Samumed Interview w/ Dr. Yusuf Yazici

[Folliman]

http://www.forbes.com/sites/matthew...omise-in-treating-male-baldness/#57a40d391600


"The treatment is a topical solution that is rubbed on the head. It works, Samumed says, by affecting the Wnt pathway, a fundamental signaling pathway discovered in fruit flies (w stands for “winglessâ€￾) that is crucial in the development of embryos and in cancer in all animals. "

why cancer of all things?? the studies are too short to show safety. :/ As much as I want my hair back I don't want to risk getting cancer.

 

[Giiizmo]

http://www.forbes.com/sites/matthew...omise-in-treating-male-baldness/#57a40d391600


"The treatment is a topical solution that is rubbed on the head. It works, Samumed says, by affecting the Wnt pathway, a fundamental signaling pathway discovered in fruit flies (w stands for “winglessâ€￾) that is crucial in the development of embryos and in cancer in all animals. "

why cancer of all things?? the studies are too short to show safety. :/ As much as I want my hair back I don't want to risk getting cancer.

Two things in short:

1) The Wnt pathway is one of many factors that promote growth in a normal cell cycle. A tumor - and ultimately, cancer - only happens when the cell cycle goes awry and the proper guarding mechanisms fail to drive the cell to apoptosis (e.g. pRb protein: https://en.wikipedia.org/wiki/Retinoblastoma_protein).

More on this: https://en.wikipedia.org/wiki/Wnt_signaling_pathway#Cell_proliferation + https://en.wikipedia.org/wiki/Cell_cycle.


2) There are unmistakable bio-markers that can be measured when a tissue starts to break away from the normal cell cycle and towards tumorigenesis. Not to mention that the tissues themselves tend to adopt abnormal histological characteristics and shapes that can be seen with a microscope. That doesn't mean the drug is 100% safe, but Samumed should have a pretty good idea whether their compound induces tumorigenesis or not.

 

[Swoop]

Tommorow is the big day ladies and gents.

Edit: Mandatory Swoop gif

:mrgreen::mrgreen::mrgreen:

 

[NewUser]

[h=1]Experimental Drug Shows Early Promise In Treating Male Baldness[/h]

An experimental drug from a largely unknown biotechnology company has shown promise in regrowing bald men’s hair, according to data to be presented at the American Academy of Dermatology in Washington, D.C., today.

The result is preliminary, and doctors who reviewed the presentation ahead of publication for Forbes characterized the results as promising, but also raised concerns about whether or not it would hold up in larger studies.


Drug maker Samumed, based in San Diego, says that it will be taking the medicine, code named SM04554, into larger studies aimed at getting approval from the Food and Drug Administration. The treatment is a topical solution that is rubbed on the head. It works, Samumed says, by affecting the Wnt pathway, a fundamental signaling pathway discovered in fruit flies (w stands for “wingless”) that is crucial in the development of embryos and in cancer in all animals. The results will be presented today by Yusuf Yazici...



In the study, 300 patients were assigned randomly either to get a placebo version of the topical solution without any drug, a 0.15% solution of SM04554, or a 0.25% solution of SM04554. The medicine seemed generally safe.
Patients who took the drug seemed to see the number of hairs in a 1 square centimeter area of their scalp increase, while those in the control group lost hair. In the control group, hair count dropped from 114 hairs per square centimeter to 111.5. In the 0.15% group, hair count increased from 104.9 to 115. In the 0.25% group, hair count increased from 110.8 to 118.5.
Similar results were seen on another measure, called hair density. Samumed is not presenting the results on self-reported measures of hair quality, another measure of efficacy, at this time. The differences between the 0.15% group and the vehicle were statistically significant.

I quoted all but 4 words in paragraph 3, last sentence.

 

[hellouser]

Experimental Drug Shows Early Promise In Treating Male Baldness




I quoted all but 4 words in paragraph 3, last sentence.

This article doesn't make much sense. In one part it writes as if they're speaking about the presentation as if it were yet to happen.. (according to data TO BE presented). Seems like we don't really have all the info from the presentation.

 

[baldowaldo]

100+ follicles per square centimeter, this doesn't seem like the kinda density in a bald area, probably the sides/back.
I think we'd know better once we have complete information from the presentation, about hair growth in areas which were actually bald.

 

[NewUser]

This article doesn't make much sense. In one part it writes as if they're speaking about the presentation as if it were yet to happen.. (according to data TO BE presented). Seems like we don't really have all the info from the presentation.

And they they are not reporting patient satisfaction, or photos, which makes me think a couple of things. Perhaps they weren't expecting cosmetic results comparable with minoxidil at the low dosage they were using. What are the solution concentrations of the drug they were using, 0.15% and 0.25%? Comparing results for an experimental drug still in phase II with a commercial product like Rogaine might not be a good comparison.

