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Human trialss!


#1

so wait has follica started human trials already or not!!??? some people say yea and some say no!


#2

» so wait has follica started human trials already or not!!??? some people
» say yea and some say no!

they started a research study where they want to get biopsies from bald heads and see how it wounds afterwards and study the biopsies.

they do not plan to use any hair growth stimulation during that, and no hair growth is expected as well.

its not a trial of their product, its a research and they hope to find a drug and fill in IND in around 2-3 years time if I remember the timescale correctly. Then they will start trials.


#3

» » so wait has follica started human trials already or not!!??? some people
» » say yea and some say no!
»
» they started a research study where they want to get biopsies from bald
» heads and see how it wounds afterwards and study the biopsies.
»
» they do not plan to use any hair growth stimulation during that, and no
» hair growth is expected as well.
»
» its not a trial of their product, its a research and they hope to find a
» drug and fill in IND in around 2-3 years time if I remember the timescale
» correctly. Then they will start trials.

okay i dont know what do u mean by biopsies and “IND” but other then that… ohhhhhhhhh! lol oh anddd what is it that they are trying to figure out with this research?


#4

I heard,Follica makes a update of this trial in January!I’m right?


#5

» I heard,Follica makes a update of this trial in January!I’m right?

Haven’t heard that, but yeah they well may be


#6

» » » so wait has follica started human trials already or not!!??? some
» people
» » » say yea and some say no!
» »
» » they started a research study where they want to get biopsies from bald
» » heads and see how it wounds afterwards and study the biopsies.
» »
» » they do not plan to use any hair growth stimulation during that, and no
» » hair growth is expected as well.
» »
» » its not a trial of their product, its a research and they hope to find
» a
» » drug and fill in IND in around 2-3 years time if I remember the
» timescale
» » correctly. Then they will start trials.
»
»
» okay i dont know what do u mean by biopsies and “IND” but other then
» that… ohhhhhhhhh! lol oh anddd what is it that they are trying to figure
» out with this research?

they are trying o figure out what mixture of drugs to use to grow hair safely in humans. Thats how all human drugs start. They come up with something that they will have strong scientific evidence that it might work in bald scalps. Then they will propose drugs to be used, then they will fill in for IND (investigational drug application), get approval, and after all that, they are allowed to study the drugs on human volunteers and see what happens (ie start the human trials of the drug).


#7

» » so wait has follica started human trials already or not!!??? some people
» » say yea and some say no!
»
» they started a research study where they want to get biopsies from bald
» heads and see how it wounds afterwards and study the biopsies.
»
» they do not plan to use any hair growth stimulation during that, and no
» hair growth is expected as well.
»
» its not a trial of their product, its a research and they hope to find a
» drug and fill in IND in around 2-3 years time if I remember the timescale
» correctly. Then they will start trials.

The current research study (to test human scalp response to disruption) is an IND stage.
They must have already done the bulk of the IND work as IND’s are usually pre clinical animal studies which the IRB decide whether it would be safe and ethical to test in humans.
Folica have already done this with the mouse studies.
Follica have started testing in humans under this research study (which is unusual for IND as they are typically animal only studies, human studies are normally not untill NDA stage)
It is probable that they will continue another research study in a month or 2 adding in a topical compound or 2.

I put it to you that the Follica trials will be shorter than you or I expect, they are planning on applying for an IND within 1-2 years and then completing NDA stage 1-3 trials within 1-2 years after that.
I’m sure we will know how well this will work sooner rather than later.

They are not hopping to FIND a drug, they have found them.
They are reformulating them into a topical (hence IND, to see how safe say gefitnib cream is)
Then they need to find the most efficient dosages and corect time to administer them effectively, which is what they will be doing at NDA stage.

An NDA is essentialy FDA approval to comercialize a product.
Once they have their NDA they can sell their product and as they are reformulating existing drugs, that are already approved for other uses they still have to do phase 1-3 trials but they can be faster. (especialy if they show safety and efficiacy early on aswell (i.e at IND stage :stuck_out_tongue: ).

Taken from the NDA and IDA Wiki’s:

IND:

Criteria for application
A clinical study requires an IND if it is intended to support a:

New indication
Change in the approved route of administration or dosage level
Change in the approved patient population (e.g. pediatric) or a population at greater or increase of risk (elderly, HIV positive, immunocompromised)
Significant change in the promotion of an approved drug

The IND application must contain information in three broad areas:

Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).

Chemistry and Manufacturing Information - Information pertaining to the chemical composition, manufacturing methods, stability, and controls used for manufacturing the drug substance and the drug product. The chemical stability and activity of the product must also have been tested. This information is assessed to ensure that the company can adequately produce and supply consistent and active batches of the drug.

Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators–professionals (generally physicians) who oversee the administration of the experimental compound–to assess whether they are qualified to fulfill their clinical trial duties. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.

