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Samumed Interview w/ Dr. Yusuf Yazici

Discussion in '9th World Congress for Hair Research Conference' started by hellouser, Nov 29, 2015.

  1. hellouser

    hellouser Senior Member My Regimen

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    My meeting with Samumed went well, although a few very important details could not be disclosed (ie; what exactly is the molecule). In either case, the interview is below along with a photo of their poster.

    Also interesting are the following PDF files found by lifelonglearning in another thread:
    https://www.samumed.com/files/Samumed_Poster_238.pdf
    https://www.samumed.com/files/WHC_OP_SM04554-01_Final.pdf

    Enjoy.

    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Q)
    Dr. Bergfeld is lead of Samumed?
    A) Dr. Bergfeld is a consultant.

    Q) Who is the lead doctor at Samumed?
    A) We have several doctors, I'm (Dr. Yusuf Yazici) the chief medical officer.

    Q) Can you tell us more about Samumed's Phase 2B trial and why it was needed?
    A) We're presenting on Saturday our oral presentation. We finished our Phase 2 but we don't have the results as it just closed a couple days ago. We're still going through the analysis and data, so we'll answers in upcoming meetings. *NOTE: Not sure if he said meetings or weeks.

    Q) Are you aware of the 21st century act and do you feel it will benefit Samumed in a faster release? Other thoughts?
    A) Yes, we are aware of that of course, but there is as you know a house version and a senate version. So it's not clear as to how the 21st Century Act is going to be in it's final version. So we'll see what it means, but I don't think anyone knows how it will be.

    Q) Can you tell us how Samumed works? What's the process?
    A) It's a pharmaceutical company, based in San Diego, a private company and we have 5 programs in 3 different disease areas (arthritis is one area). Then we have skin with alopecia.

    Q) What's the process like for Samumed SM04554? What is actually in the product?
    A) We don't disclose what's in the product, but it's a small molecule. But it has effects on the WNT pathway.

    Q) Is it similar to Histogen's HSC?
    A) I'm not sure how Histogen's product works either, so I can't comment on that.

    Q) Since Phase II is complete, and once results are out and you're satisfied with them, what would be the turn around time to make it a commercially available product?
    A) If you know, let me know, haha. But we have to do further studies, Phase 3 with FDA and see what they have in mind. Then we have to talk to our site's investigators so we have to see what the data shows and see what the path would be. It's difficult to say what the timeline would be.

    Q) Ballpark figure? A couple or few years?
    A) Well, the normal development time it's at least a few years.

    Q) But you've already been in clinical trials for a few years.
    A) So we finished our Phase 1, we finished earlier this year. And we just finished 2.

    Q) That's incredibly quick. How did you manage that?
    A) I think this is ballpark average, but there are longer and shorter trials but I think we're within the average lengths.

    Q) Are you aware of the new deregulated laws in Japan for expedited clinical trials?
    A) No, I was not aware of that. What happens with them. But I will find out more about this. *NOTE: Samumed's SM product is not cell based. I think the new regulations in Japan are for cell based therapies only.

    Q) Since it's not a stem cell treatment, is it more like a growth factor treatment, vegf.... or?
    A) Well, we do have a novel target, but we cannot disclose it and I cannot say much at this time.

    Q) When would Phase 2 results be made public?
    A) Next year we hope after several meetings. *NOTE: A more specific date was not specified.

    Q) Can you comment on results from first trial?
    A) First trial was safety with three doses, treatments was for 14 days and 14 days of observation for a total of 28 days without any adverse events, or at least any serious adverse events. We saw trends in slowing down and growth of hair loss. *NOTE: The middle dose I think will be used in the next trial.

    Q) We're women used in the trial?
    A) No, just men. *NOTE: I think this may work for women as well though as it targets WNT factors rather than androgen receptors.

    Q) Is there a possibility that this could work for women?
    A) Our phase 2 is only men also, so now we're only focused on men.

    Q) Once the product is commercially available, will it be available for women or will it be exclusively for men?
    A) It depends on the label. So, it's hard to say what the final label will be, depending on the safety data.

