Replicel Is On Fire Lately — Data In Feb.

[MeDK]

Aren't they doing a lecture based on the released study ?

Which also concluded

"In conclusion, this clinical study of autologous cell therapy using DSC cells to treat male and female PHL has shown positive, although temporary, responses at the lowest cell concentration injected, and further studies are warranted to determine the best concentration of cells and treatment regimen. In order to determine if this cell-based treatment provides a significant clinical change noticeable to patients and practicing physicians, additional clinical studies injecting DSC cells in larger hair shedding areas should be performed to demonstrate a visible effect by global photo-assessment." - Autologous Cell-Based Therapy for Male and Female Pattern Hair Loss using Dermal Sheath Cup Cells: A Randomized Placebo-Controlled Double-Blinded Dose Finding Clinical Study

So maybe they will talk about what else to do, to achieve better results, who knows.

 

[Milkonos]

So what ? are they launching a third phase ?

And can anyone connect at the zoom meeting in December 5th ? or have we completely abandoned to attend any of the conferences since it doesn't bring us any actual news??

 

[MeDK]

Replicel and shiseido will release official information when its ready, no need to hunt down conferences.

 

[MrV88]

Another frustrating Info for Jan and the other son of a b**ch:

Shiseido signed a patent in May 2020

WIPO - Search International and National Patent Collections

View attachment 150056

looks like a nipple

 

[MeDK]

If people want to be a fly on the wall at an Annual General Meeting at Replicel.

Date: Tuesday, 8 December 2020 (Vancouver)

Time: 16:30 Pacific Time, 17:30 Mountain, 18:30 Central, 19:30 Eastern

01:30 (Wednesday, 9 December) CET

08:30 (Wednesday, 9 December) China

09:30 (Wednesday, 9 December) Japan

Its an online meeting open for everyone.

 

[MeDK]

Remember its today for those who where interested, the link for the meeting and password is in the link in previous post

 

[MeDK]

Quite interesting meeting they had.

They talked about RCH-01, and talked about the reason for a second phase 2 trial.

Short story about the second phase 2 trial, is that the first phase 2 trial, only focused on a 1 cm2, on the scalp, where the second phase 2 trial, they will be focusing on the entire scalp more or less, which also could provide for before/after pictures. And of course take advantage of the knowledge the first from the first phase 2, where it was shown, that the small dosis is more potential than the bigger ones, and then to multiple injections.

And then one asked about the dispute between Replicel and Shiseido.

simply put It was about that Replicel's lost a "chain" in their supply chain, those who provided for that growth medium for their cells. So Replicel had to spend (obviously) a lot of times to find a new partner that could provide with the right growth medium for their cells. They talked about that they tried one that couldn't provide the right growth medium and it was very hard for them to find a new partner, and they had to start at square one and invent their own kind of growth medium. Which they then provided with too Shiseido.

Meanwhile Replicel was looking out for this growth medium partner, Replicel started on the tendon and skin R&D too, which Shiseido wasn't happy about because Shiseido then felt that Replicel didn't have the same focus as Shiseido themself.

And then they also talked about a worst case scenario for Replicel and Shiseido, which if Shiseido went on with their R&D and commercialization and didn't include Replicel in on it, then Shiseido would lose their license for Asia, and Replicel would go out and find a new one for the asian License.

It was an very informative meeting, and they still strongly believe in RCH-01 and believe is will do good in the second phase 2 trial, which sounds exciting and I hope that they provide the before/after pictures and start commercialization shortly after. Time will tell what happens.

But the supply chain problem isn't something new in this business, we have seen it with Tsuji too, who used 7 years to establish their supply chain too. And if the market is very small for a "cell cultivation plant" and doesn't have the expertise and knowhow to engage with the cell cultivation and the medium for them. Then it can explain a lot of why we always see these big delays for clinical trials.

 

[-G-]

Quite interesting meeting they had.

They talked about RCH-01, and talked about the reason for a second phase 2 trial.

Short story about the second phase 2 trial, is that the first phase 2 trial, only focused on a 1 cm2, on the scalp, where the second phase 2 trial, they will be focusing on the entire scalp more or less, which also could provide for before/after pictures. And of course take advantage of the knowledge the first from the first phase 2, where it was shown, that the small dosis is more potential than the bigger ones, and then to multiple injections.

And then one asked about the dispute between Replicel and Shiseido.

simply put It was about that Replicel's lost a "chain" in their supply chain, those who provided for that growth medium for their cells. So Replicel had to spend (obviously) a lot of times to find a new partner that could provide with the right growth medium for their cells. They talked about that they tried one that couldn't provide the right growth medium and it was very hard for them to find a new partner, and they had to start at square one and invent their own kind of growth medium. Which they then provided with too Shiseido.

Meanwhile Replicel was looking out for this growth medium partner, Replicel started on the tendon and skin R&D too, which Shiseido wasn't happy about because Shiseido then felt that Replicel didn't have the same focus as Shiseido themself.

