RepliCel Reports Progress on Shiseido Technology

RepliCel Reports Progress on Shiseido Technology Transfer for RCH-01 Treatment for Pattern Baldness



Vancouver, Canada - December 19, 2013 - RepliCel Life Sciences Inc. (OTCQB: REPCF) (CNSX: RP) today reported on the progress of its technology transfer agreement with its partner, Shiseido Company, Limited.



Recently, a group from Shiseido met with RepliCel management and advisors in Vancouver, BC to continue the technology transfer between the two companies as outlined in the July 9, 2013 licensing agreement. The Shiseido team spent three weeks in the lab with RepliCel's Chief Scientific Officer, Dr. Kevin McElwee and Director, Research and Development, Dr. Hisae Nakamura learning techniques of specific hair follicle cell isolation and replication methods for RCH-01. Furthermore, RepliCel's Vice-President of Clinical Affairs, Darrell Panich reviewed progress to date in the clinical development program of RCH-01 and discussed the plans for future development in the companies' respective regions.



During this past quarter, Dr. Nakamura and representatives from the Shiseido team visited RepliCel's contract Good Manufacturing Practice compliant facility in Innsbruck, Austria. It was during this visit that the transfer of RCH-01 manufacturing technology between the two companies and its contract manufacturer was initiated.



"These meetings have done much to foster the collaborative relationship between RepliCel and Shiseido and both companies are committed to working very closely on the successful development of RCH-01," said Chief Scientific Officer, Dr. Kevin McElwee. "Both teams will continue in-depth research and development in the laboratory and clinical trials with the goal of commercializing a safe and effective hair regenerative treatment to help those suffering from pattern baldness and thinning hair." In this regard, RepliCel expects to initiate a Phase 2 clinical trial for RCH-01 in the EU in the first half of 2014. In addition, both companies will work towards establishing a clinical research program in Asia with the goal of increasing the available human clinical data on RCH-01. Collaborative technology transfer will continue between the companies as any new improvements to the RCH-01 technology are developed by either party.



As per the agreement, Shiseido will have an exclusive geographic license to use RepliCel's RCH-01 hair regeneration technology in Japan, China, South Korea, Taiwan and the ASEAN countries representing a population of approximately 2.1 billion people.



New Regenerative Medicine Legislation Passed in Japan

On November 20, 2013 the Japanese Legislature approved new legislation targeted at improving the development and regulatory processes for regenerative medicine therapies. The Regenerative Medicine Law directs the Ministry of Health, Labour and Welfare to adopt new procedures and rules that will accelerate the clinical development of regenerative medicine and cell therapies. The Japanese Pharmaceutical Affairs Law will now become the Pharmaceuticals and Medical Devices Act that will include a new branch specifically for Regenerative Medicine Products, which will be regulated on a fast track process that focuses primarily on product safety. Under the law, the government is responsible for mapping out and implementing measures to safely accelerate research and development projects and make regenerative medicine widely available in the country. The law specifically stipulates that the government must make basic plans for the promotion of regenerative medicine and change such plans if necessary by reviewing them at least every three years in light of any changes in external conditions that may occur. This news positively impacts RepliCel and its licensing partner, Shiseido, as it looks to conduct human clinical trials on RCH-01.

So I am wondering if this means RepliCel will be going to market SOONER in Asia as the result of this??? Phase II in EU for 2014 means we're not looking for this until 2015 IF we're lucky

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Originally Posted by Sparky4444

So I am wondering if this means RepliCel will be going to market SOONER in Asia as the result of this??? Phase II in EU for 2014 means we're not looking for this until 2015 IF we're lucky

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It was never speculated to be out before 2015. Aderans was supposed to be available in 2014 but because they couldn't get their sh*t together for funding, the whole project got put in limbo.

2015 is only possible in Asia... though with our luck, I have a feeling it won't happen until 2016 or later.

I was just browsing through the website and read the pdf provided to investors. It says on the main page that the trials will start in the first half of 2014 and run through 2015. In the presentation for investors, it says they hope to collect and analyze phase 2 data in 2016...

If anything, 2017 is most likely for a release .. and even that's a little optimistic seeing how things have been "progressing".

