Updated on July 17, 2019
墨西哥在2019年组织原审查:第2部分(更新)
This article is a continuation of aprevious deep diveinto one of the most fascinating stories in the biotech industry.
The Ziering Study
We left off in the previous article with the release of data from Dr. Craig Ziering’s independent trial of HSC. This small study has literally produced the most data we’ve ever seen from any of the next generation hair growth therapies. OnOctober 19, 2012,apress release was submittedby Histogen includingthe following data from Dr. Z’s study.
This photo depicts the crown area of an african-american woman who was able to shrink her patch of hair thinning and regrow new hair. Terminal hair growth was achieved by the administration of a few simple needle injections. It makes you wonder how easy life could be for us all.
This is another comparison from a gentleman who received HSC injections over a 6 month time period. He appears to have made some pretty decent progress in his mid-scalp area. Typically, results like these are not common for men of this age using traditional hair loss medicines. All of these results seem to vindicate HSC as an ideal addition to hair growth therapies; hair transplants, minoxidil, you name it. HSC could improve results for anyone.
When Things Got Quiet
It was around this time period when things got quiet again for Histogen’s HSC. The Honduras trial was an apparent success, the Dr. Ziering trial was another success, but for some reason the Histogen Express seemed to run out of gas. Refresh buttons were worn out on internet explorer by those who were looking for news from the company. Emails must have been hitting the Histogen inbox like Vlad Guerrero Jr. at the Home Run Derby. Still, no sign of a follow-up trial that would help bring HSC to market.
Back To The Courtroom
An article published onAugust 26, 2013perhaps shed some light on the lack of progress in HSC’s clinical trial development. It turns out that Skinmedica, the company which lost a patent lawsuit to Histogen in November 2011,had appealed that decision and was again obstructingHistogen’s plans to bring products to market. This time a three-judge appellate court upheld the lower court ruling in favor of Histogen 2-1. “Hopefully this is the last time I hear the word Skinmedica”, sighed many online hair enthusiasts.
New Photos, Still Waiting On Trials
After another 2 year hiatus, Histogen made quite a splash at the 9th World Congress for Hair Research onNovember 18-21, 2015.Gail Naughton presented never before seen photos from the Dr. Ziering trial andthen shared the presentation online. This is actually when the “Histogen guy” with black hair photo was released from the stash.
Above is another photo comparison from the upper-tier of the Histogen vault. This woman had experienced stress-induced hair loss causing a deep temple recession and appears to have made a complete reversal after 18 weeks and 10 injections of HSC. This was another re-emergence for Histogen after a couple years of silence, now with legal battles behind them. Again, it seemed as though they were ready to get their product to market. At this time, the talks of Histogen becoming available in Mexico by 2018 began to flourish around the internet and excitement returned to the HSC conversation.
Yet, another year went by, and onSeptember 27, 2016, Histogen announced it had received a $6 million investment from a China based healthcare product company, Huapont Life Sciences. Thepress release even mentionedthat Histogen planned to negotiate a license agreement with Huapont Life Sciences for the development andcommercializationof HSC in China. Now, internet enthusiasts had two product destinations to daydream about, China and Mexico.
A New Version Of HSC Emerges
Finally, onJuly 2, 2018, Histogen announced it had initiated a new US based trial to test HSC in female pattern hair loss. This time, Histogen would be testing a newer version of hair stimulating complex called HSC660. The news was welcomed, but left people wondering what happened to the development of HSC for men in USA and potentially Mexico. Then, seemingly miraculously, an established San Diego-based news publication announced thatHistogen had begun a phase 3 trialin Mexico. This was not the only announcement of said trial, asNaughton told Allure magazinethat she expected HSC to gain approval in Mexico first, perhaps in 2020, and then in the US sometime after. Also, Histogen Board MemberStephen Chang announced at a conferencethat Histogen had filed for a phase 3 trial with the Mexican FDA (see 6:02 mark). But as of July 2019 there has been no further mention of the phase 3 trial in Mexico and rumors have popped up online that the trial has been cancelled. To be fair, these were only just rumors, until now.
