Follica - Good News!

[chancer]

Yeah i did only diliptate and abrade.... but on a big level, 1inch coverage existing hairline, and side walls... I was excited..

Nobody has used avara or getfitb because they simply cant buy it, or should i say they can buy it, it just wont get delivered to them...

im sorry my post did smell of pessimism, which im not normally one to broadcast such gloom...

people really have copied the experiments apart from the super drugs... if you visit hairtalk, see threads by respected posters like Tagohl, Cal, Baccy.... their threads continue to speculate and theorise daily, adding new things to the mix and expelling others... where has our's has stood still... the only person in our thread i know to have some success is ORIN, but his hairloss isnt severe yet, and he has very blonde hair, with that its much finer and hard to differentiate between terminal and non terminal.

nobody since april has yet to come back to this forum or one of the other respectable forums with any pictures...

and talk in other forums suggests the mass variations are throwing us all of the scent... i know that may read negatively but it is what it is...

i think we really need a breakthrough right now... im sure it will come, but we could be waiting some time before there’s a "super post"... hope im bloody wrong though...

but, maybe im having one of those weeks... there hasnt been any ray of light in the follica experiments for a while... i just hope someone like Orin, First or Michael post something to lift the gloom...

 

[scalpt]

I've really enjoyed reading about all the ideas about how follica might work. The discussions have died down it seems. On this forum the thread has gone quiet, on another forum it's turned into arguments about expectations and optimism vs. pessimism.

I'm really amazed that some people would have the courage to try this on their own, though we've yet to see much documentation of results.

It's cool that you guys are keeping your eyes peeled for new info, and holding follica's feet to the fire to get this product developed and released. Thanks

 

[michael barry]

Both of the getfitinib pictures we have seen with the hair growth were with cancer patients. Chemotherapy suppresses (and sometimes almost completely) the immune system. Both of these people likely had chemotherapy, and I thought that one of them had it for sure. Does it make more sense now?



Why do I have a feeling that the two drugs necessary for hair regrowth are going to turn out to be an immunosuppressant and getfitinib. These two drugs aren't approved for hair growth, just like Daphne Zohar said.



Just putting a immunosuppressant in a cream wont necessarily do the trick. Topical cyclosporin isn't as effective for androgenic alopecia as internal cyclosporin is. Internal cyclosporin usually has hirsutism as a side effect. Topical cyclosporin was tried for baldness if memory serves, but was only about 20% effective. The immune system is a "body-wide" phenomenon, with T-cells and Killer cells and marker cells going through the blood and lymphatics looking for "foreign" bodies to attack. So just blocking formation of these cells and whatnot in the scalp alone isn't going to keep others from "making their rounds".






Neither of the two people whom we have seen getfitinib-related hairgrowth were on finasteride or minoxidil. Thats almost a given. But chances are good they had compromised immmuno-capacity from chemotherapy.



This is probably why nobody has had much success with the wounding/natural egf inhibitors or wouding/lithium thusfar other than them using carriers and whatnot that might interefere with the process anyway.






I keep going back to Experiment number 7 and the ENSUING experiments done with human skin grafted to SCID mice. They got hair EVERY TIME according to them. No EGF-Inhibition was needed......................the only difference between these mice acting as "life support" for the human skin grafted to their backs and us is that we have an immune system.



As for why animals can be wounded and regrow hair pretty regularily and we cannot-----pretty simple: Our immune systems are much more evolved than theirs. We all have read Hideo Uno's comparison between Stumptailed Macaque balding and human balding. The lymphocytic infiltrate, the collagenous streamers, the inflammation, the T-cell infiltration. The immune system gets involved in human androgenic (as well as areata) alopecia, but none of that is apparent in ape-balding. Their hair just shrinks. Our whole scalp changes.





I bet this is the "missing link" that would lead to success. The problem is.............................I cant think of anywhere one could get a hold of internal cyclo w/o a prescript. I'd like to be wrong about all of this............but what Daphne Zohar said now appears to really make sense. Those two drugs are indeed not for hair, but minoxidil or finas are. The anti-microbial and anti-biotic and anti-inflammatory now make sense also.

 

[chancer]

makes complete sense Michael...

those mice had no immune system, those cancer patients probably had on chemo..

How follica will get around this one i dont know... there are too many complications in suppressing the immune system. Unless they have a trick up their sleeve to do it locally in the scalp and not systematically??

Would it be possible to do it topically? they must have a technique planned for this or they wouldn’t be this far down the line...

But we now know its more than likely the immune system needs to be tackled in the stem cell creation stage...

