Follicum Phase 1/2A Hair Growth Results

Two days ago, I received an email from one of my readers which informed me that Follicum had just made an announcement about important developments that would be of interest to me. Upon further investigation, I found the Follicum website (only on the “Swedish” content) had put out a press release pertaining to the results of their candidate FOL-005 in its latest phase 1/2a trial.

The peptide, FOL-005, has shown a statistically significant increase in hair growth in its latest trial on humans. This was actually somewhat of a surprise to all those who were watching this development carefully. The CEO of Follicum, Jan Alenfall, had stated before the trial began that the company expected to observe the inhibition of hair growth in this trial. Pleasing to most of us, the peptide pulled a bit of a switcharoo, and produced the stimulation of hair growth instead. For those just joining the conversation on Follicum, the peptide FOL-005 has shown the ability to both inhibit and stimulate hair growth in its preclinical trials. The company is now furthering the development of FOL-005 through clinical trials to better understand and produce each of those effects in the desirable situations thereof.

What’s it Looking Like?

In this phase 1/2a trial, FOL-005 showed an 8% increase in hair growth in people who received the treatment. The treatment was administered by injection into the front thigh area of the trial subjects. Those who received a placebo injection in the trial showed a decrease in hair growth of 2%. There were no adverse events reported from those who received FOL-005. As far as I can tell from this press release, the subjects received injections twice per week.

So, 8%…..what does this mean? Is this good?

Here’s what is relevant to the stats and the design of this trial:

  • This study was completed over a 3 month time period. That is a small window of opportunity to observe an increase in hair growth due to the time involved in the hair growth cycle itself. How much hair growth could be observed over 6 or 9 months, then?
  • The biological area which was treated in this study was the thigh. I just took a moment to look at my own thigh. Yes, there is a lot of hair growth there (laughs), but not the same as a scalp, obviously. There is a chance the peptide could behave differently (potentially better) when used on the scalp.
  • There were 4 dosing ranges being tested in this trial. The second lowest dose showed the best response. It appears that this drug shows a dose-specific response similar to Samumed’s drug. What is more pertinent, those doses of FOL-005 that were used in this study and found to be non-optimal, affected the statistics, which came out to be an 8% increase in hair growth. What could the % be if the whole group was treated with the optimal dose?
  • The press release mentions the data from this trial indicates that changing the dosing frequency to three times a week or more, could further improve results.
  • This trial has provided Follicum with information on how to improve upon their formulation.

You knew that the optimism was coming, and it’s deserved. Things are still early here for FOL-005 with more to come.

Moving Forward

Jan Alenfall states at the end of the new publication that Follicum is now getting things together for FOL-005’s phase 2 trial, also the company will be focusing on creating an optimal formulation for their peptide (which may include nanoparticle delivery), and notably, the next trial will be administered on the scalp. Good news to hear, for now.

This is the link to the press release, now posted in English.

Anti-Aging Peptide, Replicel Check-In: Weekly Thoughts 4/7/17

Hello Everyone,

It is good to be back for another Weekly Thoughts. This edition is headlined by an anti-aging technology from The Netherlands that has shown interesting regenerative effects on mice. I even got some exclusive info on the potential of this technology to be applied to hair growth to share with you. Also, we get an update on how Replicel’s treatment has faired on people’s scalps five years after the injections. And while we are still looking forward to an update on a particular hair cream coming out of Turkey, I have some good news about another cosmetic hair cream that may be of interest.

Foxy Science

Researchers at the Erasmus University Medical Center have discovered a peptide capable of reversing age-related symptoms in mice. The research was led by Peter de Keizer of Erasmus. The main function of this peptide is to get “senescent” cells (cells affected by aging) to go through “apoptosis” (cellular death). Kind of like cleaning out the old cellular closet. The peptide affects the communication between two proteins – FOXO4 and p53. In this case, it blocks the signal from protein FOXO4 to p53 to tell the cell to not kill itself. When that signal is blocked, the cells revert to apoptosis and die. What is attractive about this approach is the FOXO4 protein is virtually non-existent in healthy cells, and so this treatment does not interfere with the lifespan of healthy cells, only the damaged aging cells.

