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Histogen Hair Loss Treatment Update From Dr. Gail Naughton

Discussion in 'New Research, Studies, and Technologies' started by Tomtom21, Jun 23, 2016.

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  1. Tomtom21

    Tomtom21 Established Member

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    I have been in contact with Eileen Brandt from Histogen over the course of the past three months. She had agreed to provide me with an update on Histogen from Dr. Gail Naughton because I know Histogen is a big hope for a lot of guys here as a potential treatment in this battle of hair loss. Well, after more or less harassing her with emails back and forth, I finally received the update from Gail herself yesterday. It is very exciting news and for those of you who don't have your passports it is time to get them! Below is the email response from Dr. Naughton:


    Question 1:

    > What progress has been made towards the commencement of clinical trials either within the United States or outside of the United States where you suggested potential partnerships in the interview (Turkey/Mexico/Japan)? Can you divulge any information on how you plan to investigate HSC in the next planned trial? For instance, multiple dosages, repeat dosages at different time intervals, etc.


    Histogen has found a license partner in Mexico, and initial meetings with the COFEPRIS have been completed to discuss conducting a definitive trial in Mexico for hair loss in men. The proposed trial would be 330 patients across 3 clinical sites, with dosing of 50 0.1cc injections at baseline, 6 weeks and 12 weeks. Primary safety and efficacy will be collected at week 24.




    Histogen is also in late-stage negotiations with a potential HSC partner in China, and plans to make a formal announcement of that partnership soon. In the United States, Histogen is planning a Phase I trial in women and a Phase II trial in men as the next clinical steps. Clinical sites for both US trials have already been identified.




    > Question 2:

    > Does your initial timeline of potential market release outside of the United States by 2017-18 still possible? If yes, where do you believe this treatment will be available?




    At this time, we believe that HSC treatment will be on the market first in Mexico, which is an excellent aesthetic tourism market for products like HSC. Following Mexico, the US and Asia continue to be are our target regions for HSC development and introduction. If a worldwide partner for HSC was secured, we could then prioritize clinical development in Europe as well.



    > Question 3:

    > Do you believe that additional dosages of HSC will increase its efficacy and improve further hair regrowth?




    Yes. In Dr. Ziering's Investigator-Initiated Trial in men and women, he saw excellent results with 4 treatment timepoints and a total of 120 injections.



    > Question 4:

    > It has been mentioned that your company is currently trying to raise capital for clinical trials and product development. Have these fundraising efforts been successful or are you still trying to secure adequate funds for product development and commercialization?




    We are in late-stage negotiations with an HSC partner in Asia, who will also be making a sizable equity investment. This will be intrumental to the advancement of HSC over the next 1-2 years. Histogen will be seeking to close the remainder of its Series D funding as well, to prepare the Company for an IPO.




    > Question 5:

    > I know the employees are very busy at Histogen and press releases or presentations made available to the public are scarce. However, will future clinical trials be announced? I am positive a great deal of the public would highly appreciate that and volunteer to participate.


    Yes, Histogen plans to announce the start of HSC clinical trials here in the United States.



    > Question 6:

    > Is there any information you can disclose at this time regarding potential launch of your product HSC, estimated cost of the procedure when its released or new data to the public?


    We are currently doing market analysis with our partners in each geographic area to determine the optimum HSC price point for Histogen, our partners and the patients. We expect it to be in line with currently available hair loss treatments.



    > Question 7:

    > Lastly, is there any way you would be willing to provide any supplemental documents from your latest presentation at the Stem Cell Summit? It would be greatly appreciated.



    Attached is the Stem Cell Summit presentation and an HSC overview which contains more information about the science behind HSC.


    This is all very exciting news! Lets hope and pray there are no more hiccups along the way. To Dr. Gail Naughton and Eileen Brandt, if you are reading this, thank you so much again for your time, patience, and generosity for even providing me with any answers regarding your company and its pipeline. It is truly appreciated.
     
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  2. Xaser94

    Xaser94 Established Member

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    This is very good news and I thank you for effort! I wish she didnt dodge the question on if it will be still on track for 2017/2018, but I guess beggers cant be choosers? Im assuming its still on track to start in July. Does anyone know if the phase trials will last a year? Since she did say time point was only 24 weeks, maybe it will be less.
     
