Rophe Pharma Announces Hair Growth Candidate

It was recently announced that Rophe Pharma will enter the hair growth market with a repurposed drug candidate. Robert Gadimian, CEO of Rophe Pharma, has put out a press release this month pertaining to the development of his hair growth compound RPHE-7193. See below for text of press release.

Rophe Pharma, announces it has applied for the International Patent Application (PCT application) for RPHE-7193, which is a topical drug for the treatment of hair loss. Hydralazine, the active substance in RPHE-7193, was approved decades ago for treatment of blood pressure but in an exciting development it spurred hair growth as a side effect.

NEW PRODUCT HAS FDA APPROVED COMPOUND

Rophe Pharma plans to apply for the expedited review of its patent with the US Patent and Trademark Office before the end of 2017.  In an exploratory study conducted with RPHE-7193 significant hair growth is observed in men after 8 weeks of use compared other hair loss products that take 6-12 months to show noticeable hair growth.

The background for hydralazine in RPHE-7193 is almost the same as minoxidil, the active substance in Rogaine. Hydralazine is currently approved as a blood pressure drug. RPHE-7193 does not contain alcohol and polyethylene glycol, the two solvents in other hair products that cause skin irritation and sensitivity, hence RPHE-7193 is formulated to avoid these skin related side effects.

RPHE-7193 WILL BE STUDIED IN RELEVANT AGE GROUPS

Robert Gadimian explains the two already approved drugs for male pattern baldness (MPB), have not been studied in men above age 41 but Gadimian is testing RPHE-7193 in that age group — since as mentioned above, most of the men who suffer from hair loss are above age 41.

Gadimian also explains that the only 2 available treatment for hair loss (minoxidil and finasteride ) don’t have satisfactory hair growth properties, leaving men who suffer from hair loss desperate. Table 1 presents the clinical study results for Rogaine max strength solution and as shown, At week, 16, there is no difference between placebo and minoxidil! Even after 32 weeks of treatment, half of the patients only see minimal growth.

Table 1: Investigator evaluation of Hair Growth using Rogaine Max strength (5%) solution
  5% Rogaine 2% Rogaine Placebo
Week 16
No growth 44%* 53% 42%
Minimal growth 49% 46% 46%
Moderate growth 4% 1% 13%
Dense growth 3% 0% 0%
Week 32
No growth 14% 14% 9%
Minimal growth 46%** 51% 34%
Moderate growth 38% 35% 57%
Dense growth 2% 0 0

*   As bad as placebo
** Little better than placebo

Hydralazine has demonstrated much greater efficacy regarding hair growth stimulation in humans than Rogaine and should prove to be very attractive to men and women who are unhappy with the inconsistent results often yielded by Rogaine. Table 2 presents the difference between minoxidil and RPHE-7193.

Table 2: Comparison of minoxidil and RPHE-7193
Minoxidil RPHE-7193
Rogaine has alcohol and PEG which are known skin irritants RPHE-7193 does not contain alcohol and PEG
There are no clinical data with men over age 41. RPHE-7193 will be studies in men up to age 65
It may take up to 4 months or longer to notice new hair growth Improvements have been observed in 90% of men after 6-8 weeks of treatment with RPHE-7193

Robert Gadimian is working on raising the funds required to initiate the clinical studies in US and pursue the development of this drug in order to being in to the market and provide a needed alternative for men and women who suffer from hair loss.”

Some key points I’ve noticed while reading up on RPHE-1793 :

  • The compound will go through FDA trial process
  • Can start at Phase 2 for hair growth due to previous approval for other indication
  • Will be trialed against minoxidil in its clinical trial

Please check the press releases below to gain more details:
http://robertgadimian.com

RiverTown Therapeutics Inc. Clinical Update

I’ve had many readers inquire lately about the current progress of RiverTown Therapeutics Inc.’s RT1640. RTI’s therapy for hair regeneration, RT1640, is a topical medication composed of minoxidil, cyclosporine A, and a novel molecule called RT175. The company debuted some impressive hair growth photos on this site last year. The question that’s been on a lot of people’s minds since then – “how’s things coming along at RiverTown?” I recently caught up with David Weinstein MD PhD, the CSO/CMO of RiverTown Therapeutics Inc. to give you all a clearer picture of what they’ve been working on and what the future may look like for this company of interest.