Mice on left was treated with FOXO4 therapy (Credit: Peter de Keizer)

And you guessed it, one of the effects that this therapy created in mice was hair regrowth. Other effects that were noted in the study included kidney function and energy level. The researchers at Erasmus are now looking into whether this therapy will also increase life-span. A human study is being planned using the FOXO4 therapy to treat a specific type of brain tumor. I read some brief comments from the leader of this research, Peter de Keizer, about using this treatment to grow hair in humans. I decided that it would be worthwhile to see if I could get a few comments from de Keizer about how close hair growth R&D really is for this peptide. I’m happy to present a brief interview with Peter de Keizer which explains what’s going on with the FOXO4 peptide currently and how he intends to use it to treat human conditions.

Exclusive interview with Peter de Keizer

FT: What is the next step in R&D for the FOXO4 peptide?

PdK: We designed this peptide to interfere with the interaction between FOXO4 and p53. We now have more structural information about this peptide and its interactions. As such, we will focus on optimizing it further. In addition, we observed that this FOXO4-peptide is effective against senescence in vivo. However, before we think we are ready for clinical translation, we will put a lot of effort into finding out how safe these compounds truly are. We observe this peptide to have a benefit in certain types of recurrent cancer. We are therefore very eager to see whether it can be employed against those initially, and when successful and safe, whether more age-related diseases could be targeted.

(In regards to hair)
Yes, we are now allowed by the ethics committee to test this peptide in a cream against skin diseases present in the fast aging mice. In the meantime, we will then of course also address (take note of) hair regrowth. The downside is that this peptide might not penetrate the epidermis and be useless as a cream. But we hope the hair follicles might enhance uptake.

FT: If the cream shows potential as a topical hair growth treatment in mice, what then would be your plan moving forward?

PdK: This is a difficult question to address. It is amazing to see that people, especially men, are most interested in the hair phenotype (hair growth effect) and less in the effects on organ function, actually. While we certainly are interested in the effects on hair (re)growth, there are more severe, and even life-threatening, diseases for which we think this might be useful too. It is too early to tell in what scenarios it is going to work best, but from an ethical point of view it would be best to start with severe disease indications. Needless to say, if the experiments with this peptide in a cream are successful, this is definitely worth pursuing.

FT: You mentioned there are many health concerns that this peptide may address, what will this peptide be used to treat first?

PdK: For now, we think that the first disease indication for which we might move to the clinic, could be some specific types of late stage, recurrent cancer. Still, much needs to be done before we are ready, including a more elaborate safety assessment, but, given that for those indications there are no alternatives and we appear to have a promising effect, this might be the first point on the horizon. Thereafter, milder age-related diseases could be targeted – provided that the compounds are deemed safe enough. Eventually, perhaps aging as a whole, but this would be in the far future.

FT: Is there anything else you’d like to announce or express at this time?

PdK: Over the last couple of years, we’ve seen some very exciting developments in the anti-aging space. For long it has been known that aging could be delayed by eating less and exercising more (or using compounds that mimic these effects as Rapalogs, Metformin or Resveratrol). To a degree it is disappointing that this was nearly the only thing that could be done. By now, it seems that it is also possible to not just stall the deterioration, but to also revert it. We showed this in the case of senescence removal and a recent paper by Ocampo et all, 2016 Cell showed that transient expression of Yamanaka factors could promote tissue rejuvenation. Altogether these three areas (delay of aging, targeting senescence and tissue rejuvenation) could be 1+1+1=6 in order to combat aging. I am very excited to see more on this in the future!

Thank you very much Peter de Keizer for taking the time to share a few words with us.