  3. Swoop

    Swoop Senior Member My Regimen

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    [​IMG]

    Although still a skeptic of Histogen, primarily because of their pictures as their dataset looked ok, this is good news. Especially their N=330 across 3 clinical sites which should give valuable evidence.

    OP, thank you for your effort in this one with obtaining that information.

    In an ideal world I would love to have 2 cellular therapies that work potently. Shisheido & Histogen combined. Just getting some injections by flying from Japan to Mexico :).
     
    Stop hovering to collapse... Click to collapse... Hover to expand... Click to expand...
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  4. Xaser94

    Xaser94 Established Member

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    This has probably been said alot of times already in the past but I really think 2017 is the make or break year for us. Not only will Histogen hopefully have data by the end of 2017, but so will Follica. And if Samumed enters phase 3 and Replicel enters phase 2 in Japan, and Fidia releases Brotzu's lotion in 2017, then we will have alot of stuff we can tackle male pattern baldness with. Even if the efficacy is small for all of them, putting them all together may start putting a dent in the disease.

    I wonder if we can organize a hair loss treatment tour over the forums. Where we send people to Follica in the USA, then Histogen in Mexico, and lastly Replicel in Japan. We can maybe even all pitch in money and the ones who go on the tour can document their progress and the whole "tour."
     
    #4 Xaser94, Jun 23, 2016
    Last edited: Jun 23, 2016
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  5. Blackber

    Blackber Experienced Member

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    Good news and good job OP.

    Although this is nice to hear I still find myself skeptical just because nothing ever works out for us lol.

    It would be great to have another weapon in the arsenal though.
     
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  6. Kagaho

    Kagaho Established Member My Regimen

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    Very juicy info man. Thanks a lot! Im very suprised with Histogen. I was convinced they were done but thats really not the case.

    The chance to augment efficacy with multiple doses is really exciting. Lets hope they can confirm this findings
     
  7. hellouser

    hellouser Senior Member My Regimen

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  8. newplayer

    newplayer Established Member

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    Effin' good news!
    Nice, as I said years ago - we're in a state of huge tech/med advancements! Great things await us.
     
  9. Bagels

    Bagels Established Member

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    good work! hopefully I can maintain my density with current treatments then get 60 injections at my nw2-3 area and be set :p
     
  10. Pavi

    Pavi Senior Member My Regimen

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    First hair loss treatment to initiate phase III in what? Over 20 years? Great stuff
     
  11. Xaser94

    Xaser94 Established Member

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    Lmao I almost dont want to celebrate untill they actually finish enrolling all 300 trial subjects.
     
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  12. hellouser

    hellouser Senior Member My Regimen

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    Yup, long overdue, it's pretty insulting. Big thanks to Gail and the Histogen team.
     
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  13. Blackber

    Blackber Experienced Member

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    Agreed big thanks to all the researchers who keep pushing along especially when the online community gets frustrated and jumps to conclusions.
     
  14. whatevr

    whatevr Senior Member My Regimen

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    What do you make of the pricing info?

    "In line with other hair loss treatments" Like, hair transplant expensive?
     
  15. hellouser

    hellouser Senior Member My Regimen

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    Very unlikely.
     
  16. Pavi

    Pavi Senior Member My Regimen

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    Isn't it funny how Histogen got the most hate but get is the only company to go into phase III for hair loss since propecia? :rolleyes:
     
  17. monoid

    monoid Established Member My Regimen

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    Good news indeed!
    Thanks Tomtom21 and the Histogen team!
     
  18. hellouser

    hellouser Senior Member My Regimen

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    Lot's of naysayers around man. I don't blame them though, baldness has been made into a joke of a condition along with all the treatments for it.
     
  19. pegasus2

    pegasus2 Senior Member

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    She didn't specifically answer, but it sounds like they're still on track for late 2017, early 2018.
     
  20. Joxy

    Joxy Established Member

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    Can you ask Histogen why they used fake pictures and why they think that we will believe?
     

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