Updated on January 18, 2018
An interesting bit of news was released by the company Follicum this morning. In conjunction with a specialized research company Dualsystems Biotech, Follicum has identified receptors in hair follicle cells that their lead drug candidate FOL-005 binds to. This represents a viable mechanism of action for their product.
The press release mentions this information could be leveraged in Follicum’s discussions with regulatory authorities and commercial partners. I wonder if this information could also be leveraged to create new therapies for hair growth or improve upon their initial peptide formulation. I am impressed that Follicum continues to share worthwhile news regarding its progress and is moving towards a phase 2a trial for the scalp to begin first quarter this year. To read the full press release click here.
Updated on January 11, 2018
A Happy New Year to all of you from Follicle Thought. I’ve always enjoyed doing the year ahead preview posts and this one is no exception. A new year does bring us new opportunities and should be a reason for renewed hope. This is also the first year since I’ve started Follicle Thought that a clinical stage treatment is (semi) scheduled for market release. That therapy and a potential marvel from Italy are at the top of the list for change this year. It’s no surprise they are the first two treatments from the Ultimate Guide to Hair Regeneration 2018.
The Top Prospects
Shiseido – RCH01
For several years now we have marveled at the prospect of RCH-01, Replicel’s hair growth therapy, being released to the Japanese market through Shiseido under Japan’s expedited regulations for cell therapies. The two companies agreed on a licensing deal back in July 2013. Now, to actually look at the calendar and see it says “2018” seems a bit euphoric. Don’t get it misconstrued, this technology still has a lot to prove. But, it is the closest we have been to seeing a next-gen hair growth treatment make it to consumer approval in the last 25 years. That’s a fact. The trial that Shiseido has been implementing for RCH-01 over the past 1.5 years serves as a proverbial “phase 3” trial, in which upon its success Shiseido has the opportunity to market the therapy to consumers while continuing to complete other larger clinical trials for RCH-01.
Here’s where RCH-01 stands, in a nutshell. Previously, the treatment had completed only one clinical trial all the way back in 2009 (wow, 2009?). The initial trial showed efficacy. Not a ton of efficacy, but efficacy. Multiple subjects received an improvement in hair density above 15%. At that time, Replicel noted that insufficient delivery and preservation methods of the cultured hair cells may have lead to diminished results in some of the trial subjects. Since then, the company has been working hard to improve many aspects of the product development to correct their mistakes. Subsequently, the trial with Shiseido launched around July 2016 and here we are. They had time to get it right and make improvements. I am confident that Shiseido administered this therapy efficiently in their trial, the only thing that remains to be seen is exactly what it’s really worth.The results from Shiseido this year are really everything you want to know…
You’ve heard of it. You’ve googled it. You’ve wondered how it’s pronounced. The lotion which originally spurred from a treatment for vascular disease in diabetes patients is as enigmatic as it gets in the hair game. But, we hope the mystery will come to an uplifting conclusion in 2018. According to Fidia Pharma, the Italian pharmaceutical company who acquired the rights to manufacture Dr. Brotzu’s formula, 2018 is very likely the year we get the Brotzu lotion.
The product is a thoughtful combination of three key ingredients to fight hair loss; an anti-inflammatory – Gamma Linolenic Acid, an anti-dht agent – ‘S-Equol’, and a metabolic enhancer – L-Carnitine. Their effectiveness is further enhanced by adding liposomes to the formula to increase scalp penetration. Various formulations of the product have been tested by Dr. Brotzu himself on patients with alopecia areata and androgenic alopecia. One photo displayed by Brotzu at an alopecia areata conference shows significant reversal of AA in a young girl. We have been told that Fidia Pharma has conducted their own trials of the product over the past two years or so. Everyone is eager for updates from the company, but I’d like to take this time to remind people that flooding a company’s inbox is not an effective way to get more info about a product release. My final thoughts are: “it’s going to be weird when this product actually has a name.” 😉
While the two treatments listed above really do represent the greatest potential hair growth treatments that we have coming in 2018, here are some other worthwhile milestones slated for 2018:
- Setipiprant trial estimated to complete in June 2018. If it finishes on time, that would almost certainly lead to a data readout before year’s end.
