Samumed E-mail

Someone associated with Samumed just e-mailed me today (see blue text below for contents) and I was pleasantly surprised since I have not contacted the company anytime recently. The e-mail pertains to their SM04554 topical product to treat male pattern hair loss. Please list your questions for Dr. Yusuf Yazici in the comments, but do not be disappointed if he never responds. Even though they have offered us the opportunity per the last sentence of the below e-mail, I have doubts that I will get any response. Any profanity or sarcasm laced comments will be deleted and/or ignored.

E-mail:

Subject: Samumed presented data on increases in hair follicles observed in its Phase 2 biopsy study for a potential treatment of androgenetic alopecia (AGA) at annual meeting of the American Academy of Dermatology (AAD)

Hi,

I wanted to share a brief update about Samumed, which presented the results to its phase 2 biopsy study on a potential treatment for androgenetic alopecia at the annual meeting of the American Academy of Dermatology.

Specifically, the study revealed three compelling findings:

  • There were statistically significantly higher total follicle counts compared to the vehicle.
  • Samumed’s treatment may be the first leading to follicular neogenesis.
  • There were no serious adverse events reported.

The full release can be viewed on Samumed’s website HERE and I’ve also copied the text below.

Please let me know if you’d like to speak with Samumed’s Chief Medical Officer, Yusuf Yazici, and I’d be happy to connect you.

Best,

Mr. XYZ

Interview with Dr. Alexey Terskikh

I first mentioned Dr. Alexey Terskikh on this blog a little over two years ago here. His team of scientists (who work at a non-profit institute in the USA) used pluripotent stem cells from humans to create dermal papilla type cells that were then injected into hairless mice. Lo and behold, these mice then  started to grow human hair and at the time this major development was widely covered in the media. I e-mailed Dr. Terskikh for an interview about a year ago, but never got a response (turns out he never saw the e-mail until very recently). However, thanks to commentator “sets” and his now several months of persistence in acting as an intermediary between myself and Dr. Terskikh, I was finally able to get the doctor to answer our questions. Note that 90 percent of the below questions were extracted from blog reader comments and questions to this post from a few weeks ago.

Before I proceed with the interview, special thanks to Dr. Terskikh for answering every single question below, including some in great technical detail. If any of the readers of this blog have ideas on how to raise funding for Dr. Terskikh, please post them in the comments or e-mail me and I will forward the responses on to him. Also make sure to read his responses to several reader questions about fundraising in the bottom half of the below interview.

Interview

HLC2020: On Twitter you previously mentioned the need to raise $3 million to $5 million in order to proceed. However, just to start and finish pre-clinical trials and then move on to clinical trials, you need $1 million per your recent e-mail to me. So does this mean you need $1 million asap, and then another $2-4 million over the next several years for a maximum potential total of $5 million?

Dr. Terskikh: That’s correct. $1M should cover immediate research and developments in the laboratory (like optimizing transplantation into the human skin grafts) and bring us to the next stage. For instance, we will need to derive from iPSCs and integrate into our protocol autologous human keratinocytes from the same patient. Although much has been done in this field it’s still a challenge.

HLC2020: Assuming you are able to raise funds quickly, what kind of time frame would you think is needed to finish pre-clinical trials? To start stage 1 trials (is it possible in 2017)? And to finish all 3 stages of clinical trials? And do you think that new favorable US government regulations will help speed up stage 3 trials? Since you are using a patient’s own stem cells, does that mean that pre-clinical and stage 1 trials can get completed faster than usual due to no major issues with safety and side effects?

Dr. Terskikh: It all depends on the success of our human skin grafting experiments and safety tests. The safety is critical for FDA approval of clinical tests.

HLC2020: So because of lack of funding, no new progress has been achieved in your hair related research during the past 2 years? If that is not true, can you please summarize your team’s new advances since 2015?

Dr. Terskikh: We made some progress mainly academic research with some funds that were available to us. One important development is our ability to derive DP cells from subject specific iPSCs (original publication was using ES cells). We have also started transplanting DP cells into human skin patches grafted on the back of immunodeficient mice. In addition, we are wrapping up a very exciting study investigating the heterogeneity of individual human dermal capsules. So we’ve done a lot of cool experiments, the problem being we need to do much more to scale up the volume and to accelerate the pace of development.

HLC2020: How is hair loss research progress in Russia (both from your team as well as from others)? In my page on MAJOR hair loss research centers around the world (see here –> http://www.hairlosscure2020.com/hair-loss-research-around-the-world/), I have nothing in Russia at present, which is probably incorrect!

Dr. Terskikh: The team formerly led by my father (now led by Prof. Vorotelyak) is moving parallel with us and we keep collaborating on characterization of human DP cells in vitro and in vivo.

HLC2020: Will you keep using iPS cells, or do you plan to also use embryonic stem cells in future? Note that several blog readers thought that you are currently using embryonic stem cells and I assume that is not true? (Edit: I think I was mistaken and initially they did use embryonic stem cells — see earlier highlighted red text).

Dr. Terskikh: The future procedures will be based on autologous cells. Patient’s own cells (say couple of hairs, tiny piece of skin, or 1ml of blood) is reprogrammed to iPSCs. These iPSCs are banked and kept forever in liquid Nitrogen. An aliquot of iPSCs is used to differentiate these cells into DP cells and keratinocytes. In the future other cells like melanocytes will be obtained as well so one can have hair of any color.. )) Then DP cells will be mixed with keratinocytes within specialized matrix scaffold and transplanted back into the same patient’s skin. This will be done for each patient.

HLC2020: Do the DPs that you have created show similar gene expression to ordinary, healthy DPs? Do they maintain the gene expression when multiplied by 3 orders of magnitude (I think that means 3 hair follicle cycles)?

