2017: A Look Ahead

I’ve got a good feeling about 2017…

For the past several years we have been pacified by the news of a research study or startup company working on a treatment that grows hair. Ultimately, we would prefer the treatment in our hands, but reading about it on a computer screen has been supportive as well. It’s something we can think of throughout the day or in a quiet moment which helps to release a little more serotonin in the brain. However, the time has to come for a treatment to be made available for us all and I believe that 2017 is going to be that year. This will mostly take place in the cosmetic market, but the treatments should be worthwhile.

For Starters…

  • You knew it was coming on this list. The acclaimed, enigmatic, and exceptionally Italian: Brotzu Lotion. As of January 2017, the product is reportedly still in clinical trial. Once the trial is finished Fidia Pharma will decide how to move forward with the product. There are tons of reasons to believe that this product will be a great success as far as cosmetic treatments go. One question that supports that belief is: how many products/research studies have been acquired by pharmaceutical companies and put through human trials in the past 10 years? If you’re new to the subject you may read more on the back story of the Brotzu Lotion by reviewing these articles.
    *Update* Fidia Pharma has finally released an official communication on their website about the Brotzu Lotion. The news was a bit of a curveball. Fidia has targeted 2018 as a release date for this lotion. While this is unexpected news (many thought the lotion would be available in 2017) the fact that this product exists in the first place is still reason for cheer.
  • Turkish Delight. The stem-cell derived cosmetic cream which was actually slated to be released last year at this time: Kelopesia. The research done to create this product was done at Yeditepe University and was lead by Dr. Fikrettin Sahin. And yes, this is the cream that involves using cellular derivatives from newborn foreskins. Why is that, might you ask? Well, the cells that are extracted from the newborn foreskins are still at a stage where they are very potent for growth and tissue generation. Let’s just leave it at that for now (laughs) and celebrate this potential breakthrough. This product should be released in Turkey within the first Q2017. Keep your eyes peeled on Ebay.
  • As of now Kelopesia is set for release in 2017. However, there is always the possibility for one of these

    The Wild Cards of 2017

    ‘Wild cards’ are products that emerge all of the sudden, show good promise, and are said to be made available shortly after their announcement. Stay tuned everyone 🙂

Clinical Players

2017 will be a great year for hair growth cosmetic products. On the clinical side of things, it is somewhat of an ‘in-betweener’ year. Most of the highly anticipated therapies, including Shiseido and Tsuji/Organ Technologies will still be in a trial process or R&D phase all the way through 2017. However, we will be getting trial results from many treatments. The trial results do give us valuable information about how the treatments are shaping up and they are necessary for the treatments to move forward. Here’s the most significant clinical trials for hair growth that will be taking place in 2017:

  • I was surprised to see them in this spot myself, but here they are. Follica is set to begin a phase III clinical trial in 2017. Or, maybe they already have begun this trial. Follica is kind of like the Carmen Sandiego of hair growth companies so no one really knows except for them. We know the phase III trial will happen in 2017. Pending results, this trial can lead to FDA approval for Follica. If all goes well Follica is aiming to put their micro wounding + compounds treatment for hair growth on the market in 2018. The treatment is now being titled as “RAIN” according to PureTech’s pipeline page. Does anyone know what the acronym stands for yet? My guess is “rejuvenate and induce neogenesis.”
  • Its electric. HairCell, the surprising company that was incepted by Howard Leonhardt in 2016 will be initiating its human pilot study in early 2017. The treatment involves wearing a bioelectric device on your head with stimulators that send signals to the cells of your body to repair and regenerate itself. This cap is also coupled with a micro-pump containing electro-acupuncture needles that inject stem cells/growth factors into the scalp. The entire concept is highly unique and advanced and I am a big fan. I look forward to hearing more about this human pilot study.
  • Getting set. Results from the setipiprant phase IIA trial. More hair follicle research stemming from the work of Dr. George Cotsarelis, setipiprant is an oral medication that is intended to halt hair loss and thicken existing hair. The drug is a protaglandin D2 receptor antagonist and was originally developed for inflammatory conditions such as asthma. However, when Dr. Cotsarelis found that the PDG2 receptor plays a significant role in hair growth, he patented that use and suddenly PDG2r drugs that were shelved became useful again. Kythera Biophrama decided to take a crack at it and licensed the use of setipiprant to treat hair loss. Because of the drug’s previous clinical trial involvement Kythera was allowed to start setipiprant at a phase IIa trial for androgenic alopecia. Since the time Kythera began this development of setipiprant their company was acquired by Allergan. This trial is set to complete in September 2017 and will compare results from setipiprant alongside finasteride to gauge its effectiveness. I find that comparison interesting.
  • The dynamic duo. Allergan is also anticipating the phase I results of their new and improved bimatoprost formula for the scalp. Bimatoprost was originally developed for glaucoma and later used to enhance eyelash growth. If it can grow eyelashes then it can probably grow hair, right? Right. Apparently, the bimatoprost scalp formula has recently been enhanced to promote even greater hair growth and hence they have begun another phase I trial. This trial should bear results sometime after October 2017.
  • Just maybe. Last year it seemed likely that right about now Histogen would be gearing up for a 2017 market release for its Hair Stimulating Complex in Mexico. As of late the company has been quiet about the potential of releasing HSC in Mexico. The HSC treatment still needs to go through a phase III trial for approval in Mexico, and if Histogen were to release the product in 2017 that trial would have begin very shortly. We know Histogen made some notable business developments in China in the 2nd half of 2016, if they will do the same in Mexico still remains to be seen. Veremos.
  • River of Hope. RiverTown Therapeutics Inc. is hoping to push forward with their phase 1B/2A this year. Getting the trial in place only depends on the company raising the necessary funds to finance the trial. RT1640 is RiverTown’s lead candidate for hair regeneration. The drug is composed of three agents: minoxidil, cyclosporine A, and a novel molecule called RT175. The RT175 molecule is said to promote the growth and migration of stem cells to the hair follicle, which multiplies the effects of both minoxidil and cyclosporine A, resulting in hair follicle regeneration. The company has previously shared some impressive photographs on Follicle Thought, displaying what RT1640 is capable of. Keep in mind these results came from a very small number of subjects who used the treatment for a short period of time. The potential is big here. Let’s see something great develop for RT in 2017.
  • A clone like no other. HairClone of the UK is taking a unique approach to get a next generation hair growth treatment to market. They are marketing the treatment to work in conjunction with hair transplants, they are utilizing crowd funding, and they are taking advantage of an innovative opportunity to get this treatment to patients very quickly. The most important factor here is that through a special medical designation in the UK known as “Specials” HairClone will be able to make their treatment available to patients prior to going through a clinical trial process. Under the guidelines of Specials a doctor in the UK will have the discretion to prescribe a treatment like HairClone for an unmet medical need; in this case it would be hair loss. If HairClone secures the funding to move things forward they can begin administering cellular treatments to patients in the year 2017!