 

[michael barry]

The patent possibilities are in this paragraph:



In yet another particular embodiment of the methods, kits, and compositions of the invention, the EGFR inhibitor (e.g., a small molecule EGFR inhibitor or EGFR antibody) is combined (e.g., administered, formulated, or contained in a kit) with an additional biologically active agent selected from an antihistamine (e.g., mepyramine, diphenhydramine, and antazoline), an anti-inflammatory (e.g., corticosteroids, NTHEs, and COX-2 inhibitors), a retinoid (e.g., 13-cis-retinoic acid, adapalene, all-trans-retinoic acid, and etretinate), an anti-androgen (e.g., finasteride, flutamide, diazoxide, l lalpha-hydroxyprogesterone, ketoconazole, RU58841, dutasteride, fluridil, and QLT-7704), an immunosuppressant (e.g., cyclosporine, tacrolimus, rapamycin, everolimus, and pimecrolimus), a channel opener (e.g., minoxidil, diazoxide, and phenytoin), an antibiotic, and an antimicrobial (e.g., benzyl benzoate, benzalkonium chloride, benzoic acid, benzyl alcohol, butylparaben, ethylparaben, methylparaben, propylparaben, camphorated metacresol, camphorated phenol, hexylresorcinol, methylbenzethonium chloride, cetrimide, chlorhexidine, chlorobutanol, chlorocresol, cresol, glycerin, imidurea, phenol, phenoxyethanol, phenylethylalcohol, phenylmercuric acetate, phenylmercuric borate, phenylmercuric nitrate, potassium sorbate, sodium benzoate, sodium proprionate, sorbic acid, and thiomersal).






The simpleist protected embodiment of the patent is this:

In a particular embodiment of the methods, kits, and compositions of the invention, the EGFR inhibitor is administered, formulated, or is part of a kit with an anti-androgen (e.g., finasteride ) and a channel opener (e.g., minoxidil).

 

[michael barry]

Going to stick this here for reference.....
Pimecromilus, Rampycin, tacrolimus are all in cream forms............but I dont know if that is how they'd be delivered. One is used for eczema...



Imm unosuppressants

In certain embodiments, a nonsteroidal immunosuppressant can be used in the compositions, methods, and kits of the invention. Suitable immunosuppressants include cyclosporine, tacrolimus, rapamycin, everolimus, and pimecrolimus.

Cyclosporines

The cyclosporines are fungal metabolites that comprise a class of cyclic oligopeptides that act as immunosuppressants. Cyclosporine A is a hydrophobic cyclic polypeptide consisting of eleven amino acids. It binds and forms a complex with the intracellular receptor cyclophilin. The cyclosporine/cyclophilin complex binds to and inhibits calcineurin, a Ca2+- calmodulin-dependent serine-threonine-specifϊc protein phosphatase. Calcineurin mediates signal transduction events required for T-cell activation (reviewed in Schreiber et al., Cell 70:365-368, 1991). Cyclosporines and their functional and structural analogs suppress the T cell-dependent immune response by inhibiting antigen-triggered signal transduction. This inhibition decreases the expression of proinflammatory cytokines, such as IL-2. Many different cyclosporines (e.g., cyclosporine A, B, C, D, E, F, G, H, and I) are produced by fungi. Cyclosporine A is a commercially available under the trade name NEORAL from Novartis. Cyclosporine A structural and functional analogs include cyclosporines having one or more fluorinated amino acids (described, e.g., in U.S. Patent No. 5,227,467); cyclosporines having

modified amino acids (described, e.g., in U.S. Patent Nos. 5,122,511 and 4,798,823); and deuterated cyclosporines, such as ISAtx247 (described in U.S. Patent Application Publication No. 2002/0132763 Al). Additional cyclosporine analogs are described in U.S. Patent Nos. 6,136,357, 4,384,996, 5,284,826, and 5,709,797. Cyclosporine analogs include, but are not limited to, D-Sar (α-SMe)3 Val2-DH-Cs (209-825), Allo-Thr-2-Cs, Norvaline-2-Cs, D- Ala(3-acetylamino)-8-Cs, Thr-2-Cs, and D-MeSer-3-Cs, D-SeI-(O-CH2CH2- OH)-8-Cs, and D-Ser-8-Cs, which are described in Cruz et al., Antimicrob. Agents Chemother. 44: 143 (2000).

