Home | News | Find a Doctor | Ask a Question | Free

Getting pretty pessimistic about a cure coming anytime soon


#1

I’m getting pessimistic now that we’ll see a real cure anytime soon.

Dr. Cotsarelis has announced several discoveries and developments in the past 3-5 years, but they seem to be heading nowhere.

He is currently developing a commercial PGD2 inhibitor, which had seemed to be his most hopeful announcement, but I think if it were really effective, we’d know about it by now – like the medical community and the public knew of the hair-growing effects of Minoxidil and Proscar (Finasteride) well before these drugs were approved as Rogaine and Propecia, treatments for hair loss.

If Dr. Cotsarelis’ PDG2 inhibitor really could produce significant hair growth, don’t you think this would be news by now, and we’d see some kind of statement or evidence in the media?

Even with all the people testing PGD2 inhibitors and blockers by themselves, there has not been a single instance of this, to my knowledge, where someone has grown a significant amount of hair.

The same goes for Dr. Cotsarelis’ other discoveries.

With respect to Sanford-Burnham, Dr. Xu might be correct (see my post here from last week)… They might have been growing mouse hair instead of human hair, and maybe they were not even aware of it. If that’s true, that means they are back to Square One.

As for all the other researchers like Replicel, Sumitomo, Dr. Lauster, Dr. Lindner, and Dr. Xu himself, where are they now?

It seems they have each worked on a rather small part of the problem, but none of them has solved the ENTIRE problem – building a brand new working hair follicle.

To really solve the problem, THEY ALL NEED TO BE WORKING TOGETHER, but they are not, and probably never will, because they all want the acclaim and the financial rewards for themselves. This fragmented effort is actually hindering scientific progress and dramatically slowing down the time to market of any possible cure.

According to Dr. Xu, in order to successfully create new, working hair follicles, you have to have BOTH functioning stem cells AND functioning (hair-inductive) dermal papilla cells. You can’t just have one of those for it to work. He has succeeded in creating – even multiplying – functioning hair follicle stem cells, but he hasn’t done so with DP cells, and now he’s saying, neither has Sanford-Burnham, which I thought was our big hope.

What Dr. Xu said is here:

http://www.uphs.upenn.edu/news/News_Releases/2014/01/xu/

Furthermore, Dr. Xu’s work with activating stem cells involves changing two genes in them – which is gene therapy – the most cutting-edge and highly-regulated field of biomedical research. From what I know, that means that any “cure” based on Dr. Xu’s work will take a ridiculous amount of time to be reviewed and approved by the FDA – probably not within the next 10 years. That’s just my opinion – I may be wrong.

As far as Histogen goes, I think their HSC has some promise, but I believe there will be roadblocks for most people based on the fact that they’re only testing it for 2 applications, which may result in the FDA controlling its use, and limiting applications to 2 per patient. Again, I’m not sure about this, but that is definitely one possible scenario, in my mind, and it’s not promising.

That means that even if HSC works well on you, you may be limited to only getting 2 applications, because Histogen doesn’t have certification of the safety of applying it more than twice. Of course, if it is regulated in this way, many people will succeed in getting around the regulations. But that will just add one more complication for us, plus the concern of “What if there really are bad side effects from long-term use?”

I don’t know how this will play with the FDA and patients, but that is one possibility.

Even so, HSC appears to not be a real cure for most people. Even their own tests show they can’t simply grow hair at will. Their photographs were kind of cherry-picked, and only showed the best responders. How many patients will respond that well? And even the BEST HSC responders were far from cured.

With Dr. Christiano, too – same as for Dr. Cotsarelis. She announces a discovery, it’s covered all over the media, and then nothing happens. It falls into a black hole. If JAK inhibitors really worked, I think someone by now would have confirmed that by testing it himself. But that hasn’t happened.

What does everyone here think?


#2

Yea, the Histogen pics do not show great improvement but that was with one treatment. What if you have more follow-up treatments? We don’t know the answer to that yet. There’s room for hope there.