 

Replicel at 5

The five year safety data of Replicel’s phase 1 clinical trial has finally been released. Man, has it been 5 years already? I guess it has. Within the five year safety data was also released the two year’s efficacy data. To be honest, the results were mostly what would be expected, based on what we already know about the treatment. From the top seven responders of the treatment, there was a >10% increase in hair density after 6 months ,and at 2 years that increase dropped slightly to 8.3% over baseline. A slight drop in density after 1.5 years seems reasonable due to the fact that the subjects were not receiving any further treatments. I was, however, surprised to read that one responder from the cohort held a 21% increase in hair density after 2 years time. That is noteworthy, folks. Another meaningful tidbit from the data is the claim that “an overall stabilization of hair loss was observed among all the patients treated per protocol.” This means some of the benefits of RCH-01 could be materializing in ways that are not recorded in statistics, e.g. the halting of the progression of hair loss.

What’s most important is that the treatment displayed a high level of safety through the five year analysis and now Replicel can look into ways to optimize the efficacy of RCH-01.

Rolf Hoffman, CMO of Replicel, has already stated: “Over the past 36 months, we have invested a great deal in both basic research and manufacturing optimization which we believe will be critical to minimizing batch-to-batch variability and further improving efficacy. We have invested in process and product development initiatives including a modified tissue culture technique, improved culture media with addition of 12 new ingredients, introduction of a cell activity promoting step, and cryopreservation storage to improve cell stability and viability. We believe these programs have already resulted in a significantly more robust and better-defined product than the one used in this trial by many measures and look forward to translating our continued R&D into next-phase clinical trials in due course.”

Now let’s see what RCH-01 can do when given in smaller doses, more frequently, over a period of time. While there is a phase 2 trial planned for Replicel in North America, there has been no set date as to when that trial will commence.

Samumed Still Thinking 3

Good news was released by Samumed this past week in an online news publication. After seeing roughly a 10% increase in hair density in a phase 2 trial for its topical hair growth treatment SM04554, Samumed will continue on. During the initial phase 2 trial, a .15% solution showed better results than the .25% solution of SM04554. In a second phase 2 trial, the .25% solution showed slightly better hair growth. Now, apparently the company is planning one last phase 2 trial to get the final verdict on which % solution to use before heading into a phase 3 trial. It looks like SM04554 is destined for phase 3.

My Trial of a Cosmetic Cream

Many of you may not know that over the past year I have been trialing a cosmetic hair growth cream. The cream itself is known about online and sometime very soon I will give my full personal review of the product. I don’t want to give an exact date when, due to the possibility of a change of schedule, but the review will be out soon. I’m just waiting on info from the company. And, just in case you were wondering, no it is not the ReBoost cream. Speak to you soon.

Until next time, be well.

Kelopesia Update: Coming Soon

I got some great news today, everybody, that I am excited to share with you all.

Prof. Fikrettin Sahin gave me an update on the Turkish hair cream that has many people on the edge of their seats. The update includes a new release date and a new name for the product. Here is the info from Prof. Sahin himself as of 2/20/17:

“Our hair cream will be introduced into the market soon (within 2 weeks). Commercial name of the product will be ReBoost.”

ReBoost….hmmm. Interesting name. I was also told by Prof. Sahin that after the release of the product in Turkey, he will let me know how the cream may be purchased from Turkey by those who live abroad. Rest assured, you will all get that info when it is available. Making sure you are subscribed for email updates on the right sidebar of this blog is a good idea. Other than that, smile. 🙂

To Prof. Sahin and the rest of the team who worked on this product – Thank You!

Update 3/3/17:

We are now close to the time period in which Prof. Sahin stated ReBoost would be launched in Turkey. In lieu of inquiries about the progress of the launch I am making this statement to my readers:  Thank you very much for your patience as we anticipate the launching of a potentially pivotal treatment for hair growth. As has been stated on this site before, Prof. Sahin and his team have been working diligently to get this product to market. Let’s give them time to get it done and respect the time it may take to be completed. As with all project completions in life, exact dates are subject to change. If I do not receive an update sooner, I will contact the company for information towards the end of next week. I have no further information until I receive an update from the company. Thank you

Update 3/23/17:

I have still not been able to get another official update from the ReBoost company, yet. I just wanted to check in with you all because I realize this has seemingly been a while to wait for news. A friend of mine who lives in Turkey informed me that he contacted the University via telephone this month and they told him things were still progressing for the hair cream, with just a few more regulatory passages needing to be cleared in order for the cream to launch. For now, I will continue to wait for an update from the company and will be moving forward with new posts and topics. Thank you all for your patience.

