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Follica


#1

If this works, which i suspect it does based on the comments from the inventor would trials really be needed? A doctor can use drugs off label and lasers are already FDA approved. This may get to market quicker than we realize. I read a lot of articles this afteroon and they stated in May of 2007 that they feel the product would be on the market late 2008 or early 2009. I still think they may be using AZT for some reason.

Zohar says Follica has further developed this work and filed additional patents to protect the technology. What’s so beautiful about the approach, she says, is that translating it into a treatment for humans involves only devices and drugs that are already on the market. A doctor would first use a microdermabrasion tool, say, or a laser to remove the top layers of the skin—as is already commonly done in a number of dermatologic and cosmetic procedures—knocking some cells back into a primitive state. The doctor can then use this newly created therapeutic window to inject drugs that push the cells to develop along one pathway or another and grow hair or skin. Zohar won’t reveal what drugs Follica is using, except to say that they are small molecule drugs normally taken orally for purposes with no relation to hair growth.

Because the components of the system are already approved, the regulatory path is pretty straightforward, and Follica can perform human studies without jumping through a lot of governmental hoops. That’s exactly what the company plans to do with the money it has just raised. A proof of concept study involving 15 to 20 patients (Follica has no shortage of volunteers, as several hundred people sent in e-mails when word of Cotsarelis’s work reached the public) should begin in the next few months. The trial has several phases, however, and Zohar cautions that final data won’t be in for at least a year. So don’t pull your hair out waiting for results.


#2

» If this works, which i suspect it does based on the comments from the
» inventor would trials really be needed? A doctor can use drugs off label
» and lasers are already FDA approved. This may get to market quicker than we
» realize. I read a lot of articles this afteroon and they stated in May of
» 2007 that they feel the product would be on the market late 2008 or early
» 2009. I still think they may be using AZT for some reason.
»
» Zohar says Follica has further developed this work and filed additional
» patents to protect the technology. What’s so beautiful about the approach,
» she says, is that translating it into a treatment for humans involves only
» devices and drugs that are already on the market. A doctor would first use
» a microdermabrasion tool, say, or a laser to remove the top layers of the
» skin—as is already commonly done in a number of dermatologic and cosmetic
» procedures—knocking some cells back into a primitive state. The doctor can
» then use this newly created therapeutic window to inject drugs that push
» the cells to develop along one pathway or another and grow hair or skin.
» Zohar won’t reveal what drugs Follica is using, except to say that they are
» small molecule drugs normally taken orally for purposes with no relation to
» hair growth.
»
» Because the components of the system are already approved, the regulatory
» path is pretty straightforward, and Follica can perform human studies
» without jumping through a lot of governmental hoops. That’s exactly what
» the company plans to do with the money it has just raised. A proof of
» concept study involving 15 to 20 patients (Follica has no shortage of
» volunteers, as several hundred people sent in e-mails when word of
» Cotsarelis’s work reached the public) should begin in the next
» few months. The trial has several phases, however, and Zohar
» cautions that final data won’t be in for at least a year. So don’t pull
» your hair out waiting for results.

only one thing is sure: if the technique works, this will be in market very soon. It’s a simple work to do on patient, and very important is that all the components are already approved. If they start to say, we commercialize not in two years, but 3, and after 3,5 , and after again 1 year… this mean that they are another BUG like ICX-TRC…
So wait and see what they say about the trials…


#3

» If this works, which i suspect it does based on the comments from the
» inventor would trials really be needed? A doctor can use drugs off label
» and lasers are already FDA approved. This may get to market quicker than we
» realize. I read a lot of articles this afteroon and they stated in May of
» 2007 that they feel the product would be on the market late 2008 or early
» 2009. I still think they may be using AZT for some reason.
»
» Zohar says Follica has further developed this work and filed additional
» patents to protect the technology. What’s so beautiful about the approach,
» she says, is that translating it into a treatment for humans involves only
» devices and drugs that are already on the market. A doctor would first use
» a microdermabrasion tool, say, or a laser to remove the top layers of the
» skin—as is already commonly done in a number of dermatologic and cosmetic
» procedures—knocking some cells back into a primitive state. The doctor can
» then use this newly created therapeutic window to inject drugs that push
» the cells to develop along one pathway or another and grow hair or skin.
» Zohar won’t reveal what drugs Follica is using, except to say that they are
» small molecule drugs normally taken orally for purposes with no relation to
» hair growth.
»
» Because the components of the system are already approved, the regulatory
» path is pretty straightforward, and Follica can perform human studies
» without jumping through a lot of governmental hoops. That’s exactly what
» the company plans to do with the money it has just raised. A proof of
» concept study involving 15 to 20 patients (Follica has no shortage of
» volunteers, as several hundred people sent in e-mails when word of
» Cotsarelis’s work reached the public) should begin in the next
» few months. The trial has several phases, however, and Zohar
» cautions that final data won’t be in for at least a year. So don’t pull
» your hair out waiting for results.