I've never got my hopes up for this joke of a product...2017, forget that noise...there'll be a cure by then ...what a hopeless project this RepliCel is

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New Regenerative Medicine Legislation Passed in Japan

On November 20, 2013 the Japanese Legislature approved new legislation targeted at improving the development and regulatory processes for regenerative medicine therapies. The Regenerative Medicine Law directs the Ministry of Health, Labour and Welfare to adopt new procedures and rules that will accelerate the clinical development of regenerative medicine and cell therapies. The Japanese Pharmaceutical Affairs Law will now become the Pharmaceuticals and Medical Devices Act that will include a new branch specifically for Regenerative Medicine Products, which will be regulated on a fast track process that focuses primarily on product safety. Under the law, the government is responsible for mapping out and implementing measures to safely accelerate research and development projects and make regenerative medicine widely available in the country. The law specifically stipulates that the government must make basic plans for the promotion of regenerative medicine and change such plans if necessary by reviewing them at least every three years in light of any changes in external conditions that may occur. This news positively impacts RepliCel and its licensing partner, Shiseido, as it looks to conduct human clinical trials on RCH-01.

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This is the part to be actually happy about. This will speed any potential stem cell treatment and among them is the technique of Tsuji lab, when they start their human clinical trial. So...

http://www.replicel.com/replicel-rec...on-technology/


They do indeed seem to be marching forward in terms of developing the company. Let's hope the new trials show results.

...wtf with more trials?? They did phase II trials two years ago, just about now...They know by now if that crap works or it doesn't...the fact they need to do more trials means the technology is a joke

http://www.replicel.com/hair-regeneration/phase-i/


only Phase 1 has been powered

https://www.facebook.com/RepliCelLifeSciences?fref=ts

the answer to my question remains fog results....:confused::confused:

if it really works they have accelerated everything.
do not you think?:confused:

they have done more than phase I..that's bs..they put out an application for phase II trials a couple of years ago now...

...they're accelerating everything so this can get to market and they can sucker in everyone with marketing to make some profit...

...they posted some minor results a couple of years ago on sample areas the size of a dime, I believe...where are the results from the last phase of testing??

...don't get me wrong, I do believe this will offer some results for some, but nothing that will be substantial...they have been at this for a long time and to only be going through phase II trials now, and selling off to a Japanese company, does not wreak of a confidant company!! wake up!!

Unfortunately your reason :( :(
results rotten, just to make money.:mad:
big scam!:mad:
have had better be grafted mouse hair on them it works.
to resemble rat splinter, that's the future nothing else.
http://i2.cdnds.net/12/12/618x428/mo..._gallery_6.jpg

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Originally Posted by Sparky4444

they have done more than phase I..that's bs..they put out an application for phase II trials a couple of years ago now...

...they're accelerating everything so this can get to market and they can sucker in everyone with marketing to make some profit...

...they posted some minor results a couple of years ago on sample areas the size of a dime, I believe...where are the results from the last phase of testing??

...don't get me wrong, I do believe this will offer some results for some, but nothing that will be substantial...they have been at this for a long time and to only be going through phase II trials now, and selling off to a Japanese company, does not wreak of a confidant company!! wake up!!

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They did not sell off anything, they simply partnered with a larger incumbent in the Asian market to raise enough funds to continue their projects.

They did not have a phase 2 yet. They had a phase 1/2A. It's the same thing histogen did. But they still do need to go into phase 2B. They just did 2A along with phase 1 to speed things up.

And the results from phase 1/2A are on the website.

...c'mon you guys -- you think if they had something that will knock the doors off they'd go through all this hassle?? If they had something that was revolutionary, they'd be drowning in money to bring this to market...plus they would have gone through Phase II last year instead of wasting all this time ...

...this is NOT the one gents...nothing more than what L'Oreal did...

Ok sparky you obviously sound like an expert (not). Only time will tell so there's no point debating any further. While we wait for the truth to reveal itself to us, you could go back to elementary school and learn how to write.

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Originally Posted by Thinning87

Ok sparky you obviously sound like an expert (not). Only time will tell so there's no point debating any further. While we wait for the truth to reveal itself to us, you could go back to elementary school and learn how to write.

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I get it...you're desperate for something and when the truth hits home the first reaction is to lash out at the one bearing the truth...these personal attacks don't even make sense -- I'm not attacking you, I'm attacking what you are desperate to believe in...Not much difference than a holy war...a sad display here for sure...