Q&A with David Weinstein MD PhD

FT: When/where is the next clinical trial for RT1640 taking place?
DW: We are currently negotiating a Phase 2 trial in Australia. The Australian government has made a concerted and focused effort to enhance the biotechnology effort in their nation. To that end, they have made it both easy and very cost-effective to carryout trials there by granting very liberal tax incentives and R&D rebates to small companies. We will let you how these negotiations progress.


FT: At this point, what would your estimate be for a market release in US if all goes well in the trials?
DW: While it is impossible to accurately predict how the regulatory agencies will react, under current conditions, we estimate entry in late 2021 or early 2022.

FT: Do you think RT1640 will be effective for other types of alopecia (areata, etc.)? 

DW: Alopecia areata is an autoimmune disease. Like most autoimmune diseases, the underlying etiology is unclear. We know that this is a systemic disease, in which T cells recognize elements of the hair follicle as being foreign, and attack them, resulting in lots of inflammation and hair loss. We also know that people with one autoimmune disease are more prone than others to develop additional autoimmune disorders, and that this is particularly true when the first disease is very active and there is a lot of inflammation. While I believe that RT1640 will induce additional hair growth, I am concerned that such growth will provide “fuel” for the underlying autoimmunity, and “rev”up the system, resulting in more inflammation. As a physician, my first priority is to do no harm. I am concerned that growing hair in patients with alopecia areata will do harm as I described. Therefore, we have no plans to explore this indication.

Having said this, we have some preliminary evidence that RT1640 treatment does restore hair growth in the setting of taxane-induced “permanent alopecia.” These are people that have been treated with taxane drugs to treat cancers- usually breast cancers- and have suffered what has been thought to be an irreversible alopecia. More on this as we learn more.

FT: Will RT1604 be effective on areas of the scalp other than the crown, such as the frontal scalp/hairline?
DW: The distribution of androgenic alopecia is a function of two factors: the concentration of androgen receptors (ARs) and the concentration of the testosterone to DHT conversion enzyme 5AR. There is good evidence that the areas with the highest degree of androgenic alopecia are the areas with the highest concentrations of both ARs and 5AR. Unfortunately, these tend to be at the temple and the crown. We have not studied the effects of RT1640 in enough people to say for sure, however, our anecdotal evidence suggests that our therapy will regrow hair at the temple, and on the crown for certain.

About Krox20
DW: Recent work from Dr. Lu Le the University of Texas has shown that the transcription factor krox20 expressed by cells in the hair follicle is essential for the growth of new hair. Throughout my career I have studied another transcription factor, called Oct6. In every tissue we have ever found Oct6 expression, it is closely associated with the expression of krox20. In fact, krox20 expression is dependent upon cells first expressing Oct6. Our work shows that treatment with RT1640 strongly induces Oct 6 expression. This finding supports our hypothesis that RT1640 treatment induces molecular changes in the hair follicle that drive new hair growth.

Thank you David, for taking the time.

Once again, here is a RT1640 result on a male crown at 3.5 months

Asia: Hair Growth R&D

Just when we thought we knew of every company in the world working on hair growth treatments…

With all of the scientific articles on hair biology that continually get published from Asian establishments there was bound to be a few companies springing up at some point. I’m happy to say I’ve got 4 new companies to discuss in this article, most of which have not been previously discussed online. I will make one small disclaimer about these companies, they’re almost all still in the preclinical phase (have not entered phase 1 yet), so they have work to do. What’s most important is scientists from across the globe are working on this thing called hair growth. Let’s see what’s going on for hair research in the world’s largest continent.

New Entries


1) Taisho Pharmaceutical – This company is mostly unknown to the online hair community, though it’s not completely a secret, as Taisho is one of the sponsors of the World Congress for Hair Research 2017. On the WCHR2017 scientific program you will notice Taisho sponsoring a seminar right in the center of the program layout. Besides having greater notoriety, Taisho also differs from other companies mentioned in this article because its therapy candidate has progressed all the way to a phase 2a trial. TS-133 is the name of Taisho’s therapy and it is listed as a topical medication. What is not clear at this time (and this goes for most others on this list) is whether this drug is being developed for alopecia areata or androgenic alopecia. I have a guess. To reiterate, this is a guess, but I will give the one reason why I made it. Let’s go back to the scientific program I mentioned above. Now, find that Taisho Pharma box in the middle again and take a look at who the speaker is. It’s Dr. Amos Gilhar. A simple search of his name will bring back many publications and studies on alopecia areata, a subject that the Dr. is possibly most well known for. It’s quite possible that Taisho, who has an alopecia drug in trial, has sponsored the seminar with Dr. Gilhar for a reason; meaning their drug is a therapy for alopecia areata. We’ll have to wait until the WCHR to hear more. 


