RepliCel Reports Progress on Shiseido Technology

[macbeth81]

And let's not forget that they are adding some things to their treatment that they didn't do before. At minimum they will be adding repeat treatments and nobody knows how that will turn out. But they may also have made some other treatment changes as well.

Group 1 of 66 patients: 1 single injection, 4 sites, 3 doses, 1 placebo,
Group 2 of 66 patients: 1 single injection on Day 1 and 91, 4 sites, 3 doses, 1 placebo.
Hair counts at 12 months since last injection.

Note the inclusion criteria is male pattern baldness. The initial Phase I/IIa trails were almost 50/50, male/female. Second, RCI-02 is to be completed in 2014; hopefully they use their updated device. Third, they extended the waiting period from 6 months to 12 month from injection.The Phase I/IIa check may be due to the original mouse study which also checked at 6 months.

http://www.replicel.com/wp-content/uploads/Corporate-Presentation-Final-May-22-14.pdf

I have not seen anything regarding Sheseido trails, but I don't know Japanese either. The only statement to note is rather vague and general.

We will establish the Shiseido Cell-Processing and Expansion Center in Kobe in May and use this facility as a base for related research and development aimed at future commercialization. It is expected to be some time before this innovation makes a profit. However, we expect it to be very profitable and create value and new markets in the future.

http://www.shiseidogroup.com/ir/pdf/ir20140425_854.pdf

I guess we will see in 2-3 years...

[Sogeking]

Replicel stock has been low ever since they published their Phase 1 results, can't remember when it was, man time passes on fast. However despite those lackluster results they still signed a deal with Shiseido. So the stock price can tell you absolutely nothing. No one is willing to risk investing in Replicel until they show good credible results because a lot of people got burned when they saw Phase 1 results...

[Thinning87]

And this is how sdsurfing lost all credibility on this forum.........

[sdsurfin]

replicels stock has been plummeting consistently. Im not sure if this is part of a broader market crash, but can't be good news. Im pretty sure we are all screwed, cures happen every century or so, medicine moves so damn slow and no one who has anything now is impressive at all. al least not enough to waste your money or energy on. even things like aids and cancer research move at a glacial pace and they get tons of money thrown at them. the sad reality is that the government and capitalists don't give a crap about medicine or health or education or anything worthwhile. the only things that get money are war and oil and other shitty pursuits. I think replicel and CB are so hyped up, I for one am not interested in dropping thousands on something that isn't even gonna grow much hair back.

[nameless]

The estimated time for the Phase IIb data was stated on slide 10 of their Annual General Meeting, May 2014.

http://www.replicel.com/wp-content/uploads/AGM-2014-Presentation-Final-Web.pdf

The estimated time for the US Market was stated as a response to a question on their Facebook, July 2014. I am assuming they mean four years from 2014, and not four years after Phase IIB completes which would be even longer.

https://www.facebook.com/RepliCel/posts/709806722411496?comment_id=711837128875122&offset=0&total_comments=2

Phase I-IIa results they published back in 2012. The numbers are nothing to be excited about. If I recall the injections were on thinning zones and not slick bald zones. Even then only +11.8% on average for responders. Also note the results state a follow-up after 24 months to assess safety and efficacy. Instead they extended the trail for 36 months for safety only. That give 5 years of safety data. Not a bad thing but what about efficacy? Did the hair gained remain, did more grow, were the gains lost, did they not even care to check? Also note the interm results state Phase IIb was to start late 2012. They pushed this date back two years, so don't take their estimates too seriously.

http://www.replicel.com/wp-content/uploads/2012/Phase-I-IIa-Interim-Results.pdf

Sheseido is our only hope for earlier release. Unfortunately, I don't have a lot of faith on Japaneses companies after what happened to Aderans.

And let's not forget that they are adding some things to their treatment that they didn't do before. At minimum they will be adding repeat treatments and nobody knows how that will turn out. But they may also have made some other treatment changes as well.

[macbeth81]

The estimated time for the Phase IIb data was stated on slide 10 of their Annual General Meeting, May 2014.

http://www.replicel.com/wp-content/uploads/AGM-2014-Presentation-Final-Web.pdf

The estimated time for the US Market was stated as a response to a question on their Facebook, July 2014. I am assuming they mean four years from 2014, and not four years after Phase IIB completes which would be even longer.

https://www.facebook.com/RepliCel/posts/709806722411496?comment_id=711837128875122&offset=0&total_comments=2

Phase I-IIa results they published back in 2012. The numbers are nothing to be excited about. If I recall the injections were on thinning zones and not slick bald zones. Even then only +11.8% on average for responders. Also note the results state a follow-up after 24 months to assess safety and efficacy. Instead they extended the trail for 36 months for safety only. That give 5 years of safety data. Not a bad thing but what about efficacy? Did the hair gained remain, did more grow, were the gains lost, did they not even care to check? Also note the interm results state Phase IIb was to start late 2012. They pushed this date back two years, so don't take their estimates too seriously.

http://www.replicel.com/wp-content/uploads/2012/Phase-I-IIa-Interim-Results.pdf

Sheseido is our only hope for earlier release. Unfortunately, I don't have a lot of faith on Japaneses companies after what happened to Aderans.

[efedrez]

Thank god they partnered up with a company based in Japan. That's like the best case scenario for us. Shiseido could have something out by 2016 if they take advantage of the fast-track approval, though they would be idiots not to.

