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

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Originally Posted by Artista

Des, you have done a great thing in researching all of this and sharing. Thank you brother

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Artista, its a pleasure :)

I don't know what I would do without all you folks guiding me along with this damn genetic defect! I'm just doing everything I can to give back to the community I love so much & undrestand so well

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Originally Posted by Desmond84

OK guys, in 2 weeks Histogen will officially complete their entire Phase 1/2a trials :)

Not only that, we know for a fact that they ACTUALLY got very strong positive results both in terms of Safety & efficacy (unlike Aderans which is completely silent about what the hell they're up to :( )

So we can safely assume that:

• 2013 (Feb/March) will be the Phase 2b trials (48 week efficacy trial), and
  
• 2014 (June/July) will be their 48 weeks Phase 3 trial.

This makes October 2015 a very realistic date for Histogen to become available in Singapore and Feb 2016 for USA.

Don't forget guys, Histogen is like "Laser Hair removal" just in the opposite way. Normally Laser takes 12-14 sessions at 2 month intervals to have a satisfactory cosmetic effect in a male subject, which takes approximately 2 years. The patient will then need to do 1 follow-up session every 1-2 years to maintain these cosmetic effects.

Histogen will be exactly the same. You will have to go back for multiple sessions to get back to where you want to be, and then a single follow-up session every 2 years just to keep it stable :)

To 2015 :cool: Hipip ..........

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Thanks for the info desmond, maybe we'll get more pictures/results early in the new year.

promising treatment so far!

I thought next up was phase 3.

Can anyone provide an official piece of evidence that shows their current trial is the first of two phase 2 trials?

I would be very interested to know what exactly are they planning to change in those upcoming phases... seriously what? More injections? More charts and vague paragraphs?

I remember in the interview when Spencer asked is it realistic to expect HSC to be available in 2015 and that guy said that probably two years after that...

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Originally Posted by UK_

I thought next up was phase 3.

Can anyone provide an official piece of evidence that shows their current trial is the first of two phase 2 trials?

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Hey UK,

So far, they've only conducted ONE trial which was split in TWO parts:

First part was a 12 week Phase I trial to assess safety, which was then extended to 48 weeks to assess efficacy as a Phase 2 trial. Here's how Histogen broke it down:


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 ]
  
• Non-vellus hair counts [ Time Frame: Change from Baseline to week 12 in treatment areas ]

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 ]

Now that they have proven that Histogen's HSC is SAFE & EFFECTIVE, they will have to conduct a Phase 2b "Dose-range finding study", which will assess how many injections at what intervals would produce the most beneficial result. They will have multiple arms with different treatment regimens which should hopefully answer a lot of 2020's questions, the most important of which are:

1) Histogen's limits: Can you go back to a NW1 with enough injections or does it plateau at some point?

2) What would happen if you injected 200 injections rather than 8? Is it still safe?

etc.


:)

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Originally Posted by 2020

I would be very interested to know what exactly are they planning to change in those upcoming phases... seriously what? More injections? More charts and vague paragraphs?

I remember in the interview when Spencer asked is it realistic to expect HSC to be available in 2015 and that guy said that probably two years after that...

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Yeah, but Spencer specifically asked: "When can we potentially see this available here in the US? Is it safe to say 2015?" to which he replied "Hmmmm, well maybe +2 years..."

That being said, if its available in Singapore by 2015, you can always get a head start by flying over there and getting your treatments until it becomes FDA-approved.

If you really care about keeping your hair, extra costs should not be an issue :)

From what I understand the reason why Aderans Phase II trials took SO LONG (over 5 years) was because every new treatment arm (C, N, CN, CND, DO, etc) was dependent on what they had observed in the previous arm which meant they had to complete one treatment protocol to prepare for the next one <sigh>

With Histogen however, they will simply pick different combinations of:

1) Number of injections (40, 80, 120, 200)
2) Intervals (6 weeks, 8 weeks)
3) Sessions (2, 4, 6)

And create different treatment arms, prior to starting Phase 2b. Once, subjects are enrolled they will follow these treatment protocol for 12 months and will then assess the results.

That's why they will need 3-4 months from now to start Phase 2b: a) To prepare both the study protocol and b) recruit enough patients. So, unlike Aderans, Histogen should not take another 4-5 years just to complete Phase 2.

2015 is very much possible in my eyes :)

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Originally Posted by 2020

I would be very interested to know what exactly are they planning to change in those upcoming phases... seriously what? More injections?

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Histogen showed that increasing the dose increased the effectiveness...

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Originally Posted by Dan26

Histogen showed that increasing the dose increased the effectiveness...

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Exactly right :)

This is the whole "Laser Hair Removal" story: with every session you start to see better cosmetic results. After 12 sessions or so the cosmetic effects are more than satisfactory.

What's interesting is I've been reading on some of these Laser clinics sites and what stood out to me was they ask you to come back every 6-8 weeks for your next session!

Surprisingly, Histogen picked 6 weeks as their second treatment time point in this trial, which showed greater efficacy. So I think we might be on the right path!

Now nobody can become anywhere near hair-free with 2 sessions of Laser hair removal so you can't expect a full head of hair with 2 sessions of Histogen :)

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Originally Posted by Desmond84

Yeah, but Spencer specifically asked: "When can we potentially see this available here in the US? Is it safe to say 2015?" to which he replied "Hmmmm, well maybe +2 years..."

That being said, if its available in Singapore by 2015, you can always get a head start by flying over there and getting your treatments until it becomes FDA-approved.

If you really care about keeping your hair, extra costs should not be an issue :)

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Here's Gail Naughton's plans to try and release it early in ASIA :)

https://www.youtube.com/watch?v=g4KE...E&noredirect=1

Korea & Singapore will most likely market the product first!