Also, you completely disregard Samumed’s SM04554 for some reason that I don’t understand. Samumed is not Follicept. Samumed is a major company and there’s a ton of good science supporting its’ SM04554. Even if it’s only as good as minoxidil it may be compoundable with minoxidil and/or dutasteride. We don’t know what’s going to come of SM04554 yet but I do have some positive feelings about it. Although I do agree that the company is sending mixed signals about it.

Have you noticed how quiet it is about Samumed’s SM04554? How are they keeping things quiet? It seems like whether the news is good or bad we should be hearing inside info but somehow they’re completely controlling
the information.


#3

Yes, it is very quiet – and my first inclination is to say that probably means it isn’t progressing well. But who knows?


#4

Roger, it looks like Samumed is presenting on Saturday March 5 in Washington D.C. I think you live in that area. Would you be able to go to the event on March 5 and record it for all of us? Here is the information about the event:

https://www.aad.org/scientificsessions/am2016/SessionDetails.aspx?id=9717


#5

Wow… Thanks, jarjar. I will try. Don’t know if I need to be a Dermatologist to get into the conference. Looks like no admission or ticket is required, so this is promising.


#6

[quote][postedby]Originally Posted by roger_that[/postedby]
Wow… Thanks, jarjar. I will try. Don’t know if I need to be a Dermatologist to get into the conference. Looks like no admission or ticket is required, so this is promising.[/quote]

Their contact information is in links at the site so perhaps you could email them and ask them if any person can attend.

I just checked on their supplemental phase 2 study to see if they are still proceeding with it and at this time it’s still active.


#7

hi roger_that,

Ive been silently checking in here ever few weeks… My impression is that things have become rather quiet… Unfortunately i have to agree, that at the moment i dont see anything extraordinarily promising in the pipeline… To me the most promising still appears to be histogen… But obiously, its not going to work on a slick bald person…

As for compoundability of histogen treatment… I’d say it’s not that easy… More isnt always better, that approach seems far too naive… Its like suggesting that using a bottle of minox or eating a handful of finasteride per day will cure hairloss… Most things rarely are that simple

I think if a cure comes about, its going to take another 10-15 years…

Regards hairman2


#8

[quote][postedby]Originally Posted by hairman2[/postedby]
hi roger_that,

Ive been silently checking in here ever few weeks… My impression is that things have become rather quiet… Unfortunately i have to agree, that at the moment i dont see anything extraordinarily promising in the pipeline… To me the most promising still appears to be histogen… But obiously, its not going to work on a slick bald person…

As for compoundability of histogen treatment… I’d say it’s not that easy… More isnt always better, that approach seems far too naive… Its like suggesting that using a bottle of minox or eating a handful of finasteride per day will cure hairloss… Most things rarely are that simple

I think if a cure comes about, its going to take another 10-15 years…

Regards hairman2[/quote]

  1. Different treatments work by different modes of action. It’s possible
    that one treatment (minoxidil) for example)could be more limited than a
    different treatment that works by a different mode of action.

  2. Concerning Samumed’s silence - Samumed will be presenting at the ADD on
    March 5. They will be presenting in the late breaking groundbreaking category
    and I’m told that this category requires that once they’re submission is accepted
    for presentation they have to remain quiet until the presentation. This explains
    their silence.

Now that I understand why they’ve been silent the only negative I can think
of about Samumed is that back in November they termed their preliminary results
for their original phase 2 study “significant.” I don’t like that term. It
typically means a little regrowth. But keep in mind that Samumed is new to
hair loss so they may not be up-to-date with hair loss parlance and those
results were preliminary so maybe they just wanted to convey that there was
some hair loss without being specific about how much because they hadn’t
tallied the final results yet.

Everything else were hearing connected to SM04554 is positive.

I’m very optimistic about SM04554. I’m more optimistic about it than I
am about Histogen. I suspect that SM04554 will prove to be a breakthrough
treatment. We should find out March 5.

I’m surprised you completely neglected SM04554 in your assessment. The science
behind it is quite good.