- Follicum phase 2a trial on the scalp to begin in the first quarter of 2018 and read out data sometime later this year.
- PolarityTE and the results from their first applications on wound healing. The company’s platform is miraculously approved for use without going through the 3-phase clinical trial process. PolarityTE’s lead product candidate SkinTE is aimed at regenerating skin tissue. If initial results are successful they will also pursue a hair regeneration product. Data should come 1st quarter 2018.
- I would be remiss if I did not include our old friend, the Wild Card. For those new to this site, a “wild card” is a product that is announced unexpectedly with an imminent market release date. To be considered a real wild card, the product/treatment has to be legitimate. Truth is, there’s always a few companies shuffling their deck of Uno.
Until next time, Be well.
Updated on January 14, 2018
(Updated 1/5/18 with Tesla Brush Photos)
The electrifying startup, HairCell, has just launched its new website. HairCell is part of the Leonhardt Ventures portfolio, a venture creation lab that focuses on regenerative medtech and regenerative economy startups. The core technology of HairCell is a biolelectric stimulator device that controls expressions of specific proteins in sequence for regenerative purposes. In other words, it mimics the natural bioelectric signals that your body sends throughout itself to repair, and build, tissues and organs. The HairCell signals are sent out through an electrode equipped helmet.
Combining Approaches For Hair Growth
HairCell’s new website comes with some interesting new information. The company has developed three clinical trial protocols involving the HairCell stimulation technology.
- The first protocol includes using the HairCell stimulation technology in clinic and an electrostatic device for at-home use called the Tesla Brush.
- The second protocol involves the two previously mentioned treatments plus amniotic fluid and/or PRP delivered via the Dermapen microneedling device in clinic.
- The third protocol includes everything from the second protocol and adds HC-15 fifteen component stem cell + growth factors + exosomes + micro RNAs + selected alkaloids + nutrient hydrogel + hair scalp/ECM matrix mixed hair regeneration composition.
This is a highly intriguing therapeutic combination. The amniotic fluid itself contains mesenchymal stem cells and growth factors. These would act as a “fertilizer” to go along with the Dermapen microneedle which activates the skin’s wound-healing mechanisms. Previous research has shown that wounding plays an enigmatic, yet positive, role in hair follicle formation. This Dermapen/fluid combination is added to the base therapy of bioelectric stimulation which is intended to stimulate the release of native proteins in the body for organ and tissue generation. The HairCell protocols comprise a thoughtful array of therapeutic techniques to stimulate hair growth. It all really comes down to a specific point of emphasis: Will this bioelectric stimulation device cause hair follicles to sprout, or rejuvenate vellus hairs back to terminal hairs?
HairCell’s Origin In Human Trials
One question that is always important to ask when being presented with a new hair regeneration therapy: where did this treatment originate from?
i.e. Why is it here? The FAQ page on the HairCell website gives some background as to where the initiative to create HairCell came from. Here is a quote describing a clinical trial led by the Leonhardt team which opened their eyes to the potential of hair regeneration:
“In 2012, 2014 and again in 2015 the Leonhardt led team initiated clinical studies in Czech Republic, Switzerland, Germany and Mexico for limb salvage and ulcer wound healing to stave off imminent amputation. In the Czech Republic study we were able to save 12 of 16 legs treated just one time with a stem cell composition. In the study in Switzerland and Germany we worked with a team in Denmark (Wetling) to apply non-invasive bioelectric stimulation to 47 patients with non-healing leg ulcers. The team achieved 95% healing of all ulcers in all patients at 8 weeks. In Mexico we were able to save 7 of 7 legs treated with just two bioelectric signals for only 2 hours 2X a week for 8 weeks. We observed in these leg studies that when the wounds healed and the blood flow improved, that their was also very healthy hair growth on the treated legs. This launched the start of HairCell in 2016.”
This would make HairCell the second hair-growth treatment we’ve heard of that was discovered during diabetic leg ulcer trials. 5 bonus points if you can name the first one.
Clinical Ready To Go
The good news is the HairCell team is currently initiating clinical trials in North and South America to answer all of our questions. At least one of these trials is scheduled to read out data around the end of 2nd quarter 2018. Even better news is the bioelectric stimulator device has a previous FDA 510(K) approval. This means if the HairCell therapy proves to be safe and effective in its clinical trials it could potentially enter the market shortly following the trials’ completion.
