Sm04554

[sdsurfin]

It doesn't outright say that outright (and it never will), but with enough digging, it can be determined with the records on clinicaltrials.gov.

1. Their trial started in Nov with 300 participants (about the maximum for a phase 2). 2. According to this record, they added recruitment locations, and began recruiting for more patients in Feb and March (4 & 5 months after phase 2 began, which would be long enough to determine whether or not the medication was working). Here's the record, it tells of updates and such: https://clinicaltrials.gov/archive/NCT02275351. 3. Phase 3's are larger than phase 2 with up to thousands of patients. 4. Their clinical trial page, was last updated at the end of march, so their recruitment status is valid. Why else would they be recruiting at 25 locations at this point in the trial unless they intended to go to phase 3?

I don't give a crap about things like follicept, that's like crack to someone on a hair loss forum, but I doubt it will work. Check out scientific journals related to the WNT pathway and hair growth, it tells A LOT.

This is nonsense. You might be the most egregious speculator on this forum. There are many reasons companies do things and many reasons that they could be recruiting more people. also, there is no difference in the amount of researching linking IGF-1 to hair growth as there is research on the ant pathway. I agree SM could be great, but WE HAVE NO IDEA whether this has been successful so far. Stop randomly deciding what companies plans are based on your hopes.

[It's2014ComeOnAlready]

This is nonsense. You might be the most egregious speculator on this forum. There are many reasons companies do things and many reasons that they could be recruiting more people. also, there is no difference in the amount of researching linking IGF-1 to hair growth as there is research on the ant pathway. I agree SM could be great, but WE HAVE NO IDEA whether this has been successful so far. Stop randomly deciding what companies plans are based on your hopes.

So, currently recruiting more participants, adding recruitment sites 4 and 5 months into a trial is a bad thing? Why would they recruit more participants if things were going poorly? Are phase 3's bigger than phase 2's, hell yeah. What other purpose is there than to recruit more participants nearly 7 months into a phase 2, other than purpose of recruiting them for a phase 3. Give me an answer.

I'm sure the people over at Samumed have said to themselves: "So things are going poorly for SM after 6 months of trials for safety and efficacy. Time to recruit more participants, and have an ongoing recruitment all the while." Let's say they needed to do a phase 2b like bim did, they wouldn't recruit more participants. If things were going poorly, they wouldn't recruit more participants, and add testing sites. PERIOD.

How is using logic that recruiting in 25 locations, and adding participants and locations more than halfway through a trial, egregious speculation? THEY ARE EXPANDING THEIR AMOUNT OF PARTICIPANTS WHILE PHASE 2 IS MORE THAN 6 MONTHS COMPLETE. THESE ARE FACTS. What do you know? You're not BTT police, and what I'm saying makes a lot of sense. Sorry you can't add 1+1

[It's2014ComeOnAlready]

The only negative thing i could find was this

"OncoMed Halts Wnt Pathway Inhibitor Trials due to bone side effects. What does this mean for programs at #Samumed?"

http://www.dddmag.com/news/2014/06/o..._zVRyQ.twitter

SM04554 is a WNT pathway activator, not an inhibitor. Also, on the clinical trial page it says this drug at the administered doses are not designated as a safety issue.

[Seuxin]

Is there actually a way to activate wnt pathway ? A way...available of course

[sdsurfin]

So, currently recruiting more participants, adding recruitment sites 4 and 5 months into a trial is a bad thing? Why would they recruit more participants if things were going poorly? Are phase 3's bigger than phase 2's, hell yeah. What other purpose is there than to recruit more participants nearly 7 months into a phase 2, other than purpose of recruiting them for a phase 3. Give me an answer.

I'm sure the people over at Samumed have said to themselves: "So things are going poorly for SM after 6 months of trials for safety and efficacy. Time to recruit more participants, and have an ongoing recruitment all the while." Let's say they needed to do a phase 2b like bim did, they wouldn't recruit more participants. If things were going poorly, they wouldn't recruit more participants, and add testing sites. PERIOD.

How is using logic that recruiting in 25 locations, and adding participants and locations more than halfway through a trial, egregious speculation? THEY ARE EXPANDING THEIR AMOUNT OF PARTICIPANTS WHILE PHASE 2 IS MORE THAN 6 MONTHS COMPLETE. THESE ARE FACTS. What do you know? You're not BTT police, and what I'm saying makes a lot of sense. Sorry you can't add 1+1

Maybe they weren't getting the data they wanted. maybe they needed more participants in order to determine efficacy. maybe there were problems at the other testing sites, funding ran out at some, maybe the people who signed up didn't all follow through. maybe some test centers fell through. How many times has replicel been delayed due to testing logistics? there are a million things that could result in needing more people or test sites. sure, one of them could be that its going well and they want to expand the test. however, on the same token, if it was going great why would they need to test more people? Sure, it could be because they are foreseeing a phase 3 trial, but if you look at how companies run these tests they have to comply with the FDA, present results, and then move ahead accordingly. this is why we always see time delays between trials, the parameters change, things need to be set, its a bureaucracy. its much more likely that they need more participants and test sites due to one of many other possibilities.

you could also be correct. who the hell knows. the point is that you state your hunches as fact, when they are anything but. You take one fact and you spin it into a reality of your own making based on your hopes. you did the same thing with bimatoprost, and right now none of us can guess whether that treatment will even see daylight. No one knows for sure what these companies are doing or why they are doing it unless you happen to work for them or have inside info, which you don't. I'm not saying you shouldn't have high hopes or be encouraged by news that sounds good, just stop stating your wild guesses as fact.