I had hoped to add some positive news to the ending of this article by sharing that the Mexico trial was still in progress, however I have received an email from Gail Naughton of Histogen stating that the“partner in Mexico sold their business and so they did not pursue the trial.”This is not the kind of news I want to share on Follicle Thought, however it’s best to know where things really stand for pivotal trials that people hold much hope for. I know many people would have liked to hear differently.
What’s Next?
Well, in a recent Q3 2019 newslettersent out by newly appointed Histogen CEO Richard Pascoe, he mentions that Histogen’s HSC660phase 1 trial in women was completed, showed safety, and “met all primary trial endpoints.” He also mentions that Histogen will “continue to evaluate the HSC development pathway in both men and women with the goal of moving it forward in late-stage clinical trials early next year.” It’s not clear if the company is going to continue to pursue a partner for a late stage trial in Mexico or if Histogen is still working towards a late stage trial in China with partner Huapont Life Sciences. The most concrete pathway we can see for HSC right now is a phase 2 trial for men and a phase 2 trial for women, both in the US.
What a wild and unpredictable ride for a company who holds an important key to hair loss sufferers around the world. It almost sounds like something out of a movie. Is there any bright side for HSC/will it ever make it to market? What do you guys think?
Thanks Admin. Always appreciated. TBH was really hoping this product would find some pathway to commercialization by 2020. Presently, it still feels about 5-6 years away.
I hope I’m wrong.
Thanks Biff, yes I agree, barring a miracle HSC still seems 5 years away. It’s wild. Even in 2015 many would not have guessed it.
Let’s concentrate on the present any updates on the release of Medipost in Korea yet? it’s supposed to be available now, would like to purchase it As soon as possible. Thanks
I think it`s available for purchase in some regions right now, but they are selling product without releasing study information which is super shady.
I’ve certainly been following the NGF product for a while, and rightfully so a cosmetic topical made by a legit stem cell company (with a product in FDA trials for arthritis treatment) was very interesting. Now the product is coming into the market and like always no one knows how well it’s going to work for everyone. This is the time where some people become very critical if the product turns out to perform below expectations. For this reason I’m going to step back and observe any user reports posted online and what the company shares on social media over the next several months before I make a further update on NGF.
Question: Is there anything at all on the horizon, like even remotely close, where they take out a sample of hair follicles, replicate them a bunch of times and then transplant them to your balding area? I feel like that is the most likely way this whole thing is going to get solved.
Jason, several companies working on it. It seems likely that one of them should have some important milestone news by the end of 2019.
What companies are working on it and who would you say is furtherst along or most likely to have that milestone news in 20`9?
Companies working on some sort of cloned/multiplied hair follicles: Stemson, Rapunzel, L’Oreal-Poeitis, Tissuse-J.Hewitt, and in early stages HairClone.
I’m not exactly sure at this point who is furthest along but am going to following up on all of these companies over next several months and will have some reports soon.
Hello admin…indeed, frustrating news.
That leaves us in the near future with two stem cell derived topicals from Korea and USA and Follica probably next year if we are lucky.
Sisheido…we really dont know
Is stem cell topical from USA FDA approved?
Evidently a cosmetic product…admin knows.
Ok, so here’s the deal on the US topical. Made by a US stem cell company, I’ve seen one result that was impressive on a man, as of 3 months ago they were going to move forward with some tests before launch but got delayed. (most likely because of money, hair growth is not this companies first order of business) The executive there told me he will get back to me when there is news. Until then, I probably won’t be saying much about it.
Product looks cool and exists, but the way these things can go, I recommend staying level about it. Let’s see how it goes.
I guess its a cosmetic product thus no extensive trials because we did not hear of any stem cell derived topical from California before.
Admin how do you define impressive?
Anyway, it exists and hopefully it will be a matter of months and not years till release.
I do expect that either this product or NGF-574H will be ‘the topical’. A winner takes it all situation.
Must be hard for both companies to set the purchase price of their product as they dont know the competitors efficacy and purchase price.