#9

The section where Samumed will be presenting is for late-breaking groundbreaking
presentations. Here is exactly what it says:

These forums will highlight the latest ground-breaking observations in
clinical, therapeutics, surgical, pediatric, dermatopathologic and basic
research. Researchers are invited to submit abstracts describing their
most recent results and the top scoring studies will be invited to discuss
their findings in a brief oral presentation during one of the themed Forums.

(enlarging by me)

Samumed is the 1st presenter in this section. I’m not sure it means
something that they’re presenting first but abstracts from all over the
world were submitted and it’s a good sign that Samumed was selected at all.
And since the submitted abstracts were all given scores there is a very real possibility
that the reason why Samumed presents first is because their submitted material
provided the most groundbreaking news.


#10

They’re purportedly going to present their final results from their
original phase 2 study. This would mean that they know their final phase
2 results. If this is the case then doesn’t it seem like they would pull
the plug on their supplemental phase 2 study if their original phase 2
results were bad?

Of course Samumed made their submission at least a month or two ago
and their supplemental phase 2 is still moving forward. So they’re keeping
their supplemental phase 2 moving forward even after a month or two since
finding out their final results from the original phase 2 study. Hmmmmm…


#11

I have said this before:

Many HM research projects continue to fund trials on things when they are obviously not working.

You can call this illogical but it still happens all the time.


#12

Hair cloning research was a “sexy” topic many years ago, not so much anymore, seems like venture capitalists are no longer hot on the idea of investing in research or finding a cure. Now the only people who care are baldies like us.


#13

My one scientific problem with SM04554 is that I don’t understand how it can be expected to keep working if they cease using it after 3 months. This is really nagging at me.

I read an identical twin study a long time ago wherein one twin lost his hair but the other didn’t because he had been castrated. But scientists knew that since the bald identical twin’s hair had reached the point he lost it that meant the other twin’s hair had also reached that point and the only reason he hadn’t lost it was because he’d been castrated. So scientists exposed the twin with hair to testosterone and his hair started falling out, but instead of the hair taking years to fall out it fell out in weeks or a few months.

Based on this it seems to me that even if SM04554 gets hair to grow you will lose that new hair within a few weeks or a few months unless you keep applying the SM04554. People who stop using minoxidil lose their hair. People who stop using finasteride lose any hair they gained from it. People who stop using RU58841 lose any hair they gained from it.

But the great Wilma Bergfeld is on the SM04554 team and surely she knows all of this.


#14

[quote]So they’re keeping their supplemental phase 2 moving forward even after a month or two since finding out their final results from the original phase 2 study. Hmmmmm…

[postedby]Originally Posted by cal[/postedby]

I have said this before:

Many HM research projects continue to fund trials on things when they are obviously not working.

You can call this illogical but it still happens all the time.[/quote]

You’re comparing apples and oranges. Those HM companies are kind of shyster companies so they hype their companies to suck $ from foolish investors, but Samumed isn’t even traded.

Samumed is more like Aderans and Aderans went belly-up as soon as they produced lousy phase 2 results. Like I said, Samumed has had its’ final phase 2A results at least a few months.

I guess we’ll find out what’s up with SM04554 in about 2 weeks. Right now, I do have some optimism but I also do have a few issues with it. Most importantly, I can’t understand how it

could possibly keep working if you stop using the treatment after 3 months. That seems odd to me.


#15

Aderans extended & dragged out their phase#2 for literally years while their results weren’t improving at all. Intercytex did a full phase#2 for nothing and IMO they probably knew it wouldn’t work before they started. Etc.

Call it illogical, but happens on a regular basis in this business.


#16

It wasn’t many years ago, but just a few years ago, that there was a huge buzz about “hair cloning” in the media and investment community, but true, that seems to have died down a lot.


#17

[quote][postedby]Originally Posted by ipod[/postedby]
Hair cloning research was a “sexy” topic many years ago, not so much anymore, seems like venture capitalists are no longer hot on the idea of investing in research or finding a cure. Now the only people who care are baldies like us.[/quote]

Hair loss is a relatively small market, the annual sales for Propecia is approx $400M compared to blockbuster drug such as Lipitor at approx $12 BILLION a year at its peak.

