Samumed — SM04554

October 2014 has perhaps become the most eventful month ever in the hair loss world when it comes to important new developments. Unfortunately, my day job allows me only so much free time, and I am therefore often forced to delay writing posts on new developments by a few days, especially in busy months such as this one.

So that is the excuse behind my delay in writing about Samumed’s SM04554 product and its pending phase 2 US clinical trials.  That clinical trials page was updated several days ago, and the latest development is that these phase 2 trials will run from November 2014 to October 2015.  The company is enrolling 300 male volunteers between the ages of 18 and 55 in this trial, with a number of inclusion and exclusion criteria.  The trial will involve three group (two differing doses, one placebo), and volunteers will be recruited in 14 states spread across the US.  Some of the people supervising these trials are well known in the hair loss world (e.g., Dr. Wilma Bergfeld in Ohio).

What is Samumed’s SM04554?

Samumed is a company that is based in San Diego and is involved in developing small molecule drugs that selectively activate or inhibit Wnt pathways.  I have written a few posts on this blog related to Wnt (see here, here and here).  The whole concept of Wnt signaling pathways is extremely complicated and it is well worth checking out the wiki on it as well as Stanford University’s page on it.  They even have a Linkedin Wnt group where people can ask questions.  Most of the ongoing work regarding Wnt research is related to serious medical problems rather than cosmetic problems.

Samumed’s SM04554 topical solution is thankfully an exception to that rule, and is designed to counter androgenetic alopecia via activating a Wnt pathway.  The company already started initial trials in Australia in 2013 and might even have completed those.  In that Australian trial link, there are a list of contact names underneath and blog readers who are very keen to know more might want to contact some of those people to find out further details.

Funnily enough, earlier this month when I was searching for and updating readers on Histogen’s and Replicel’s presentations at the San Diego Conference of the Mesa, I totally missed that Sanumed was holding an investigative pre-phase 2 clinical trials meeting on its important SM04554 product from October 16-18….also in San Diego of course!

I will be interested to see how this trial works out.  And if successful, will Samumed (like Histogen and Replicel) think about doing further trials in Japan and/or licensing their SM04554 product to a Japanese company in order to speed up time to market?

36 thoughts on “Samumed — SM04554”

  1. Excellent reserches bro !
    Do you knwo what the situation about PGD2 and crth2 antiagonists.
    Any news from Cotsarelis and his team ?

  2. Lo de las células madres entiendo que es un proceso complicado y lleva tiempo. Ya estamos mas cerca y creo que va a ser una solución. Pero la verdad es casi imposible de entender que desde los años 80 hasta la fecha no haya salido otra opción de medicación oral o tópica para la alopecia aparte del minoxidil y finasteride. Por lo menos para mantener lo que uno tiene hasta que salga algo definitivo. Es una verguenza. Todos dicen que la ciencia avanza pero en el caso de la AGA no mucho. Yo ruego que para el 2015 o 2016 salga por lo menos un nuevo fármaco. No quiero ir a una cirugía.

  3. Good evening

    Great blog.

    Usually, I used to follow the Balding Blog of Dr William Rassman and I noticed that he doesn’t follow as you do all the research and tests related to new therapies . Although he got a hair cloning category on his site, he rarely mentions any news about hair cloning research : most of the time it’s done by his readers. Of course, Dr Rassman is a famous hair restoration surgeon so mainly he focuses on questions about FUE , FT and hair medication

    I discovered your blog few days ago, and I’m delighted and very grateful that someone is closely following the latest developments in hair cloning.

    So Many thanks and keep it up.

    P.S. : I’m french so forgive my english.

  4. Thanks Montreau! Feel free to post in French too. I know a bit, and can also “cheat” with…or post in English if you want everyone else to be able to read your comments too.

    1. Très bien, mon cher,

      Je vais faire un essai en français :-)

      Pour revenir à notre sujet, le Dr William Rassman n’est pas aussi optimiste que toi concernant les nouvelles thérapies de clonage du cheveu (hair cloning). Il soutient que dès 1989, des chercheurs prétendaient qu’il fallait 10 ans pour que cela devienne une réalité. Aujourd’hui en 2014, les chercheurs parlent d’un délai de 5 à 10 ans. Autrement dit, c’est le même discours. Quel est ton opinion là-dessus ?

      Bien amicalement.

      My very best regards.

      1. Bonjour William,

        Un numer de chirurgiens de greffe de cheveux tels que le Dr Rassman sont pessimistes sur le clonage de cheveux. Je ne peux pas prendre leur opinion au sérieux parce que leur entreprise serait effondrer si le clonage de cheveux ou de la multiplication de cheveux ou de poils régénération réussi! En outre, un autre chirurgien de greffe de cheveux a récemment déclaré qu’il était scpetical sur le clonage de cheveux, mais ne dit rien à propos de la multiplication des cheveux ou la régénération des cheveux.