All the drugs they plan on using are listed in their patents, they are not using AZT.


#4

Not sure but I think Propecia and Rogain had to go through FDA trials even though the drugs were already approved for uses other than hairloss treatments. I even think I remember hearing that the foam version of Rogain had to go back through FDA trials before it could hit the shelves.

I wonder if the same would be true for the drugs involved in the Follica method.

» » If this works, which i suspect it does based on the comments from the
» » inventor would trials really be needed? A doctor can use drugs off
» label
» » and lasers are already FDA approved. This may get to market quicker than
» we
» » realize. I read a lot of articles this afteroon and they stated in May
» of
» » 2007 that they feel the product would be on the market late 2008 or
» early
» » 2009. I still think they may be using AZT for some reason.
» »
» » Zohar says Follica has further developed this work and filed additional
» » patents to protect the technology. What’s so beautiful about the
» approach,
» » she says, is that translating it into a treatment for humans involves
» only
» » devices and drugs that are already on the market. A doctor would first
» use
» » a microdermabrasion tool, say, or a laser to remove the top layers of
» the
» » skin—as is already commonly done in a number of dermatologic and
» cosmetic
» » procedures—knocking some cells back into a primitive state. The doctor
» can
» » then use this newly created therapeutic window to inject drugs that
» push
» » the cells to develop along one pathway or another and grow hair or
» skin.
» » Zohar won’t reveal what drugs Follica is using, except to say that they
» are
» » small molecule drugs normally taken orally for purposes with no relation
» to
» » hair growth.
» »
» » Because the components of the system are already approved, the
» regulatory
» » path is pretty straightforward, and Follica can perform human studies
» » without jumping through a lot of governmental hoops. That’s exactly
» what
» » the company plans to do with the money it has just raised. A proof of
» » concept study involving 15 to 20 patients (Follica has no shortage of
» » volunteers, as several hundred people sent in e-mails when word of
» » Cotsarelis’s work reached the public) should begin in the
» next
» » few months. The trial has several phases, however, and Zohar
» » cautions that final data won’t be in for at least a year. So don’t pull
» » your hair out waiting for results.
»
»
» only one thing is sure: if the technique works, this will be in market
» very soon. It’s a simple work to do on patient, and very important is that
» all the components are already approved. If they start to say, we
» commercialize not in two years, but 3, and after 3,5 , and after again 1
» year… this mean that they are another BUG like ICX-TRC…
» So wait and see what they say about the trials…


#5

This will most certainly need to go through the FDA. Any new use must be reviewed. As mentioned, Propecia and Avodart were both approved, and yet both required new trials for new uses. The reason is that the user profile changes. Propecia, for example, is finasteride, a drug developed for BPE. The user profile of a man with BPE will be different than that of those who might use Propecia, and so it must be tested on the new intended profile. Propecia dosage was even 1/4 of its previous use, and still the drug required new trials.


#6

That won’t stop anyone from getting the drugs off-label or just buying them online as soon as we get reasonable feedback that the process is not deadly and it works.


#7

» This will most certainly need to go through the FDA. Any new use must be
» reviewed. As mentioned, Propecia and Avodart were both approved, and yet
» both required new trials for new uses. The reason is that the user profile
» changes. Propecia, for example, is finasteride, a drug developed for BPE.
» The user profile of a man with BPE will be different than that of those who
» might use Propecia, and so it must be tested on the new intended profile.
» Propecia dosage was even 1/4 of its previous use, and still the drug
» required new trials.

Your right it would need some sort of FDA approval, the point is that it will be more straight forward than if they created the drugs they are using from scratch.

I’m not sure however if they would need to review each drug separately or the process as a whole.

I don’t know why everyone is saying it wont need approval at all because the drugs are already approved, it was made clear in the first ever account I read about follica that they would need to be reviewed.


#8

» That won’t stop anyone from getting the drugs off-label or just buying them
» online as soon as we get reasonable feedback that the process is not deadly
» and it works.

BINGO Cal, if it works, it will be bootlegged if not approved. The key is, does it actually work?


#9

» This will most certainly need to go through the FDA.

