Sm04554

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  • burtandernie
    Senior Member
    • Nov 2012
    • 1563

    I can understand 2 years for something like this, but CB is an AA. There are lots of AAs so there is already some good evidence for how they work. Does CB need 2 years to prove its safe? Just seems something like that could go faster given the smaller risks with that compared to say this or other new approaches.

    Comment

    • It's2014ComeOnAlready
      Senior Member
      • Sep 2014
      • 584

      Originally posted by nameless
      The poster did not say that he saw regrowth on anyone. He simply said he's encouraged. That could easily mean he feels positive about the treatment based on his view of the science involved or he could feel encouraged because of some pep talk given to him by the clinical trial staff.
      Yeah, which is why I included in the post before that this is the last round of recruits. Each participant takes this medication for 90 days, with a follow up one month later. The trial is 11th months long, they stopped recruiting on May 26th, and the trial is over in October. At this point in the study, they'd have a pretty good idea of whether this drug works or not to some degree. He could have been very encouraged by the clinical trial staff, but based on the knowledge of the effect it had on previous participants.

      Where did I say he saw regrowth?

      Comment

      • nameless
        Senior Member
        • Feb 2013
        • 965

        Originally posted by It's2014ComeOnAlready
        Yeah, which is why I included in the post before that this is the last round of recruits. Each participant takes this medication for 90 days, with a follow up one month later. The trial is 11th months long, they stopped recruiting on May 26th, and the trial is over in October. At this point in the study, they'd have a pretty good idea of whether this drug works or not to some degree. He could have been very encouraged by the clinical trial staff, but based on the knowledge of the effect it had on previous participants.

        Where did I say he saw regrowth?
        Can you show me where I said that you said that he saw regrowth? I never said you said that. I simply pointed out that his encouragement might have nothing to do with seeing hair growth and his encouragement might simply be because of his intuition about the science involved or positive remarks he heard from clinical staff.

        Also, I think that the poster is probably not a troll because his post does not sound like something a troll would say. I think he's probably in the study.

        Comment

        • nameless
          Senior Member
          • Feb 2013
          • 965

          Originally posted by SM04554 patient
          Hello all, new to the board here.

          Start this trial today (USA). The doctor is extremely encouraged by the potential of this treatment, although the clinical research nurse with whom I spoke said she hasn't witnessed much growth in the patients she has seen thus far.

          We shall see.

          This does not sound good at all.

          Comment

          • TooMuchHairWontKillYou
            Senior Member
            • Apr 2015
            • 104

            is it possible to skip phase 3 somehow? :\

            Comment

            • It's2014ComeOnAlready
              Senior Member
              • Sep 2014
              • 584

              Originally posted by TooMuchHairWontKillYou
              is it possible to skip phase 3 somehow? :\
              Unfortunately, no.

              Comment

              • joachim
                Senior Member
                • May 2014
                • 559

                Originally posted by TooMuchHairWontKillYou
                is it possible to skip phase 3 somehow? :\
                only in japan.

                Comment

                • Illusion
                  Senior Member
                  • Jul 2014
                  • 500

                  Originally posted by It's2014ComeOnAlready
                  2 yrs - 1 more year for phase 3, 10 months for FDA approval.
                  I just thought about this, you mean 2yrs from when phase 2 has ended right? So we would need to add up a couple of months (4 months? maybe we can round it up to half a year to err on the safe side) to that number because phase 2 isn't finished yet, right? It sucks that transitions between phases always seem to go so slow but then again, this is if all goes well. Maybe 2,5 yrs could be a decent guesstimate.

                  Btw, why is it that there's so little information about SM online? I can only find facts about trials, the only background article I could find was the one one hairlosscure2020, from Oct. 2014. I'm sure this has been brought up before but I just don't get it, normally there's always someone hyping up new potentional hair loss treatments, be it the daily news (lol) or an actual reputable source. But nothing this time, even though phase 2 is already rolling...

                  Comment

                  • It's2014ComeOnAlready
                    Senior Member
                    • Sep 2014
                    • 584

                    Originally posted by Illusion
                    I just thought about this, you mean 2yrs from when phase 2 has ended right? So we would need to add up a couple of months (4 months? maybe we can round it up to half a year to err on the safe side) to that number because phase 2 isn't finished yet, right? It sucks that transitions between phases always seem to go so slow but then again, this is if all goes well. Maybe 2,5 yrs could be a decent guesstimate.