2) Hyundai Pharmaceutical Co. – Pretty sure this is not the same company that sells Sonatas and Elantras, but ya never know. I’m most interested in their HTB-005, the company’s candidate for alopecia. Besides the information displayed on Hyundai’s pipeline, there is not much else known about this therapy. One encouraging sign is HTB-005’s mechanism of action is listed as “New” in the pipeline chart. This is where it would typically say something like “PGD2r antagonist” or “Wnt agonist.” It’s most likely for proprietary reasons that Hyundai has left this information out. Like many other drugs on Hyundai’s pipeline, HTB-005 is an IMD or “incrementally modified drug.” A simple definition of an IMD is a “known Active Pharmaceutical Ingredient with modifications made to the drug product.” This means HTB-005 could be derived from any kind of modified drug, not just a drug which was previously used for hair growth. 
The chart also depicts this therapy has made it through the “proof of concept” stage and is ready to enter a phase 1 clinical trial. Intriguing stuff.


3) Kuhnil Pharmaceutical – The R&D pipeline of Kuhnil Pharma shows not just one, but two candidates for hair loss – KI1104 and KI1105. The wording of “hair loss” as the indication makes me tend to believe these two drugs are being developed for androgenic alopecia. KI1104 is listed at the preclinical stage and KI1105 is a step behind that in the research stage. Both of these therapies are listed as “modified formulation/improved drugs.” This is slightly different wording than “IMD” which we saw earlier, but may mean the same thing. I’m hoping that these two drug candidates are modified from drugs which we are unfamiliar with. Nothing like new hair growth science, ya know?


4) Kunshan RiboQuark Pharmaceutical Technology Co. –  This long named entity is the joint venture between Suzhou Ribo Life Science Co. and Quark Pharmaceuticals. Commonly referred to as just “RiboQuark”, the company is developing RNAi therapies for both androgenic and chemotherapy induced alopecia. RNAi stands for RNA interference therapy. 
RiboQuark has one therapy listed on its pipeline for alopecia, RB-AG010, while Quark shows therapies for both of the alopecia types in its pipeline. Don’t worry about the semantics though, it’s all the same stuff. This research is perhaps the most interesting on this list because we actually know what the technology is based on. It’s a RNAi therapy, and the CEO of Quark Pharma, Dr. Daniel Zurr, has elucidated “We know how to deliver the siRNA to the kidney,…….and even into the hair follicles — to suppress the antigen receptor involved in hair loss.” Sounds clever. siRNA stands for small interfering RNA, also known as silencing RNA, which is essentially a therapy that blocks or silences the expression of certain genes that would cause non-desirable biological conditions. What’s even more interesting, these two therapies are supposedly being developed as cosmetic products in China. The only thing keeping me from flying to China to try to peak in the company’s windows is the fact that this technology is not quite in the preclinical stage yet. So, it will be a little while, but I do look forward to learning more about a precise and cutting edge technology like RiboQuark’s.

 

Pretty cool, huh? The industry just got a little bigger. Hopefully this will inspire even more ambition from all of the known hair growth players to keep at their goals. I certainly was happy and intrigued to discover these companies and I hope that this knowledge has made you happy too. With all of these companies and so many different approaches being implemented we are ensured some very interesting developments over the next few years.

HairClone Cont., KROX20 Discovery: Weekly Thoughts 5/23/17

Hello Everyone,

Welcome to a new edition of Weekly Thoughts. I’ve got some details to share on how things are going at HairClone these days, as well as notions on two promising studies on genes involved in hair growth. One of the studies has had the internet ablaze lately with KROX talk. It’s surely a wonderful discovery, though it may be some time before we hear more about it. The other gene therapy discussed is a bit more of a surprise. Let’s see what’s going on.

The HairClone Zone

Over a month ago, a video was released through a local Texas news station detailing the current progress of HairClone. The video features Dr. Ken Williams, a clinical partner of HairClone, discussing the option of administering HairClone’s new technique on one of his patients. Video seen below: Read More

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. Read More

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. Read More

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:

Read More

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. Read More

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