RepliCel Reports Progress on Shiseido Technology

[efedrez]

Next Tuesday Replicel CEO will be presenting to a group of investors in NY, I hope he will give an update on phase II which is planned to start before the end of the year

"RepliCel CEO David Hall will be speaking at the New York Palace Hotel on Tuesday, September 9 at 9:15 a.m.

The 20 minute presentation will include an update on the Company’s current programs for chronic tendinosis (RCT-A-01), sun damaged and aging skin (RCS-01) as well as pattern hair loss (RCH-01)."

[joel203]

What does this mean?

[hellouser]

Good news from Replicel:

RepliCel Life Sciences Joins Centre for Commercialization of Regenerative Medicine, Industry Consortium


CCRM and RepliCel to Partner on Development of Cell Therapies for Tendon Repair

VANCOUVER, BC and Toronto, ON - September 3rd, 2014 - RepliCel Life Sciences Inc. (TSXV: RP) (OTCQB: REPCF), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, is the newest member of the Centre for Commercialization of Regenerative Medicine's (CCRM) industry consortium.

"The company is pleased to have been accepted as a member of CCRM's industry consortium," states David Hall, CEO of RepliCel. "CCRM represents one of the leading global entities in the area of regenerative medicine and being part of its industry consortium embeds us in an exemplary network. Their broad industry activities and, in particular, their regulatory services are an important current asset to RepliCel. Furthermore, RepliCel is pursuing CCRM as a secondary manufacturing site for the company's fibroblast platform, which is a key step in demonstrating technology transfer, as well as risk mitigation away from a single site cell replication model."



CCRM is currently engaged in providing RepliCel with contract regulatory services including documentation and filings related to RepliCel's RCT-A-01 product for chronic Achilles tendinosis. This program is the subject of a planned clinical trial in Canada to start in 2014 that will involve clinical testing to address chronic tendinosis, a degenerative disease of the tendon caused by a cycle of injury, improper healing and re-injury until there are very few pain free and functional periods. Despite the body's attempts to heal itself, complete healing of the tendon is never achieved, potentially due to a deficit of type I producing fibroblast cells needed to support the healing process.



RCT-A-01 will attempt to address this cellular deficit by providing an injection of a patient's own fibroblasts to the site of the injury. Collagen-producing fibroblast cells will be isolated from hair follicles taken by a punch biopsy from the back of the patient's scalp. These cells will then be grown in controlled processes. The new cells are injected directly into the wounds within the tendon via ultra-sound imaging. After injections are performed, patients return to the clinic for assessments of safety, function and pain, as well as changes in tendon thickness, echo texture, interstitial tears and neovascularity (growth of new blood vessels).



This treatment is designed to provide the necessary number of fibroblast cells to initiate and complete the disrupted healing process leading to a normally functioning tendon with higher tensile strength. Further indications will include patellar tendinosis, or jumper's knee, and lateral elbow tendinosis.



"RepliCel is one of a small, but quickly growing, class of companies emerging in the Canadian landscape that are leading the way with clinical-stage development of cell-based therapies being developed, tested, and hopefully commercialized first in Canada," says Michael May, President and CEO of the Centre for Commercialization of Regenerative Medicine. "CCRM is pleased to play a pivotal role in supporting RepliCel's efforts to develop a new class of therapies for patients and, in the process, contribute to the growth and success of this emerging segment of the biotechnology industry."



About the Centre for Commercialization of Regenerative Medicine (CCRM)

CCRM, a Canadian not-for-profit organization funded by the Government of Canada's Networks of Centres of Excellence program and six academic partners, supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based technologies and therapies. A network of academics, industry and entrepreneurs, CCRM aims to translate scientific discoveries into marketable products for patients. CCRM launched in Toronto's Discovery District on June 14, 2011. CCRM is hosted by the University of Toronto.



CCRM has three core development themes: cell reprogramming and engineering; cell manufacturing; and, biomaterials and devices to carry out projects commissioned by academia and industry. CCRM has a fully resourced, 6,000 square foot development facility where all development work takes place.



CCRM's industry consortium currently numbers nearly 40 companies representing the key sectors of the industry: devices, therapeutics, reagents and cells as tools. Please click here to see a complete list of CCRM's members.

[sascha]

Can one of you guys please explain to me what he said? I do not really follow his show anymore, since all he does is to talk about surgery and fin. He could tell us way more than he is, I think that is really a f***** up move.

