Sanford-Burnham: Funding

I guess Sanford-Burnham won’t be short of cash now that they’ve been given $100 million:

Incredible news! Thanks.

The article mentioned another $275m coming from an anonymous donor. So by now SB must have most of $400m on their hands. That’s a whole lotta cash for any research outfit.

If they dumped 1/10th of that dollar figure into an MPB research effort, and pointed it at applying their recent cellular research . . . . it could be the biggest MPB progress we’ve ever seen.

I really think baldness is almost vanquished. I know I thought the same thing when Aderans and Histogen were actively progressing in clinical trials, and I know I was wrong back then. But those two failed treatments did teach us that there are pieces of the puzzle missing and I think we now have enough of those missing pieces to finally cure baldness. I think the technology to cure hair loss finally exists and all that’s really left is getting the technology through clinical trials and approved. I think a cure will definitely hit the market by 2020…maybe sooner. But I think that 2020 is definitely the worse case scenario.

2020?

Heh heh heh. I think you mean “best case scenario” not worst.

If a repair man tells you he’s going to charge 24 hours of labor to fix your home furnace, do you expect it to be finished at that exact time the next day?

The world doesn’t work like that.

There might only be technically 2-3 years of things left to do before this new hair is growing on our heads. But that doesn’t mean it will happen that fast.

I think 2020 is the worse case scenario.

I think that there is already sufficient information/technology to cure baldness by at least one method - IPS cellular implants.

I think that when S & B follicles made the news there were some issues that needed to be worked out in order to make that concept commercially feasible but I think those issues are sufficiently worked out now. I think that all that is left is putting all of the pieces together and turning it into a treatment and bringing it to market. I think that the latest you will see S & B type follicles reach the marketplace is 2020.

And IPS cells is just one potential way to treat hair loss. There are other ways they could potentially cure baldness and there is research into those areas as well. For example WNT mediators, fat cell implants, wounding, growth factors, DP cellular implants, etc, etc, etc.

I really think that the news from the upcoming hair loss congress in Miami will be that the technology to cure baldness via at least one of the above mentioned treatment methods is finally on the planet, or at least almost on the planet.

If I’m right that the technology to cure baldness is finally on earth (or almost on earth) then the main issue left is getting that technology to market. Civilized countries are making new laws to speed up their medicine delivery regulatory process. The USA even has a bill in the works to try to speed up the process by eliminating the phase 3 trial altogether, but that bill is not passed yet. But Japan has already passed such a bill.

I say a breakthrough baldness treatment/cure will hit the market by 2020 at the very latest. And really, I’m allowing for a full year (or longer) of dawdling so I actually think the first breakthrough cure will reach the market a year (or so) sooner than 2020. We should get a better feel for which of us is right in a little over 2 months when the 2015 hair loss congress takes place.

I agree that Sanford-Burnham is the most likely group of researchers that will be able to offer a real cure, and that it will probably be near commercialization in a few years, especially now with the massive infusion of funds they’re received. They already had an approach that scientifically left all the others in the dust – now with these enormous donations, they will be firmly on track to getting this in the pipeline to the consumer market.

On the other hand, I think we have to be really careful about what we call a “cure”. To my mind, ONLY a treatment that can guarantee unlimited follicles, or production of new (or regenerated) follicles at will, is a real cure. What I mean by “production at will” is that it will have to be a process that removes almost all the guesswork from follicle production. Not a drug or topical that you have to slather on your skin and wonder if it’ll work on you or not – that you’re maybe one of the biochemical outliers or poor responders. To me, a process that can produce follicles at will will HAVE to be a cell-based process.

Things like manipulation of Wnt, wounding + some chemical, drugs, implantation of fat cells like Kerastem is doing, etc. are all TREATMENTS, not potential cures.