    Q) Would id be available 'over-the-counter' or doctor prescribed.
    A) It might turn into 'OTC' over the years but initially it will be doctor prescribed.

    Q) The hair results from Phase 1, did you see any rejuvination of follicles to their original size?
    A) No, we didn't look into that as Phase 1 was safety only. There were no biopsies or macro photography done during Phase 1. *NOTE: It doesn't seem like FDA allows efficacy for phase I relative to Samumed but Replicel did have some efficacy reports. Odd.

    Q) In January, could we see some photographs of the next phase results?
    A) Well, I'm not sure if January is enough time, because we have to go through a lot of analysis.

    Q) How many people were involved in the second trial?
    A) Yes. We had 200 people total (100 in SM, 100 in Placebo).

    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Poster:

    [​IMG]
     
  2. nameless

    nameless Banned

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    Q) Can you tell us more about Samumed's Phase 2B trial and why it was needed?
    A) We're presenting on Saturday our oral presentation. We finished our Phase 2 but we don't have the results as it just closed a couple days ago. We're still going through the analysis and data, so we'll answers in upcoming meetings. *NOTE: Not sure if he said meetings or weeks.

    Hellouser you asked why the Phase 2B was needed but he didn't answer the question as far as I can tell. If you have his email address could you please ask him via email why the Phase 2B was needed?
     
  3. Solomon

    Solomon Established Member

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    Wow is he/she from Samumed or Pentagon? We've got almost nothing from the interview :\
     
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  4. whatevr

    whatevr Senior Member My Regimen

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    That's how it is folks, hope you're maintaining, if not, put your balls on the table cause I don't think we'll be seeing anything from these companies for years to come.
     
  5. Follisket

    Follisket Established Member

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    with what exactly?
     
  6. Baldie_86

    Baldie_86 Member

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    Relax, we will know if this thing work in a few months.
     
  7. bobby dearfield

    bobby dearfield New Member

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    what do you think he'd give, their formula?? they're supposed to have some secrecy, don't you think?

    - - - Updated - - -

    I like it this way, if there is no secret there is no worth.
     
  8. Illu2ion

    Illu2ion Established Member

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    This interview indeed doesn't give that much information but I'm really happy that you did the interview because it does kind of reveal that we won't be seeing this product on the market soon (couple of years at least). This is important for people to realize so they don't get their hopes up by putting their faith in unrealistic timelines. I remember the thread on BTT about SM going bonkers at times because people thought it would be a cure which could come out real soon.

    Too bad though he didn't tell a bit more about SM itself and the results of the phase 2 study but I guess he's right when he says they have to go through all the data and analyse everything. These things take a lot of time.
     
  9. nameless

    nameless Banned

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    If it turns out to be a breakthrough treatment it could be out sooner than you think if the 20th Century Cures Act passes soon.
     
  10. bags

    bags Established Member My Regimen

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    WOW! I just read up on wnt pathways and the need for them to be fully functional in order to develop neurogenesis of cells in brain tissue. There are several pathways in the human body that the wnt mechanism regulates all of which are vital to human health. Shutting down pathways in the brain for example could lead to severe brain damage! These goofs only did a 28 day safety trial. Even then there were side effects. Nothing major but still! Forget this junk, I'd rather risk finasteride and Mon and I won't touch those. Forget playin with fire. Lets hope histogen and Replicel pull through
     
  11. Jaym

    Jaym Established Member

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    Why are you talking about shutting down WNT pathways?
     
  12. Superuser

    Superuser New Member

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    Is it known when the senate will vote about this?
     
  13. whatevr

    whatevr Senior Member My Regimen

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    That's because none of this crap is going to come out anytime soon. If you are balding in 2015 your only hope realistically is still the same **** as Finasteride Dutasteride Minoxidil and maybe if Seti works that's all we have to look forward to. 2018, 2020, 2025, what the ****. What hair will I even have left by that time worth saving? What matters is what's available now. If you can maintain with what you have currently, you are lucky, if not, bye bye to your hair by then. Even if it comes in 2025 my 20's aka the best years of my life will not come back so whatever.
     