New Players

One of the greatest things about turning a new year: the announcement of new companies. Last year was fruitful in this category and I expect 2017 to be even more exciting. Most of the new companies that we will see emerge in 2017 will come from names that we are familiar with. Here’s what to look for on the horizon in 2017:

  • Rapunzel. You’ve heard it mentioned here before. Rapunzel is the latest startup company of Angela Christiano which seeks to bring an injectable cellular treatment (using 3D cultured cells) to the clinical setting. Anyone who spends a bit of time reading up on hair follicle research knows that Angela Christiano is about the biggest name in the hair research industry. She has studied gene therapy, JAK inhibitors, cell culturing, and other areas of hair biology. The only other researcher who has probably spent more time studying the 3D culturing of hair cells would be Dr Colin Jahoda. And oh, guess what? Colin Jahoda is teaming up with Christiano for Rapunzel. Booya.
  • Tissuse. The German biotech company which is a spinout of the Technical University of Berlin is finally moving forward with its hair follicle multiplication work. This is evident from Tissuse’s recently updated website displaying a page for “Smart Hair Transplants.” The entire treatment process of SHT is not yet described on their website, though it does mention ‘extracting 30 hair follicles (via FUE) from the donor scalp to create 10,000 neopapillae (baby hair follicles).’ This just sounds incredible to hear, my imagination runs wild with possibilities. Man, is it just me or is this hair industry getting so big it’s not that easy to remember all of them now? It’s certainly a welcomed situation that we are at.

Let me thank you all for your support and being readers of the site. It is great to hear positive feedback from those of you who take a moment to share a few words on the site. As you can see, the hair growth treatment landscape is really turning into something that we all hoped it would for so long. Here’s to an amazing 2017 and hair growth success for the world. Cheers

Kelopesia Update, Brotzu Trial, Cures: Weekly Thoughts 12/16/16

Hey everybody, welcome to another edition of Weekly Thoughts. This week I touch on two topicals that have been at the forefront of the attention of hair growth enthusiasts this past year. Also, I take a look at an intriguing healthcare legislation that was just passed in the United States this week.

Kelopesia Update

Remember when Kelopesia burst onto the scene earlier this year? Man, that was a hoot. It was slated as a new stem cell-conditioned media cream which would be available by the end of April in Turkey. Well, turns out that was not the way it happened. We’re not quite sure what lead to the delay, but that’s not really important anymore. What’s important is that we are actually close to the re-scheduled release date of Kelopesia. This past week I decided it was a good time to get an update from Yeditepe University.

Prof. Fikrettin Sahin, the gentleman and scholar who developed the Kelopesia cream, told me this week that his team is “working hard” to get Kelopesia released to the Turkish market in Spring 2017 and “hopefully” it will be released in January. There you have it.

Yes, he does mention that the release will be for the “Turkish” market. What does that mean for the rest of the world? It does mean that it will take more time for the product to be officially released in the rest of the world. However, it does not mean that the cream will be impossible to get if you do not live in Turkey. You can always visit Turkey or find other options on the internet.

Brotzu Lotion Trialing

It is only right that if we got news about Kelopesia we should hear more about the other top-notch topical making waves in the hairternet. I heard from a representative at Fidia Pharma that the famed Brotzu Lotion is still undergoing a clinical trial with the company and therefore a release date is not certain yet. 

My own personal take is that things should be winding up in the trial soon. The lotion seems to have been in a clinical trial for a good amount of time now; the trial was reported to begin last March. Personally, I have a good feeling about it, I do feel that this product is going to be released by Fidia at some point. For now, the release date is unknown.