Update: Tesla Brush
In response to commenter “Michael” (thanks again) I reached out to Bernhard Rudert for more information and asked him to share photo results of the Tesla Brush. Bernhard is an electrical engineer and the inventor of the Tesla Brush. First, I will copy and paste Bernhard’s reply from the comments thread and following that I will share some before and after photos of the initial Tesla Brush model.
I fully understand your sentiment. When I was asked by a very successful wellness clinic to design a device for them I was hesitant because it did not look like a worthy project for a professional engineer. Soon I changed my mind when I saw the results from an experimental device. It was not an easy task to develop a device with the same characteristics while meeting mandatory regulatory requirements.
People loved the device. However, I still had a problem in that we engineers work with concrete facts. I had to learn to get used to the thinking of pharmaceutical companies where in many cases only a small percentage of patients can be helped with a given drug. However, the percentage was significant enough to make me go ahead with confidence. One thing that stood out was the fact the majority of users benefited from stopping or reducing hair loss and at least quite a good number got some hair back.
We still know very little about electrical stimulation regarding hair loss. I simply copied the stimuli of the experimental device realizing that there needs to be big investment to find an optimum. I use an electrical field to generate the pulses in comparison with devices which use direct electrical contact with the skin. The advantage is that the penetration into the skin is much more effective even in the presence of existing hair or dry skin.
There is still considerable research required as to why this device works. However, we see that with some users the skin takes on a faint pink color indicating that blood circulation is enhanced. Furthermore, after a while very tiny brown spots appear around dormant follicles indicating that excessive sebum is excreted from the follicle. Due to the electrical stimulation it can safely be assumed that on the cellular level more ATP is produced which makes more energy available for the process. I believe however, that the major benefit is derived from a neurological process which aims at restoring homeostasis.
Including the Teslabrush in the study is very sensible because it is very likely that it will enhance the other processes. I am very much in favor of a multi-pronged approach to hair loss. We don’t have a single pill that will solve the problem and from the immense pool of knowledge with the contributors this study could well lead to one of the most successful hair loss treatments available to date.
I have not put any photos on my website because they will be copied by those using scam methods. For this reason a summarized version of the original study has been presented. When trying to find a solution for hair loss your critical mind is a very useful tool.
I hope this answers some of your fully understandable skepticism.”
What I see here are some realistic, worthwhile results from a product intended to support hair growth. Obviously, ‘Ricky’ and ‘Cuong’ received advantageous results using the device. It seems to be an improvement from a hand-held LLT hair growth device. We could do ourselves a service by treating the Tesla Brush as it is, a product intended to support hair growth and prevent loss. There are no inflated claims being made by the Tesla Brush company. For clarity, this is not an affiliate endorsement, this added information came about simply as a response to a reader’s comment from 1/03/18.
Updated on December 23, 2017
Rophe Pharma submitted a press release this week announcing its topical hair growth drug has shown positive results for restoring eyebrows. Rophe’s hair growth candidate RPHE-7193 is a topical form of the FDA approved blood pressure drug hydralazine. The drug apparently has a similar mechanism to minoxidil. Here’s a quote from the press release which was featured on Yahoo News:
“Rophe Pharma researchers analyzed results of RPHE-7193 in women suffering from thinning eyebrows and were amazed by the positive results. Since cosmetic treatments do not provide satisfactory results and are usually a temporary remedy it seems the efficacy of RPHE-71093 in helping women to gain their own eyebrows back could become the most preferred option for restoring hair growth in this area. Encouraged by these results, the company has also initiated an exploratory study to evaluate if RPHE-7193 can stimulate the growth of eyelashes in women. The results will be announced shortly.”
I’m hoping for photos of RPHE-7193’s results in scalp hair growth and eyebrow growth to be released soon. Documented images would certainly add to the interest in RPHE-7193. For more information contact Robert Gadimian, CEO of Rophe Pharma.