[Thinning@30]

What ever happened to the news that Spencer got from David Hall about 9 months ago that Spencer was so excited about, and he was supposed to share with us?

I am wondering about that too.

[FearTheLoss]

What ever happened to the news that Spencer got from David Hall about 9 months ago that Spencer was so excited about, and he was supposed to share with us?

[sascha]

https://www.shiseidogroup.com/ir/pdf/ir20130530_701.pdf They already wanted to conduct trials last year, with intention to get to market within 5 years -> 2018. Maybe with the new facility the timeline comes even down to 2016 for early release as hellouser already pointed out, because they still can make money and collect data points at the same time.

[Thinning87]

I think it's likely that the Japanese will want to run their own trials and study the product extensively. Keep in mind guys it is likely that the only reason why the Japanese even decided to buy the technology is that the longer time point outcomes were more positive than the ones published, and this demonstrated potential for improvement with different methods/protocols applied.

I deduce this from what spencer had said in an episode last year after speaking with Hall.

This all means for us that we are going to have to wait some time

[joachim]

Japan allows conditional commercialization during Phase II trials. It's possible they could release the product much sooner than 39 months.

that's true. if they see some good results after 1 year already then they theoretically could release it sooner. in case they are not satisfied with the results and want to try more dosing protocols etc. then they probably will stick to the whole time frame.
but i have a good feeling that shisheido is involved with separate trials, too. maybe they are eager to release it sooner if efficacy turns out to be useful. we should ask for a status update in 1 year or so to see what's their results and if they are thinking about an earlier release.

[hellouser]

Nope. They are supposed to start this year. But 39 months long phase 2 trial is really long. I mean they did prove safety with phase 1 trials, why go 3 years for effectivity(granted they are safety as well) trials?

I don't know I can only speculate we'll see how Shiseido plays it. But although Shiseido might get to market sooner, effectivity could still be downplayed...

Japan allows conditional commercialization during Phase II trials. It's possible they could release the product much sooner than 39 months.

[Thinning87]

Nope. They are supposed to start this year. But 39 months long phase 2 trial is really long. I mean they did prove safety with phase 1 trials, why go 3 years for effectivity(granted they are safety as well) trials?

I don't know I can only speculate we'll see how Shiseido plays it. But although Shiseido might get to market sooner, effectivity could still be downplayed...

It's obvious that they will be working with repeated injections to improve results.

[sascha]

Nope. They are supposed to start this year. But 39 months long phase 2 trial is really long. I mean they did prove safety with phase 1 trials, why go 3 years for effectivity(granted they are safety as well) trials?

I don't know I can only speculate we'll see how Shiseido plays it. But although Shiseido might get to market sooner, effectivity could still be downplayed...

Thanks for clearing things up, man.
I just saw this article where it was written they want to start trials in germany(Charité Berlin) in 2013, so I was a bit confused.
To me it makes perfect sense what they did. The new trial in germany will bring 288 data points or so, compared with the roughly 16 data points from phase 1.
In the meanwhile Shiseido does a more practical study with access to the general public(with conditions). That is pretty smart. Asian men and women tend to treat their hair loss earlier and seem to care even more, of course members of hair loss forums care the most in my opinion.
But as you said, we will see

[Sogeking]

Arenīt they already in phase 2 studies in germany since 2013?

Nope. They are supposed to start this year. But 39 months long phase 2 trial is really long. I mean they did prove safety with phase 1 trials, why go 3 years for effectivity(granted they are safety as well) trials?

I don't know I can only speculate we'll see how Shiseido plays it. But although Shiseido might get to market sooner, effectivity could still be downplayed...

[sascha]

I doubt that it will be available that soon, their phase 2 trial is just about to begin which is over three years, i know they now have the whole Japanese thing happening now, just cant see a reputable company wanting to release a product after only a safety trial and possible small efficacy if they don't know it will work that well i don't think they will risk it!

Arenīt they already in phase 2 studies in germany since 2013?

[joely]

Could this really be available in 3 years?

I doubt that it will be available that soon, their phase 2 trial is just about to begin which is over three years, i know they now have the whole Japanese thing happening now, just cant see a reputable company wanting to release a product after only a safety trial and possible small efficacy if they don't know it will work that well i don't think they will risk it!