Propecia ranked near the bottom 1/3 among other drugs in terms of annual sales


#18

“My one scientific problem with SM04554 is that I don’t understand how it can be expected to keep working if they cease using it after 3 months. This is really nagging at me.”

Jarjar, do you see that this is EXACTLY the issue I keep on bringing up about Histogen’s HSC?

The problem is that these treatments may be effective, but these companies may be limiting themselves by trials which only prove to the FDA that their treatment is safe for a few applications.

What if the FDA looks at this and says, “That’s all you can have, then.”

Actually, I think that the real reason these companies are limiting trials and limiting protocols to a few treatments (2 injection sessions in the case of HSC, 3 months in the case of SM04554) is that they’re trying to avoid prolonged use because they suspect that will raise the incidence of side-effects.

With this approach, the FDA might take them literally and impose “official” limits on how much can be used, or how many treatments patients can get.

Originally we were in the era of “unlimited” treatment hair loss medications – like Minoxidil or Propecia, where you just keep taking it every day for the rest of your life.

Now we seem to be moving into a new era – where the drugs they’re testing are much more potent – and companies are self-limiting themselves in trials to very brief application periods or a small number of treatment sessions.

If they weren’t scared of dealing with side effects, then they’d be trialing these drugs in an open-ended way – a year or more of regular applications.

The problem you see with Samumed’s SM04554 is exactly the same problem I see with Histogen’s HSC.


#19

[quote][postedby]Originally Posted by roger_that[/postedby]
“My one scientific problem with SM04554 is that I don’t understand how it can be expected to keep working if they cease using it after 3 months. This is really nagging at me.”

Jarjar, do you see that this is EXACTLY the issue I keep on bringing up about Histogen’s HSC?

The problem is that these treatments may be effective, but these companies may be limiting themselves by trials which only prove to the FDA that their treatment is safe for a few applications.

What if the FDA looks at this and says, “That’s all you can have, then.”

Actually, I think that the real reason these companies are limiting trials and limiting protocols to a few treatments (2 injection sessions in the case of HSC, 3 months in the case of SM04554) is that they’re trying to avoid prolonged use because they suspect that will raise the incidence of side-effects.

With this approach, the FDA might take them literally and impose “official” limits on how much can be used, or how many treatments patients can get.

Originally we were in the era of “unlimited” treatment hair loss medications – like Minoxidil or Propecia, where you just keep taking it every day for the rest of your life.

Now we seem to be moving into a new era – where the drugs they’re testing are much more potent – and companies are self-limiting themselves in trials to very brief application periods or a small number of treatment sessions.

If they weren’t scared of dealing with side effects, then they’d be trialing these drugs in an open-ended way – a year or more of regular applications.

The problem you see with Samumed’s SM04554 is exactly the same problem I see with Histogen’s HSC.[/quote]

Roger is it possible that when Samumed’s SM04554 activates Wnt it activates it in such a away that it stays activated long term even after you stop applying it?


#20

[quote]Hair loss is a relatively small market, the annual sales for Propecia is approx $400M compared to blockbuster drug such as Lipitor at approx $12 BILLION a year at its peak.

Propecia ranked near the bottom 1/3 among other drugs in terms of annual sales[/quote]

And it’s such a shame this is true up to now. Because a real treatment for MPB will eventually make Lipitor-size money. We don’t even know how big it is because we haven’t seen the change in social expectations it would eventually cause.

It’s like trying to assess the profit potential of a novel new treatment for crooked teeth 100 years ago. It’s too early to tell because the problem has never been treatable so it’s still socially acceptable to go around looking that way.

Also, the BS story about Propecia having little or no side effect problem is not helping us either. When the number crunchers evaluate the market for MPB drugs, they aren’t assuming that tons of men don’t take Propecia because of side effects. They are assuming it’s a virtually harmless pill to stop MPB in its tracks for virtually everyone.