Samumed Interview w/ Dr. Yusuf Yazici

Jaym

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Lol @ Acell and PRP to maintain. finasteride/dutasteride does way better than that ****e.
 

shwareb

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Aha sorry if I came on too strong, I didn't mean to offend anyone. I mean I am losing my hair too and of course I want my thick hair! That's why I am here to follow progress and see if people recommend any treatments! However, being miserable about something that there is no cure for, just won't do anything... I mean I try to focus on what I can improve; education, extracurricular skills, gym etc.. That I can control and so I work on that! It doesn't mean I don't want my hair really bad but letting it control the way I live my life, that's wrong. I think you can overcome that!
Yeah finasteride is supposedly a great drug too but the idea of inhibiting a hormone that I naturally produce. It doesn't ring that well with me!

When I said "man-up" I didn't mean that you guys are not "men". Of course not but haha in Sweden we say like man-up more like when you show that you are mentally strong and DEAL WITH IT. That's what I meant with "man-up".

Trust me guys I really want a cure too, but until then I'll live my life as well as I can! :D


Lol @ Acell and PRP to maintain. finasteride/dutasteride does way better than that ****e.

Yeah of course! finasteride and dutasteride is the best we have! I have seen such great results on that drug. But I mean other alternatives which don't give you potential sides and where you don't have to take a pill everyday!

There is supposedly one guy called Amiya Prasad in NY, who has started a company based on the idea of PRP Acell. He also says it's a one time treatment cause for 6 years and counting no re-injection has been needed. He seems like a reputable doctor, but I heard in the US doctor's can fool people. Here in Sweden doctors are pretty ethical so the idea that a very reputable doctor would do that seems foreign to me...
He supposedly says that it works for almost all his patients, except for the really progressed ones. I remain quite skeptical but he does have great results!
 

farkhairloss

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Aha sorry I came on too strong, I didn't mean to offend anyone. I mean I am losing my hair too and of course I want my thick hair! That's why I am here to follow progress and see if people recommend any treatments! However, being miserable about something that there is no cure for, just won't do anything... I mean I try to focus on what I can improve; education, extracurricular skills, gym etc.. That I can control and so I work on that! It doesn't mean I don't want my hair really bad but letting it control the way I live my life, that's wrong. I think you can overcome that!
Yeah finasteride is supposedly a great drug too but the idea of inhibiting a hormone that I naturally produce. It doesn't ring that well with me!

When I said "man-up" I didn't mean that you guys are not "men". Of course not but haha in Sweden we say like man-up more like when you show that you are mentally strong and DEAL WITH IT. That's what I meant with "man-up".

Trust me guys I really want a cure too, but until then I'll live my life as well as I can! :D




Yeah of course! finasteride and dutasteride is the best we have! I have seen such great results on that drug. But I mean other alternatives which don't give you potential sides and where you don't have to take a pill everyday!

There is supposedly one guy called Amiya Prasad in NY, who has started a company based on the idea of PRP Acell. He also says it's a one time treatment cause for 6 years and counting no re-injection has been needed. He seems like a reputable doctor, but I heard in the US doctor's can fool people. Here in Sweden doctors are pretty ethical so the idea that a very reputable doctor would do that seems foreign to me...
He supposedly says that it works for almost all his patients, except for the really progressed ones. I remain quite skeptical but he does have great results!

Dr Prasad claims are bullsh1t. He is/was in partnership with Dr Hitzig who is a known crook In the industry. Do some research on Dr Hitzig and you will see what i mean. If PRP and Acell actually worked we would of seen decent proof well and truly by now.
 

shwareb

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Dr Prasad claims are bullsh1t. He is/was in partnership with Dr Hitzig who is a known crook In the industry. Do some research on Dr Hitzig and you will see what i mean. If PRP and Acell actually worked we would of seen decent proof well and truly by now.

Oh wow, I had no idea! I just looked at his reputation on different websites like "realself" and it seemed excellent to be honest! The name Dr. Hitzig I haven't heard before; can you link me to any thing said about him?

