Category Archives: Intercytex

Aderans and Intercytex: Hair Multiplication Failures

In a first for this blog, I am updating a post from ten years ago! Perhaps I should change the title and remove the word “failure”? I wonder how many of the original 15 commentators are still visiting this site?

Update: March 9, 2024

Stemson Therapeutics Aderans Licensing Agreement
Stemson Therapeutics (US) and Aderans (Japan) new licensing agreement. Screenshot from Nikkei Asia.

Stemson Therapeutics and Aderans Announce Licensing Deal

Earlier today, Stemson Therapeutics (US) and Aderans (Japan), the parent company of Bosley® and HAIRCLUB®, announced a partnership agreement (licensing deal).

This arrangement secures Stemson the exclusive global rights to research, develop and commercialize hair regeneration therapeutic products based on Aderans’ proprietary hair regeneration cell therapy technology. Note that Aderans and and Intercytex represented the only two major hopes for a hair loss cure throughout the 1990s and early 2000s. And then companies both folded and made me originally write this post a decade ago.

Stemson today likely represents the number one hope for a hair loss cure, although there are a number of other contenders in China, Japan, South Korea and the US. At least when it comes to much improved hair loss treatments

Getting back to Stemson, the company is developing a proprietary cell therapy for reversing hair loss that is based on induced pluripotent stem cells (iPSC). Per the press release, it now:

“Gains a complementary technology through this agreement. Stemson will resume Aderans’ Phase 2 clinical stage cell therapy hair regeneration program, integrate the technology into its existing hair loss cell therapy development pipeline, and provide multiple products for patients experiencing hair loss.”

What a great development. Aderans is back from the dead. It also seems like a backup plan for Stemson in case its main iPSC technology does not pan out. Moreover, Stemson seems to want to resume Phase 2 trials for Aderan’s hair regeneration technology. And Japan has more favorable regenerative medicine sector regulations when it comes to trials and in-clinic use.

Quote from Stemson CEO Geoff Hamilton:

“The synergies between the Aderans technology and Stemson’s in-house technology will help us accelerate timelines across our programs.”

Quote from Aderans CEO Yoshihiro Tsumura:

“We look forward to working with the Stemson team to enable their development efforts and to support the commercialization through our global network of clinics serving hair loss patients.”

Quote from the evergreen Ken Washenik (Chief Medical Officer of Bosley Medical and former CEO of Aderans Research Institute):

“Our pioneering work at the Aderans Research Institute to develop the first ever cell therapy solution for hair loss showed tremendous promise in clinical trials to treat early stage Androgenetic Alopecia in men and women. We believe Stemson, with their advanced expertise in hair follicle cell and tissue engineering, is ideally positioned to successfully complete development and commercialization of this exciting hair regeneration solution.”

November 25, 2014

Aderans and Intercytex: Hair Multiplication Failure

All the great news this year related to hair loss research, trials and potential cures has made people very optimistic. However, a lot of hair loss sufferers are becoming excessively passionate about a select few companies (especially Histogen and Replicel) or about the results from a select few clinical trials.

I therefore decided to write this post as a warning from past experiences of putting too much faith into any one or two entities. Something as simple as lack of sufficient funding despite successful stage 2 clinical trials can cause a company to stop pursuing highly promising products.

In the early-to-late 2000s, two companies named Aderans (Japan) and Intercytex (UK) caused tremendous excitement in all the online hair loss forums. Both were involved in groundbreaking research related to hair cloning and hair multiplication.

Moreover, Aderans’ research was led by the renowned Dr. Ken Washenik through the Aderans Research Institute. He made numerous presentations about their technology at various conferences. Below are two of those:

However, in 2013, Aderans decided to liquidate its research institute. Spencer Kobren had a segment about this on his usually weekly Bald Truth show. Also starring legendary hair loss sufferer and caller “Joe from Staten Island”.

Intercytex abandoned its dermal papilla cell culturing work in 2010 due to financial difficulties, despite positive results from phase 1 trials. According to the company’s website, in 2010 the Intercytex name and ICX-RHY were purchased by private investors and relaunched as Intercytex Ltd. ICX-RHY is a skin repair product.