                    Btw, why is it that there's so little information about SM online? I can only find facts about trials, the only background article I could find was the one one hairlosscure2020, from Oct. 2014. I'm sure this has been brought up before but I just don't get it, normally there's always someone hyping up new potentional hair loss treatments, be it the daily news (lol) or an actual reputable source. But nothing this time, even though phase 2 is already rolling...
                    About the timeline - Samumed has launched each trial in quick succession. Also, they have 24 recruiting locations, and 300 participants already, so if it's successful in phase 2, they could immediately gear up for phase 3. Phase 2 was originally 10 months, but was recently extended to 11 months because of recruiting. As for FDA approval, 10 months is the maximum amount of time, it could be approved sooner. You're quibbling about a few months here and there, you say 2.5, I say 2. I don't care. If this drug is successful, they will want to get it to market ASAP.

                    SM is actually a drug that was discovered by Samumed in Pfizer's chemical library, because of it's WNT-activating ability. Pfizer and Samumed have some sort of agreement of the development of drugs, and even have some of their own people working in R&D with Samumed.

                    As noted by nameless in a different thread, phase 1 was safety and lasted for 14 days of use. Anagen entry take 7-9 days, and they definitely took scalp biopsies after use. If they saw dormant follicles entering anagen, they'd be popping champagne corks. I'd keep it quiet until there was a chance to further develop the drug, if that's what they saw. It's possible they did, because they immediately launched a massive phase 2, immediately after phase 1. We've gotten a little bit of information about the trial from participants, and they all said that the doctors conduction the trial are very excited, and encouraged about this drug.


                    If you want an idea about what SM aims to do, have a look at this journal - http://www.nature.com/jid/journal/v1...d2012446a.html

                    and this press release - http://www.uphs.upenn.edu/news/News_...013/12/millar/

                    Comment

                    • Illusion
                      Senior Member
                      • Jul 2014
                      • 500

                      Thanks 2014, very constructive post. Interesting links as well.

                      Btw, no hard feelings about the discussion regarding how long it will take from now to commercialisation mate

                      Comment

                      • Marconi SK
                        Junior Member
                        • Apr 2015
                        • 3

                        can we try it?

                        Comment

                        • It's2014ComeOnAlready
                          Senior Member
                          • Sep 2014
                          • 584

                          Originally posted by Marconi SK
                          Bad idea.

                          No way to tell if that's even the real drug. Plus, if used improperly or at too high a concentration, there holds the risk of cancer.

                          Comment

                          • Illusion
                            Senior Member
                            • Jul 2014
                            • 500

                            Would be interesting to see for how much it is being sold on black (?) market though. It's prob not a good indication for the price of when this comes out, but still.

                            On the other hand, it doesn't really matter to me if this is going to be expensive or not. Hell, even if this will cost me $100/month, I'll still buy it if the results are good.

                            Comment

                            • It's2014ComeOnAlready
                              Senior Member
                              • Sep 2014
                              • 584

                              Originally posted by Illusion
                              Would be interesting to see for how much it is being sold on black (?) market though. It's prob not a good indication for the price of when this comes out, but still.

                              On the other hand, it doesn't really matter to me if this is going to be expensive or not. Hell, even if this will cost me $100/month, I'll still buy it if the results are good.
                              There's no way to tell what the actual drug is. They call it SM04554, but that's the name Samumed gave it. The compound itself is unknown.

                              Comment

                              • nameless
                                Senior Member
                                • Feb 2013
                                • 965

                                Originally posted by SM04554 patient
                                Hello all, new to the board here.

                                Start this trial today (USA). The doctor is extremely encouraged by the potential of this treatment, although the clinical research nurse with whom I spoke said she hasn't witnessed much growth in the patients she has seen thus far.

                                We shall see.

                                This patient posted this on 1/29/15. This is very bad news because this phase 2 study was well under way when he posted this and that means that the clinical nurse he referred to would have seen numerous patients by then and if the product was working she would have seen patients with regrowth by then. I think this is indicative that the treatment probably doesn't work or at least it doesn't work very well.

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