Tacrolimus

Tacrolimus and tacrolimus analogs are described by Tanaka et al. (J. Am. Chem. Soc, 109:5031 (1987)) and in U.S. Patent Nos. 4,894,366, 4,929,611, and 4,956,352. FK506-related compounds, including FR-900520, FR-900523, and FR-900525, are described in U.S. Patent No. 5,254,562; O- aryl, O-alkyl, O-alkenyl, and O-alkynylmacrolides are described in U.S. Patent Nos. 5,250,678, 532,248, 5,693,648; amino O-aryl macrolides are described in U.S. Patent No. 5,262,533; alkylidene macrolides are described in U.S. Patent No. 5,284,840; N-heteroaryl, N-alkylheteroaryl, N-alkenylheteroaryl, and N- alkynylheteroaryl macrolides are described in U.S. Patent No. 5,208,241 ; aminomacrolides and derivatives thereof are described in U.S. Patent No. 5,208,228; fluoromacrolides are described in U.S. Patent No. 5,189,042; amino O-alkyl, O-alkenyl, and O-alkynylmacrolides are described in U.S. Patent No. 5,162,334; and halomacrolides are described in U.S. Patent No. 5,143,918. Tacrolimus is extensively metabolized by the mixed-function oxidase system, in particular, by the cytochrome P-450 system. The primary mechanism of metabolism is demethylation and hydroxylation. While various tacrolimus metabolites are likely to exhibit immunosuppressive biological

activity, the 13-demethyl metabolite is reported to have the same activity as tacrolimus.

Pimecrolimns Pimecrolimus is the 33-epi-chloro derivative of the macrolactam ascomyin. Pimecrolimus structural and functional analogs are described in U.S. Patent No. 6,384,073.

Rapamycin Rapamycin structural and functional analogs include mono- and diacylated rapamycin derivatives (U.S. Patent No. 4,316,885); rapamycin water-soluble prodrugs (U.S. Patent No. 4,650,803); carboxylic acid esters (PCT Publication No. WO 92/05179); carbamates (U.S. Patent No. 5,118,678); amide esters (U.S. Patent No. 5,118,678); biotin esters (U.S. Patent No. 5,504,091); fluorinated esters (U.S. Patent No. 5,100,883); acetals (U.S. Patent No. 5,151,413); silyl ethers (U.S. Patent No. 5,120,842); bicyclic derivatives (U.S. Patent No. 5,120,725); rapamycin dimers (U.S. Patent No. 5,120,727); O- aryl, O-alkyl, O-alkyenyl and O-alkynyl derivatives (U.S. Patent No. 5,258,389); and deuterated rapamycin (U.S. Patent No. 6,503,921). Additional rapamycin analogs are described in U.S. Patent Nos. 5,202,332 and 5,169,851.

 

[harold]

Hmmmmm. I dont know anything more but I suspect a major difference between Follica and us will be the depth of abrasion. The Follica method may go pretty deep in order to get really impressive results. But then again there was that hint that the kit would include an "abrasive foam" that would indicate abrasion might not be that deep at all.

As to this thread being quiet and the lack of mny positive testimonials for DIY Follica I do a bit of mild scraping/abrasion once every couple of weeks or so along with my daily minoxidil and probably buzz my head every couple of weks as well. I dont have any real bald areas yet so its difficult to impossible for me to say whether that has made any difference. I have been told that my hair has thickened up since I first buzzed it by a couple of people but I have also been hitting the minoxidil a little harder (I quit finasteride) so it could be due to that. At any rate I dont think I will ever be able to say definitively whether my token efforts at Follicaness make any difference and I have deprioritized hair in general, or at least made an effort to do so, so I have not gone to great lengths to check.

I suspect that we will probably see results like hatchet at regrowth or Orin here from DIY Follica people - some note definite improvement but nobody regrows a large amount of hair. At least not from a single pass. I dont think it has much to do with immunosupression and more to do with a general lack of effective topicals and depth of abrasion. This is just my guess though.
hh

 

[jakeb]

The more I think about it, the less I can imagine Follica going for fringe cancer drugs as EGFR inhibitors if something like lithium or caffeine would do it. They're still going to have to deal with the FDA on this... not as an Investigational New Drug (which could add 10 years to this process), but I can't see how they'll get around a New Drug Application.

 

[Matt27]

Jake, why don't you do some digging into what laser hair removal, electrolysis, breast augmentation, liposuction, etc. etc. had to go through before they could all be offered to the public?

There is no "new drug" here as we all know, so there will be no need for the standard New Drug application process that we are all used to. This is more accurately a "new cosmetic procedure", like the aforementioned procedures once were, so whatever regulatory route those procedures had to go through will very likely be the same route Follica will have to travel before it can be offered to the public.

Follica will not be offering any new drug to the public, they will be creating and licensing a procedure. Two totally different worlds which need to be distinctly differentiated in terms of required regulatory filings/procedures/timelines etc.