Good for us though…
Thanks for the update, Admin. Going on Topical Finasteride this week. (0.1%) Will update every now and then. Also, is Shiseido phase II trial our yet? Or still to come out in the next couple of weeks?
Great work man, at least we got closure. I hope they will be punished by the market and their procedure will be obsolete in 5 years. Also, I doubt they`ll have money to fund trials all the way up to the FDA clearance.This is probably redundant, but do you have any info on RCH-01 and NGF-574h since their trials ended?
组织原需要快速通道与他们的第三阶段new hsc or at least phase 2b and get this through fda approval in the next 2 to 3 years max. Focusing on China and mexico is just a wrong pathway. More balding guys in USA tHan in mexico. Histogen has a horrendous business developmet team or they are just faking their success and using photoshop to bring investors in to keep the lights on. A company can’t be that unlucky or dumb to not get this potential breakthrough hair loss drug to market. Those pics show huge cosmetic improvement. They should just push the original hsc to phase 3 in USA and get the new version to phase 2 fda and get the show on the road. If they don’t have a real product and are scamming then they deserve the law suit and should be shut down.
I believe Histogen has already started trials in California but women only from what I’ve heard
Well that is disheartening.
Another 5 years at least then right?
Did Gail Naughton mention any future plans for trials in her email at all?
Does seem crazy how they have had a product that works for nearly 10 years now but don’t seem any closer to releasing it than they did in 2010.
Also,
Why does HSC660 for MPB still show as being in the middle of phase 2 on the product pipeline in their website?
I asked if they had any plans to continue to pursue a late stage trial and did not hear back. I would imagine they would keep their eyes out in Mexico.
Ziering is a fraud and so is Histogen
https://www.independent.co.uk/news/uk/home-news/ziering-medical-uk-hair-transplant-clinic-told-to-withdraw-misleading-ad-10461279.html
An important note about Histogen and Ziering:
1) Histogen is not a fraud, they just have business issues which will never be discussed in public.
2) Ziering may make some poor ad choices, but one thing is certain: the man is passionate about being at the forefront of hair restoration treatments. He is very wealthy and has about 5 clinics around the world. When another breakthrough hair growth treatment is emerging onto the scene, do not be surprised is Craig Ziering is involved. Just because he used a cheeky ad does not mean he isn’t a millionaire who wants first dibs on hair technology.
buried forever Histogen totally uncertain the future, a joke everything around him. Looks like a teenage teen’s company in his garage.
At this rate, Elon Musk’s Neuralink will order our brain to make hairs before any new treatment hit the market XD
If only Musk would get involved….
That’s what I’ve been saying for years Elon Musk or Jeff Bezos should be putting money into these companies instead of wasting it on space crap that no one really cares about
Finasteride & Minoxydil were already FDA-approved for medical condition, that would explain they could hit market for hair loss much easier and faster. And probably regulations were less strict than now.
也许更重要的是他们公司的支持mpanies with big budgets, Upjohn and Merck. If this were the case with Histogen in 2010 they’d probably at least be somewhere overseas by now.
Thanks again admin for great reporting. Although, not the news I wanted to hear, but at least no more false hopes for HSC. It does not seem the company is in any hurry to get a product to market. When you have a development as exciting as “it works” and such a large addressable market, I would think they either have other companies (large cosmetic or pharmaceuticals) who want to license their proprietary science or want to become an investor and even in the U.S. should not take 10 years only to be stuck in trials. I am skeptical, because something does not add up. Why are they spending time on a new formulation? Doesn’t that mean that puts them back to square one? Or is the new formulation only for the women’s trial?
Why not try to bring to market what has already been proven to work and once that is available, they will have all the funding they need to fiddle with an even better formulation? Seems to make the most business sense to me, can someone communicate this to Gail?
You raise good points. Here’s some feedback/potential theories:
– One reason no one could license it and help out over past 10 years was the legal battle with Skinmedica/Allergan, but now that Allergan has become a partner it’s truly is not clear why Allergan is not putting up big money and getting this through trials. That’s the current twilight zone question with no explanation.
re: Why spend time on new formulation?