And then they also talked about a worst case scenario for Replicel and Shiseido, which if Shiseido went on with their R&D and commercialization and didn't include Replicel in on it, then Shiseido would lose their license for Asia, and Replicel would go out and find a new one for the asian License.

It was an very informative meeting, and they still strongly believe in RCH-01 and believe is will do good in the second phase 2 trial, which sounds exciting and I hope that they provide the before/after pictures and start commercialization shortly after. Time will tell what happens.

But the supply chain problem isn't something new in this business, we have seen it with Tsuji too, who used 7 years to establish their supply chain too. And if the market is very small for a "cell cultivation plant" and doesn't have the expertise and knowhow to engage with the cell cultivation and the medium for them. Then it can explain a lot of why we always see these big delays for clinical trials.

Thanks!

 

[NorwoodGuardian]

Quite interesting meeting they had.

They talked about RCH-01, and talked about the reason for a second phase 2 trial.

Short story about the second phase 2 trial, is that the first phase 2 trial, only focused on a 1 cm2, on the scalp, where the second phase 2 trial, they will be focusing on the entire scalp more or less, which also could provide for before/after pictures. And of course take advantage of the knowledge the first from the first phase 2, where it was shown, that the small dosis is more potential than the bigger ones, and then to multiple injections.

And then one asked about the dispute between Replicel and Shiseido.

simply put It was about that Replicel's lost a "chain" in their supply chain, those who provided for that growth medium for their cells. So Replicel had to spend (obviously) a lot of times to find a new partner that could provide with the right growth medium for their cells. They talked about that they tried one that couldn't provide the right growth medium and it was very hard for them to find a new partner, and they had to start at square one and invent their own kind of growth medium. Which they then provided with too Shiseido.

Meanwhile Replicel was looking out for this growth medium partner, Replicel started on the tendon and skin R&D too, which Shiseido wasn't happy about because Shiseido then felt that Replicel didn't have the same focus as Shiseido themself.

And then they also talked about a worst case scenario for Replicel and Shiseido, which if Shiseido went on with their R&D and commercialization and didn't include Replicel in on it, then Shiseido would lose their license for Asia, and Replicel would go out and find a new one for the asian License.

It was an very informative meeting, and they still strongly believe in RCH-01 and believe is will do good in the second phase 2 trial, which sounds exciting and I hope that they provide the before/after pictures and start commercialization shortly after. Time will tell what happens.

But the supply chain problem isn't something new in this business, we have seen it with Tsuji too, who used 7 years to establish their supply chain too. And if the market is very small for a "cell cultivation plant" and doesn't have the expertise and knowhow to engage with the cell cultivation and the medium for them. Then it can explain a lot of why we always see these big delays for clinical trials.

Thanks, very detailed. I just hope that they are a no-sides finasteride+Min so that most of us can have a hair transplant to NW1-3 no matter what Norwood we are at.

 

[FilthyFrancis]

Thanks a lot for this briefing.

Let's hope supply chain issues will disappear as time passes and the market becomes more mature.

 

[MeDK]

Great update but I'm more interested in what Shiseido will do with RCH, they're closer to commercialization than replicel.

You do know that Shiseido work under the license of Replicel?

But the plan is that they want to take advantage of the Phase 2 early release to market, but want to do the second phase 2 trial, with the lower and multiple dosages and be able to release a before/after pictures to show how the treatment works.

 

[MeDK]

Yes I know but isn't Shiseido going their own way now?

How can they if they are under license?

If Shiseido breach the contract, then they have no License and won't be able to release anything. Like i stated before. Shiseido can lose their license and then Replicel can find another partner for the asian license.

So if Shiseido have to go their own way, then they have to do it without any license and maybe even have to start from square one. So they would move back maybe a decade of R&D. I don't think Shiseido would like to do that.

 

[Throwaway94]

How can they if they are under license?

If Shiseido breach the contract, then they have no License and won't be able to release anything. Like i stated before. Shiseido can lose their license and then Replicel can find another partner for the asian license.

So if Shiseido have to go their own way, then they have to do it without any license and maybe even have to start from square one. So they would move back maybe a decade of R&D. I don't think Shiseido would like to do that.

Shiseido have full development rights using replicel's technology in Asia, as well as having a lot of power over them in general after Replicel's alleged contract breach. Replicel would struggle to find a partner for funding in Asia that could front the kind of capital that Shiseido did, especially seeing how replicel managed to squander the money they got without delivering on anything.

They are going their own way but with Replicel's tech, they did a slightly disappointing trial but are still continuing with the research and are therefore much closer to commercialisation than Replicel.

 

[MeDK]

Shiseido have full development rights using replicel's technology in Asia, as well as having a lot of power over them in general after Replicel's alleged contract breach. Replicel would struggle to find a partner for funding in Asia that could front the kind of capital that Shiseido did, especially seeing how replicel managed to squander the money they got without delivering on anything.

They are going their own way but with Replicel's tech, they did a slightly disappointing trial but are still continuing with the research and are therefore much closer to commercialisation than Replicel.

What is your source?

And for the alleged contract breach, i think i have written about replicels view on that.

So would be awesome with some source, so we have a change of cross reference for the different kind of information.

