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What are ARI and Washenik actually doing?


#1

I just read an interview with Washenik from 2004 and I have to say it was damned informative. He gave clear concise, scientifically backed information with a heavy focus on realism, presenting the difficulties faced and so on. However it can (and has) been claimed that Ken is a publicity hound who has produced diddly squat. He said in 2003 "Yeah HM in 5 years ", which has lead to a lot of cynicism regarding all HM on this board.

What is the state of the ARI protocol? There have been patents issued and a Phase 1 that may or may not have already started. Washenik mentioned they were preparing to submit their findings to the FDA, do you have to do that before starting human trials?

ARI have stated that their goal is no less than to replicate the follicle formation that takes place during foetal development. This is a massive task, and if done, the research could be taken up by other scientific disciplines. Dr Kemp on the other hand, stated that are not really that bothered in going that deep- they are just looking to get the hair growing again. At least this is the impression I got from my laymans perspective.

There seems to be practically zero interest in ARI on this board.

Opinions?

EDIT: To somewhat answer my own question, I did a bit of googling and found this site which I’ve never seen before (although it is probably old hat to some of you). The press release is dated July 06 which is almost a year ago now.

http://www.clinicalhairtrial.com/home.htm

I’ve emailed them with a few questions, what is the current state of the trial, when are results due, blah blah blah. If I get a response I will post it here.


#2

» I just read an interview with Washenik from 2004 and I have to say it was
» damned informative. He gave clear concise, scientifically backed
» information with a heavy focus on realism, presenting the difficulties
» faced and so on. However it can (and has) been claimed that Ken is a
» publicity hound who has produced diddly squat. He said in 2003 "Yeah HM
» in 5 years ", which has lead to a lot of cynicism regarding all HM on this
» board.
»
» What is the state of the ARI protocol? There have been patents issued and
» a Phase 1 that may or may not have already started. Washenik mentioned
» they were preparing to submit their findings to the FDA, do you have to do
» that before starting human trials?
»
» ARI have stated that their goal is no less than to replicate the follicle
» formation that takes place during foetal development. This is a massive
» task, and if done, the research could be taken up by other scientific
» disciplines. Dr Kemp on the other hand, stated that are not really that
» bothered in going that deep- they are just looking to get the hair growing
» again. At least this is the impression I got from my laymans
» perspective.
»
» There seems to be practically zero interest in ARI on this board.
»
» Opinions?
»
» EDIT: To somewhat answer my own question, I did a bit of googling and
» found this site which I’ve never seen before (although it is probably old
» hat to some of you). The press release is dated July 06 which is almost a
» year ago now.
»
» http://www.clinicalhairtrial.com/home.htm
»
» I’ve emailed them with a few questions, what is the current state of the
» trial, when are results due, blah blah blah. If I get a response I will
» post it here.

Well aderans chosed not to speak much about their current status. They do not give any major updates. They do not release much information about HM in their yearly reports but they primarily focus on the wigs. It is logical they started human trials last year so this year it could be for the first time when they have something viable to tell to public. Though I seriously doubt they will. It is too early, they are going through safety / small scale (ie few mm squared or max 1 cm squared test areas). There is thus a quite huge probability that the results wont be any astonishing but rather will just give them some feedback that would tell them: oh yeah, this might work if we work on it litthe further.

Anyway we will see tommorrow. I think that they could make much more money in HM than they do in wigs. They can price hm to the price of wigs worth of 10 years mainterance/repurchasing costs and still there will be much more people who will be willing to sign this devils contract than are there now willing to wear some glued hairpiece.


#3

LONDON - CHOSEN LOCATION FOR PIONEERING CLINICAL STUDY

Source: InterMark Associates, Ltd.

Aderans Research initiates Phase 1 clinical trial

for autologous cellular treatment of hair loss

UK plans are unveiled for the commencement of Phase 1 clinical studies for the treatment of hair loss using unique tissue engineering techniques

London, United Kingdom, July, 2006 – Aderans Research, the specialist tissue engineering research group for hair loss, has announced plans for the commencement of London based clinical studies for the treatment of hair loss using its unique tissue engineering technique, a bio engineered hair loss solution that cultivates a persons own cells to overcome the problem of insufficient hair supply and pattern baldness.

The Aderans Research proposed solution has received Guy’s and St Thomas’ and King’s hospital approvals by the East London and the City research ethics committee for the Phase 1 trial. Subjects taking part in the study will be treated at private clinics located at London Bridge hospital and Harley Street.

The treatment under study proposes to overcome a key limitation of conventional surgical hair transplantation by creating new hair growth. Current procedures are limited by one central problem – each patient has only a finite number of hair follicles for redistribution with approximately 100,000 follicles in place at birth. Thus, once hair loss starts, the head of hair that each person has at that moment in time is the most hair that they can expect for the rest of their lives.