Well thing is that many clinics, and not only prasad is offering PRP and Acell, and I have seen clinics here in Sweden starting to offer PRP alone. If it was just bad news, then how come it's gaining ground in other countries?
 

blubber911

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Samumed Announces Increases In Both Hair Count And Hair Density Observed In Its Phase

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).

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Poster:



Samumed Update ,..check it out guys :) :) :):bravo: ... would love to hear hellouser's thoughts on this considering he talked to the CEO dr yusuf at the World Hair Congress...
 

moarhairpls

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Samumed Update ,..check it out guys :) :) :):bravo: ... would love to hear hellouser's thoughts on this considering he talked to the CEO dr yusuf at the World Hair Congress...
I saw that yesterday. They didn't give any details; they just said that preliminary results indicate positive results, which most of us were already assuming. I hope the Senate passes the21st century cures act soon, and we don't have to wait for the phase III trial to be completed.
 

paleocapa89

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I'm interested what they mean when they are talking about "new follicle generation in animal models" is this drug capable of generating new hair follicles out of thin air? Considering the animals probably didn't have miniaturized or dormant follicles due to male pattern baldness I can only assume that when they are talking about new follicles those are not reawakened follicles. That would be awesome, but it needs more clarification.
 

NewUser

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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.

Yes, and without having tallied all of the results at the time of the announcement, Samumed ppl already sounded confident that their phase II safety and efficacy results will support a move to "Pivotal studies." For me it means they believe they have something worthy of a phase III clinical trial and will seek FDA approval.

New follicles? Increased hair count? That is very good news by what I can tell.
 

NewUser

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I'm interested what they mean when they are talking about "new follicle generation in animal models" is this drug capable of generating new hair follicles out of thin air?

Apparently altering Wnt signals to grow hair is a relatively new technology. They've been able to grow new follicles in lab mice.

Tuning Wnt Signals for More or Fewer Hairs
2013


And I'm guessing that if they started a phase 1 trial in Australia in 2013, perhaps they also started a phase 2 to coincide with a trial North America? Just guessing, tho, and so would only add to the time to collect and analyze the data.

"The Phase II safety and efficacy data so far are very promising and support moving this program into pivotal studies. We are analyzing the efficacy data further and plan to present results of both preclinical and clinical studies at upcoming medical conferences," said Yusuf Yazici, M.D., Chief Medical Officer of Samumed.

If they thought SM04554 is a dud for growing hair, they likely wouldn't consider bringing it to phase 3 pivotal studies because it would be a waste of time and money for them.
But apparently Samumed's chief medical officer, Yusuf Yazici, thinks phase 2 results are not just promising but "very promising", and so it appears they plan to go ahead with it.

What I like about it is the fact it's a topical solution which by design should have a far lesser systemic effect and therefore better safety than an oral drug.
 

nameless

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Does anyone have the schedule for when Samumed will be doing presentations over the next few months?

They say they will release more info at upcoming presentations.

- - - Updated - - -

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

Great! If it works don't use it and then the rest of us won't have to worry about you getting any of the women when the rest of us have our hair and we're all competing against one another.
You can sit on the sidelines and watch all the fun.
 

paleocapa89

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One thing I don't understand though is there are several possible treatments in the pipelines (setipiprant, CB etc.) and we all know the molecules and they can be synthesized in Chinese labs illegally but then how is it possible that no one knows what samumed is cooking up and no one is testing it already under the radar?
 

hellouser

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NewUser

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I could be wrong but I think phase IIB means they have established "statistically significant" efficacy and are now looking to find best dose for optimal results. Test patients are Norwood 4 to 6. Fingers crossed.
 

gimmehair

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How do we know this won't affect other hair types on the body? How are they specifically targeting head hair without DHT?
 

nameless

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The US Senate originally intended to complete the 21st Century Cures Act in January 2016 and Samumed originally intended to conclude its' supplemental phase 2 study in January 2016.
The Senate has delayed the 21st Century Cures until Spring 2016 and Samumed has also extended their supplemental phase 2 study until Spring 2016.

Interesting. It looks like Samumed is mirroring the Cures Act.

This feels like a positive sign.
 
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