Update 4/24/17:

Suffice to say, things have not gone as expected for ReBoost over the past two months. There has not been an official word from the company since the initial announcement of its launching. I am now in question of whether the cream will be sold worldwide as foretold. Because of the lack of communication from the people behind ReBoost I am now moving past the subject and will only revisit it if I hear back from an official source and the cream does in fact launch in Turkey.  My apologies to everyone who is disappointed by this turn of events, the initial announcement came directly from the company and what has transpired since then was unexpected. Let’s stay positive for many of the other great products working towards release.

HairClone in Action, Scar Prevention: Weekly Thoughts 2/4/17

Hello everyone,

Welcome to another edition of Weekly Thoughts. I’ve been looking for some significant info to share with you all and today I came across just that. I expect this news to create quite a positive ripple in the hair enthusiast crowd. Let’s see what’s going on.

HairClone Begins

Dr. Bessam Farjo tweeted this photo today:


Exciting 2017 indeed.

For those unaware, Dr. Farjo is is one of the founding clinical partners of HairClone, a company developing a cellular based hair regeneration treatment. In this tweet he tagged @HigginsBioeng which is the Twitter account of Dr. Claire Higgins’ lab. Apparently the entire team has been working diligently and they are moving things forward. CEO of HairClone Paul Kemp recently told me they will be providing an update on their work soon.

Dr. Farjo also added on Twitter “(we are) Not trialing yet @HairClone, but doing investigative clinical work in preparation.”

For those who have been asking lately if HairClone could begin treatments this year (2nd half 2017) and how this would be possible please refer to this article A New Approach to Solving Hair Loss: HairClone. The company continues to seek funding to continue their plan of development.

New Plikus/Cotsarelis Research

A scientific paper was recently published on the role that hair follicles could play in preventing scar formation. The team responsible for the paper was quite large and included two familiar names: Maksim Plikus of the University of California at Irvine and Dr. George Cotsarelis of the University of Pennsylvania.

The team of researchers discovered that in order for fat cells to regenerate in a wound, there needed to be hair follicles present first. Scar tissue, which is normally devoid of both hair follicles and fat cells, forms from wounds. When hair follicles are added to a wound environment, the hair follicles naturally recruit fat cells. The presence of fat cells or ‘adipocytes’ in a wound environment promotes normal tissue regeneration instead of scar tissue.

This article does a great job of breaking it all down, and here is the original article from Science Magazine. I wonder how this research could be applied to the use of scar prevention during hair transplant surgeries.

Until next time, be well.

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 that led to 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 in a state 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 3 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 3 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.”
  • It’s 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 2a 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 prostaglandin D2 receptor antagonist and was originally developed for inflammatory conditions such as asthma. However, when Dr. Cotsarelis found that the PGD2 receptor plays a significant role in hair growth, he patented that use and suddenly PGD2r 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 the 2017 market release of its Hair Stimulating Complex in Mexico. Lately, the company has been quiet about the potential of releasing HSC in Mexico. The HSC treatment still needs to go through a phase 3 trial for approval in Mexico, and if Histogen plans to release the product in 2017, that trial would have to 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 trial 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 bring 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 that 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 the 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 hair growth enthusiasts’ attention this past year. Also, I take a look at an intriguing healthcare legislation that was just passed this week in the United States.

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. Read More

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. Read More

2016: A Year in Review

It does not feel that long ago that I wrote 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. Read More

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. Read More

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 growth startup rolling out their new website and business plan. 

Read More