As of 2014, Aderans’ research is focused on wigs and hair replacement. They purchased US-based hair restoration market leading companies Hair Club in 2013 and Bosley in 2001. Intercytex as a company is no longer in existence.

HairClone’s CEO Dr. Paul Kemp Provides Feedback

FYI — Dr. Paul Kemp is answering reader questions in the comments.

Paul Kemp of HairClone Provides More Details

Paul Kemp
Paul Kemp, CEO of HairClone.

After I published a post on new company HairClone several weeks ago, I got an unexpected (but welcome) e-mail from the company’s CEO Dr. Paul Kemp. I responded to Mr. Kemp’s e-mail, he replied back, and I am pasting most of the contents of our communication below. Mr. Kemp offered to share some presentation slides with me, but I was on vacation and preferred waiting till returning home. I will probably get in touch with him again soon, although I am unsure if I want to devote a third post to HairClone in just one month.

In our e-mail correspondence below, I learnt some very interesting things, and perhaps the most surprising of these was the fact that Paul Kemp was formerly the founder and CEO of Intercytex. I covered Intercytex in the past and read about the company numerous times many years ago, but had completely forgotten ever reading Mr. Kemp’s name. In Mr. Kemp’s e-mails, the parts about UK clinical trials potentially moving along faster and about the Hiroshima University technology licensing are very interesting.

I am highly skeptical of HairClone moving along faster than the Tsuji team or Shiseido (both in Japan), but I find Dr. Paul Kemp to be sincere, and, without any doubt whatsoever, his past 2-3 decades of experience in this type of work makes him extremely well qualified. Maybe if I end up seeing Mr. Kemp’s presentation slides I will get more interested in HairClone, but I suspect I need to brush up on my scientific knowledge before checking out those slides.

Mr. Paul Kemp’s first e-mail to me:

“Thanks for mentioning us on your blog and I just wanted to offer to find a way to answer some of the responses in a hopefully constructive way. I would therefore be very happy to chat with you and answer any questions that you may have.

We are certainly not a “get rich quick” or “snake oil” company which is one of the main reasons that we have taken the investment approach that we have. We have been involved at a senior level in a number of biotech companies and have had an enormous amount of experience in raising VC and other funds. We have seen first hand how the influence of all this investment can misdirect the work and how management can lose control of what they feel should be done in return for short term gains.

We wanted to do something different here and involve those directly involved in developing this treatment so that things weren’t abandoned if things needed more work. As well as raising funds and operating biotechs, we have also between us run around 20 different cell therapy clinical trials in the US and Europe.

Some of these have resulted in approved therapies, but we also understand the huge expense and risk of failure in this approach. As you know, several companies have shown less than optimum responses with this “one shot” clinical trial approach when trying to develop a cell therapy for hair regeneration and have dropped out.

All the funds that we raise will go into the development of a treatment and the intention is that we will take small iterative steps, combining increases in our understanding of how dermal papilla cells change during cell culture and how to minimize these changes during multiplication and how these cultured cells will behave and interact with hair follicles when re-implanted in the scalp.

Only when we have a process and treatment that works in the clinic, will we then use this information to design a full clinical trial which will then have a much greater chance of success.

I am very happy to discuss this in detail if you are interested and hopefully we can convince you that our approach is genuine and has a much higher chance of success than previous attempts.

regards

Paul

Paul Kemp PhD
Founder, Chief Executive Director”

My Response to Mr. Paul Kemp’s first e-mail to me:

“Hi Dr. Kemp!

Thanks for your e-mail.

I am currently travelling, but would still like to talk to you when I return.

I have to admit that I am skeptical about your company because you are a ways away from commencing clinical trials, and there are others such as Dr. Tsuji/RIKEN, Shiseido and Histogen that are much further ahead and are aiming for product releases around 2020 or earlier.

