I want to see a press release saying that Aderans has started Phase I. I'd also like to see something from Intercytex officially announcing that they have started Phase II.
The FDA takes a very long time, even after the drug has passed all 3 phases. After the trials are all done, the FDA has a year to do its review. They take every bit of that year.
When drug companies say 4 years to market, they are allowing 1 year for each Phase and then 1 year for FDA review. It gets so depressing when you read the statistics on how few drugs make it to market .
Follicle neogenesis, a bio engineered hair loss solution, is not many years away; in fact, it is likely that before the end of this decade patients will have access to hair multiplication technology. We anticipate that it will be, like many cosmetic procedures, a same-day, in-office procedure.
Follicle neogenesis, a bio engineered hair loss solution, is not many years away; in fact, it is likely that before the end of this decade patients will have access to hair multiplication technology. We anticipate that it will be, like many cosmetic procedures, a same-day, in-office procedure.
A same day in-office procedure???? I am assuming they are talking about just implanting the new follicles, and not the process of multiplying them in the first place. It would probably require them sampling some follicles and then culturing them or multipying them over an extended period of time prior to the surgery.
Yes, Terri. They would culture cells from the hair that grows on the back of your head, the hair that is not vulnerable to pattern baldness, and make new hair follicles where you need them.
In theory, enough new hair follicles could be created to fill in large areas of balding.
I want to see a press release saying that Aderans has started Phase I.
This is from Aderans' Annual Report (2006):
To date, progress has been on track. ARI completed preclinical trials with animals, which paves the way for Phase I human clinical trials. At present, the company is engaged in preparing applications to gain approval from th U.S. Food and Drug Administration for the Phase I clinical trial. Therefore, a practical date for commercialization will be in 2008 or later, and efforts are directed earnestly toward this goal.
2008 sounds very optimistic to me. I mean: Intercytex are about to start Phase II trials, and their estimate is that their product will hit the market in 2010. ARI have not yet started Phase I trials, so I don't think their product will be on the market in 2008. However: This is the second time since April that they have said that they are aiming for a 2008 release, so maybe they know more than they're letting on...
There is some kind of conference in London tomorrow. Someone from Inercytex is going to participate. (Maybe they're gonna announce the start of Phase II trials...???)
A poster on another hair forum summarised the main points as follows:
-The induced hairs were aesthetically indistinguishable from those of the epidermal donor in length, thickness, and pigmentation, and they were also histologically normal.
-The hair grows and cycles like normal hair.
-Intercytex says that they are able to do 7 passages but will only need 3 to do a full head of hair. 3 passages = multiplication factor of 4000
-A japanese company called Shiseido Co. says they found a way to do more than 30 passages.
-Korean study shows that fin doesn't effect dht or t on occipital follicles(donor hair area) That means we wouldn't have to stop our drug habbits before getting HM.
There are still a few points that need clarification:
- What about direction?
- We know that the new hair grows and cycles normally for one year. What happens afterwards?
- And most importantly: When will it be available???
Man, this seems like it is more and more becoming a reality.
I still think that this would be combined with a regular transplant and would be used as a "filler."
"Korean study shows that fin doesn't effect dht or t on occipital follicles(donor hair area) That means we wouldn't have to stop our drug habbits before getting HM."
It means that you won't have to stop using finsateride months before an HM procedure.
I still think that this would be combined with a regular transplant and would be used as a "filler."
I also think that the first generation of HM won't be perfect. However, if the multiplication factor is really 4000, then you would not need a regular transplant.
If there are issue concerning direction of growth and such then how would they create a natural looking hairline without a typical transplant procedure.
Don't get me wrong: I did not say there were any issues concerning the direction of growth. I merely pointed out that the summary of the conference did not address that particular issue. In fact, I read somewhere that direction is no longer a problem.
I think this is the first time that one of these companies has revised their timeline in our favour. (Not too long ago they said that they expected their product to hit the market in 2010.)
News from Intercytex: This is an e-mail that someone posted on another hairloss forum:
We will be using the Norwood scale but only to guage the success
ICX-TRC in trials - the only limiting factor is if someone has no hair
at all because the procedure requires a tiny biopsy from which to
culture cells for injection back into the skin.
We are involved with the FDA and the other regulatory agencies in the
world. What they are trying to decide at the moment is how cell therapy
products should be regulated and the jury is out at the moment. This
will impact on the nature of the trials we conduct and when the products
get to market.
I hope that this is helpful.
Kind regards
Katharine Harris
Corporate Communications
I'm a bit surprised that they don't know yet how cell therapy products should be regulated. I mean: They've already completed Phase I trials and are about to start Phase II. (Didn't they say back in May that they wanted to start Phase II by the end of the month? Maybe this e-mail explains the delay.)
Let's hope that all goes well and that a product that has been proven to be safe and efficient hits the market as soon as possible.
There are a lot of rumours going around about HM. Apparently Intercytex want to skip phase III trials in order to get their product on the market in the UK in 2008.
The latest rumour I've heard about ARI is that they want to launch their product in... OCTOBER 2007!!!
(No, I don't believe it either...)
News wrote:There are a lot of rumours going around about HM. Apparently Intercytex want to skip phase III trials in order to get their product on the market in the UK in 2008.
The latest rumour I've heard about ARI is that they want to launch their product in... OCTOBER 2007!!!
(No, I don't believe it either...)
I suspect that Intercytex going to market will be similar to what another company, Isolagen, is doing in the UK with facial rejuvenation.
Isolagen takes cell samples from patients, cultures that person's fibroblasts, and reinjects them to fill in wrinkles and facial scars. They are allowed to do this in the UK, but not in the U.S.
Isolagen is having to go through the FDA trial process to bring their procedure to the U.S. So, while they are going through trials to bring it to the U.S., they are making money and gaining experience by offering the procedure in the U.K.
Intercytex has a similar facial rejuvenation procedure in trials and, of course, they have the hair thing. It does not seem far fetched or unreasonable to me that they would start offering this in the U.K. before FDA trials are complete.
Intercytex will start their phase II trials in late August / early September. These are two e-mails from Intercytex:
Intercytex are hoping to hold their phase II clinical trial with
ICX-TRC, a new hair regeneration product, at the Farjo Medical Centre in
Manchester, UK in late August/early September 2006.If you are interested
in participating please contact the clinic at the following address
where your details will be logged until further trial information is
available and can be sent to you.
Farjo Medical Centre
Arthur House
Chorlton Street
Manchester
UK
Tel: 0870 7555 495
e-mail: info@farjo.com
Thank you again for your query.
The Phase II trial for ICX-TRC is due to start shortly and although I
cannot say precisely when, it will be about mid 2006. There is a wealth
of protocol that surrounds clinical trials before they commence (mainly
for the patients' protection you will be pleased to know) which is what
we are finalising now. Please do keep an eye on our website which will
provide updates when we have them. Trial results will probably be
forthcoming later this year or in 2007.
Cell therapy products are regulated by the same agencies that regulate
drugs and medical devices. The different agencies view cell therapy
products in different ways and because they are new products - it is not
fixed or finalised yet. The way a product is regulated dictates the
nature of the trials and ultimately how long it takes to get a product
to market. Legal directives may also have an impact - so it is a
complicated process. In the UK, ICX-RHY may be unregulated - this means
fewer and shorter trials before it can go onto the market. This is a
specific position for ICX-RHY in the UK and it may not translate to
ICX-TRC, although ICX-TRC is also a cell therapy product.
I am sorry if this is a somewhat frustrating answer - it is just a
complicated process. "
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