The company doesn’t think so, and they are in the best position to know.

Any new use must be reviewed.

No. The companies that make these drugs are not marketing them for another indication, so no new review is required. A doc or clinic can use these drugs for any purpose they see fit – it’s called off-label use, and it’s perfectly legal.

As mentioned, Propecia and Avodart

As mentioned, spironolactone and phenytoin, for example, have been reformulated as topicals for the treatment of MPB and sold to the public. No FDA approval was required. There are many other examples, including Retin-A and Botox, which were widely prescribed for cosmetic purposes before any FDA approval for these indications was obtained.

In the case of Propecia and Avodart, my doc gave me finasteride (and later dutasteride) for MPB without FDA approval for this condition. It’s called off-label use.


#10

» This will most certainly need to go through the FDA.

Follica is not manufacturing and not marketing any drug for any purpose. Therefore, they need not have FDA approval.

Follica’s treatment is a medical procedure performed by a physician. Part of that procedure is applying a drug to the skin. Pretty simple.


#11

» » This will most certainly need to go through the FDA.
»
» The company doesn’t think so, and they are in the best position to know.
»
» > Any new use must be reviewed.
»
» No. The companies that make these drugs are not marketing them for another
» indication, so no new review is required. A doc or clinic can use these
» drugs for any purpose they see fit – it’s called off-label use, and it’s
» perfectly legal.
»
» > As mentioned, Propecia and Avodart
»
» As mentioned, spironolactone and phenytoin, for example, have been
» reformulated as topicals for the treatment of MPB and sold to the public.
» No FDA approval was required. There are many other examples, including
» Retin-A and Botox, which were widely prescribed for cosmetic purposes
» before any FDA approval for these indications was obtained.
»
» In the case of Propecia and Avodart, my doc gave me finasteride (and later
» dutasteride) for MPB without FDA approval for this condition. It’s called
» off-label use.

Are you nuts? Yes, individual physician off-label use happens, but wide-spread protocols CAN NOT use drugs off-label. This is clearly a new protocol involving many drugs in conjunction and in a manner they were not intended for.

As for the Spiro and other liquid formulations, they exist in a grey area that, if the FDA had the desire to, could shut-down tomorrow.

What is legal and what happens are two different things. This technique - like all new protocols - will require trials.


#12

» » In the case of Propecia and Avodart, my doc gave me finasteride (and
» later
» » dutasteride) for MPB without FDA approval for this condition. It’s
» called
» » off-label use.
»
» Are you nuts? Yes, individual physician off-label use happens, but
» wide-spread protocols CAN NOT use drugs off-label. This is clearly a new
» protocol involving many drugs in conjunction and in a manner they were not
» intended for.

He is right to an extend, basically, It all depends on the drug!

Propecia is taken internally and affects the hormone levels in the body so it can’t be taken lightly and an FDA approval is required.

Same goes for rogaine, there is a chance of systemic absorption and since it was originally prescribed for heart patients, systemic absorption and hence the side effects are a big concern. Therefore they probably needed FDA approval.

As of Follica, well it is a TREATMENT not a drug! and depending on the ingredients they end up finalizing FDA approval may or maynot be needed. E.g. if they use EGf inhibitor drugs then there is a strong chance that FDA might step-in, however, something like lithium wouldn’t really need any FDA approval - at least I can’t think of any reason why.

In a scenario FDA approval is required it would be a lot quicker/faster than any drug. Just like with lasers (hair removal, skin resurfacing) they don’t have to go through 5 years of trials because, in a sense, they are topical treatments and they don’t affect the internal chemistry of the human body. Same goes for Follica!

Another thing to note is that FDA approval doesn’t always mean that drug is potentially dangerous or could have bad side effects. Some companies pursue FDA approval just to add a seal of authenticity to their marketing campaigns.


#13

» » »
»Dermabrasion…legal and performed every day and can be done with sandpaper at home

Finasteride…available on the internet (Genhair.com)

Minoxidil…Every grocery store in America

Arava…Available on the internet with no prescription. Simply an arthritis drug.

Anti-histamines…Every convienience store in America

Anti-bacterial and Anti-microbials…depends on what kind you use

Cyclosporin…you’d definitely need a prescript for that, but its not in every embodiment of the patent so they think you can grow hair without it apparently

Lithium Chloride…not mentioned in the “kit” patent, but obtainable via the internet and can be used as a table salt (but has long-term toxicity if you use it for several months)

Thats really it.