America Accelerates Cures

This past week US President Barack Obama signed the 21st Cures Act into law. The bill is referred to as “Cures” and is heralded to advance the discovery, development, and delivery of drugs and therapies in the US market. It will do this by providing major funding to the National Institute of Health over the next several years, modernizing clinical trials, and utilizing health records and patient data in new ways to promote research collaboration. If you do a little internet research on the subject you will find some differing opinions on the impact of Cures among the healthcare industry, but whose really got time for that? 

Readers of this blog pretty much want to know one thing — how does Cures affect hair growth treatment development?  The answer is no one really knows yet. Experts in the regenerative medicine industry are still reviewing this huge piece of legislation to understand it better. Also, the way the bill is written leaves room for variables in how the FDA will actually utilize Cures.

Here’s what we do know about Cures for now:

  • Regerative medicine products, including stem cell therapies, can be granted “accelerated approval” by the FDA
  • Accelerated approval does allow a treatment to be available to patients before completing a phase III trial
  • Accelerated approval is typically intended for medical conditions with unmet needs

The questions of whether hair growth treatments will be allowed to utilize accelerated approval and exactly how all of this will work are unanswered at this point. To be honest though, it’s really nothing to lose sleep over. Treatments will go through the process anyways, if Cures provides some expediency to that, then very good. We’ve got to keep pushing forward, regardless. Time will tell how the FDA intends to utilize the new provisions of the 21st Century Cures Act. I recommend these three articles for more background: STAT, Wired, and TheHill. If there are any scientists or industry persons reading this that can offer some insight on the Cures Act please comment below. 

It has been a good year everybody and unless something major pops up in the next two weeks, I’ll speak to you all in 2017. Have a Happy New Year 🙂

RiverTown Therapeutics Inc. Launches Website

Today, I woke up to discover that one of my favorite companies developing a hair growth treatment, RiverTown Therapeutics Inc., has launched their website. Site can be viewed here.

One of the new significant announcements shared on the website is the introduction of the Scientific Advisory Board which includes two familiar names: Maria Hordinsky MD and Elaine Fuchs PhD. Both have been prominent at major hair conferences and in the hair growth research field over the past several years.

RiverTown has a few more treatments in development according to its Pipeline page. One of the indications listed is wound healing, very interesting. I like how they have listed their lead candidate drug which you should be familiar with, RT1640; it’s titled as “Hair Regeneration.” yipee. I was also pleased to read positive information about RiverTown’s patent strategy, which should be supportive of its efforts at gaining investment. Send them your best wishes, people.

I bet you’re all eager to go poke around the website now. Here is one interesting quote to leave you with about the hair regeneration treatment RT1640 and its three agents that compose the drug.

“RT1640 is made up of three small molecule drugs that together synergize to act on three distinct pathways in hair biology.  One drug promotes the growth and migration of new stem cells, one drug promotes the commitment of the follicular stem cells to become new hair and one protects the dermal papilla from the effects of DHT.”

Happy Friday Everyone.

2016: A Year in Review

It does not feel that long ago when I was writing the article 2016: A Look Ahead, but just like that here I am bringing a recap of a rather exciting year in the hair growth industry.

To start, let’s review what I highlighted in the original “2016 look ahead” post.

  • Samumed’s Phase II results – The results did not actually blow the door off the hinges, however they were positive. This treatment grows hair. Since the time that the initial phase II results were announced, Samumed has also completed another phase II trial which involved taking a biopsy of the scalp to observe how the drug was working in the tissue. So where does that leave everything now? Well, Samumed has a decision to make. That decision is whether they believe this treatment is worth going into a phase III trial for commercial approval. Hopefully the biopsy study has given them some insight as to how to improve the efficacy of their compound.
  • Shiseido Trial in Japan – The big announcement finally showed this past July. Shiseido received approval by the regulatory authorities of Japan to initiate their trial of RCH-01. The trials are being done at the Tokyo Medical University Hospital and Toho University Ohasi Medical Center. We look forward to hearing about these results in 2017.
  • Histogen Trial – We did not get any official word about Histogen initiating a trial this year, though they did make several business transactions to help further the development of their HSC product. Now, both China and Mexico are potential landing spots for HSC commercialization.
  • Follicum Phase I Trial – The first half of Follicum’s phase I/IIa began back in January, with the second half commencing in September. Follicum recently announced that the phase I/IIa study will be completed in January 2017. Follicum’s lead drug candidate, FOL-005, is interesting in the fact that it has the ability to both stimulate hair growth as well as inhibit hair growth. Jan Allenfall of Follicum mentioned in a press release that he believes the initial clinical trial of FOL-005 would produce hair inhibition. I’m sure that this crowd is more interested in the hair stimulation bit. Nonetheless, I believe Follicum has a savvy plan moving forward and we hope to hear about the results of this peptide getting hair to sprout.
  • Dermal Papilla Cell Culturing Trial – This long-lived and mysterious trial is set to finally be completed next month. There has been no word on whether the results will be released, but rest assured if they are I will give you all an update. The methods involved in this trial were derived from the research of Dr. Colin Jahoda, hair follicle Jedi master. Word on the street is that he is looking to get his work into the clinical setting soon and I will have more on that in the upcoming “2017 look ahead” post.
  • The Wildcard – In the original “look ahead” counterpart to this post I created a category for those discoveries that seem to come out of nowhere and surprise us (delight us). It’s good to leave room for something along the lines of a miracle to happen in the hair growth industry world. The announcement of a cosmetic topical that “produces legitimate hair growth and will be out on the market by the end of July”, or something to that effect. Well, in 2016 we had a flash of just that, a wildcard. It came be to known as the “Brotzu lotion.” The Brotzu lotion is currently being trialed in Italy as a cosmetic and it is likely that that trial should be winding up soon. I will update on it’s progress as soon as information becomes available. I have a feeling 2017 will be another fortunate year for wildcards. Stay tuned.

