It’s no crazier than believing Follica does work based on the amount of strange & misleading & contradictory info we have on them.
Indeed my opinion and strategy is to wait and see…if we do not have any proof (negative or positive) we can not judge
I never said that Follica’s tech didn’t work! In fact, i think Follica is the only company that has a legitimate approach for solving the problem. They essentially have the answer to growing hair. Now it’s really a matter of can they do it consistently, can the create a good cosmetic effect (density, direction, hairline etc…) . Based on them posting the Cots paper about FGF9, and the previous info i talked about, i would say the lithium/wounding protocol that they took through phase I and II either didn’t meet their expectations in terms of a cosmetic result or it worked, but needs to be improved before going commercial. Basically, i think they’ve proved they can grow de-novo hair on a human head with their technique but that they still are a long way from a procedure that will give a nice cosmetic result. They didn’t have a ton of money to play with, and it’s been 6 years now since this started, their well is probably running dry - which might explain alot of their activity or lack there of that we are seeing.
That is pretty much my viewpoint too. Whatever they were doing is not working well enough to go commercial and after 6 or 7 years the investors are probably getting tired of waiting.
But it stumps me that we have examples of the phenomenon happening purely by accident and they still can’t nail it down.
Wounding + Lithium does not work alone. Multiple people in the online MPB community have experimented with it over the last few years and gotten nothing to speak of, and that speaks volumes. If something that simple was capable of producing viable cosmetic hairs then somebody would have stumbled into it by now.
If one single person produced one single photo of a patch of 2 or 3 colored hair shafts sprouting together in an area of balded skin - that would convince us all, hands down. That single incident of hairs visibly growing from Lithium + wounding has not happened so I conclude that it will not work. Not without something else involved at the very least.
please cite the posts
the only post i can find is someone saying it worked
The burden of proof is on the people to prove that it does work.
You can find lots of people on the net making posts saying laser combs work too - but you cannot find a single picture of several terminal hairs sprouting on previously balded skin from it.
If lithium did anything by itself then we would know about it by now.
I wouldn’t rule out any delay having something to do with patenting the treatment, for all we know that could be the hold back.
[quote][postedby]Originally Posted by AleMB81[/postedby]
So basically all of you are saying that nothing is gonna change since aderans is about to close, histogen did not show really interesting pictures and follica did not release any information? Moreover we still don’t know if the pgd2 could be considered a game changer…am i right?[/quote]
The only potential game changers I see right now are PGD2 receptor blockers, but mainly for people in very early stages of MPB, and two lines of research being done by Dr. Nigam: First,INJECTING CULTURED PROGENITOR CELLS, and second, protofollicles (the latter is also being pursued by Dr. Lauster in Berlin). Of those 2, I think that injecting cultured progenitor cells and stem cells is the better short-term option, whereas protofollicles, I believe is a much longer-term possibility which is still in its infancy and will require, probably, a long time to perfect.
I don’t see Follica or Histogen as viable options at all.
For Follica, I think it all depends on whether they will stumble upon a compound which will optimize their tissue wounding concept. Personally, I don’t think they will find this hypothetical compound or growth factor, that combined with skin perturbation, will grow a lot of hair.
Histogen has a big problem because, although they’ve shown they can grow hair (there are real pictures), I believe they’re fighting a battle with TOXICITY in that the more HSC you use, the greater the chance of toxicity or cancer. The problem is, to grow a lot of hair, you have to use a lot of HSC. So, it reaches a Catch 22 or brick wall situation, wherein to use enough HSC to grow a substantial amount of hair, you probably have to use a TOXIC or at least a DANGEROUS DOSE.
This is a REAL problem with Histogen but of course all the people on the hairloss forums don’t think about it, or just don’t want to think about it. It’s not even on their radar screens, and it should be. I attribute that to one thing: the vast majority of people on the hairloss forums haven’t had enough scientific or medical education to understand these problems or conceive them as real, practical problems which actually prevent the APPROVAL of drugs, or their approval in effective forms.