If Follica works in more than areas that already have hair and can make hair grow on bald scalp, the companies biggest fear is almost assuredly people coping the procedure at home, which indeed could be done rather easily if the procedure works. I imagine where people will phuck it up is putting stuff on their heads that will nullify the regenration process. I really think they intend for you not to even wash your hair for a good ten days post wounding.


#14

» Are you nuts? Yes, individual physician off-label use happens, but
» wide-spread protocols CAN NOT use drugs off-label.

What do you mean by ‘widespread’? Retin-A (and many other drugs), for example, was/is used ‘widespread’ for indications other than what it’s approved for. I never heard of dermatology clinics getting shutdown when they used Botox to treat wrinkles, even though it wasn’t approved for that for a long time.

Follica is not making drugs, marketing drugs, or selling drugs to treat MPB. They are performing a minor surgical procedure, which makes use of some already approved drugs during the healing process.

Follica hasn’t laid out their business model yet, but they may open clinics to perform procedures (much like the hair transplant chains), or they may license their procedure to individual dermatologists, who then offer the service to their patients.

If someone wants to walk into a dermatology office tomorrow and have a doctor slather prescription EGF receptor inhibitors on their skin, that’s perfectly legal. No FDA approval required. There is a ton of precedent backing this up.


#15

I’ll say this one thing…you can bet that (I dont mean to sound like ol’ John the Revelator here) some executives at Bosley in particular probably really will try to get the FDA to delay Follica or prod them into looking into it. I GUARANTEE you Bosley isn’t happy about this little find. Neither would the investors of Intercytex or any other entity like Aderans that has invested money in HM. If Follica really did “work like a charm”, it would put all other forms of hair replacement literally out of business overnight. If it does indeed “work”, one can forsee a time in the future where particular genes might be able to be topically blocked or interefered with during the ten or so days after the wounding, and thus the hair created would be very much donor-area-like as far as androgen response is concerned…a literal cure for baldness that some tech could perform.

I never really appreciated how crazy people could act over hair until I seen Stephen Foote “come out of retirement” and post a dire warning about how the FDA would never “approve” follica and there would not be “any remote chance” of this “ever being approved”. He was simply upset because Follica’s success in humans would forever destroy his alternative baldness theory. Even if it meant him growing no hair for his own damned head, you could tell he was literally hoping that something went awry in their trials. Some of the “resentment” against Follica and even ACELL on this board is no doubt from some people who have financially invested in Intercytex or Aderans and probably were counting on getting rich if those companies had success.

I dont give a damned how “hair replacement” is achieved, and would hang upside down at night to regrow my temples if I thought it worked.

I really feel that either Follica or more remotely, ACELL, represent the last chance to have real hair replacement for SEVERAL years…and I mean as many as ten years out there, for another kind of HM. In fact, if this or HM doesnt “work”, I think gene therapy would be decades away as I dont feel like any stimulant is going to regrow lost hair that doesnt wind up being cancerous or what not. Too much apoptosis has happened in those lost follicles and too much immunological response in the surrounding skin just make the environment uncondusive to regrowth. Bald men need “new” hair. So we all better hope THIS works.


#16

I just saw this video on bbc about the guy who regrew his finger

http://news.bbc.co.uk/2/hi/health/7354458.stm

When I heard about it on this board, I was thinking its probably finger look-a-like growth (since thats what happens with new research and eventually it gets better). But when I saw the pics of the new finger its looks just like a regular finger, no one can tell that the finger has been regrown from scratch - literally the entire tip of it!

I also noticed two things:

i) that guy mentioned that his new nail grows twice as fast as the other ones which means that in a way it re-energizes the whole organ i.e. resets the time clock on it or something.

ii) He said that it took just 4 weeks for the finger to complete and about 4 months for the nail. I find it hard to believe that he completely protected his finger from water, dust etc etc during that 1 month…so we probably won’t need to avoid water and such after dermabrasion either. And if the signaling is right, we shall see new fur!


#17

» I’ll say this one thing…you can bet that (I dont mean
» to sound like ol’ John the Revelator here) some executives at Bosley in
» particular probably really will try to get the FDA to delay Follica or prod
» them into looking into it.

That may happen, but with all the money on the line, I think Follica would have a team of high-priced lawyers arguing otherwise.