Updated on December 22, 2017
Gunnar Gardemyr of Follicum recently reached out to Follicle Thought to share some messages with its readers regarding the progress of Follicum and details on what the company is looking forward to next year. Follicum is casually strolling into a major pivotal position in the hair growth industry and also has in the works some new research aimed at diabetes. The phase 2a trial for scalp hair growth is planned to commence 1st Q 2018 and should produce data by year end 2018. The results of this trial will be extremely interesting.
Here’s a message from Gunnar Gardemyr including exclusive info about FOL-005’s formulation development:
“2017 has been a very exciting year with positive progress in our research projects. Our first breakthrough was the result of our phase I/IIa trial with FOL-005 for hair growth. The result showed increased hair growth after treatment in three out of four of the healthy individuals included in the trial. This has led to that we recently filed a new application for a phase IIa clinical trial on the human scalp with the German authorities. Furthermore, we received a patent approval in China, which is especially important, considering the huge market potential in Asia.
We are in parallel with the clinical program developing three different topical formulations from which we will select the one that is most attractive during Spring 2018 to be used in phase IIb clinical trial 2019. The prototype formulations are the following: 1.Powder formulation – FOL-005 in emulsion of lipid-based suspension. 2.Cream – nanoparticles of FOL-005 in lipid-based suspension. 3.Gel – FOL-005 incorporated in polymer nanoparticles.
After an intense and fascinating year we look forward to 2018 with many activities to demonstrate the value of our research and development. We will initiate and conclude on the phase IIa study on scalp, chose a topical formulation for FOL-005 that we can use in the phase IIb study, present data around the MoA and much more! I wish you a restful Holiday period and a great start 2018.
With best wishes
For a detailed review of Follicum’s year read their entire Season’s Greetings press release.
Updated on December 1, 2017
I’ve had a few readers asking about updates lately which tells me that not everyone is aware of the new Updates thread. It is a post that acts as a Newsfeed. I use it to add quick news items and links to articles. These are for news items that do not necessitate an entire published post. Once again, I recommend going to the page >http://www.folliclethought.com/updates/< and bookmarking it in your browser so you can check it on a daily basis, or as often as you like, to see if news has been posted. You will not receive an email when the thread is updated; emails only go out for published articles (like this one).
One news item which has been burning up the internet lately is the research done by Professor Kang-Yell Choi of Yonsei University and colleagues in South Korea. The research is centered on using a protein chain called PTD-DBM to interfere with a protein called CXXC-type zinc finger protein 5. The PTD-DBM prevents the CXXC protein from interrupting the Wnt signaling pathway which is responsible for initiating hair follicle growth and regeneration. So, with PTD-DBM in place, the Wnt signaling pathway can function as normal and thus hair growth continues as normal. This development so far, has only been tested on mice.
I will certainly continue to follow this research. Keep in mind, the excitement from this discovery is stemming from a research paper. The steps ahead for Choi and his team include testing the PTD-DBM compound for safety and toxicity in animals. Then it will further be developed into an actual drug candidate for humans. When discoveries like these are announced people always wonder, “is this really it, the cure?” We will find out more as things progress. It does seem compelling as far as hair growth news goes, but of course, for “research paper discoveries” it is best to keep hopes balanced. There are steps ahead.
Thank You For Your Support
I had a pleasant experience with a reader of the site today I’d like to share. Some of you may be aware I have started a donation page for Follicle Thought where readers who find value in this site can make a big or small contribution for my efforts. Patrons of the site can choose to make a one-time donation or a monthly contribution. I received this message today from a supporter of my page:
“There are few places online that one can find reliable, informative and positive information and discussion. I am currently donating $5 monthly, and will be increasing to $10 next month because I really feel I am getting my money’s worth.”
It really warmed my heart and thanks to ‘M’ for your contribution. To make a contribution to support this site and my efforts please click on the image below which will take you to my Patreon page. Thanks much in advance, any and all support goes a long way. 🙂
South Korea Growth Factor Hair Loss Treatment
With so much news coming from South Korea at the moment, I thought it was only right to add a bonus. To be honest, I love “research paper” news, it’s great. However, I’ll typically favor news of an actual biotech firm working on a hair growth drug if given the choice. This newcomer drug candidate is actually very early in its development also and comes from Daewoong Pharmaceutical Co. of Seoul, South Korea. The drug is listed as a “growth factor” in the company’s pipeline chart and is aimed at treating hair loss, as well as arthritis. Click the logo below to visit Daewoong’s pipeline page. And if you missed it, check out the article I did a few months ago about other compelling drug development coming out of Asia.
