General Replicel/Shiseido News

[efedrez]

I'm not sure if it has been published before but replicel answered a question about their phase 2 trial on their facebook page.

"Yes, our phase 2 trial start date has been pushed off many times; however we believe the reasons for us doing so are in the stakeholder’s best interests. When we completed our phase 1 trial it was with the anticipation that we would almost immediately apply to commence a larger phase 2 trial but a significant manufacturing issue that was out of our control conspired to prevent that from happening. GE pulled the growth media off the market that we had always used to grow the dermal sheath cup cells (the basis of RCH-01). When Lonza tried to reproduce the same media it did not work, so we had to go back to the R&D bench and essentially recreate a media that would give us the same product. We tried many different formulas and even after that was accomplished we then had to conduct all the validation runs and testing to gather the data needed to prove to the regulators that it was materially the same product we had tested in phase 1 -- a prerequisite for them to consider an application for a phase 2 trial (rather than having to go back and repeat phase 1). This has taken an incredible amount of work but it is now almost complete. In the meantime, we took advantage of this opportunity to improve other aspects of the manufacturing in order to optimize the product/process robustness, minimize product failures, better define the product specifications, etc. We also began to work on developing other more proprietary media solutions such as serum-free media and animal-free media which we anticipate will add future value to the product. We have also worked on optimizing cell recovery from the original tissue biopsy. In the end, we believe the RCH-01 that we expect to use for next-phase clinical testing both in Japan and Germany is in biologic terms the same product but is a more commercially viable product because of the various process optimizations we conduct. We continuing to invest in manufacturing optimization of RCH-01 and our other cell-based products with the aim of bringing any improvements possible such as abbreviating manufacturing time, increasing cell yield, lowering production costs, etc. With this said, we should be able to file our clinical trial application with German regulators before the end of this year, and expect Shiseido to announce the start of their trial this year as well."

[brocktherock]

These delays do get annoying but they are literally the only company that has given us news updates, timelines, expectations and answers email questions. I don't think they are just goofing around.

[runrunrun]

Guys Replicel updated new PPT files in their facebook homepage.

[Arieux]

This is their updated presentation from Mesa: http://replicel.com/wp-content/uploa...n-Oct-2015.pdf

Note:

• Shiseido manufacturing and clinical trial in Japan: (...) Trial expected to readout late 2017 with potential to predicate a market approval
application

[TooMuchHairWontKillYou]

Shiiiet now they're saying they will conduct phase 2 in 2015/2016. In 2016 they will say 2016/2017 and so on...

[Sogeking]

This is their updated presentation from Mesa: http://replicel.com/wp-content/uploa...n-Oct-2015.pdf

Note:

they are still aiming for 2018 on the market.Hopefully it will be more effective than Replicel Phase 1.

[Renee]

Their chief medical officer Rolf Hoffman filed a new patent, don't know what that means though!

https://www.google.com/patents/US201...IVTMZjCh2yVQpy

[lacazette]

Thanks Arieux, it's good to have update


May 2014 Shiseido
opened new cell
-
processing facility; PMDA certified 2015
–
Tech transfer & comparability/validation runs completed 2015
–
Clinical protocol under ASRM (clinical research pathway) currently in review by
MHLW
–
Trial expected to readout late 2017 with potential to predicate a market approval
application


Can't wait for their trial to begin, if 2016, their 2018 market timeline will finally become a real concrete option

Again it's incredible how japan regenerative medecine system is an insane benediction for us, it cut 7/10 years in timeline. just imagine if it doesn't exist o0 we would depressly talk about 2022/2025 as the shorter possibility if everything would go well

Now with japan, any company who would come out with a strong protocol is one phase away for possible marketing ( as they explained the timeline between preclinical and commercialisation now is 2/3 years ( safety phase/prediction efficiency, approval administration, GMP manufacturing), unlike the 7/10 years that would be needed in the old approval system

[hellouser]

Thanks Arieux, it's good to have update


May 2014 Shiseido
opened new cell
-
processing facility; PMDA certified 2015
–
Tech transfer & comparability/validation runs completed 2015
–
Clinical protocol under ASRM (clinical research pathway) currently in review by
MHLW
–
Trial expected to readout late 2017 with potential to predicate a market approval
application


Can't wait for their trial to begin, if 2016, their 2018 market timeline will finally become a real concrete option

Again it's incredible how japan regenerative medecine system is an insane benediction for us, it cut 7/10 years in timeline. just imagine if it doesn't exist o0 we would depressly talk about 2022/2025 as the shorter possibility if everything would go well

Now with japan, any company who would come out with a strong protocol is one phase away for possible marketing ( as they explained the timeline between preclinical and commercialisation now is 2/3 years ( safety phase/prediction efficiency, approval administration, GMP manufacturing), unlike the 7/10 years that would be needed in the old approval system

Hey Lacazette,

Is there anything you'd want to ask the guys at Replicel during the Hair Congress next month?

[ShookOnes]

So from phase 1 regrowth was garbage but anyone know if participants lost hair? Freezing hairloss would be a cure asbi just had a 1600 fue..