2016 was really a good year for us all. Some other excellent accomplishments were:

  • Aclaris Therapeutics acquired JAK inhibitor IP to be trialed for use in AGA.
  • RiverTown Therpeutic’s wonder drug RT1640 was announced to regenerate and restore pigment to follicles.
  • Tsuji/Organ Technologies announced they will embark on a revolutionary hair growth venture aimed at a 2020 release.
  • New Follica website and unveiling of a clinical treatment to be coupled with at-home treatment regimen.
  • Kythera Biopharmaceuticals embarked on its phase IIa study for Setipiprant as an oral hair-loss prevention treatment.
  • HairCell announced it will initiate a trial for hair growth using a bio-electric stimulation device with growth factor pump delivery.
  • Clinica CFS reported an average of 82% donor hair regeneration while testing its Stem Cell Transfer hair transplant method.
  • HairClone announced new plan to revolutionize the process of cellular hair growth treatment commercialization.
  • Kelopesia was announced as a potential game changing topical cosmetic from Yeditepe University.

Wow, looking back on all of these developments I realize how much of a monster year 2016 really was for us. I have heard people say it in comments before, and I will reiterate it now, there has never been a time like there is now in the landscape of the hair growth industry. We have multiple cellular treatments being developed, JAK inhibitor drugs, a PGD2r antagonist, a topical peptide, a Wnt agonist, a wounding treatment with compounds, a bio-electric stimulation device, and much more. Multiple pathways and approaches are being addressed and the future looks bright. I bet your outlook has changed in just the past several sentences. 2016 was also a very nice year for me and I made some valuable friendships in the hair industry. I am very grateful for those friendships and you know who you are.

Finally, looking ahead I will remark on a topic that I have spoken of in the past and that is gratitude. If you are looking for a way to improve your outcome of receiving one of these hair treatments then find gratitude now. Don’t wait until a treatment is in your hands to appreciate all of this work. As this post has illustrated there is a lot to be thankful for in the hair growth industry currently. Many people have taken the initiative to dedicate their lives to help solving a problem that is perhaps extremely important to you. Take a moment to feel happy about it, say a prayer or whatever you do, write a company an email or a hand written letter to say thanks for what they are doing – let go of the question “when is it coming out?” When it comes out, you will be well aware of it. We are all anticipating that day when one of these new hair treatments is available for purchase. That day will come. And during this waiting process it is important to “recharge” our outlook and keep our perspectives healthy. This post was designed for that.

Until next time, Be well

HairClone Growing, Aclaris IND: Weekly Thoughts 11/9/16

Hello everyone and welcome to another edition of Weekly Thoughts.

It has been a little while since my last check in with you all. You can chalk it up to a busy schedule and the fact that there hasn’t been too much significant news in the hair-growth treatment world recently. As always, there are positive developments happening behind the scenes. Let’s take a look at what has popped up in the past couple weeks.

HairClone Expands Their Team

The new-school hair growth startup HairClone has recently added members to it’s scientific advisory board as well as it’s clinical partner group. They’re expanding personnel the same way they hope to expand dermal papilla cells in culture. (hey, I’ve got to find a way to keep things light around here) The first big edition was Prof. Paul Sharpe to the scientific advisory board. Prof. Sharpe works extensively in the developmental biology of teeth. In other words, he studies the molecular and cellular processes that go on as a tooth is formed and grows. His research also includes looking at the role of mesenchymal stem cells for the purpose of tooth regeneration (useful venture as well). HairClone has noted on their website that the biological development processes of hair and teeth are similar and that Prof. Sharpe’s insight on the biology of tooth formation will be useful to them as they endeavor to construct hair follicle formation.  More scientific board members are to follow as well.

The company also welcomed four new hair transplant surgeons to their clinical partner program. Dr. Jerry Cooley, Dr. Ken Williams, Dr. James Harris, and Dr. Russell Knudsen round out that group. Dr.’s Williams, Harris, and Knudsen are said to Founder Members of HairClone and Dr. Cooley is the first ‘Platinum’ member of the clinical partner program. I like the way things are going for HairClone and hope to hear more exciting announcements soon.