I have little interest in those things because I’m pretty certain they’ll never give me a full head of hair. What I want is a FULL HEAD OF HAIR, not some treatment that’ll produce a few vellous hairs, mild and uneven thickening, or moderate regrowth where I have to abide by some ridiculous daily regimen of slapping some liquid on my head and scrutinize my scalp in the mirror everyday. I’m too old for that. I think that, with recent developments in cell-based therapies, we are moving way beyond that now.

I think most of us on this forum, at least the very active and informed members, are beyond the stage of slight thinning. The only thing that will really satisfy us, ultimately, is a CURE – and that means being able to grow as much hair as we want. I mean, a custom head of hair – so-called teenage density or something close.

With Sanford-Burnham and a few other researchers like Lauster/Lindner in Berlin, I think we are finally close to seeing that.

Roger, since you think that treatments like Wnt mediators can’t initiate superior hair growth to current treatments why do you think Samumed is doing a supplemental phase 2 study of SM04554?

Samumed initiated the supplemental phase 2 study near the end of the original phase 2 study, at a time when they would have had an idea if the drug produced good results or not in the original phase 2 study.

The supplemental phase 2 involves biopsies. They could have done biopsies on the test subjects in their original phase 2 but they didn’t. So why would they waste millions of dollars to do a supplemental phase 2 involving biopsies if the original phase 2 study failed to produce good results?

This supplemental phase 2 study seems adhoc.

We wouldn’t be so bent on getting THE CURE if we had a treatment option that wasn’t a pathetic frustrating failure.

We always rant about how the difficulties of the treatments aren’t worth it. That’s because we don’t get decent results out of the deal. Dropping the price of a new car, spending 20+ months in ugly duckling grow-out periods, daily topical regimens for life . . . this is all a big cost.

It would seem worthwhile if the results were decent. They aren’t. They say transplants need “realistic expectations?” People without MPB should be jealous of good transplant results after what they cost.

Treatments with sexual sides are not acceptable under any circumstances. None. Lots of people avoid treating far more serious issues than hair loss when the medication causes even minor sexual sides. Dick-limping MPB treatments are not a reasonable compromise to expect of anyone, period.

If Wnt mediators prove to grow hair then maybe they will do so without causing sexual side effects. Nobody knows.

You guys seem to be much more optimistic about this than me. I think it’s possible (but by no means guaranteed) that Sanford-Burnham will have a product that works in the next five years or so. But that doesn’t mean it’s going to be commercially available. There is the small matter of FDA trials, and as far as I know it can take up to 10 years for new treatments to be approved. (Yes, they could try to make the treatment available in Japan or somewhere else first, but we have no guarantee that they would do that.)

Also, just because “it works” doesn’t mean that it’s “perfect” (or affordable, for that matter).

We’ve been excited about other products before that we thought could not possibly fail (Intercytex, Aderans etc.), but in the end these didn’t pan out.

I think Sanford-Burnham’s approach shows promise, but I don’t think it’s going to be commercially available in the next five years. (I hope I’m wrong, but I think even ten years is optimisitic, and it wouldn’t surprise me if we were all still bald twenty years from now…)

[quote][postedby]Originally Posted by News[/postedby]
You guys seem to be much more optimistic about this than me. I think it’s possible (but by no means guaranteed) that Sanford-Burnham will have a product that works in the next five years or so. But that doesn’t mean it’s going to be commercially available. There is the small matter of FDA trials, and as far as I know it can take up to 10 years for new treatments to be approved. (Yes, they could try to make the treatment available in Japan or somewhere else first, but we have no guarantee that they would do that.)

Also, just because “it works” doesn’t mean that it’s “perfect” (or affordable, for that matter).

We’ve been excited about other products before that we thought could not possibly fail (Intercytex, Aderans etc.), but in the end these didn’t pan out.

I think Sanford-Burnham’s approach shows promise, but I don’t think it’s going to be commercially available in the next five years. (I hope I’m wrong, but I think even ten years is optimisitic, and it wouldn’t surprise me if we were all still bald twenty years from now…)[/quote]

Unfortunately, you’re correct. There is literally zero chance of this becoming commercially available in the next five years. They’re still in the basic research phase of just growing a follicle. There will be many other issues that need to be solved before they could even think of going commercial. Once they’ve worked out the basic research, then they can start using their technique in preclinical work. And after they’ve demonstrated success there, which will be difficult, only then can they make the case to go on to full blown clinical trials. And to do that, they’d most likely have to sell their IP to a large, well funded company. There will be bureaucracy and delays the entire way through the process. Even if no snags, all of that would take many years to happen. Sh*t, if they even managed to figure out the basic research in 5 years, it be a damn miracle.

And then, if all that basic research and preclinical work is a success, then they can begin clinical trials. Add 10-15 years from that point. If they run trials in far east, subtract 3 years or so…7-12 years.

Realistically, the day when you can walk in a clinic and walk out with a full head of iPS stem cell generated hair is 10 - 20+ years away. And that being if it works at all, which is not a given. This is the reality.

Things that are realistic in a shorter time frame (less than 10yr): samumed, replicel, pilofocus. Maybe Follica… they made it up to phase II, but there doesn’t seem to be much going on with them, outside of patent activity.

No, fortunately, he’s wrong.

iPS cells have already been cleared for human testing in Japan. As a matter
of fact, iPS cells are already being injected into test subjects in Japan.

http://www.nature.com/news/next-generation-stem-cells-cleared-for-human-trial-1.15897

http://www.nature.com/news/japanese-woman-is-first-recipient-of-next-generation-stem-cells-1.15915

Basic Research is in the rear view mirror.

Preclinical research is in the rear view mirror.

Human testing is beginning NOW!!!

I don’t know if the Japanese will let human testing of iPS cells proceed
for hair loss but I don’t see how they can reject the idea when they are
already allowing human testing of iPS cells for other diseases.

The day when the first human trialists get cosmetic regrowth is still a bunch of years away from the day when we get it on OUR heads. This stuff may really work but it isn’t happening very us very soon.

[quote][postedby]Originally Posted by cal[/postedby]
The day when the first human trialists get cosmetic regrowth is still a bunch of years away from the day when we get it on OUR heads. This stuff may really work but it isn’t happening very us very soon.[/quote]

If they did a human phase 1 study in 2016 and a human phase 2 study in 2017 then it could be commercialized by 2018 in Japan. We need to wait to see what Shiseido says at the upcoming hair loss congress.

Why is this hard to understand?

[quote][postedby]Originally Posted by cal[/postedby]

Why is this hard to understand?[/quote]

next 5 years?? :smiley:
I admire your optimism jarjar, I really do :smiley:

Does anybody have pictures of this actually working? It is all bull until you see real hair growing. However, if real terminal hair can be grown in a lab, it will be fast tracked after safety is approved. Until you see several pictures of real hair growing on bald heads, don’t bet your house on it. Either they can grow hair or they can’t. It’s called being a realist!

Superhl, SB has shown pictures of terminal hairs growing in a lab.

If they showed pictures of terminal hairs growing on someone’s head at this point, that would be tantamount to admitting they violated the law, because without FDA approval for human clinical trials, which hasn’t been granted yet, they can’t do experiments directly on human patients. Sounds unreasonable, but that’s the law.

The only way I could see them possibly getting around this requirement is if one of the researchers performed an experiment on himself. That would at least negate the liability for doing an unapproved human clinical trial without informed consent of the subject. However, since this procedure involves using human stem cells, there are other legal requirements and so I suspect that is why we haven’t yet seen pictures on a human. You are not likely to see such pictures until clinical trials are approved… And even then you might not see them for awhile into the trials.

Things are not as simple and black-and-white as you think

swizz templez the god already cured this… welcome to 2015

[quote][postedby]Originally Posted by needhairasap[/postedby]
swizz templez the god already cured this… welcome to 2015[/quote]

What??