– Original HSC has issues with FDA and thus, new formulation made more sense.
– It’s not clear whether the mens program at phase 2 is still with original HSC or HSC660.
It seems this whole “industry” is based on “cheeky ads”.
This is basically correct. Apart from a few hair transplant clinics, every company takes at least a tiny liberty when presenting data. We’ve even seen some photos from a pharmaceutical company in the past 2 months that appeared to have a bit darker shading in the after photos.
我认为是由于大多数的一部分people in general population take for granted how hard it is to make a therapy that gets hair to grow and also don’t realize how many hairs it takes to make a cosmetic difference. That doesn’t mean that trying to enhance data is ok, but perhaps if everyone had a realistic understanding about hair growth the companies wouldn’t feel pressured.
Turkish company develops treatment for baldness as an alternative to hair transplantation
The company, which operates in the United
States, launched four months ago tests in Turkey, in partnership with the Faculty “Jarrah Pasha” medical, of the University of Istanbul.
The new treatment consists mainly of a special substance, which helps to grow hair in the head, after being regularly applied to the skin.
The testing and testing phase is continuing in 14 health centers, spread over 10 Turkish cities, to date, 625 people.
If the tests are successful, the resulting material will be effective in the treatment of bald people without the need for hair transplantation, and will be the first local production in this area.
In an interview with Anatolia, test coordinator Dr. Sardar Oglu said he expected the phase to be completed by August 2020.
He added that the preliminary results show the success of treatment in principle, and that the use will be of both sexes.
Ahmed: This is Samumed
Admin
Not sumumed
https://www.medimagazin.com.tr/hekim/tibbi-gelismeler/tr-cerrahapasa-tip-kellik-sorununu-ortadan-kaldiracak-ilacin-son-faz-arastirmalarina-gecti-2-19-82417.html
Use Google Translate
According to admin they started Q3 2018 so it could be August 2019??
Samumed product page:
https://www.samumed.com/pipeline/detail.aspx?id=16
Phase 3 trial page:
https://clinicaltrials.gov/ct2/show/NCT03742518?term=samumed&rank=6
There’s no correlation about being wealthy and not being a fraud, can cite countless examples, Madoff, Epstein, Enron, etc. I’m not saying Ziering is a fraud, I’m just saying….
Always a pleasure when you stop by Yoda. Just for clarity, my mentioning he was a millionaire did not allude to whether he was a fraud/not a fraud. All it meant was that with money does come power, factor in that he owns an international hair transplant biz, showed his interests with Histogen, he’s in a position to be at the forefront of hair technology. Like I said, don’t be surprised if Craig Ziering is in the news with another hair tech co over the next year or so.
Being from San Diego, I had high hopes for Histogen. Gail Naughton has a good reputation in the Biotech community and I thought I’d be able to blast across the boarder in the next year or so and get the treatment. The news that they have abandoned their Mexico plans has pretty much taken the wind out of my sails on this one.
ASSIOPEA ANNOUNCES RESULTS FOR FIRST HALF OF 2019
Very positive Phase II twelve months dose ranging study results for Breezula®/Clascoterone solution in treating androgenetic alopecia
Wtf replicel rch 01 7月?仍然没有news?
Prediction: Shiseido won’t release RCH 01 in Japan, and Replicel won’t release RCH 01 anywhere, ever.
What are people’s predictions for what will be successful?
If the news is fake ,hard to accept ,my hair almost ….admin which time will contal replicel again
I will work on a Shiseido/Replicel update within a week or two.
Admin ,is that main after 2-3week will have news?what u think ,fail or not：（
At this point I’m beginning to wonder if Shiseido is going to release any positive data anytime soon.
I sincerely hope you are wrong.
Does anyonr know where Shisiedo will be publishing their results?
Would it be on their website or?
Their website doesnt seem to have any refence to RCH 01 at all as far as I can see, which is concerning.
Any word on Paul Kemp or Hairclone?