Thus, if and when HSC is approved in the US, it will be approved only in such a form where dosage and number of injections you can have in whatever space of time, are so low and infrequent as to render the treatment essentially useless, no better than Minox for most people.
How do you know Follica won’t find this growth factor? It seems that’s exactly what they’ve focused their efforts on, and we know by now that Wnt and FGF are crucial.
Mr. Z has made a decent case for the suspicion that Follica is not actively doing any research. And they are not acting like a company that already has the solution. Dr. Garza said “years” when asked how far away a commercial product is. The writing is on the wall suggesting that they have not found something yet and they may have lost their window of funding to find it.
Most of the Follica linked research is probably still carried out within a university lab, not a conventional ‘company’ with employees clocking in and out. As soon as they have something substantial and marketable Follica would be their spin-off plan.
I am aware that Follica’s scientific staff left more than a year ago. However, Bernat Olle’s comments on the Follica articles and the FGF research seem to suggest that they are continuing preclinical work. It will likely be done in Cots’ lab, and Follica is more of a “shell” company that holds the IP.
I’m wondering if all the noise that Follica, Cotsarelis etc make in the media is to get new investment, but they never get the right amount of right they need.
Follica will almost certainly need more cash if they are to advance to the next round. Before the pilot trial at Harvard in 07 they did a financing round, and prior to the 2010 P2 trial I believe they also did one. A new round of financing will prepare them to trial a device or another combination.
In my opinion, that is THE thing to look out for, not their results, which they will likely never release.
Interestingly in one of their patents, they released the results of the control group from the P2 trial, but not the treatment group. lolwut?
[quote][postedby]Originally Posted by Aran Linvail[/postedby]
I am aware that Follica’s scientific staff left more than a year ago. However, Bernat Olle’s comments on the Follica articles and the FGF research seem to suggest that they are continuing preclinical work. It will likely be done in Cots’ lab, and Follica is more of a “shell” company that holds the IP.[/quote]
This is exactly what i think is going on with Follica. Which sort of sucks, because anything they cook up in the University lab that results in a different protocol is going to have to go back to phase I for safety studies again. It’s as if the clock has been set back to 2007 again. A full suite of clinical trials can take 7 or more years to get through. That puts us into 2020 if they begin now!
Personally, I’ve given up hope on follica, histogen (what the heck have they been doing?) and replicel. I’m waiting on Mwamba to report back on doubling, and then my other hope is with Pilofocus. Realistically, those are the only treatments that can become available in a reasonable time frame. If those don’t pan out, i’ll be declaring the birth of a new era in MPB research… the dark ages. Viva La Wig!
I don’t believe this is strictly true. EG, in their Phase 1 study, all they did was dermabrade a few guys at Harvard. In their Phase 2, they applied Lithium in addition to Dermabrasion.
My expectation is that any new treatment will go to Phase 2 first, and if the results are good enough, then I think we will see licensing with medical device firms, and then a Phase 3 trial.
But before all that…it needs to work!
That’s exactly right, and that’s why I call Follica an immature technology. Basically they have a company, but their intellectual property consists of only a half-completed idea that requires something unknown to be marketable. You can’t really operate or fully fund a company on that basis – investors won’t have it – and you certainly can’t complete clinical trials and market a product.
[quote]I don’t believe this is strictly true. EG, in their Phase 1 study, all they did was dermabrade a few guys at Harvard. In their Phase 2, they applied Lithium in addition to Dermabrasion.
My expectation is that any new treatment will go to Phase 2 first, and if the results are good enough, then I think we will see licensing with medical device firms, and then a Phase 3 trial.[/quote]
I don’t know about that. It seems that applying topical Lithium has already been vetted and trialed to rule out safety probems, in other words, it’s already had its “Phase I” somewhere else.