Aclaris Aims for AA Cure

Aclaris Therapeutics Inc. announced just before the start of this month that they have submitted an IND application (Investigational New Drug) to the US FDA for ATI-50001 which is Aclaris’ oral JAK Inhibitor for the treatment of alopecia areata. We knew this was coming and is a sign of good progress. Aclaris also has in it’s pipeline ATI-50002, their topical JAK Inhibitor for alopecia areata, and ATI-50003, their topical treatment for common pattern hair loss. Be on the lookout for news on IND’s for those in the future. Right now Aclaris is still presumably working on it’s topical formulas for both. It’s worth noting that optimizing a formulation of topical JAK inhibitors will be key to its success of treating common pattern hair loss. Angela Christiano did mention in an interview that hair follicles would need high local concentrations of JAK inhibitors in order for the JAK drugs to be effective at [potentially reversing pattern hair loss.

And that, my friends, is about it for now. Keep holding the vision of what you want to see and I’ll see you all back here with more good news to share.

Until next time, be well.

Update: New Follica Website

The times they are a-changing.

Nowadays you can’t even take a trip to the fridge to grab more hummus dip without some hair bio-tech startup rolling out their new website and business plan.

Jokes aside, Follica has been the ultimate tight-lipped company in the hair regeneration biz for about 8 years now. To be honest, I understand the approach. You keep working on the treatment behind closed doors until you’ve got something that really works and all of the sudden you hit the world with a Hoo-Ah that would make Al Pacino proud. At least that’s how I like to think of it. Anyways, let’s just take a look at the new revelations.

For starters here’s the syntax from Follica’s new layout:

“Our technology is based on a proprietary approach intended to create an “embryonic window” in adult skin, allowing new follicles and new hair to form from epithelial stem cells. Following skin disruption, cells that migrate to help healing are forced to make a decision: Should I make epidermis, or should I make a hair? There is a window of opportunity in which we can potentially push them to choose the latter, and we believe there are multiple biological pathways to target to enhance this outcome. This regenerative effect is called hair follicle neogenesis.”

The significant info on Follica’s new website:

  • Non-invasive skin disruption treatment to create new follicles done in-office by a physician
  • At home device + topical compounds to maintain and continue the new hair growth
  • Smartphone app to remind users of their treatment times and re-order supplies
  • A doctor affiliate program

This is a thoughtful program that Follica has created. The at-home device and progress tracking app are welcomed ideas and should improve compliance.

The only question left is…..how much new hair are we talking about here, Follica?

 

Credit to Stump at HLT on the find

L’Oreal 3D Printing, Hope for AA, Stem Cell Transplants: Weekly Thoughts 10/10/16

Hello everyone and welcome to another edition of Weekly Thoughts.

Things have really busy in the hair world as of late, new companies are popping up all the time and companies that we have known about are finally making the announcements we’re looking to hear. Lo and behold it’s almost been two months since the last edition of Weekly Thoughts due to all of the feature articles! Let’s get into some news from different sectors across the hair growth industry.

Bonjour L’Oreal

Cosmetic giant L’Oreal has announced that they are partnering with a French bio-printing company named Poietis to take on the monumental project of 3D printing human hair follicles. Poietis uses an advanced form of laser-printing cell-based materials which makes them an ideal partner for the task of hair follicle printing which has not been attempted before. One of the advantages of laser bio-printing is that it does not involve “pushing” the cellular materials out through a nozzle, which is the approach taken by most of the industry. Through the laser technique Poietis is able to print without putting additional stress on the cells which helps keep them intact. Initially, L’Oreal will be using the engineered follicles to test their new hair growth products. This will provide them with a safe and expedited approach to trialing new hair growth compounds. Here’s a look at Poietis’ very neat laser printing technology:

 

But will they attempt to mass breed hair follicles to create an unlimited donor supply for hair transplants? Yes, they will. No one knows how long that process could take, and it will definitely be some years before that treatment would be out on the market, but at least they are interested in that potential. In the meantime, this could really boost L’Oreal’s efforts to put out a really good hair growth cosmetic and give them some extra insights as to exactly how these fascinating little hair follicles are created in our scalps. Source article here.

Love for the AA Crowd

News on alopecia areata treatments is not a common item on this blog, but I do like to support the crowd of people who deal with this autoimmune issue when I can. The drug ruxolitinib, a JAK inhibitor, showed up in the news again a few weeks ago for it’s use to regrow hair for people with AA. It is quite amazing just how much hair ruxolitinib is able to regrow for alopecia areata patients. This is the same drug that Dr Angela Christiano researched, along with tofacitinib, which caused a quite a stir last year in the online hair discussion world. The intellectual property from that research was eventually sold to Aclaris Therapeutics, who we know is pursuing clinical trials for the use of JAK inhibitors in treating alopecia areata, as well as common pattern hairloss.

RiverTown Revisited

I debuted some impressive photo results of the pharmaceutical-in-training, RT1640, a few weeks ago. In my opinion, this treatment deserves more attention for the potential it brings to the table as a home-use hair regeneration treatment. In the original post I noticed there were some speculative comments about the photos, which is not rare for the internet. So, I decided to run the photograph through a lighting filter to see if I could “shed some light” on the situation (ok sorry, but hopefully that made you laugh). There’s no two ways about it, this guy regrew a good amount of hair in the second photo. Keep in mind, these results came in at 3.5 months, imagine what they might look like after a full year…

rivertownlight

Histogen is Coming to China

Histogen has offically agreed to license it’s hair growth product, HSC, to Pineworld Capital of China. Through this agreement Pineworld Capital will be commercializing HSC to the world’s largest national population of China. They’re probably gonna get a few tourists to visit as well. Histogen will receive milestone payments on the sales of HSC from Pineworld Capital as part of the agreement. According to this article Gail Naughton of Histogen is looking to go straight into a Phase III (final) trial for HSC approval in China.