...but the truth is this -- If this was going to work, they wouldn't partner with a flippin cosmetics company!!! They could have written their own ticket to getting this to market...it's that simple and you know it!! This is such a three-ring circus display that it's ridiculous...

...Repli-cel will NOT get anything better than what people are getting by derma-rolling ... there are other things coming out wayyyy before this does that will make this whole thing toast....

sorry

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Originally Posted by Sparky4444

I get it...you're desperate for something and when the truth hits home the first reaction is to lash out at the one bearing the truth...these personal attacks don't even make sense -- I'm not attacking you, I'm attacking what you are desperate to believe in...Not much difference than a holy war...a sad display here for sure...

...but the truth is this -- If this was going to work, they wouldn't partner with a flippin cosmetics company!!! They could have written their own ticket to getting this to market...it's that simple and you know it!! This is such a three-ring circus display that it's ridiculous...

...Repli-cel will NOT get anything better than what people are getting by derma-rolling ... there are other things coming out wayyyy before this does that will make this whole thing toast....

sorry

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No you don't get it. Your conclusions are based on false logic. The fact that it's a cosmetic company doesn't prove they are not a reliable partner for funding, nor that they have not been able to partner with anybody else.

You see, you tell me that I'm desperate, but in fact it's the depressed ones like yourself who are the truly desperate members of this forum. Just like you showed in your posts, these members are completely ignorant about the topic they are discussing and will instead pick two or three details to prove their own ultra pessimistic conclusions, all reflecting their feelings of self pity and failure.

Replicel's initial data is indeed disappointing, but it's what every phase 1 study is. All of them don't show much, including the more promising Follica. That's because phase one is performed to prove safety, not efficacy. This doesn't mean replicel will necessarily show a full blown cure in phase 2B, but it will work to develop methods to optimize the process and improve its results, to an extent you in all your ignorance cannot predict.

In conclusion, and I will go to end after writing this, allow me to remind you that if you're an ignorant idiot like you've shown so far, there is no full head of hair that will ever save you from your own stupidity.

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Originally Posted by Thinning87

No you don't get it. Your conclusions are based on false logic. The fact that it's a cosmetic company doesn't prove they are not a reliable partner for funding, nor that they have not been able to partner with anybody else.

You see, you tell me that I'm desperate, but in fact it's the depressed ones like yourself who are the truly desperate members of this forum. Just like you showed in your posts, these members are completely ignorant about the topic they are discussing and will instead pick two or three details to prove their own ultra pessimistic conclusions, all reflecting their feelings of self pity and failure.

Replicel's initial data is indeed disappointing, but it's what every phase 1 study is. All of them don't show much, including the more promising Follica. That's because phase one is performed to prove safety, not efficacy. This doesn't mean replicel will necessarily show a full blown cure in phase 2B, but it will work to develop methods to optimize the process and improve its results, to an extent you in all your ignorance cannot predict.

In conclusion, and I will go to end after writing this, allow me to remind you that if you're an ignorant idiot like you've shown so far, there is no full head of hair that will ever save you from your own stupidity.

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You're the one talking ignorant and going on a rant, not me..you're the one name calling, not me...:p

You're just pissed off because you know the only way you're gonna keep your hair is with a HT and it's going to cost you ten's of thousands of $$ ...plain and simple...I've accepted it...maybe it's time you do to...

You're a sad, pathetic and desperate human being....I feel pity for you :(

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Originally Posted by Sparky4444

You're the one talking ignorant and going on a rant, not me..you're the one name calling, not me...:p

You're just pissed off because you know the only way you're gonna keep your hair is with a HT and it's going to cost you ten's of thousands of $$ ...plain and simple...I've accepted it...maybe it's time you do to...

You're a sad, pathetic and desperate human being....I feel pity for you :(

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This is no rant, I'm very calm. Your logic is wrong because it uses irrelevant details to infer something you have concluded not based on all the facts but based on what you have decided will be true. Which is a failure of everything that has a potential to improve current treatments. Your attitude reflects a tendency to find refuge in self pity, ultimately reflecting your uncommonly small intellect (which is also clear from your poor command of the language).

Like I said, you should consider more schooling because if they will every come up with a cure, you will still remain the useless idiot you have proved to be and no hair will save you from your own stupidity.