 

[MeDK]

@MeDK what percentage growth is expected, do you know that? Will it grow every time, so per treatment? If so and if it stops the hair loss, it would be a cure in the end. (After a few years)?
Thank you

we don't know. They have only done a single injection study. And is planning/working on a multi injection study.
But what we do know is something happens after 9 month, then its loses potency (density goes down), they phase 2 study counts in total hairs pr 15 mm2, so for men its about 2-3 more than placebo, and women its about 5 hairs more than placebo, where it peaks for both sexes at 9 months.

Also it was shown that the older you are, the better the treatment works, and lower norwood (3 -4), but higher norwood (5, 6) shows to have a later reaction but still increases after 9 months, where lower norwoods decreases after 9 months.

But all of this you have to think is a single injection, and the new study is about multiple injections, and probably better knowledge about how to improve the treatment even more. But we also know from the existing phase 2 study that they will use less number of cells for injections.

A very simple comparison, form the highest to lowest dose used, 7,5*10^6 / 3*10^5 = 25, so with some simple math, if they extract for one high dose there should be for 25 small doses, which might cover the entire scalp multiple times for the multiple injections over time. Which is my own speculation of course.

We know from the original phase 1 study, the best responders had an +19% increase in density, and worst case was a lost at 6% density at the 6 months mark.

So they might develop a better formulation for the cells and growth medium meanwhile, we can't really know.

But we do know that they keep on developing the methods for the treatment and can only wait for the next phase 2 study release where they talked about releasing pictures for before/after and show how good or bad the treatment is on a full head.

And the last study was a 12 month check up on the patients, and i think this study might be as well, so IF they have started well off, then we might now in 2-3 years what the result will be. I don't think we will know anything sooner than that, when talking about the new phase 2 study they will do.

Unless Replicel or Shiseido them self does an update while the study is going on.

But if we go deeper into the speculation, we do know that the medium for the cells to be cultivated in, isn't the same from the first study, since that company isn't available for market anymore, and that might be why we don't get the same results from phase 1 to phase 2, because that medium isn't the same, and somehow it have an effect.

And we know they have tried another medium after the one they couldn't use anymore, and that wasn't as effective as the original one, so they have to develop a whole new medium from scratch that shiseido then could use. So maybe that have been improved also, we don't know right now.

 

[-G-]

we don't know. They have only done a single injection study. And is planning/working on a multi injection study.
But what we do know is something happens after 9 month, then its loses potency (density goes down), they phase 2 study counts in total hairs pr 15 mm2, so for men its about 2-3 more than placebo, and women its about 5 hairs more than placebo, where it peaks for both sexes at 9 months.

Also it was shown that the older you are, the better the treatment works, and lower norwood (3 -4), but higher norwood (5, 6) shows to have a later reaction but still increases after 9 months, where lower norwoods decreases after 9 months.

But all of this you have to think is a single injection, and the new study is about multiple injections, and probably better knowledge about how to improve the treatment even more. But we also know from the existing phase 2 study that they will use less number of cells for injections.

A very simple comparison, form the highest to lowest dose used, 7,5*10^6 / 3*10^5 = 25, so with some simple math, if they extract for one high dose there should be for 25 small doses, which might cover the entire scalp multiple times for the multiple injections over time. Which is my own speculation of course.

We know from the original phase 1 study, the best responders had an +19% increase in density, and worst case was a lost at 6% density at the 6 months mark.

So they might develop a better formulation for the cells and growth medium meanwhile, we can't really know.

But we do know that they keep on developing the methods for the treatment and can only wait for the next phase 2 study release where they talked about releasing pictures for before/after and show how good or bad the treatment is on a full head.

And the last study was a 12 month check up on the patients, and i think this study might be as well, so IF they have started well off, then we might now in 2-3 years what the result will be. I don't think we will know anything sooner than that, when talking about the new phase 2 study they will do.

Unless Replicel or Shiseido them self does an update while the study is going on.

But if we go deeper into the speculation, we do know that the medium for the cells to be cultivated in, isn't the same from the first study, since that company isn't available for market anymore, and that might be why we don't get the same results from phase 1 to phase 2, because that medium isn't the same, and somehow it have an effect.

And we know they have tried another medium after the one they couldn't use anymore, and that wasn't as effective as the original one, so they have to develop a whole new medium from scratch that shiseido then could use. So maybe that have been improved also, we don't know right now.

Only people like you should be talking here haha.

 

[newdutuser10]

This will be big for people already on the big three. It could fix those areas that are reluctant to regrow.


It's something and another step in the right direction.

 

[pegasus2]

I haven't seen a company yet that didn't believe their trial would be successful. Too bad 86% of them aren't.

 

[MeDK]

I haven't seen a company yet that didn't believe their trial would be successful. Too bad 86% of them aren't.

Which is true, but if i remember correctly Replicel and Shiseido would have had the option for conditional market release after their first phase 2 clinical trial. Which they chose not to do, because of they want to do a second phase 2 trial.

 

[Milkonos]

So, when will the second phase 2 trial end ?