Naughton also mentions that Histogen is considering going forward with a study for HSC as a preventative hair loss treatment for women undergoing chemotherapy.

Stem Cell Extraction in Spain

Clinica CFS is a hair transplant clinic in Spain that has been working on a method of extracting follicle stem cells and re-implanting them into the scalp for over a year now. The theory is similar in nature to the technique of Dr. Gho of the Netherlands. Clinica CFS will remove just the stem cells from a hair follicle with very fine instruments and then implant those stem cells into the recipient area of a patient’s scalp. The proclaimed advantage of this procedure is to not damage the donor hair follicle, as is the case with the more common FUE, and thus creates a virtual unlimited supply of donor hair. That was what they were aiming for, at least.

After a year’s wait the results are finally in from the first several patients that trialed this technique being dubbed “Stem Cell Transfer” by Clinica CFS. From three paitents the clinic reports an average of 82% total donor hair regeneration. That’s not bad. 

During the Stem Cell Transfer procedure stem cells are extracted from all of the donor follicles. Clinica CFS reports that currently 50-60% of the extracted stem cells are producing hair growth in the recipient area but hope to get that number up to about 90% after further developing the procedure. Here’s some photo results of patient “Toni” who had 78.45% regeneration of his entire donor area.

hair regeneration with stem cells - Toni

hair regeneration with stem cells - Toni 1year

Donor after 1 year

I’d say these results are quite interesting and I look forward to further developments from Clinica CFS on their SCT technique. It is great news that hair restoration is evolving at all levels. Salutations to all of the fine people across the world who are engaged in this work.

Until next time, Be Well.

A New Approach to Solving Hair Loss: HairClone

I had the opportunity to speak with Paul Kemp PhD this week about his new hair growth venture, HairClone. Paul shared a brief presentation with me about the concepts and business plan that HairClone is based upon. I can say I am genuinely impressed, there is evolution here. An experienced medical and business team, elements of crowd funding, and an ideal medical development system are all part of the formula that makes HairClone.

haircloneteam

The Experienced and Diverse Team of HairClone

The formula that HairClone is based upon could be described as “innovation.” The true innovation of HairClone is not so much the treatment itself, as others are working on cellular treatments, but more so the format in which HairClone will develop their treatment. They are calling the process “Medical Innovation” and are bringing together groups of patients and clinicians to co-develop the treatment. This is similar to the process that hair transplantation has followed. In hair transplantation, surgeons began with hair plugs, then strip surgeries, and eventually FUE surgery was developed and refined with the patients to the benefit of the patient. HairClone plans to integrate that process of ‘treatment practice of medicine’ with ‘scientific advances’ into hair cloning treatments. From HairClone’s website:

“The basic elements of hair cloning involves obtaining a patient’s follicles, dissembling them to obtain the required cells, expanding these cells in culture and then re-implanting them in the patient. Some of these stages are already understood and HairClone will optimise each in parallel both in the laboratory and the clinic in order to develop an effective therapy.”

Specials Delivery

Sounds brilliant, but how is it possible? Paul has worked extensively in the US and UK and feels that this process of Medical Innovation for hair cloning can best be carried out in the UK. In the UK a doctor may decide under his or her own judgement that a treatment is suitable for their patient and administer that treatment to their patient. There are regulatory criteria that the treatment must meet in order to be used under the regulator’s so called “Specials”  exemption. The biggest factor is that the decision to use the treatment has to come solely from the doctor and the company developing the treatment must not market their treatments to doctors or make any claims about said treatments.

In other words, through Specials the doctors are empowered to utilize a treatment that under their best judgement they believe to be safe, and believe is likely to be effective for their patients when a licensed alternative treatment is not available. When first hearing about this system used in the UK I was surprised and also impressed. It is a modernized development and I hope that other countries would take a look at a system like this and consider it for their own use.

Because of this Specials system, HairClone isn’t going to need to develop their treatment in isolation, carrying out clinical trials for several years and then launching the treatment onto the market. They will make use of an iterative approach, constantly learning and adapting through the tried, tested, and successful approach of Medical Innovation.

Better Together

Another innovative facet that really stood out to me from the slideshow is the community based approach HairClone is taking to create their solution. The HairClone treatment is aimed to work in conjunction with hair transplantation. Said treatment could potentially be useful for people who were not previously a good candidate for hair transplant surgery and especially younger patients who would have traditionally not been good candidates for surgery due to the uncertainty of their future hair loss. I know some of you are getting ready to ask, No, this does not mean that HairClone is only going to be used during a hair transplant surgery. What it means is that this treatment is aimed to be conducted in offices already practicing hair transplant surgery. I like this because I feel that it removes the apprehension that a hair transplant surgeon might have towards a cellular hair growth treatment and encourages cohesion and optimism.

hairclonegram
Also, as you’ve heard before HairClone is looking into both equity based and reward based crowdfunding to help finance their developments. This is something that myself and many others have been calling for in hair growth research for quite some time. It would be a wonderful sight to see the world come together and be successful in supporting a new treatment that is able to restore hair in a graceful manner.

