Sm04554

[Tenma]

Has anyone seen this trial about SM? https://www.anzctr.org.au/Trial/Regi...aspx?id=368801

Wow thats great news!

Now they are running 3 trials.

Btw, I don’t know if it was mentioned before but found info from april about samumed expanding their facilities and obtaining a good reduction in taxes:

http://www.sandiegometro.com/2015/04/daily-business-report-april-17-2015/

“…Samumed LLC of San Diego, a biopharmaceutical research and development firm that will create 273 jobs by investing $30.5 million, for which it will receive a $2.1 million tax credit.”

One thing is for sure, they are investing heavily and have high hopes for this drug.

[lacazette]

lacazette aswell

[JayM]

Hey man no worries. What's your name on ***? I will send you a message

[lacazette]

Hey Jaym, I tried the other day as you asked to contact you on ***, but they don't allow me to access to your profile and send a msg. and still not today dude

[JayM]

Guy's we have already been though all of this like 20 pages back.

[unbalding]

It's gotta be either what you said, or in anticipation of the 21st century cures act which allows the use of biomarkers to speed the approval process.

That's a great point, I hadn't thought of that. Hopefully you're right.

[baldybald]

Now the problem is that we do not know what it contains so we can use it on ourselves, like setipiprant

[Justinian]

It seems to me it's probably working, but not as well as they had hoped. They want more information to modify it to improve efficacy. They must be getting pretty decent results though to even bother with that.

It's gotta be either what you said, or in anticipation of the 21st century cures act which allows the use of biomarkers to speed the approval process.

[unbalding]

the way I'm reading this purpose portion of the clinical trial is that they're trying to understand exactly how this is working... Which may mean that it actually is working. this may be a good sign

It seems to me it's probably working, but not as well as they had hoped. They want more information to modify it to improve efficacy. They must be getting pretty decent results though to even bother with that.

[Tenma]

the way I'm reading this purpose portion of the clinical trial is that they're trying to understand exactly how this is working... Which may mean that it actually is working. this may be a good sign

Agreed. No way they would waste money funding another trial if the stuff is performing poorly.

What intrigues me is how effective is SM.

[champpy]

the way I'm reading this purpose portion of the clinical trial is that they're trying to understand exactly how this is working... Which may mean that it actually is working. this may be a good sign

[Hairmore]

I cannot open the link. Seems like they closed the recruiting since yesterday or there are just to many who were still wanted to participate very badly.

[unbalding]

If anyone is in Texas, Ohio, Virginia, or Michigan, they are still recruiting participants.

https://clinicaltrials.gov/ct2/show/study/NCT02503137?term=SM04554&rank=1#contacts

[Seuxin]

I really would like to know too the timeline of this SM !

[candu2015]

Hey good find thanks Candu . The first ever trial of SM was in australia, they have facilities there
that new micro trial is interesting, it adds some safety biomarkers and seems they had choose a define protocol

Daily topical application of 0.25% (w/v) solution of SM04554 to scalp for 14 days.
SM04554 is supplied as in a non-aqueous solution of PEG400 at concentration of 0.25% weight per volume (w/v);1 vial of 0.5mL
Subject will apply at least 0.3mL of a 0.5mL study drug (SM04554) at site during visits under supervision of site staff.


Primary outcome
To characterise pharmacokinetics of topically applied 0.25% SM04554 solution to male subjects with androgenetic alopecia, estimated using available concentration-time data for Cmax, tmax, AUC (0-24), AUC (0-infinite time) and t(1/2) from collected blood samples.
Timepoint
On treatment days 1 and 14 blood samples will be taken prior to study drug application and at 1, 2, 4, 6, 12 and 24 hours post study drug application.

On treatment days 5 and 10 blood samples will be taken prior to study drug application only.
Secondary outcome
To characterise safety and tolerability of topical SM04554 0.25% solution to scalp of male subjects with androgenetic alopecia as determined by changes from baseline in vital signs, clinical laboratory parameters and electrocardiography(ECG)
Timepoint
ECG: days 1 and 14 prior and 4 hour post study treatment
Vital signs: screening day, days 1, to 14 prior to study treatment, on days 1 and 14 at 4 and 12 hours post study treatment. ECG also performed at follow up visit day 15.
Clinical chemistry, haematology parameters and urinalysis: screening day and day 14 prior to study treatment and day 15 post study treatment
Secondary outcome
To characterise safety and tolerability of topical SM04554 0.25% solution to scalp of male subjects with androgenetic alopecia as determined by adverse events (such as skin irritation (erythema,scaling puritis, stinging) , eye irritation) and assessed by medically qualified study staff.
Timepoint
Every day from first day study drug application to day 14 and at end of study day 15.
Secondary outcome
To characterise safety and tolerability of topical SM04554 0.25% solution to scalp of male subjects with androgenetic alopecia as determined by investigator skin assessment of the scalp and hands.

I follow with great interest this product, it's a different approach.
I am very hopeful that this treatment will come soon.
It seems they already have chosen the 0.25%?
What do you think?
I'm sorry for my English