        Je suis d’accord que les experts ont prédit que la guérison est de 5 ans de suite depuis longtemps:-(Cependant, il n’y a jamais eu autant de sociétés actives dans le domaine car il existe aujourd’hui, et le nombre de vidéo et autres présentations qui sortent chaque mois est à un niveau record.

        Cette fois, ce sera différent à mon avis!

        1. Merci Admin de ta prompte réponse,

          Je suis d’accord avec toi sur le fait que les tests sont prometteurs et que nous devrions arriver à une solution dans un horizon proche du tien (2020). Pour le Dr Rassman, effectivement, cela changerait la nature de son travail. Mais je crois qu’il avait écrit une fois que les chirurgiens sauront s’adapter à cette nouvelle évolution. Mais il est évident que cela bouleversera l’industrie de la greffe du cheveu.

          En tous cas, les nouvelles que tu publies dans ton site concernant le clonage ou la régénération du cheveu sont les plus complètes que j’aie pu lire à ce jour.

          Merci encore pour ton travail.

          Bien amicalement. My very best regards.

          1. Merci Wiiliam! Je dois beaucoup d’autres choses à écrire dans les prochains mois et espère que vous apprécierez le travail.

  5. I wanted to ask a question of the admin. Its slightly off topic– is there a way to do this via e-mail/private message or would the comment section be best?

    Thanks in advance!

  6. Admin you are the man!!! Seriously… A few quick ques. Do you have hair loss? Do you feel they are going to have “hair cloning” on the market in Japan in the next couple yrs? And if so are we Americans that are bald are going to have to travel there if we finally want this procedure done ASAP?

  7. Mike yes I have hair loss, but on some days after Rogaine and Nizoral usage, the head looks decent unless there is strong lighting. But most of my remaining hair can not grow long any more and I even have hair loss in the area above my ears.

    I cannot answer your question about when hair cloning will be available precisely because no-one can do that. I am guessing that by the end of 2020, some kind of cure involving cloning/multiplication/regeneration/stem cells etc.. will be realized. Initially, we might very well have to go to Japan or another country for treatment.

  8. Hola les dejo un video de una importante clínica de españa. En enero de 2015 presentan los resultados. Es el mismo procedimiento que con la técnica FUE pero solo retiran parte del fóliculo y lo implantan donde lo necesitas. Osea que se regenera la zona donante y la receptora. Parece que está dando buenos resultados en los ensayos.

  9. Gracias Diego! ¿Has leído algo sobre el Dr. Gho Coen? Yo podría escribir un post sobre él y su técnica en un futuro próximo, y este video usted envió parece ser algo similar estoy adivinando? No han hecho una investigación detallada hasta ahora en la técnica de Gho, pero muchos foros los mensajes parecen sugerir que no funciona demasiado bien.

  10. Hola! si he leído algo, es parecido. La verdad que no tengo demasiada información si lo que ofrece el Dr Gho. Lo bueno de esta técnica es que las personas que tienen zona donante limitada van a poder tener mejores resultados. Vamos a esperar los resultado en enero. No entiendo porque estas cosas no se hacen más públicas para ver si otros países pueden adoptarlas. Le consulto, estimativamente se espera una cura para el 2018. Es posible que en 2015 o 2016 salgan nuevas medicaciones u otros procedimientos que nos permitan por lo menos mantener el cabello existente? Gracias.

    1. No have not bruno. I also posted links in the post where you can find other e-mails, especially in the Australia trial link.

  11. Hola quién se cree que va a salir primero al mercado??? Replicel, Histogen, Follica o Pilofocus??? alguien puede dar lineas de tiempo???? de acá al 2018 es posible que salgan nuevos tratamientos, medicaciones o tópicos que nos permita mantener el cabello hasta que salga una cura???


  12. Samumed’s Phase 1 trial in Australia was completed and failed to show any hair growth, according to sources at the company. Subjects felt better, but hair counts were no different in the treated vs. placebo groups. To be fair, the study was only one month in duration, so quite short for a hair growth/re-growth trial. This trial will tell if activation of Wnt signaling in the scalp is a potential treatment for baldness. Keep in mind that like rogaine and propecia, you’d still have to use this to retain your new hair.

  13. Interesting John H. Makes no sense for them to be pursuing further expensive trials in the US if what you say is true and not just rumor.

    1. Can you tell us a little bit more – Is this from what you’ve heard, or what you’ve seen yourself?

  14. That’s a good sign. I don’t know. Maybe they are adjusting the most effective dose. That’s important clinical trial.

    Great Blog.

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