HairClone aims to begin follicle banking for patients in the UK in 1st half 2017 and transplanting cellular treatments in 2nd half 2017, though this is dependent upon HairClone getting sufficient investments to carry out their development plan.

Commentary for the Enthusiasts

I know that even at this stage inquiring minds are going to want more details about how HairClone aims to get it done. I did have a brief segment at the end of the presentation to ask Paul a few questions that I thought the readers of this site might ask. Here’s a little more background info on how HairClone got started and how it may work out:

FT: What was the deciding factor that made you want to get back into hair growth research and launch HairClone?

Paul: Hair research has been in the back of my mind since the program at Intercytex ended prematurely due to a lack of funding. The paper by Claire Higgins et al in 2013 really peaked my interest and got me back into thinking about this (hair regeneration). I spoke to Vincent Ronfard about the paper and we thought “let’s have another look at it.” I then had a discussion with Dr.s Bessam and Nilofer Farjo about the subject and they said that they still get inquiries all the time from patients about hair cloning treatments. The Dr.s said they were interested in the new project, but instead of just participating in the clinical trial, this time they wanted to be involved from day one in the development.

FT: Is the 50 hair follicles via FUE planned to be enough for a lifetime of HairClone treatments for a person?

Paul: The short answer is that the process is still iterative at this point. We estimate that a person with hair loss loses about 50,000 hairs over the course of their life. In the culturing process we usually get about 10X the amount of cells at each of three passages, so a 1,000 fold increase in total. The theory that we have at this point is that from 50 hairs we’d get about 50,000 hair cells. Whether this would be turning vellus hairs back into terminal hairs or generating new hair follicles we don’t know at this stage. All of this is estimated for now, but of course it is possible to go back and get more FUE at a later point if necessary. What we don’t want to do is harvest many more follicles than we need from a patient.

FT: Do you plan on using a 3D culturing system for this treatment?

Paul
:
At this point we still don’t know. There are many different culturing options, including 3D culturing, that are available and through our research we intend to find the one that works the best. The techniques used by Claire Higgins give us the tools to rapidly determine which system works best before we use the cells in the clinic. This process will be supported by our follicle banking system so that when, as we are hoping, the culturing system improves we would then be able to utilize the hair follicles that are banked and create cultures using the new culturing system. 

FT: Thank you Paul for sharing this information for the readers of Follicle Thought.

HairClone – Another One

I almost couldn’t believe my eyes when I started browsing the website for HairClone, a new hair regeneration startup based out of Manchester, UK. Just like that another hair growth technology company has sprung up seemingly out of nowhere, and they have a very interesting plan to make hair regeneration a reality.

Update: The Personnel Section has been updated 9/8/16 Check it out

Image result for hairclone
The Scoop

HairClone is based on a model of “banking” a person’s extracted hair follicles in cryopreservation which can be used later when the HairClone cellular therapy has been fully developed. HairClone notes that the younger the follicles are, the more potent the cells within them may be. When HairClone’s cellular therapy is ready to go a patient’s follicles will be taken out of preservation and then dissected, expanded in culture, and micro-injected back into the person’s scalp. Apart from the cryopreservation banking, it’s a format we are familiar with. HairClone intends to raise funds for further research and create a patient pool through offering hair follicle banking initially.

There’s a lot of good information on the HairClone website about the companies plans for development and growth. The website even mentions plans for crowdfunding and getting input from patients to develop their treatment. Here are the most informative quotes from HairClone’s website:

About Business

“Other groups have tried this but it has been found that when human follicle cells are cultured, they rapidly lose their functionality. Recent scientific breakthroughs however indicate how culture multiplication systems could be developed which is why we have created HairClone Inc. now.”

“In order to develop a successful system that uses hair cloning for the treatment of androgenic alopecia, HairClone will need to develop strong and continuing interactions with leading hair transplant surgeons, scientists and forward-thinking patients in order to successfully carry out the various scientific and clinical developments.”

“HairClone will generate funding to carry out this research and clinical development in a number of ways: Clinic Membership, Follicle Banking and Storage, Pre-payment or reward based crowdfunding, Cell Treatment, and Investing in HairClone.”

“The banking activities could start within a year and will create a patient pool and short-term revenue to the company which will help support the clinical and product development and bring it closer to clinical reality.”

About The Treatment

“When the process for expansion and re-implantation has been developed by the scientist/clinician/patient partnership, portions of the banked follicles would be dissociated and expanded in culture, transported to the treatment clinic where they would be micro-injected back into the scalp. It is expected that this process will both rejuvenate miniaturising follicles as well as inducing new follicular structures. This process could be repeated every 2-3 years as the balding process continues by taking additional portions of the patient’s banked follicles and expanding them.

“In a later version of the product injected cells would be able to create brand new hair follicles by a process called follicle neogenesis.”

“..We expect that this could be in the clinic within the next few years although it will take several years before it is fully licensed around the world.”

From Twitter: “Had great @webex with @BessamFarjo and a German company that has an nice technology that could be great fit with HairClone. More to follow!”

