FYI — Dr. Kemp has told me that he welcome’s blog reader questions so please post them in the comments to this post in a civil manner. If I end up taking up his slide presentation offer, I will ask him the questions when we talk. Edit: Mr. Kemp is answering them directly in the comments.
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.”
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 after getting his approval to do so. 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 Mr. 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.
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:
Hope to be in touch with you soon.
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.
Paul Kemp PhD
Founder, Chief Executive Director”