, I think I'm getting a hair transplant!

[The Alchemist]

Tomorrow, Friday, October 19, 2012 (10:18AM-10:30AM),

Dr. Gail Naughton is going to present the following topic at the currently running ISHRS meeting:

Scalp Injection of Active Embryonic-like Cell-secreted Proteins and Growth Factors

Recently, we had a small discussion (in another context) about her presented and finally published HSC results/data during the SID Annual Meeting:

http://www.histogen.com/downloads/sid_2012_HSC_Final.pdf

Anyway …



I think the presented data during the SID meeting needs CLARIFICATION, because, as you can see (and review) yourself, the presented data simply DON’T reflect the reality!

Hopefully (maybe?) Dr. Ziering can chime in here to answer as well ...

WTF is this? You throw a bunch of random circles around some of the hairs and then declare the analysis no good? You're a joke. Take your unscientific analysis and go back hairsite, Ironman.

[534623]

Histogen's HSC study showed a statistically significant increase in the number of terminal hairs and hair thickness at 12 weeks. At the five month timepoint there was a decrease in hairs in a number of patients, but a significant increase again at 12 months, with the number of new hairs again reaching statistical significance at one year. There were approximately 25 new hairs per 0.1cc injection and the treatment effect was seen within 2mm of the injection site.

The HSC works by stimulating stem cells in the dermal papilla of the hair follicle to grow new hairs. It also seems that stem cells in the scalp can be stimulated to grow into new hair follicles. This has been shown to be possible in the mouse model using the components that are part of HSC and so Histogen's trial really substantiates in patients with male pattern baldness what has been shown to be possible in mice for the past few years.

Doc Z

Tomorrow, Friday, October 19, 2012 (10:18AM-10:30AM),

Dr. Gail Naughton is going to present the following topic at the currently running ISHRS meeting:

Scalp Injection of Active Embryonic-like Cell-secreted Proteins and Growth Factors

Recently, we had a small discussion (in another context) about her presented and finally published HSC results/data during the SID Annual Meeting:

http://www.histogen.com/downloads/sid_2012_HSC_Final.pdf

Anyway …



I think the presented data during the SID meeting needs CLARIFICATION, because, as you can see (and review) yourself, the presented data simply DON’T reflect the reality!

Hopefully (maybe?) Dr. Ziering can chime in here to answer as well ...

[Artista]

Hey PinotQ -great info

Im looking into it..a possible intermediate treatment til the long term regenerative treatments arrive.

[yeahyeahyeah]

Good point. Deserves a thread of its own though!!

http://clinicaltrials.gov/ct2/show/NCT01501617?term=histogen&rank=1

Phase 2 should end in December 2012

Further study details as provided by Histogen:

Primary Outcome Measures:
Systemic safety measures will be assessed by measuring vital signs, adverse experiences, laboratory tests (hematology, clinical chemistry and urinalysis)and immunological response (anti-drug antibodies) [ Time Frame: Clinically significant change from screening visit to Week 12 ] [ Designated as safety issue: Yes ]
Non-vellus hair counts [ Time Frame: Change from Baseline to week 12 in treatment areas ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Hair Thickness Density [ Time Frame: Change from Baseline to week 48 in treatment areas ] [ Designated as safety issue: No ]
Local safety measures will be assessed by clinical exam of treatment areas and monitoring adverse events [ Time Frame: Clinically significant change from Screening visit to Week 48 ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

[Kiwi]

What ever happened to that interview we were going to get?

Good point. Deserves a thread of its own though!!

[john2399]

What ever happened to that interview we were going to get?

[tizzle]

Im confused, do you want to use histogens HSC to grow a hairy ass?

[2020]

Dupa means arse in Polish lol.

arse means ass in American

yeah it should work for DUPA, why wouldn't it?

[Jcm800]

Does anyone know if Histogen is suppose to work on DUPA?

Dupa means arse in Polish lol.

[inkt2002]

Does anyone know if Histogen is suppose to work on DUPA?

[PinotQ]

Based on the links at the bottom of the post the 2 current Phase II trials will end in July and then the results will be available near the end of 2012. If results are positive, Allergan will gear up for Phase III immediately so they may be able to begin Phase III in very early 2013. In fact, the quote in the CBS link below suggests that Phase III could start to be geared up well prior to the end of Phase II.......i.e. as soon as they "start getting any positive feedback". But as Scott Whitcup (head of R&D) says in the transcript, two Phase III trials will be required. What is not addressed is whether those trials can run concurrently, although I see no reason why they can't as I have read about other companies running trials concurrently. Phase II began in June of 2011 and will end in July 2012 so you would have to estimate at least a year for Phase III. If the two Phase III trials ran concurrently and began in early 2013, it is conceivable that Phase III could be completed in early 2014. Assuming negligible side effects on a par with what they had w/ Latisse which has already been approved, you could probably expect quick approval from the FDA so I would say mid to late 2014 at best or 2015 is a reasonable possibility.

I am not sure what the possible side effects of a prostaglandin analog are in general but I would guess that one of the big safety issues would concern whether when going from 1 drop on each eyelid to coverage of the entire scalp, there might be a much greater chance of a toxic level of systemic absorption. However, it appears that "Bimatoprost undergoes minimal systemic absorption" http://www.drugs.com/pregnancy/bimat...phthalmic.html and since Allergan has already cleared Phase I, this issue may not turn out to be a problem.

ALLERGAN EARNINGS CALL Transcript (August 2011): Larry, clearly, this is a program that we've optimally resourced, given the huge market potential. So the Phase I was just testing the overall formulation, making sure that it was stable, making sure that it was tolerated. So we probably have some of the Phase I data at R&D Day. But it's really the Phase II data that will be proof of concept. That depending on enrollment and feedback probably won't be available till end of sort of, I'd say, latter part of next year. Clearly, we'll be monitoring this and as we start getting any positive feedback, we'll gear up, so that once we get the proof of concept data, we could go to Phase III right away. The good news is that the FDA regulatory pathway is well delineated as there are other products that have been approved. The negative is it's not quick. You've got to go through all of the steps that FDA requires and that will be 2 Phase III trials following a proof of concept study. And as you pointed out, we see a potential market, not only for male-pattern baldness which is a huge market, but the animal data suggests that for female hair thinning, that could be a very beneficial product as well.

See also http://www.cbsnews.com/8301-505123_162-42849516/allergans-potential-baldness-cure-clears-one-hurdle-heads-for-the-hard-part/ suggesting an earlier possible release date in 2013 or 2014.