  14. resu

    resu Senior Member

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    We just have to accept that the ship has sailed and is never coming back. Maybe an hair transplant for some might buy some years but if nothing comes out by then we can forget about a cure or a future treatment saving us.
     
  15. whatevr

    whatevr Senior Member My Regimen

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    Yeah, the 'ship' of waiting on these ghetto-ass companies was never waiting to pick you up in the first place. Please don't give up with a post like that, you made me really depressed just now.

    The only way you have a fighting chance in hell with this disease is to make a fair bit of money and just jump on all the experimentals possible. If I had at least 1000$ a month right now I'd be taking everything.

    finasteride, dutasteride, RU, Seti, PSI, Minoxidil, Adenosine, Dermastamp, Valproic, Stemoxydine, Azelaic, CB...everything that you can buy I'd be taking it. Nobody here is doing all that. I would but I am broke I can only afford finasteride minoxidil and castor oil. I am willing to bet some of that would work at least at stopping it and some regrowth. For me money is the problem otherwise I would be a walking apothecary and guinea pig. Don't care, I want hair. But OK I won't go off-topic here anymore.
     
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  16. resu

    resu Senior Member

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    Unfortunately there's a roof when it comes to gains by inhibiting DHT, there is a chain of events, we just need to know what treatments to apply to target each event which is what these companies are trying to find out too. When I said that the ship has sailed I was talking about getting a full pre-male pattern baldness head of hair back.
     
  17. Follisket

    Follisket Established Member

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    And we're just gonna take it lying down. What the actual %$&#? We need sthn to maintain. I don't care if we have to goddamn break into some lab. How the hell can we just accept that we're being robbed of our youth like that?
     
  18. whatevr

    whatevr Senior Member My Regimen

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    That is right, DHT just sets off a positive-feedback loop cascade which then continues to inhibit hair growth even if you cut your nuts off. Stopping DHT is just (if you are lucky) preventing all the other hair from entering into the same cycle of self destruction but it does nothing to stop the cascade on those hairs already set in motion, which is why I am hoping for things like Seti and others to work. There is still a potential need to develop side-free antiandrogens like CB but you can only really expect so much from them (which is maintenance at the very best). We need drugs which work on completely different pathways when we are talking about regrowth. The problem is that there are so many of these pathways which is why I don't foresee much success with something that only targets maybe a single path like WNT. I think it could only work if it was something very upstream.

    - - - Updated - - -

    I share your frustration believe me but the thing is you can't hold someone at gunpoint to make a cure because as much as it ****ing sucks it really isn't a simple thing to do. For now I just suggest you to research all these compounds and work on getting PLENTY cash cause you will need it, the stuff on the grey market area is expensive but at least we can get our hands on things early rather than wait 5-10 years for approval.

    People are all about bitching but are you dumping hundreds of dollars right now on Setipiprant? Are you trying to get PGE2? Trying new things? IF not you can't say you are doing everything. I know it is expensive but that is the forefront of technology and if you want a chance you have to claw at the top. Waiting for these big players to hit the market is gonna leave us all looking like lightbulbs. We have to buy and experiment on our own.
     
  19. shwareb

    shwareb New Member

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    I have looked through this forum and honestly I don't know why you make it up to be such a BIG deal. I am also loosing my hair in a DPA manner and I just turned 21. I know I'll go bald soon but honestly I don't think about it that much. Like it's how I was genetically programmed, and if there is no cure atm well then I'll just shave it off. If a cure comes up then great I'll get treatment but other than that I am just going to try to live a normal life. You guys must remember that we are not talking about a life-threatening disease here, it's purely cosmetic. So just man up and deal with it, that's what I intend to do and I hope you guys do the same! :D

    BTW, supposedly ACell + PRP is good for maintaining hair and halting hair loss. Many clinics offer that, have you tried it?
     
  20. nameless

    nameless Banned

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    Hey dude, don't be coming here telling people to "man-up."

    What are you doing here? Either you're a troll or you're someone who comes here to find out about potential cures because you want your own hair back. So this means that either you're troll or YOU don't man-up. In either case, you're a phony.
     
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