Dr. Terskikh: Currently there are no methods to amplify DP cells in the dish. They loose the hair induction properties after couple of passages. This is precisely the problem. That’s why we don’t amplify DP cells in the dish. We amplify iPSCs cells, which could grow in the dish almost indefinitely. Then the “buckets” of iPSCs cells are converted to the “buckets” of DP cells that are needed for transplantation.

HLC2020: In what form/structure do you plan to introduce the cells into the skin?

Dr. Terskikh: Aggregated within macro-scaffold. We’re trying several options. The scaffolds will be biodegradable so they will dissolve with time.

HLC2020: Was it possible for you to grow hair on a human skin graft or only in mice?

Dr. Terskikh: Yes, that’s precisely what we are doing.

HLC2020: How does one donate specifically for your hair regeneration research?

Dr. Terskikh: One can donate directly by contacting me or though the Sanford Burnham Prebys (SBP) web site. The best idea will be to organize a clever crowdsourcing campaign. This seems to be the perfect opportunity. The incentive – a discount for a hair regeneration procedure once its working. If anybody could help with this one, I’d seriously appreciate.

HLC2020: Are you aware of the other major hair multiplication or cloning related companies out there such as Tsuji/Riken, Shiseido, Hairclone and TissUse? If so, how does your method compare and what might possibly make it a superior option scientifically and commercially?

Dr. Terskikh: Sure. None of them are using iPSC-derived DP cells, but instead are focused on amplifying the existing DP cells. Different approach. I think our is more general.

HLC2020: Where do you plan to begin clinical trials? Do you plan to take advantage of countries with more lenient stem cell laws like Japan and the USA’s 21st Century Cures Act?

Dr. Terskikh: All depends on the progress in the lab and money funding.

HLC2020: What aspects of hair growth do you believe you will be able to control? Shaft thickness, direction, etc.?

Dr. Terskikh: Should be able to control all aspects. The shaft thickness (also hair length) is directly proportional to the number of DP cells in the DP capsule. We can transplant any number of cells we want.

HLC2020: What are the scientific hurdles you currently face and how do you plan to solve them?

Dr. Terskikh: There are many hurdles to overcome. The purity of DP cells is one important issue. At present we use a heterogeneous mixture of cells some of which are DP and some may not be DP cells. we are working on couple of strategies to enriched purify DP cells based on surface markers and antibodies.

HLC2020: How do you plan to administer the treatment? A proprietary device?

Dr. Terskikh: Initially this will be done manually by the doctors. Eventually, we are discussing the development of biomedical robotic machines that will be doing the transplantation automatically.

HLC2020: Have you settled on a company name, CEO, etc?

Dr. Terskikh: Almost. A very gifted individual with great success track records is willing to take on this business. Need money to move forward.

HLC2020: Does your method work on guard hair and primary hair? Since AGA occurs in guard hair first followed finally by the miniaturization of terminal hair. (FYI — I do not understand what “guard hair” means so please ignore this reader question if you do not know either)!

Dr. Terskikh: Guard hair could be distinguished in animals – the top layer consisting of longer, generally coarser, nearly straight shafts of hair that protrude through the down hair layer. Not sure about humans…

HLC2020: Does your method induce de-novo induction of follicular units, not just individual hair follicles?

Dr. Terskikh: Yes. We induce individual de novo (new) hair follicles.

HLC2020: Are you actively seeking venture capital? How successful have you been in attracting capital so far?

Dr. Terskikh: We seeking all kind of capitals. So far we got some funds from a company, which decided not to follow through due to their own financial problems. We have several individuals and funding bodies in various stages of discussion.

HLC2020: Given the competition claims to be @ market by 2018 2019 2020 Have you considered merging or selling out IP to corporations who can move the technology forward?

Dr. Terskikh: Personally, I don’t see anything to be on the market by 2018 or 2019. We are not planning to selling or merging at this point.

HLC2020: Do you have a strategy to propel this technology to be @ market before or during 2020?

Dr. Terskikh: As I pointed out earlier – all depends on funding. In principle, we might be able to deliver a product by 2020 given sufficient funding.

HLC2020: If this technology did arrive to market can the company scale up on demand or will it be a slow process that will take years to decades to scale? How many people can be treated per clinic via your technique?

Dr. Terskikh: We’re discussing the logistics. The process for each individual will take 3-4 month. The good news is that once we make and bank iPSCs, additional transplantations are unlimited and could be done within 1-2 month. I think we can also have a model where all additional transplantations are free or at minimal cost.

HLC2020: Is this a one-time treatment for patients, or a lifelong commitment requiring X number of visits per year?

Dr. Terskikh: Good question. Initial success is usually last for several years, but due to the ongoing loss the transplantation procedures is likely to be repeated every 5-10 years. That’s where we get the best edge. See above.

HLC2020: Few in the medical field are concerned with developing a treatment for the various alopecias despite an age of incredible advancements in science, medicine and technology with increasing focus on mental health. Baldness is a subject of ridicule and prejudice in society with its patients left to suffer in silence; seen as vain and narcissistic for even considering treating the problem, but at once shamed for their balding. It is especially traumatic for young patients. What are your personal thoughts on the subject in general, societal attitudes toward alopecia and how do they affect your motivations to bring an effective solution to the world?

Dr. Terskikh: Some of my friends are bald and happy. Some less happy. You can be bald and bold and happy and successful. You can have full head of hair and be measurable. Personally, my front hair is thinning a bit and I do want to get back my look of 20 years old.

Given the option I think most people wouldn’t mind hair. I’m almost confident for the gentlemen in the picture attached…

Edit: He attached a picture of the famously balding prince William:-)

 

 

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