Most likely Sheseido will be the fist to release the product.
We don't have to worry too much about replicel stating that they need x numbers of year to bring something to the market since that is not the objective of the company.
They have mentioned many times that their business model is to be the R&D engine for bigger companies and with the Shesiedo partnership they already achieve that

[HairIsLife]

+1 on hoping the Japanese move quick. Otherwise we wait until 2016 for Phase IIb data. Considering Replicel's track record it will be delayed... On their Facebook page they mention if Phase IIB is successful it would be appprox. 4 years until it is available in the US. They need to greatly improve on their results though, Phase I-IIa was lackluster. Either way nothing in the US until probably 2019. Time to give finasteride a try.

Thank god they partnered up with a company based in Japan. That's like the best case scenario for us. Shiseido could have something out by 2016 if they take advantage of the fast-track approval, though they would be idiots not to.

[sascha]

+1 on hoping the Japanese move quick. Otherwise we wait until 2016 for Phase IIb data. Considering Replicel's track record it will be delayed... On their Facebook page they mention if Phase IIB is successful it would be appprox. 4 years until it is available in the US. They need to greatly improve on their results though, Phase I-IIa was lackluster. Either way nothing in the US until probably 2019. Time to give finasteride a try.

Could you eventually back up your claims?

[macbeth81]

+1 on hoping the Japanese move quick. Otherwise we wait until 2016 for Phase IIb data. Considering Replicel's track record it will be delayed... On their Facebook page they mention if Phase IIB is successful it would be appprox. 4 years until it is available in the US. They need to greatly improve on their results though, Phase I-IIa was lackluster. Either way nothing in the US until probably 2019. Time to give finasteride a try.

[sdsurfin]

replicel news

Excerpt from a stock trading article now on replicel's website. Sounds tentatively promising, if it doesn't take forever to come out. I'm crossing my fingers for the japanese to do this right and quick. seems like you wouldn't have to get treated very often, which is great. The gains weren't great in the first trial, but even for maintenance this would be a godsend right now. So frustrating that we can't get it now. def going to japan if this is released there earlier. Wish I could take fin in the meantime, gonna lose a lot of hair before this happens, if it does.

"Improved Baldness Treatment
In terms of the company’s baldness treatment, Phase 1 showed positive results in less time than the currently available options. While micro-transplant surgery is the current gold standard – it is expensive and highly dependent on the surgeon – Rogaine and Propecia are the most commonly used options currently. Rogaine has shown 8%-16% density increases over 12 months with topical treatment, and Propecia has shown 7%-14% increases over 12 months with an oral regimen. The Phase 1 RepliCel treatment showed an average 11.3% density gain, with 70% achieving over a 10% gain, with the over 10% group averaging 14.3%. The most significant difference with the RepliCel protocol is the end point. Where Rogaine and Propecia require continued use to maintain gains, after the RepliCel injections, gains remain in place. This is a significant point of differentiation."

[sascha]

Replicel has never been about DP cells. They culture DSC cells, which can be cultured in 2D. I bet their treatment works for a little while, but if you have to keep getting re-ups of a 5000 dollar treatment then that is pretty ludicrous for most. I doubt theres any way that even a good exposure to healthy DSC cells will save your hair for good, you still have all this DP and other cells that are prone to balding. If it is not too cost prohibitive it might be great as a bridge until they can inject whole follicle seeds. I'm not sure why shiseido got into it, their preliminary results seemed pretty garbage, but shiseido probably has a lot of money to throw around, and if they can keep charging people 5000 or so a pop and you have to refresh then it'll be a great business for them

I am convinced that the treatment costs between 3000 - 5000 dollars, not one single injection. In their phase 2 trial they will try multiple injections and do not forget that this kind of hair treatments show their efficiency after a greater number of months, since the hair cycle isn't the fastes. We only know about 6-month data.

[yagazooci]

1. I think they believe so with two trials upcoming in Japan and Germany with many many data points to examine; from like 18 trialists to hundreds. I read somewhere they have improved their replication process to be much faster. They did no multiple injections last time either. It's due this time. Things like depth of injection can also be explored as well in the number of trialists this time. Japan's new regulations seem to allow changes to be made midstream, according to Sheseido news about their Kobe project etc.. In the first trial, they went in with a plan and couldn't veer from it. They'd have to start from scratch then, re-applying etc... Thats changed this time, in Japan at least. Seems they have freedom to explore from the way I read it.
2. same as 1 really.
3. no idea, but from the experienced people they have on this project, I'd say they'll have these bases well covered. I did read something about day 1 and day 91 somewhere. Or perhaps Mr Hall said it on Varney and Co. interview. Good luck to them and us all!

[nameless]

1. Why does Replicel believe that its' phase 2 results could be significantly improved over its' phase 1 results?

2. What changes has Replicel made that could possibly produce better results than their phase 1 results?

3. How many follow-up repeat injection dates will replicel perform on each patient?

[hgs1989]

I could go, it's near my house. But I highly doubt it's worth it.

However if you want the experts could prepare some questions for me to read and I could ask if I have the chance to. Kind of what Desmond did in Korea, I can record the answers with my phone and post it on YouTube.

We might even make a thread about it in the cutting edge directory as not many people view this thread

questions would be:

did replicel prove that the method resulted in the formation of new hair follicles ?

did you further monitor the results ? if so, any improvement ?