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.
12-19-2013 11:19 AM
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
12-19-2013 11:28 AM
hellouser
Quote:
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
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.
12-19-2013 06:24 PM
vcity
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".
12-19-2013 06:42 PM
Sparky4444
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
12-20-2013 11:37 AM
Sogeking
Quote:
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.
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...
They do indeed seem to be marching forward in terms of developing the company. Let's hope the new trials show results.
01-13-2014 12:55 PM
Sparky4444
...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
the answer to my question remains fog results....:confused::confused:
if it really works they have accelerated everything.
do not you think?:confused:
01-13-2014 06:10 PM
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!!