I had tweeted them asking ahout their crowdfinding campaign a few weeks ago and was told they were seeking funding from other sources (as it had failed).
But they also said they hoped to have their follicle banking and cell expansion services available by the end of the year.
It would be nice if we could maybe get a follow up on this if possible.
Thanks,
I’m planning on contacting HairClone soon for a follow up to see what plans they have after the crowdfunding campaign.
We need a Manhattan Project for hairloss.
Admin, since you have pics from Celino NGF study (you asserted that they will be released as soon as your YT channel hits 1100 subs) can you at least tell us what is your impression upon seeing them, how do you compare them to this new stem cell topical from US photos?
Faust, as the product was preparing for launch I was under the impression that more data and pictures were ready to be released. However, this did not turn out to be the case. So, until there is more data released through their social media or likewise I don’t plan on doing more updates about it. It does have another clinical trial ending in September.https://clinicaltrials.gov/ct2/show/NCT03676400
I to am also having a hard time understanding the delay – perhaps the underlying reason was the dispute which I read either here or somewhere else.
But why try to do the women’s trials? Why not stick with the men’s market then do the womens and create a different product or tweak it accordingly. To prolong the whole process to create a uniform or multiple products just does not make sense.
This is when I, among others, want to scream from the roof top saying “NONE OF IT MAKES SENSE!”
I agree,
Why must there be seperate male and female trials?
Would this mean that HSC660 would be exclusively released and reserved for whichever specific genders phase 3 trials and subsequent regulatory approval occured first?
Would the other sex need to acquire it off label?
I’m a little confused of the process.
Hello administrator, how can ngf-574H do a rehearsal for September and are already planning a commercialization soon? is that possible or normal? Thank you!!
My understanding:
1. They have ‘successfully done the approval study. Now they are waiting for approval by Korean regulators. Then it can be sold to the (Korean) public.
2. The topic can be used my medical professionals (rules allow that) in the meantime. Should happen this month
3 Saudi Arabia regulator has already approved it thus it can be sold to (Saudi) public
4. The current study is being conducted to prove efficacy for men and women (twice a day application). Apparently it exhibits a dose response. Its a study to convince the public that NGF-574H is good stuff (hopefully)
People in Saudi Arabia and people in Korea (if done by dermatologists) can use it probably from this month onwards. However, treatment outcome is still unclear since the second study is still ongoing.
Admin, is this correct?
I am in Saudi Arabia
Where do I get this product?
Is there a website or contact number?
soull, they already did a smaller trial which showed some positive data but was a shorter time period of 16 weeks.
Since it is developed in Korea, do they test for safety as well, or only for efficacy? I’m sure standards outside the U.S. are likely not as stringent, but I am curious on what the health and safety standards outside the U.S. are for some of these drugs/cosmeceuticals. Anyone know if there is a global minimum standard? I am just concerned about trading one problem for another. Also, I guess if they are getting something to market quickly, there is not enough time to build history to track long term effects.
From what I understand they are awaiting approval for a “functional cosmetic” in Korea to prevent hair loss. They would have to show safety and some efficacy, though I imagine the efficacy might not be held to the same standard as a drug would, which makes sense.
I am waiting Lactate Hair Growth Drugs hardly. People forgot about it somehow.
People don’t forget, we get tired. I started watching this news more diligently over the last 12 months. My conclusion is that nothing of substance will come to market in the next 5 years. The only company for whatever reason that has any credible stuff going for it, is Histogen. Perhaps the lengthy time is an indication that it will hit the market and with a solution to be positive about.
Cellino, came to news quickly, market quickly, small questionable results…etc.
I keep telling myself, I need to find the solution myself or ourselves. There are so many people here with various degrees of knowledge.
不要忘记超过三个临床试验years; I think it is an effective treatment
Admin,
You say you will do a Replicel/Shisiedo update in the next week or two,
Are you privy to some information that has not been released yet?
Not putting any hype to it, just hopefully have something to clarify things a little bit over the next few weeks unless a big announcement from Shiseido happens to come first.