Application categories
There are two main categories of IND: Investigator-initiated, and Sponsor-initiated. Investigator-initiated INDs are used when a physician wishes to perform a clinical trial to study an unapproved drug treatment, for example a new indication for an existing drug. Sponsor-initiated INDs are filed by pharmaceutical companies studying new drugs or new uses for existing drugs. Both of these types of studies require approval by an institutional review board (IRB), an independent body constituted of medical, scientific, and nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial. The IRB must review, approve, and provide continuing review of the trials, protocols and amendments, and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

NDA:

Before trials
To legally test the drug on human subjects in the U.S., the maker must first obtain an Investigational New Drug (IND) designation from FDA. This application is based on pre-clinical data, typically from animal studies, that shows the drug is safe enough to be tested in humans.

Often the “new” drugs that are submitted are not new molecular entities, but old medications that have been modified.

Clinical trials
The legal requirement for approval is “substantial” evidence of efficacy demonstrated through controlled clinical trials. [1] This standard lies at the heart of the regulatory program for drugs. It means that the clinical experience of doctors, the opinion of experts, or testimonials from patients, even if they have experienced a miraculous recovery, have minimal weight in this process. Data for the submission must come from rigorous clinical trials.

The trials are typically conducted in three phases:

Phase 1: The drug is tested in a few healthy volunteers to determine if it is acutely toxic.
Phase 2: Various doses of the drug are tried to determine how much to give to patients.
Phase 3: The drug is typically tested in double-blind, placebo controlled trials to demonstrate that it works. Sponsors typically confer with FDA prior to starting these trials to determine what data is needed, since these trials often involve hundreds of patients and are very expensive.
(Phase 4): These are post-approval trials that are sometimes a condition attached by the FDA to the approval.

A quote from Zohar from a recent article (August 2008):

“Right now their money is funding a small human study which Zohar describes as “more of an investigator-sponsored trial.” And the company has enough money to push the program through proof-of-concept toward an NDA - a path that’s likely to take an accelerated development path that compresses the usual early and mid-stage trials into a 24- to 36-month window. An approval could conceivably be won in four to five years”

A quote from Zohar from Xconomy.com (In which Zohar is an editor)(August 2008):

“What’s so beautiful about the approach, [Zohar] 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.”

With the regulatory path relatively clear, Follica’s plan was to use its Series A money to quickly begin a small proof of concept study, involving 15 to 20 patients. Zohar yesterday confirmed that a pilot study is underway but wouldn’t confirm where or give any other details on its timing other than to tacitly stick to the timeline she laid out in January, when she said that final data from the study would not be available for at least a year. “Everything is progressing on track,” she now says. “We are moving as quickly as possible within the constraints of clinically driven medicine.”

Zohar also demurred when I asked about the reports in the reader comments on our story from January that the study only involves testing small patches of dermabrasion without administering any drugs to the wounds. In fact, she wouldn’t even confirm that the researchers were using dermabrasion to create the wounds in the first place. “At this point we are looking at the human response to disruption and the timing of the human ‘embryonic window’ post disruption,” she said. “Disruption,” she added, “is not necessarily the same as dermabrasion.”

From the earlier Xconomy article (January 2008):

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.

I highlighted the interesting parts :wink:


#8

]
»
» A quote from Zohar:
»
» “Right now their money is funding a small human study which Zohar
» describes as “more of an investigator-sponsored trial.”
And the company
» has enough money to push the program through proof-of-concept toward an
» NDA - a path that’s likely to take an accelerated development path that
» compresses the usual early and mid-stage trials into a 24- to 36-month
» window. An approval could conceivably be won in four to five years”

When did Zohar say this? I mean four to five years from which date?

Thanks


#9

Mamoli, It means Folica hope to have a product on the market with FDA approval within 5 years (of course lol, its always 5 years).

Which is almost in line with what histogen are doing (they are a bit behind folica in terms of development), they are saying around 7 years for their product Regenica.

Coisidently Folica and Histogen are both based off the same Dr Cotsarelis discovery.

The article was dated August 2008.


#10

» Mamoli, It means Folica hope to have a product on the market with FDA
» approval within 5 years (of course lol, its always 5 years).
»
» Which is almost in line with what histogen are doing (they are a bit
» behind folica in terms of development), they are saying around 7 years for
» their product Regenica.
»
» Coisidently Folica and Histogen are both based off the same Dr Cotsarelis
» discovery.
»
» The article was dated August 2008.

5 years,its very long,i think:-|
It could be a poker game with TRC or others,nobody know’s :wink:


#11

yes, seems like everything is always 5 years away if at all. :expressionless:

Hopefuly Baccy and the others doing the experiments at home will have some good luck sooner.


#12

Just thought I’d post this here, another interesting quote from one of the above articles:

“What’s nice about it,” she adds, “is that even though this is based on breakthrough science, we are using existing compounds previously approved for systemic chronic use and reformulating them for topical acute use. We know these compounds are safe in people.”