Sometimes people get so stuck on the NDA process (understandably, since that's what 99% of all new hairloss DRUGS do in fact need to follow) that they fail to realize when something is not a drug, but a cosmetic procedure. You can probably more closely and easily associate this with a new hair transplant procedure or technique than a new drug. What would Armani or Feller legally have to do to start using a new hair transplant technique? What did the very first US hair transplant surgeon have to do in order to start offering it to the public?

 

[jakeb]

The difference is that those are all surgical procedures. Procedures are not regulated by the FDA.

There would be nothing stopping a doctor from procuring these drugs on their own and performing a Follica-like procedure on a patient. But Follica is a company intending to sell something -- the patented kit. And because this kit will contain molecules that are already listed as drugs, it's too late to call them cosmetics. If they're planning on making a topical from Gefitinib, which it kind of seems like from the patent, they'll need an NDA. If they sell and then provide instructions doctors on how to use Gefitinib to regrow hair, that's marketing for a new indication, and they'll need an NDA.

It's nowhere near as hard as an IND, but I don't see how they'll get around it.

 

[Matt27]

There would be nothing stopping a doctor from procuring these drugs on their own and performing a Follica-like procedure on a patient.

That's all you had to say.

Except you missed one small thing....the one thing that would stop a (US anyway) doctor from doing this would be the primary topic of this thread, the actual Follica patent. The doctor would need the rights from Follica in order to start offering this procedure to the public.

So now the question is, what's stopping Follica from selling the rights to perform this procedure, say, tomorrow? Forget about them even selling the kit for now. Besides, like you said, doctors can already get all of that stuff themselves.

What is preventing Follica from simply selling the rights yet providing absolutely no drugs, just specific instructions on how to use them and perform the procedure??

Now where does the FDA stand in terms of preventing Follica from releasing and profiting from their "technology" as they like to call it??

 

[goata007]

Now where does the FDA stand in terms of preventing Follica from releasing and profiting from their "technology" as they like to call it??

They could probably stop Follica from marketing the procedure, I think there is some rule about NOT making any unapproved claims (hair growth).

 

[jakeb]

Follica can't sell the rights to perform the procedure in the U.S. at least. A patent that covers a medical procedure is called a medical process patent. While Follica could file for one, new medical process patents are not enforceable in the the U.S. since 1996.

 

[Matt27]

Follica can't sell the rights to perform the procedure in the U.S. at least. A patent that covers a medical procedure is called a medical process patent. While Follica could file for one, new medical process patents are not enforceable in the the U.S. since 1996.

That law doesn't apply to the practice of a process outlined under a biotechnology patent, which is exactly what Follica's patent is.

In addition, although we were initially discussing the sale of rights only, in reality, Follica will almost undoubtedly be including the use of their proprietary agents (drugs), which would be yet another exclusion under this medical procedure patent law.

In the end, the fact of the matter is that Follica *could* sell the rights to use their procedure right now, but at this stage that would amount to nothing more than simply selling their patents, which would fetch some cash indeed, but not nearly as much as carrying out their trials and going forward with a full-on marketing plan (and physical product to attach to it). That being the case, they probably will go the route of an NDA so that they can reap the huge financial rewards down the road, in 4 or 5 years at the earliest I would guess.

 

[Moomin]

Anyone Experiencing deja vous...

For those of us that live in the old world and are having difficulty getting hold of products, namely lithium chloride, I have found a UK based company that can supply anything from 5g upwards. I purchased 25g plus p+p for £18.80 (maybe a little too much buy you can't cut a piece off something thats too short, or something. The arrival time was 2 days after payment. Anywho the contact details are as follows:

http://www.rose-chemicals.co.uk/
(0)20 7241 5100

Now all I need is some DMSO and I have everything necessary to create my army of follicles.

MWHAHHAHHAHAH MWHAHAHHAHAHAHA MWWWAHAHHAHAHAHAAAAAAAA

 

[BALDLATINO34]

http://www.hairsite.com/hair-loss/forum ... nswer.html

 

[bobs]

I'm confident that BACCY is a trustwhorthy fellow so I take these results seriously. It looks really good! Keep it up guys, great work.

 

[Noobie]

To bad he didn't document his experiment better. I am going to wait to see his second round picture before I start ordering stuff. I will try and document everything I do in the easiest format to follow and provide before and after pictures. Just waiting for someone to do it first that has the time and money to do it.

 

[jakeb]

That is nuts. I believe the guy, but honestly can't believe someone replicated the results. Truly nuts.

 

[amsch]

Ok, blame me, i'm sure this has been discussed before, but i the search function didn't really help me.

However, what i wanted to know is: If this method is really able to create new follicles, will we still be forced to take propecia because DHT will attack those new follicles as well?