The Personnel

Wait, so I didn’t say who was responsible for HairClone yet? You’re right. I wanted to build up a little suspense, this is the internet after all. The CEO at HairClone is Paul Kemp PhD who has over 25 years experience in the field of Regenerative Medicine. What’s even more compelling is that Paul was the sole founder of Intercytex aka the first company ever to trial cell therapy for hair growth. Intercytex was eventually unsuccessful at getting significant results in their hair growth trials, however, that experience and background is a big plus and adds credibility to HairClone. Vincent Ronfard PhD serves as CSO at HairClone and his resume boasts over 26 years of experience of applied research and product development in the fields of regenerative medicine, wound healing, and cosmetics.

Paul and Vincent have teamed up with two clinical partners so far, Dr. Bessam Farjo and Dr. Nilofer Farjo, both hair transplant surgeons of The Farjo Hair Institute of London, UK. Here’s a tidbit that you might have been unaware of, Dr. Bessam and Dr. Nilofer Farjo carried out the original Intercytex trials with Paul Kemp!

There is also one member of the scientific advisory board at HairClone, drum roll please…..Dr. Claire Higgins! Dr. Higgins is currently faculty at the Department of Bioengineering at the Imperial College London. She has also done postdoctoral training in the laboratory of Dr. Angela Christiano, one of world’s most renowned hair follicle researchers. The HairClone website mentions that more scientific advisory board members will be announced soon. Is it just me or is it starting to feel like Christmas already? 🙂

The Wrap

Not surprisingly, I really like this company HairClone……but I think I like that picture of Claire Higgins even better.

Cheers

RiverTown Therapeutics Inc. Results: Exclusive

 

https://i1.wp.com/static1.squarespace.com/static/575085041d07c0db05029019/t/575300488a65e246000c510d/1465057400328/rivertown+nontransparent.png?w=1000&ssl=1
I’m very happy to be bringing you all an incredible exclusive on Follicle Thought. This week David Weinstein, MD, PhD of RiverTown Therapeutics Inc. reached out to me to share some amazing photo results of his new compound RT1640. Below you will find photographs of a 60+ year old woman and a 42 year old man that received the RT1640 treatment. Both of these results came within 4 months of trialing the compound. Very impressive.

Worth a Thousand Words

RT-female

rivertownlight

I knew that if the photographs showed that much hair regrowth then the result must have been even more impressive in real life. David confirmed this to me when he remarked “both the man and the woman are ecstatic with their results.” I believe it.

With landmark results like these I knew the interest in RT1640 would be sky-high. To give you a greater picture of what’s going on at RiverTown Therapeutics Inc. I asked David to answer a few questions for the article. This is a brief interview, but all of the information is there and you will be surprised by what you read probably more than once.

Interview with David Weinstein MD PhD

FT: Can you tell us about your background in biotechnology and what lead you to hair growth research?

DW: RiverTown Therapeutics Inc. is my third biotech start-up. I enjoy building things. This includes building companies and building therapeutics. My other companies have been in the area of neurology and neuro-regeneration, which is in keeping with my professional training. I came to hair regeneration through a combination of curiosity and vanity. I lost a good deal of my hair precipitously and didn’t care for how I looked. My attitude when confronted with a problem is to think about the cause and the ways to address the problem. I needed to learn about hair, and especially about androgenic alopecia (male pattern baldness). I spent a day or so with my good friend, PubMed. The take-home message was that AGA was simple, but hair regeneration was a complex problem that like effective cancer therapies, was likely to require targeting multiple pathways. These pathways included expanding follicular stem cell pools, promoting their migration from the bulge to the follicle, driving their differentiation into the growing hair shaft and supporting the mature hair.

FT: How did you discover this combination of three agents?

DW: I remembered from my clinical training seeing kids treated with minoxidil- they had hair everywhere. The same was true of people treated with cyclosporine A- they too were hyper-hirsute. A review of the literature suggested that in spite of the exaggerated hair growth in patients taking theses drugs by mouth, minoxidil didn’t do much when applied topically to the scalp in AGA, and cyclosporine A did less. The two together had neither additive nor synergistic effects. Taking them orally was out of the question, as these are serious drugs with serious side effects. In addition to CSA and minoxidil the third drug is one I had created as a New Chemical Entity (NCE) several years ago, called RT175. Among other things, RT175 promoted the recruitment and differentiation of follicular stem cells. The three agents act on distinct pathways in hair regeneration and together, they synergize to promote the growth and maintenance of hair in men and women with androgenic alopecia. They also reanimate dormant melanocytic progenitor cells. These are the cells that add color to the hair. When the hair grows back with RT1640 treatment, it is the color that you had before it turned gray and fell out.

FT: Please tell us where RT1640 is right now in terms of the clinical trial process and what the next step is for it?

DW: We are currently raising funds to pay for a Phase 1B/2A study, and NIH document submission. We have established in a small number of people that RT1640 works: 100% of the people that have used it have had satisfactory growth and a significant percentage have had complete hair regeneration. As soon as we have the required funds, we will push forward. To that end, we are seeking interested strategic and venture partners.

Thank you very much for taking the time, David.

Wow. It’s clear RiverTown Therapeutics Inc. has a potential goldmine on it’s hands. Venture capitalists take note. Hair enthusiasts rejoice.