But what if this new, miraculous compound that we don’t know about yet, is something which hasn’t been safety tested? And I think it’s likely that a lot of these growth factors they’re studying haven’t been.
Then, it’s back to Phase I for them.
Testing a medical device is one thing. Medical and biotech companies love medical procedures that involve some kind of proprietary “device” because there is no doubt you can sue for patent infringement. But under US law since 1997, you basically can’t win if you sue for infringement of a patented medical procedure.
Follica is an interesting case, in that its eventual product might involve all three – a patented device, a patented drug, and a patented medical procedure (they’d patent the procedure anyway, especially for some foreign jurisdictions like Australia where there’s still liability for infringement of procedures).
Anyway, the way I see it, if they come up with any kind of novel drug, compound, or substance to apply to the dermabraded skin, and it’s something that hasn’t been safety-tested yet, they’d still have to go back to Phase I for safety testing.
This is KO btw.
Roger, you’re making up conjecture and presenting it as fact. This is a consistent pattern with you when it comes to Follica. Furthermore, Follica is NOT injecting growth factors or a miraculous new compounds, Follica is using topical drugs that are approved for other conditions. So much information has been posted on Follica on this forum for years now and you’ve read very little of it, and it is tiring to keep correcting you.
Follica NEVER conducted a phase I trial with lithium, and yet they were able to carry out a Phase 2 trial with it. Why is that? If you know of a P1 trial using lithium, then please post some evidence.
Follica’s whole goal is to use pre-approved compounds in a topical formulation in order to reach their goals, and the regulatory process is FAR simpler than for a new drug. The safety work has already been done.
I’m very confident, if Follica continues more testing, it won’t be phase 1, unless they’re using a drug (say a PGD2 blocker) that has never been approved for human use.
The regulatory path is not the main concern here, the main concern is getting it to work.
Aran or KO, I don’t really know what you’re talking about here. In fact, if you read my comments, above, I said the exact opposite of what you claim I said:
“It seems that applying topical Lithium has already been vetted and trialed to rule out safety probems, in other words, it’s already had its “Phase I” somewhere else.”
Certainly Lithium has undergone P1 tests. It’s prescribed as a drug to treat manic-depression and for other indications. Doctors definitely know how much it takes to cause toxicity in human beings, they know exactly what its LD50 is, and they know exactly what its pharmacokinetics are.
Regarding the rest of what you said, it may be all well and good, but you’re on an ancillary subject that is tangential to whether they can develop a workable treatment or not. I think you’re confusing and conflating what they’re trying to do with a “device” and their need to find some kind of compound that really validates their dermabrasion concept.
WHO CARES if they come up with a device, and patent it, if they can’t leverage the wounding concept because it just doesn’t work?
In order to validate the wounding concept, what they need is NOT a medical device, but some drug or chemical compound – known or unknown – that, when applied after wounding, grows a lot of hair.
Wouldn’t you agree with that?
Well, if Lithium hasn’t worked out for them, I’m sure they’re casting around all over the place to find some other drug, compound, substance, etc. that will validate the wounding concept.
Whether that drug or compound is known and has been tested, or whether it’s brand new and no one’s even heard of it before, is a secondary consideration.
Do you really think they’ll pass up their chance to validate the wounding idea because they want to restrict their research to already-known, tested and vetted compounds?
That would be ridiculous.
They may have listed a bunch of known, tested chemicals in their patent, but that doesn’t mean they’ll restrict their research to those compounds, going forward.
I don’t even know if FGF9 was mentioned in their patent. Honestly, I don’t even think it matters because I don’t think that stuff will get them very far. If it had such great potential, we’d have heard more by now.
I think you’re putting way too much emphasis on this “medical device” thing. That is just a side issue.
Who cares about their medical device??!
SIDE ISSUE.
What really matters is the drug or compound they must use to validate and maximize their wounding concept, and that HAS NOT BEEN FOUND YET.