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Originally Posted by Thinning87

..because if they will every come up with a cure,

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..ummmmm..yeah, I'm the one that needs more education..,write much??

:rolleyes:

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Originally Posted by Sparky4444

..ummmmm..yeah, I'm the one that needs more education..,write much??

:rolleyes:

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You also haven't been able to provide a logical argument on the topic and the issues I presented. You are in fact a man child, and wrong.

Can you two give it a rest...

I don't like these everlasting discussions between two members, but I've got to agree with Thinning87 here. Calling Replicel a scam is just ridiculous. They are researching a solution, but I've heard that it is quite difficult to cure hairloss, so no one should expect direct results. If every company that does not get substanial results from the start would have to stop it's project immediatly, there will never be a cure.

And off course they need money, good researchers are not going to work for free, not to mention the cost of equipment etc. Money being invested is a good sign, it means there is potential (not that it is going to work for sure).

This WONT be available in 2015. The current phase of trials is supposed to begin in early to mid 2014 and will run through 2015. I dont think this could be available until 2016-17 at the earliest. http://www.berkleyrenewables.com/s/RepliCel.asp

if everything goes as planned (and we KNOW it never does in these clinical trials) the trial might finish in mid 2015 and then a few months to go over dats etc and then we will see.

Hopefully having Shiseidos money behind them helps steamroll this bitch and keep things on track

Good news;

RepliCel Life Sciences’ Licensing Partner, Shiseido, Opens Cell Processing and Expansion Facility in Japan to Advance RCH-01, a Treatment for Pattern Baldness

Source:

http://www.replicel.com/replicel-lif...tern-baldness/

Thank god its not USA!

Interesting. I hope this doesn't get overlooked amidst all the talk and speculation coming out of the hair restoration congress. It would be nice to get confirmation that Replicel has indeed started the next phase of the trials.

Hellouser, possibly the best line of the whole article "Legislative support has come from the introduction of new laws to expedite otherwise lengthy clinical research and trial application processes to promote competitive advantage in the international market"

is this phase 2b for them or phase 3?

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Originally Posted by downandout

Hellouser, possibly the best line of the whole article "Legislative support has come from the introduction of new laws to expedite otherwise lengthy clinical research and trial application processes to promote competitive advantage in the international market"

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NICE! I think I'm going to email Tammy from Replicel and see if that part means what we hope it does.

I've said it before in other threads that the clinical trials in other jurisdictions use an arbitrary number for years to prove efficacy, in essence, what does 15 years of trials tell us that 5 years does not?

Research of this type is sloooow. Japanese governance seems to have realized that tho finding such products to be safe and effective takes time, they can cut the bureaucracy on their end and lead the way in being first out the gate in such technologies. I read somewhere that this jibes with their economic reform. And with other streams proffered by folks like Replicel in tendon and skin aging repair, there seems to be something of a boon in the industry coming… Bully for these biotech industry leaders I say.

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Originally Posted by yagazooci

Research of this type is sloooow. Japanese governance seems to have realized that tho finding such products to be safe and effective takes time, they can cut the bureaucracy on their end and lead the way in being first out the gate in such technologies. I read somewhere that this jibes with their economic reform. And with other streams proffered by folks like Replicel in tendon and skin aging repair, there seems to be something of a boon in the industry coming… Bully for these biotech industry leaders I say.

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Their economy is going to see a HUGE boost if they push these treatments out of the door quickly. I would not only go to Japan to get a socially tolerable head of hair, but I'd take a few more days off and go tour around Japan and dump even more money on hotels, travels, food, night life, etc. I'll do the very same anywhere and I'm sure many others would take advantage of the opportunity.

The hair loss industry is in the billions already with shit products over the counter. Imagine what it'd do if working treatments were isolated to a single country?

They have the territorial license and rights from Replicel to service the Asean countries with Replicel's patented technology, which is about 2.1 billion people, once the efficacy is proven up. Cant help but think that a hallmark long-lived company like Sheseido like what they see. Its right in their wheelhouse too. They are doing parallel trials with replicel and trading knowledge gleaned along the way. Seems like replicel wants to do this right. Being sent back to the drawing board is not an option. They have power in their corner with Sheseido Id say… more than they'd had all along. thats what I think. Bully for us!

