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Thread: Histogen Update

  1. #21
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    Quote Originally Posted by gmonasco View Post
    Is there research documenting that a cure for any particular disease is "impossible"?
    I should probably correct myself there. I moreso meant that research for other diseases has been much more negative(lets say cancer for example) and has taken ALONG time and billions and still needs a better solution.

    I have yet to see any researcher say they are at the end of the road in regards to hairloss research.

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    So Histogen announced on their website today that they have secured a patent for a process involved in manufacturing their cell stimulating products. Weren't they also supposed to be at the TERMIS conference in Vienna this week? I thought they would be making some kind of announcement about their HSC trials this week, or was the patent the announcement?

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    Quote Originally Posted by Thinning@30 View Post
    So Histogen announced on their website today that they have secured a patent for a process involved in manufacturing their cell stimulating products. Weren't they also supposed to be at the TERMIS conference in Vienna this week? I thought they would be making some kind of announcement about their HSC trials this week, or was the patent the announcement?
    I checked that out, I dont think they're presenting until the 6th-8th. Couldnt find specifically when but I know the 5th was just an intro day for everyone.

  4. #24
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    Hey guys,

    I am pretty new here so I thought I should introduce myself. I'm a pharmacist with some experience in clinical trials. I just wanted to point something out that is a bit worrying.

    As most of you may know, Phase I is the safety trial; Phase II is the "Dose-range finding" & "Efficacy trial" and Phase III is the "Long-term safety & efficacy study".

    What's worrying to me is that Histogen's Phase I/II involved only 8 injections in one or two sites of scalp. Dr. Ziering's study involved 20 injections in one or two sites.

    Upon completion of this study, they will move to Phase III to evaluate safety of the same concept in even larger population.

    So, it will most likely be approved for a limited number of injections per session as its safety for higher doses has NOT been established!

    That would really minimise how much growth you can achieve!

    Cheers

  5. #25
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    Quote Originally Posted by Desmond84 View Post
    Hey guys,

    I am pretty new here so I thought I should introduce myself. I'm a pharmacist with some experience in clinical trials. I just wanted to point something out that is a bit worrying.

    As most of you may know, Phase I is the safety trial; Phase II is the "Dose-range finding" & "Efficacy trial" and Phase III is the "Long-term safety & efficacy study".

    What's worrying to me is that Histogen's Phase I/II involved only 8 injections in one or two sites of scalp. Dr. Ziering's study involved 20 injections in one or two sites.

    Upon completion of this study, they will move to Phase III to evaluate safety of the same concept in even larger population.

    So, it will most likely be approved for a limited number of injections per session as its safety for higher doses has NOT been established!

    That would really minimise how much growth you can achieve!

    Cheers
    Interesting comment but dont they do repeat dosage as well though after a few months? I'd think they'd experiment to see how high they need to go for the best results.

    Im glad you clarified that they'd actually be going into phase III though!

  6. #26
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    Quote Originally Posted by Desmond84 View Post
    Hey guys,

    I am pretty new here so I thought I should introduce myself. I'm a pharmacist with some experience in clinical trials. I just wanted to point something out that is a bit worrying.

    As most of you may know, Phase I is the safety trial; Phase II is the "Dose-range finding" & "Efficacy trial" and Phase III is the "Long-term safety & efficacy study".

    What's worrying to me is that Histogen's Phase I/II involved only 8 injections in one or two sites of scalp. Dr. Ziering's study involved 20 injections in one or two sites.

    Upon completion of this study, they will move to Phase III to evaluate safety of the same concept in even larger population.

    So, it will most likely be approved for a limited number of injections per session as its safety for higher doses has NOT been established!

    That would really minimise how much growth you can achieve!

    Cheers
    Can you verify if the FDA requires additional 3 year data/results after phase III trials are over before a treatment can make it to a commercial product/service for the public?

  7. #27
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    Quote Originally Posted by rdawg View Post
    Interesting comment but dont they do repeat dosage as well though after a few months? I'd think they'd experiment to see how high they need to go for the best results.

    Im glad you clarified that they'd actually be going into phase III though!
    Hey rdawg All of Europe, Australia, North America and Japan require Phase III results before approving a medication for sale.

    As for doing repeat dosages, those dosages are given 6 weeks later at the same site just for a compounding effect. The trouble is at each session you would at least need 200-300 injections on your hairline alone; would FDA approve such practice if all available studies did not use more than 20 injections per session? Probably not!

    That's quite worrying!

    My guess is, they're planning to launch the product as a hair density booster for 2x2cm areas of treatment. This will give them enough profitability to continue their studies for greater number of injections with larger treatment sites.

  8. #28
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    Quote Originally Posted by hellouser View Post
    Can you verify if the FDA requires additional 3 year data/results after phase III trials are over before a treatment can make it to a commercial product/service for the public?
    Hey hellouser,

    What you're referring to are called Phase 4 trials (Post-approval) studies.

    First of all, they're conducted after the drug is on the market, so don't worry you'll get to use it while they're conducting these studies.

    Secondly, there are TWO main reasons why these studies are conducted:
    1) FDA has asked them to conduct a long-term safety study (for risk of cancer, mortality, etc) which would most probably be the case for a biological drug like histogen that contains Wnt proteins.

    2) Companies themselves decide to conduct these studies, to evaluate further potentials of their drug and broaden its indications. This could be things like:
    - the compounding effects of 4 treatments at 6 weeks intervals vs. 2 treatments at 6 weeks interval
    - how long does their treatment last
    -etc

  9. #29
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    Another good news I can give you "hellouser" is that when you look at a company's study design, you can tell who they're targeting their product for.

    FDA is big on "placebo-controlled" trials meaning you have to test your drug against a placebo group.

    Europe is more of a fan of "your drug vs. our current gold standard" (i.e. Propecia/minoxidil).

    So far, histogen's been conducting a "placebo-controlled" trial, where one side of scalp received Histogen's HSC complex while the other side received a placebo shot!

    This most probably means their priority is a US launch. We'll know for sure when we find out the design of their Phase III trials. If its placebo-controlled, FDA will not be too harsh on them and you would see the product in US by 2015-2016 if all goes well.

    Hope that clarifies your concerns, and don't hesitate to ask me any questions. I'd be more than glad to help

  10. #30
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    Quote Originally Posted by Desmond84 View Post
    Another good news I can give you "hellouser" is that when you look at a company's study design, you can tell who they're targeting their product for.

    FDA is big on "placebo-controlled" trials meaning you have to test your drug against a placebo group.

    Europe is more of a fan of "your drug vs. our current gold standard" (i.e. Propecia/minoxidil).

    So far, histogen's been conducting a "placebo-controlled" trial, where one side of scalp received Histogen's HSC complex while the other side received a placebo shot!

    This most probably means their priority is a US launch. We'll know for sure when we find out the design of their Phase III trials. If its placebo-controlled, FDA will not be too harsh on them and you would see the product in US by 2015-2016 if all goes well.

    Hope that clarifies your concerns, and don't hesitate to ask me any questions. I'd be more than glad to help
    Great read. Thanks for the very interesting comments!

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