Updated on December 3, 2017
As I was reading the program of the 10th World Congress for Hair Research, a few of the oral presentations caught my eye. One such presentation was titled “Topical application of siRNA against androgen receptor for treatment of androgenic alopecia and female pattern of hair loss” by Quark Pharmaceuticals.
Quark is new to the scene of the hair growth industry. From their webpage we see they have therapies in development for pattern hair loss as well as chemotherapy-induced hair loss. These therapies may be developed as clinical drugs or cosmetics depending on the regulatory options available in their development location. Quark has headquarters in Fremont, CA (USA), research operations in Israel, and a joint venture in China. I reached out to Quark shortly after the WCHR2017 concluded and was put in touch with an associate Gavin Samuels. He was kind enough to annotate the slides of the presentation for this audience and provided a paragraph summary of Quark’s hair program found below the slides.
Topical Application of siRNA Against Androgen Receptor for the Treatment of Androgenic Alopecia and Female Pattern of Hair Loss
“Short inhibitory RNA (siRNA) is a novel class of therapeutics acting via specific inhibition of target gene expression. Quark Pharmaceuticals presented data at WCHR2017 demonstrating for the first time the possibility of effective topical delivery of synthetic siRNA compounds into hair follicles. Data was presented in mice and in human skin explant models.
In human scalp skin explants, topical treatment with siRNA targeting androgen receptor (AR) produced significant dose-dependent up-to 60-70% decrease of AR mRNA and protein levels. Topically administered siRNA reduces AR levels only at the site of application and does not leak into systemic circulation as shown both in vivo in mice and ex vivo in Franz diffusing cells containing human skin. No skin irritation following repeated topical applications of AR siRNA was observed.
The proof on concept of efficacy of topical siRNA treatment in ameliorating hair loss was demonstrated in the mouse model of chemotherapy-induced alopecia (CIA) using p53 targeted siRNA. P53 gene codes for a protein activated in response to chemotherapy in matrix keratinocytes leading to their apoptosis. The results indicate that p53 siRNA-treated mice were partially rescued from hair loss while demonstrating significantly accelerated hair re-growth by 8-9 days, in the affected area compared to control.
These data support the possibility of developing siRNA-based therapeutics (or cosmeceuticals) for treatment of androgenic alopecia as well as female pattern of hair loss.”
I followed up with Gavin on a few questions to bring more clarity on where things are at with Quark’s hair growth therapy and what its future is looking like.
Q&A with Gavin Samuels of Quark Pharma
FT: What are Quark’s plans moving forward for developing this technology into a therapeutic or cosmetic?
GS: Quark is actively looking for a development and commercialization partner for this product. We are excited by the data generated but also understand that developing a dermatology product, especially for alopecia is a highly specialized skill set. Our R&D efforts and expertise have mainly been in kidney and eye diseases and not dermatology hence the desire to find a partner. Quark however does have deep expertise in siRNA chemistry and development and we can contribute to a collaboration in this way.
FT: Is there a possibility this therapy could be developed as a cosmetic and reach the market sooner?
GS: As part of our development and commercialization partnering efforts, we have also had preliminary discussions with a few cosmetic companies. Regulatory agencies in different geographical regions approach this question in different ways. A cosmetic approach may have a shorter pathway to bringing a product to the market.
Special thanks to Gavin Samuels, Dr. Elena Feinstein, and Dr. Daniel Zurr of Quark Pharmaceuticals for sharing this information with Follicle Thought.
Updated on January 5, 2018
Located within the biotech cluster which is Cambridge, Massachusetts sits a contemporary R&D platform, the LEO Science & Tech Hub. The Science & Tech Hub is an innovation unit of the international dermatology-focused LEO Pharma company. The Tech Hub seeks to engage with and bolster new technology which may offer solutions to dermatological and other medical needs. I was drawn to look further into the Science & Tech Hub after learning about: its work in the area of Alopecia Areata, and the open engagement model which the hub offers.