What I want to know is, what were test results like for 0.15% Loniten or 0.25% minoxidil? They said they are encouraged by the "statistically significant" results for SM04554 but that larger studies must be done. Apparently pivotal phase III studies will be done. No doubt that future doses tested will be adjusted upward now that 4.5 month safety (and preliminary efficacy) studies are completed.

I still have hope for this drug since they are claiming to know through analysis of punch biopsies of test animals and now people that SM04554 is creating new hair follicles and at relatively low doses, too. By comparison I don't think minoxidil creates new hair follicles. Samumed may actually be pioneering a drug that, for the first time, creates new hair follicles and thereby setting the consumer hair loss treatment standards bar a little higher than before, hopefully.

So they have preliminary safety and efficacy. I think the task at hand now is to find out if efficacy increases with dosage. This drug could become another part of our daily routine.

 

[Tracksterderm]

And they they are not reporting patient satisfaction, or photos, which makes me think a couple of things. Perhaps they weren't expecting cosmetic results comparable with minoxidil at the low dosage they were using. What are the solution concentrations of the drug they were using, 0.15% and 0.25%? Comparing results for an experimental drug still in phase II with a commercial product like Rogaine might not be a good comparison.

What I want to know is, what were test results like for 0.15% Loniten or 0.25% minoxidil? They said they are encouraged by the "statistically significant" results for SM04554 but that larger studies must be done. Apparently pivotal phase III studies will be done. No doubt that future doses tested will be adjusted upward now that 4.5 month safety (and preliminary efficacy) studies are completed.

I still have hope for this drug since they are claiming to know through analysis of punch biopsies of test animals and now people that SM04554 is creating new hair follicles and at relatively low doses, too. By comparison I don't think minoxidil creates new hair follicles. Samumed may actually be pioneering a drug that, for the first time, creates new hair follicles and thereby setting the consumer hair loss treatment standards bar a little higher than before, hopefully.

So they have preliminary safety and efficacy. I think the task at hand now is to find out if efficacy increases with dosage. This drug could become another part of our daily routine.

That's true. If it's 10% increase by new hair follicles, that could mean 10% increase (compared to baseline) every 3 months.

 

[nameless]

Hemo what do you think about Kerastem?

There's an interesting thread here entitled "Who would fund a Kerastem therapy?" that I think you should take a look at.

 

[NewUser]

Do you not understand that they can't move to Phase III with different doses/formulations of the drug than were trialed in Phase I and II? If they need to rework the drug, they need to re-do those earlier trials (to ensure that the new drug is, in fact, still safe and effective). I don't know if the FDA allows accelerated "re-trials", but I don't see how that would make sense from a safety perspective. Just as I said in the other SM thread, I'll wait for their official release, but if they aren't moving straight into Phase III then this won't be out for a long time, if ever.

Not sure about this drug, but there are examples for running safety and efficacy in parallel during phase III before finalizing to-be-marketed topicals. i.e Luliconazole 1% topical for ringworm and jock itch. Apparently Yazici believes they have enough to move it to pivotal trials.

 

[NewUser]

From the very authoritative wikipedia, it says:

A pivotal trial can refer to a clinical trial or study intended to provide evidence for a drug marketing approval,[SUP][1][/SUP] e.g. by the US FDA. Phase III trials are assumed to be pivotal so the phrase is often used for the rare pivotal phase II trials

- - - Updated - - -

Wondering about their baseline hair counts. Considering this - that they recruited Norwoods 4 to 6, and baselines were somewhere around 100-105/cm^2 - what percentages were terminal and vellus? An hair transplant doctor's site revealed that an average taken from a group of typical hair transplant candidates with Norwood 4-5 classifications are about 111 hairs/cm^2 with 15% terminal and 85% vellus.

What I'd like to know is, have they shown SM04554 to grow terminal hair follicles or vellus on what we would consider a bald patch of scalp? Apparently balding becomes obvious when sufferers lose 50% of normal non-Androgenetic Alopecia density which can be anywhere from 130 to 280 hairs/cm^2. I think that if they are growing terminal hairs and not vellus on sparse Norwood 4 to 6 scalps, then I think it's obvious that they do have something special with SM04554, and especially if it's the gift that keeps on giving at 10 and 12 months.

 

[I.D WALKER]

Valuable questions there NU.

I'm also very interested in ascertaining what this will mean in terms of it's maintenance benefits.
If we get confirmation that it's benefits can at best "effectively arrest" further hair fall,
then I'll be convinced that lower Norwood's and/or aggressive male pattern baldness patients in particular have something to be enthusiastic about.

Also I'm curious how this will do in conjunction with ie: finasteride.,min.,etc.
I'm at least hoping it elevates combination therapies to a promising new level.
So as usual we have to wait and see.