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Originally Posted by yagazooci

They have the territorial license and rights from Replicel to service the Asean countries with Replicel's patented technology, which is about 2.1 billion people, once the efficacy is proven up. Cant help but think that a hallmark long-lived company like Sheseido like what they see. Its right in their wheelhouse too. They are doing parallel trials with replicel and trading knowledge gleaned along the way. Seems like replicel wants to do this right. Being sent back to the drawing board is not an option. They have power in their corner with Sheseido Id say… more than they'd had all along. thats what I think. Bully for us!

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What's also interesting is how Desmond mentioned that many research teams overcame culturing of DP cells and retaining their properties a LONG time ago and we, the hair loss community/baldites have been clueless about their findings. I would think its not really a stretch to assume that Replicel had overcome these obstacles themselves as well. I do remember there was some kind of change in their protocol, which perhaps means 3D culturing instead of 2D culturing?? If that's the case, then we might be in for a surprise with results.

Here's some more info;

Some time before 2003 Dr. Rolf Hoffman & Dr. Kevin McElwee published a study on Dermal Sheath Cup Cells inducing hair follicles;

http://www.ncbi.nlm.nih.gov/pubmed/14675169

Shortly after that, the method was patented by Dr. Rolf Hoffman & Dr. Kevin McElwee.

http://www.google.com/patents/US8431400

The good news?

Both these guys are working at Replicel now;

http://www.replicel.com/about/leader...xecutive-team/

Hoffman's bio:

http://www.replicel.com/wp-content/u...matted_Bio.pdf

They ARE the science of Replicel, and previously Trichoscience. It was their findings that caused them to seek business-minded folks and form the company. They have a very good team now it seems. They differed from Aderans in the specific cell they used. DSCC ( Dermal Sheath Cup Cells) as opposed to dermal papilla cells. They think that is the difference maker. They have vastly improved their cell multiplication time frame, their injection paraphernalia, (more precise amounts/depths)their culture in the multiplication process etc. These things will all lead them to greater success and a shot at viability. They tout this same technology as potentially effective in a host of cell deficiency applications. Surely they aren't willy nilly on it all. They have way too much credibility to be rolling the dice… going to be interesting.

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Originally Posted by yagazooci

They ARE the science of Replicel, and previously Trichoscience. It was their findings that caused them to seek business-minded folks and form the company. They have a very good team now it seems. They differed from Aderans in the specific cell they used. DSCC ( Dermal Sheath Cup Cells) as opposed to dermal papilla cells. They think that is the difference maker. They have vastly improved their cell multiplication time frame, their injection paraphernalia, (more precise amounts/depths)their culture in the multiplication process etc. These things will all lead them to greater success and a shot at viability. They tout this same technology as potentially effective in a host of cell deficiency applications. Surely they aren't willy nilly on it all. They have way too much credibility to be rolling the dice… going to be interesting.

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They're supposed to be starting Phase II this year which should take them about 3 years to complete. If and when completed, they should have something on the market in Asia for us to use soon after. 3 years isn't that bad of a time frame. Of course, Histogen *should* be out before then too.

RepliCel Life Sciences Inc. Announces Closing of Second Tranche of Private Placement

VANCOUVER, BRITISH COLUMBIA--(Marketwired - May 21, 2014)


http://online.wsj.com/article/PR-CO-...21-917385.html

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Originally Posted by hellouser

Good news;

RepliCel Life Sciences’ Licensing Partner, Shiseido, Opens Cell Processing and Expansion Facility in Japan to Advance RCH-01, a Treatment for Pattern Baldness

Source:

http://www.replicel.com/replicel-lif...tern-baldness/

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great. going into fully automated cell production hopefully

Quote:

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Originally Posted by hellouser

They're supposed to be starting Phase II this year which should take them about 3 years to complete. If and when completed, they should have something on the market in Asia for us to use soon after. 3 years isn't that bad of a time frame. Of course, Histogen *should* be out before then too.

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3 years, really?

damn it. this is so faaaar away.

Quote:

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Originally Posted by hellouser

They're supposed to be starting Phase II this year which should take them about 3 years to complete. If and when completed, they should have something on the market in Asia for us to use soon after. 3 years isn't that bad of a time frame. Of course, Histogen *should* be out before then too.

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And Follica that juste finished their second trial.

Plus the Taiwan trial that supose to finish in 2016