“What’s so beautiful about the approach, she says (ZOHAR), 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 yearZohar 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."
Zohaz says the drugs are (normally) taken orally so it looks like they are using them in a topical form for the test.
These are the reasons I thought that Follica could get to human testing rather quickly instead of waiting on the FDA guys.
The FDA cannot retroactively go back and dissallow a drug that it has approved for INTERNAL comsumption. Dermabrasion is NOT UNDER FDA PURVIEW anway. There is nothing the FDA can do to regulate dermabrasion, even if it wanted to.
There are no “injections” in this proposed procedure. The patent allows for wnt-inhibitors and wnt-agonists to be used both internally or even topically applied. The FDA could sooner gripe about botox INJECTIONS before they could gripe about this.
So hopefully, a human trial will commence very shortly so Follica (and us) can find out if this thing is a go in human beings.
We DO KNOW that it grew hair on human skin grafted onto a mouse’s back, and it grew HUMAN hair when the hair grew. That is what got me really interested that there actually may be something to it. I must admit I did get a bit discerning when they first claimed that they grew hair on a genetically hairless mouse also. Growing hair where there had been no hair whatsoever, even vellus hair. We will see, they may fall on their faces. But they certainly seem confident that they have a winner, or they wouldn’t be moving forward with any testing whatsoever
Anyone remember that article about the powder sprinkled on a wound resulting from a severed a fingertip, that grew the fingertip back?
Sounds like a similar approach–might they be using that same powder?