[Nerve]

I don't give a crap about things like follicept, that's like crack to someone on a hair loss forum,

Can you explain this comment?

[diffuseloser]

sdsurfin is right. They could be recruiting for any number of reasons. It is, however, an encouraging sign but we don't know anything at this stage and cannot presume anything.

[Swooping]

I don't give a crap about things like follicept, that's like crack to someone on a hair loss forum, but I doubt it will work. Check out scientific journals related to the WNT pathway and hair growth, it tells A LOT.

lol!

This is nonsense. You might be the most egregious speculator on this forum. There are many reasons companies do things and many reasons that they could be recruiting more people. also, there is no difference in the amount of researching linking IGF-1 to hair growth as there is research on the ant pathway. I agree SM could be great, but WE HAVE NO IDEA whether this has been successful so far. Stop randomly deciding what companies plans are based on your hopes.

Shame on you sdsurfin. There is way way way more research regarding the WNT pathway as there is to IGF-1 in regards to hair follicle biology. How can you even compare the two? WNT is one of the first signals which leads to de-novo morphogenesis of hair follicles, together with SHH. Ablation of it leads to total retardation of hair follicles. Furthermore it maintains a highly prevalent role in anagen onset (literally moments before anagen) and holds a really important role in hair follicle cycling itself. Sorry dude, IGF-1 is nothing literally nothing to WNT in the importance of hair follicle biology. It functions on so many more things downstream.

Not only that there is even evidence arising from the pathway up to a genetic level in androgenetic alopecia;

http://www.ncbi.nlm.nih.gov/pubmed/23358095

Androgenetic alopecia: identification of four genetic risk loci and evidence for the contribution of WNT signaling to its etiology.

http://publicatio.bibl.u-szeged.hu/4816/

A Synonymous Polymorphism of APCDD1 Affects Translation Efficacy and is Associated with Androgenic Alopecia

Do your homework better sdsurfin, I expect a better response from you next time.

[It's2014ComeOnAlready]

Can you explain this comment?

Check the view count on the follicept thread - it's like 250,000 and no one even knows if this stuff works. The only reason for that is they claim that it works, and don't have to pass FDA trials. When something seems too good to be true, most the time it is.

[It's2014ComeOnAlready]

Maybe they weren't getting the data they wanted. maybe they needed more participants in order to determine efficacy. maybe there were problems at the other testing sites, funding ran out at some, maybe the people who signed up didn't all follow through. maybe some test centers fell through. How many times has replicel been delayed due to testing logistics? there are a million things that could result in needing more people or test sites. sure, one of them could be that its going well and they want to expand the test. however, on the same token, if it was going great why would they need to test more people? Sure, it could be because they are foreseeing a phase 3 trial, but if you look at how companies run these tests they have to comply with the FDA, present results, and then move ahead accordingly. this is why we always see time delays between trials, the parameters change, things need to be set, its a bureaucracy. its much more likely that they need more participants and test sites due to one of many other possibilities.

"Maybe they weren't getting the data they wanted." - Really, with the maximum allowed phase 2 (300) number of participants they couldn't get the data they wanted? That's a very uninformed joke.

"Maybe they needed more participants to determine efficacy." - You should do your homework on clinical trials, 300 is typically the maximum allowed for phase 2. If there was an issue with efficacy, concentration etc, they already have their participants. They wouldn't expand their recruitment, and include more locations for recruitment.

"Maybe there were problems at the other testing sites, funding ran out at some." - If there were problems with funding etc, then why are the original testing sites still posted, in addition to new ones? No subtraction here, only addition. Doesn't sound like a funding issue.

"Maybe some people who signed up didn't all follow through." - Really dude? You've got people on here rubbing unregulated chemicals on their heads out of desperation, and someone who is part of a trial for hair loss is just as desperate for something. Doubtful they don't keep up with the trial, they WANT something to work.

"If it was going great why would they need to test more people?" - They have the maximum number of participants for a phase 2 (don't believe me, you can look it up). If it was going great nearly 7 months in, and they chose to recruit more people at 25 locations, it's probably because they are gearing up for a phase 3 in which they need 1,000 to 3,000 test subjects. Please think logically for this one - 4,5,6 months in, they could determine some efficacy, at the same time they also have another 6 months to recruit subjects. At this point in time, it is logical to recruit more participants if things are going well and are determined to go into phase 3. It's called preparation. There's also no logical reason to expand recruitment at this point unless things were going well.

I'm sorry, you haven't provided anything concrete.