Am also curious about Intercytex (see latter part of below post) since you still seem to work for them:

https://www.hairlosscure2020.com/lessons-from-aderans-and-intercytexs-hair-multiplication-failures/

Hope to be in touch with you soon.

Admin”

Mr. Paul Kemp’s second e-mail to me:

“Thanks for getting back to me. We could chat through either Skype or Webex. The latter would be easier, as I can then walk you through our slide presentation. I can understand your skepticism but I would hope I can explain our strategy to you and reduce that. I am very aware of the status of the work at Histogen, Replicel and Organ Technologies and personally know the key players involved.

As to Intercytex, I founded that way back in 2000. We raised a lot of VC money which enabled us to carry out the first cell therapy clinical trial about 10 years ago. I felt although it wasn’t a slam dunk, it did indicate what to do next but the VC investors wanted us to move onto something with shorter timelines and we sold the technology to Aderans where a similar thing happened.

It is a feature of VC investment cycles is that they some of them aren’t in these things for the long term and they control the decisions. Intercytex was broken up in 2009 in the midst of the global financial crisis and I ran it for a few years in order to develop the last technology which was finally sold this year. The company has no employees and no facilities and your comment has made me realize that I do need to come to closure on that.

The Claire Higgins et al’s PNAS paper a couple of years ago was the thing that really made me want to get back into this field. When Intercytex ran their trial we had no way of knowing whether human dermal papilla cells, when expanded, maintained their hair inductive potential. We licensed technology from Hiroshima University that used keratinocyte spent media which, in mice maintained inductive potential in DP cells so we did the only thing we could do at the time to test whether the same was true for human cells which was to run an incredibly expensive clinical trial only to show yet again that human cells don’t behave the same as mouse cells.

The Higgins paper has indicated a simple way to interrogate the cultured cells and determine their expression profile so we can now look at lots of ways to change culture conditions and test the outcome without having to resort to human trials. Those already in trials are, to a large degree, “locked-in” to their processes because of the regulatory constraints imposed by agencies such as the FDA and EMA.

We have no such constraints as we aren’t yet committed to clinical trials and the UK regulations are such that Clinicians can legitimately treat patients pre-marketing license as long as some conditions are met.

We can therefore try lots of different alternatives before committing to the constraints imposed by the regulators when running clinical trials and we feel that the combination of the new science with the supportive regulatory system will allow us to move forward rapidly.

There is a LOT of hype and misinformation out there as you are no doubt aware both about results and timelines but also about the processes that are needed in order to develop, test and market a new medical treatment and part of that is due to industry not being able for confidentiality and investor reasons from reaching out to inform and educate. We have none of those limits and all of the founders of HairClone are committed to informing people of our progress. I am very willing to take however much time is needed to inform the “community” about what we are trying to do which I accept is different from the traditional way of developing a new therapy.

I first started working on cell therapy and regenerative medicine in 1987 and I have come to realize over the last few years that there is a better, cheaper, less risky strategy to develop new therapies and I think hair rejuvenation is the perfect platform to prove this.

Have a great time during your vacation.

Regards,

Paul

Paul Kemp PhD
Founder, Chief Executive Director”


Update: One of this blog’s regular readers sent me an excellent summary regarding HairClone’s likely UK testing approach that is worth pasting here:

“It seems like UK regulatory laws allow clinicians a good deal of leeway in testing. So the idea is that rather than being locked into a protocol that is submitted and approved for clinical trial at great expense, not to mention moving along at a glacial speed, they could test and tweak, patient by patient, on a much quicker and less expensive basis with no regulatory approval needed for changes in protocol as they tweak from patient to patient. US laws do not allow this. And if new research comes available, like the culturing method described in the recent wharton’s jelly post for example, they could quickly gear those changes up for testing in a new patient.

Of course, they could have any number of protocols going at the same time. Conceptually, I think this is a very clever, not to mention practical, idea as you only need to spend the big bucks on the FDA trial after you know the protocol works. Since this involves cell culturing of ones own cells I assume it falls relatively low on the risk scale and a loophole well suited for hair research.”