With the Aderans Research proposed technique, clinicians may be able to grow as many of the person’s own cells as necessary to increase normal hair growth and the treatment can be repeated to ensure high quality hair restoration results.

Under the Aderans Research process, doctors use a minimally invasive biopsy procedure to remove a small amount of tissue from the scalp. Hair forming cells are extracted and allowed to multiply under tightly controlled cGMP laboratory conditions. Once sufficient new cells are formed, they are then injected into the patient’s scalp with a tiny needle.

Aderans Research, in conjunction with InterMark Associates Ltd, the medical technology consulting specialists and clinical research organisation (CRO) for the study, have identified lead investigators to initiate the clinical trials for the application of the new treatment for hair loss. Mr Chris Inglefield, a leading plastic and reconstructive surgeon, based at London Bridge Hospital, is the principal investigator and Dr Alan Kingdon, medical director of the cosmetic surgery clinic in Harley Street, London, the co-investigator. Dr Mark Lewis, director of research operations at the Eastman Dental Institute of University College London, will act as the study’s medical monitor.

Mr Chris Inglefield, commenting on the trial, said: “This unique process aims to provide hair growth for both men and women who are not catered for by current hair transplant and surgical techniques. By harvesting and expanding the hair cells to many millions, this process may be able to restore normal hair density.”

Dr. Mark Lewis added: “Although a great deal of biological research has been, and continues to be, conducted into autologous cell therapies, the number of actual patient interventions available remains low. This trial represents the cutting edge of cell engineering investigations with the subjects own hair follicle cells (comprising 2 cell types) being placed into their balding scalp.”

Robert Sexauer, managing director of InterMark Associates, said: “The Aderans cellular engineering and treatment process may emerge as a significant contribution to the expanding medical use of a person’s own cells for restorative purposes.”

http://www.intermarkltd.com/
http://www.cjinglefield-plasticsurg.com/


#4

Washenik went out there and made some bold statements about how early he expected HM to be available…and then like Gho found it more complicated than he had imagined to bring to fruition. So many of us, based on things he said early this decade, thought that there would be HM available by around…now.

Its only now in phase two tests, and Aderans has finally entered its phase one safety tests. People who are led to believe something will happen on X date, only to find that date to be a good five years or so premature, are naturally going to be a little dissapointed. I suspect the mood around here will pick up considerably if ICX has a couple of pretty good results in their current tests and puts out a pic or two of those results. If we saw a pic of a guy who filled in a bald spot with his own cells…we’d be much more optomistic. I hope thats coming before year’s end or at least a favorable report of hairgrowth.


#5

I have wanted to say this for some time.In all farness to these companies claiming to be working on a bald cure using cells,none of them have made any promises or bold statements in regards to their progress or a release date. Companies like intercytex have been very,very,very conservative in their release of information,they are vague to the point where I have no belief in them.The only people hyping HM & making bold claims are the “experts” on this forum who think they know more about HM & it’s progress then the people that are actually working on a cure.


#6

» I have wanted to say this for some time.In all farness to these companies
» claiming to be working on a bald cure using cells,none of them have made
» any promises or bold statements in regards to their progress or a release
» date. Companies like intercytex have been very,very,very conservative in
» their release of information,they are vague to the point where I have no
» belief in them.The only people hyping HM & making bold claims are the
» “experts” on this forum who think they know more about HM & it’s progress
» then the people that are actually working on a cure.
That not true, Washenik himself claimed that HM would be out by so and so date in different interviews. Of course once those dates actually near, he pushes back his prediction back a a year or two to keep stringing us along.


#7

» That not true, Washenik himself claimed that HM would be out by so and so
» date in different interviews. Of course once those dates actually near,
» he pushes back his prediction back a a year or two to keep stringing us
» along.

That’s right. In 2004 he predicted that it would be available “in three to four years” (i.e. NOW), and in a recent TV interview (with Donny Deutsch) he said it was gonna be available in “late 2009 / early 2010”.
Unfortunately he did not elaborate on his latest prediction. (If ARI have only just started phase I, there is no way it’s gonna be ready in just over two years.)


#8

»»
» That’s right. In 2004 he predicted that it would be available “in three to
» four years” (i.e. NOW), and in a recent TV interview (with Donny Deutsch)
» he said it was gonna be available in “late 2009 / early 2010”.
» Unfortunately he did not elaborate on his latest prediction. (If ARI have
» only just started phase I, there is no way it’s gonna be ready in just
» over two years.)

News,

This is precisely what I mean. I remember reading about Washenik around 2002-ish, and by the tone of the interview (remeber this isn’t too long after Dolly the cloned sheep) I felt like this Washenik guy expected cloning to be the cure for baldness by sometime mid-decade. I remember feeling very confident about it.

Damon is right about ICX however, they have been conservative in what they have put out. We were all dissapointed that it took three years to begin phase two trials after phase one, which is unusually long, but they did get there. HM has been hyped by Webmd and a few other sources for a few years now. Its not as if people have “given up”, its just that breathless news reports made it seem as if it were just a couple of years away since about 03 or so. This is of course frustrating to those who want it badly.


#9

Guys,correct me if I am wrong but wasn’t he a medical director for Bosley when he made those claims ?
Was he even in a position to make such a prediction ? Was he privy to information that no one else had or was he just expressing his point of view ?


#10

» Guys,correct me if I am wrong but wasn’t he a medical director for Bosley
» when he made those claims ?
» Was he even in a position to make such a prediction ? Was he privy to
» information that no one else had or was he just expressing his point of
» view ?

This is his bio via Aderansresearch’s website,

Ken Washenik, MD, PhD
Executive VP,
Scientific and Medical Development

Ken is the former Director of the Dermatopharmacology unit at the New York University School of Medicine. He also serves as Medical Director of Bosley.

I remember when he was a lecturer based at NYU who was speak at various hair conferences…then he went to Aderans to research HM, and later Aderans bought out Bosley and they made him medical director (probably as a PR move, he doesn’t perform any surgeries----but hairloss sufferers look to him as "one of the cloning scientists, etc.).


#11

Til this very day the human body is mostly a mystery.There are an infinite amount of stumbling blocks that can arise during clinical trials.For any one person to get up & make such predications says allot about the persons motives.


#12

Bloody quick response as well…

Dear XXXXX,

Thank you for your inquiry. The trial has been underway for approximately
14 months and progressing well. Due to confidentiality, I cannot disclose
details of the trial. It will be up to the sponsor of the trial, Aderans
Research Inc., to disclose details of the trial once they have been
presented to the various regulatory agencies. If a Phase 2 trial will take
place, it is likely to be planned for sometime in 2008. You are welcome to
contact the sponsor, Aderans Research, and advise them of your potential
interest in taking part in further trials.

Best regards,
XXXX XXXXX

-----Original Message-----
From: XXXXXXXXXXX
Sent: Thursday, June 21, 2007 3:20 PM
To: info@intermarkltd.com
Subject: Hair Restoration Clinical Trials.

Hello,

Regarding your hair loss trials; I was hoping if you would be kind enough to
answer a few questions I have.

  1. Has the phase 1 trial started yet? The website
    (ww.clinicalhairtrial.com/home.htm) is dated July 2006 and I presume there
    has been progress since then?

  2. Can you confirm the extent of the treatment of the Phase 1 trials? Are
    you testing on a small ‘test patch’ of scalp?

  3. When are results due? Will they be made publically available? If Phase
    1 trials are closed or finished is there a chance to gain entry to phase 2?

Regards,


#13

» Bloody quick response as well…
»
»
»
» Dear XXXXX,
»
» Thank you for your inquiry. The trial has been underway for
» approximately
» 14 months and progressing well. Due to confidentiality, I cannot
» disclose
» details of the trial. It will be up to the sponsor of the trial, Aderans
» Research Inc., to disclose details of the trial once they have been
» presented to the various regulatory agencies. If a Phase 2 trial will
» take
» place, it is likely to be planned for sometime in 2008. You are welcome
» to
» contact the sponsor, Aderans Research, and advise them of your potential
» interest in taking part in further trials.
»
» Best regards,
» XXXX XXXXX
»
»
» -----Original Message-----
» From: XXXXXXXXXXX
» Sent: Thursday, June 21, 2007 3:20 PM
» To: info@intermarkltd.com
» Subject: Hair Restoration Clinical Trials.
»
»
» Hello,
»
» Regarding your hair loss trials; I was hoping if you would be kind enough
» to
» answer a few questions I have.
»
» 1) Has the phase 1 trial started yet? The website
» (ww.clinicalhairtrial.com/home.htm) is dated July 2006 and I presume
» there
» has been progress since then?
»
» 2) Can you confirm the extent of the treatment of the Phase 1 trials?
» Are
» you testing on a small ‘test patch’ of scalp?
»
» 3) When are results due? Will they be made publically available? If
» Phase
» 1 trials are closed or finished is there a chance to gain entry to phase
» 2?
»
» Regards,

We may have some informations in the annual report. I mean, 14 months are more than enough to know the status of the trial.

If it went well and they start phase 2 in 2008, it means that Intercytex has at least 1.5 years ahead. But you never know, if it goes bad for ICX, Aderans might win the race…

Can’t wait to read the annual report!


#14

Why does phase 1 need 14 months? That’s long, Intercytex only needed 12 months for their phase 1. At this speed, there will be nothing from ARI until at least 2010.


#15

» Why does phase 1 need 14 months? That’s long, Intercytex only needed 12
» months for their phase 1. At this speed, there will be nothing from ARI
» until at least 2010.

ICX may have taken 12 months for phase I, but at 6 persons/year for phase II, they will take 10 years to have 60 persons to complete phase II :slight_smile:


#16

» Why does phase 1 need 14 months? That’s long, Intercytex only needed 12
» months for their phase 1. At this speed, there will be nothing from ARI
» until at least 2010.

Didn’t ICX Phase one take 2.5 years? Anyway, I believe the reason these Phase 1 trials take so long is that they need to ascertain if the hair will cycle, as HM would be pretty useless if all the new hair fell out again after the 9 month hair cycle.

It’s interesting that Aderans are trialing in the UK, considering that Washenik mentioned several times in interviews about how they were getting ready to submit their findings to the FDA before they started human trials, and now they are in UK instead?


#17

» Didn’t ICX Phase one take 2.5 years? Anyway, I believe the reason these
» Phase 1 trials take so long is that they need to ascertain if the hair
» will cycle, as HM would be pretty useless if all the new hair fell out
» again after the 9 month hair cycle.
»

I don’t think ICX cares whether the hair will cycle or not. All ICX wants is to satisfy the regulartory authority and I doubt they said the hair has to cycle well or they will not approve the process.


#18

» » Why does phase 1 need 14 months? That’s long, Intercytex only needed 12
» » months for their phase 1. At this speed, there will be nothing from
» ARI
» » until at least 2010.
»
» Didn’t ICX Phase one take 2.5 years? Anyway, I believe the reason these
» Phase 1 trials take so long is that they need to ascertain if the hair
» will cycle, as HM would be pretty useless if all the new hair fell out
» again after the 9 month hair cycle.
»
» It’s interesting that Aderans are trialing in the UK, considering that
» Washenik mentioned several times in interviews about how they were getting
» ready to submit their findings to the FDA before they started human trials,
» and now they are in UK instead?

Yes, it took 2.5years. I’m not sure if it was to see the hairs cycling or if there was a certain problem to fix. Anayway, I guess, they continued to work on the process during those 2.5years and they should have been better and more knowgeable for the start of phase II last september.

As far as Washenik goes, I’ve alway heard him saying USA first, but I don’t think it will be USA first. Or maybe the FDA wasn’t answering fast enough and they decided to go to the UK because they were ready to start. Maybe they will make their UK’s trial approved later by the FDA. Because, ICX is doing that right now; they do the trial in the UK and they will get approved by the FDA later.


#19

» I don’t think ICX cares whether the hair will cycle or not. All ICX wants
» is to satisfy the regulartory authority and I doubt they said the hair has
» to cycle well or they will not approve the process.

Phase I trials are just safety trials anyway. They’re basically meant to determine if the product is safe enough to subject more people to it in phase II.


#20

» Bloody quick response as well…
»
»
»
» Dear XXXXX,
»
» Thank you for your inquiry. The trial has been underway for
» approximately
» 14 months and progressing well. Due to confidentiality, I cannot
» disclose
» details of the trial. It will be up to the sponsor of the trial, Aderans
» Research Inc., to disclose details of the trial once they have been
» presented to the various regulatory agencies. If a Phase 2 trial will
» take
» place, it is likely to be planned for sometime in 2008. You are welcome
» to
» contact the sponsor, Aderans Research, and advise them of your potential
» interest in taking part in further trials.
»
» Best regards,
» XXXX XXXXX
»
»
» -----Original Message-----
» From: XXXXXXXXXXX
» Sent: Thursday, June 21, 2007 3:20 PM
» To: info@intermarkltd.com
» Subject: Hair Restoration Clinical Trials.
»
»
» Hello,
»
» Regarding your hair loss trials; I was hoping if you would be kind enough
» to
» answer a few questions I have.
»
» 1) Has the phase 1 trial started yet? The website
» (ww.clinicalhairtrial.com/home.htm) is dated July 2006 and I presume
» there
» has been progress since then?
»
» 2) Can you confirm the extent of the treatment of the Phase 1 trials?
» Are
» you testing on a small ‘test patch’ of scalp?
»
» 3) When are results due? Will they be made publically available? If
» Phase
» 1 trials are closed or finished is there a chance to gain entry to phase
» 2?
»
» Regards,

Cockneyninja,
Where did you find that email address (info@intermarkltd.com) for Aderans?