In any case, the FDA is now implementing new regulations that are essentially going to turn a blind eye to off-label usage of drugs. They were already lax before on this subject, and now they are going to be really lax. Read this article, which was published this month:

http://www.sciencedaily.com/releases/2008/04/080402181245.htm

FDA Plans To Reduce Oversight Of Off-label Drug Use Criticized By Medical Researchers

ScienceDaily (Apr. 6, 2008) — Proposed guidelines from the U.S. Food and Drug Administration would allow companies to market more drugs for unapproved uses and are a step in the wrong direction, said a researcher from the Stanford University School of Medicine.

In an editorial to be published in the April 3 issue of The New England Journal of Medicine, Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center, criticized the draft guidelines, which are subject to public comment through April 21. They curtail the FDA’s already limited authority over the marketing of drugs for off-label uses, Stafford said.

While most people assume that the medicines prescribed by doctors in the United States have the FDA’s stamp of approval, that’s only partially true. The FDA approves drugs for specific purposes, but doctors can use drugs “off-label” for medical conditions not approved by the FDA.

Off-label prescribing for medical conditions not scrutinized during the FDA approval process is common. There’s nothing illegal about off-label prescribing, and in many cases it’s good medicine, said Stafford, who directs Stanford’s Program on Prevention Outcomes and Practices. As long as the FDA has approved a drug for one condition, physicians are free to prescribe it for anything.

Unfortunately, what’s known about the use of a drug for one situation may not apply to other clinical scenarios. Stafford pointed to the use of antidepressants in children and the use of antipsychotic medications for dementia as key examples.

“The FDA should not suddenly start telling physicians how to practice. Physician judgment is critical, especially when approved therapies have not succeeded. Off-label prescribing can be an important tool in such cases,” he said. “But in other cases, off-label prescribing has become first-line therapy even in the absence of strong evidence of benefits and safety. This is problematic.”

Stafford said these types of situations suggest the need for a better way to evaluate and regulate off-label drug use. Ideally, he said, a drug company would go back to the FDA with additional clinical studies and obtain supplemental approval for a new clinical use.

Off-label drug use is already common, but applications to the FDA for approval of new uses are uncommon, said Stafford. This process may be seen as irrelevant by drug manufacturers, who have strategies for expanding their off-label markets and boosting drug sales without formal FDA approval.

Although FDA regulations restrict drug manufacturers from overtly promoting their drugs for unapproved conditions, they are free to share educational materials with physicians, most often as published journal articles. According to current FDA guidelines, this practice is acceptable, but only if the manufacturer submits the articles to the FDA for review and is pursuing formal FDA approval for the new use. In reality, however, FDA enforcement is limited, said Stafford.

The new draft guidelines further pull back FDA involvement by eliminating both of these requirements. In addition, they reduce the remaining policies to non-binding recommendations.

This concerned Stafford, who wrote in the NEJM editorial: “The FDA may be conceding to drug manufacturers the responsibility for regulating their own off-label marketing practices. The agency may also believe that its limited resources can be put to better or more effective use in confronting other ongoing challenges. Nevertheless, I believe that the FDA must take an active role in fostering evidence-based practice, eliminating subversion of the approval process, and requiring a balanced and fair presentation of the scientific evidence.”

One of the proposed guidelines’ major pitfalls, said Stafford, would be allowing drug manufacturers to skip obtaining approval for potentially lucrative drug uses. Instead, companies might seek approval only for a narrower use that’s more easily and less expensively tested, and sponsor research on more commercially promising uses that are never evaluated by the FDA. Stafford warned that this might encourage widespread treatment of conditions with drugs never approved by the FDA for those purposes.

Off-label use is already burgeoning. In a 2006 examination of off-label prescribing of 160 common drugs, Stafford found that off-label use accounted for 21 percent of all prescriptions and 73 percent of these uses had little or no scientific support (Archives of Internal Medicine, May 8, 2006). Drugs approved for depression, schizophrenia and seizures were most likely to be used off-label without adequate support for other conditions.

The FDA is accepting comments on the draft guidelines through April 21. Comments can be made online at http://regulations.gov, search for the docket “FDA-2008-D-0053” and use the “send a comment” option.

Adapted from materials provided by Stanford University Medical Center, via EurekAlert!, a service of AAAS.


#18

» Too much
» apoptosis has happened in those lost follicles and too much immunological
» response in the surrounding skin just make the environment uncondusive to
» regrowth. Bald men need “new” hair. So we all better hope THIS works.

I strongly believe if we remove the epidermal layer and allow it to heal properly, that should take care of most of the damaged skin. Combine that with a laser like Fraxel that rejuvenates dermal layer (where the hair root is) and we can improve existing skin a lot, probably back to its original stage!


#19

#20

"This will go into clinical trial in a year or two. " :frowning: