Replicel news and answers

[lacazette]

Yep we already know that. Maybe the 21st cure bill could slightly accelerate the phase 3 and phase4 approval, but it will take so long in western

Sisheido that maybe enhance replicel technology with their hair research center where there is some of the best hair researchers is the best hope. A big phase 2 and approval could be a reality.

What I Wonder is when they talk about 2018, they talk about temporally approval or complete approval? Cause if it's total approval, that would mean few people could have the therapy before 2018 under the temporally approval system, as it is possible during phase 2.

Who would take the risk to pay for a procedure that has safety data, but not longer cancer data? and maybe not perfect effectiveness at this point?
I think i would ^^ yes hairloss makes me crazy

[Arieux]

@iamanidot: nothing new in that info. We know that under western regulations phase 3 is necessary. The only hope is sooner commercialisation in Japan.

[iamanidiot]

our phase 2 trial (approx 39 months) will need to be followed by a much larger phase 3 trial. needless to say, we are many years away from having a produce on the market.

from facebook

[JayM]

Where as IPSCS are amazing and will offer amazing treatments in the future you need to realise that they can cause an immune response - whilst even autologous. This isn't understood too well right now but it's a hurdle. One of the first clinical trials ongoing now has also had problems with oncogenic genes.

We also have to accept that if there is no immune response Japan may chose to use allogeneic cell lines and thus making the treatment a lot cheaper - because of how Un diverse they are genetically. We unfortunately don't have that luxury - as in Western people so could be a lot more expensive.

Again this isn't really anything to do with replicel but things to think about with IPSCs. Again it might not pan out like that but the more you know haha.

[Renee]

If you look at the video part 2 recently released it shows dr ohyama using ips cells to grow hair structures under mice skin. Although the video is from June 2015, per published reports he conducted that experiment in 2013. So with the recent article of shisheido claiming a cure in 2018, one can conclude in the past 2 years they have advanced that study and in fact cured hair loss. If this is true expect to here something very soon because in order to release it in 2018 they need to do trials ASAP.

[macbeth81]

For what it is worth, Shiseido mentioned RCH-01 in their 2015 Annual Report. Nothing we haven't already heard though. Shiseido has not yet started trials.

Shiseido opened the Shiseido Cell-Processing and Expansion Center (SPEC) in May 2014. Located in the Kobe Biomedical Innovation Cluster in Kobe, Japan, the center will be our core research and development facility for commercializing hair regenerative medicine. Targeting the clinical application of regenerative medicine to treat alopecia and thinning hair, Shiseido concluded a technical collaboration agreement in July 2013 with Canadian bioventure company RepliCel Life Sciences Inc. to acquire an exclusive geographic license to use RepliCel Hair-01 (RCH-01) hair regeneration technology in Asia, including Japan. RCH-01 is an autologous cell transplantation technology, in which specific cells isolated from the hair follicles taken from the scalp of a patient are cultured and injected into the balding scalp area, potentially stimulating residing hair follicles and promoting new growth in the balding scalp area. This technology has no risk of immune rejection because it uses the patient’s own cells. We will conduct research and development in the outstanding environment for applied regenerative medicine research in the Kobe Biomedical Innovation Cluster to commercialize this highly safe technology as soon as possible.

[Swooping]

I agree completely. No company that believes they have an effective therapy (let alone a cure...) takes this long between Phase 1 and Phase 2 trials. And as soon as their Phase 1 results were released, they made it clear that they were diversifying into skin and tendinosis ventures - not a coincidence...

And the notion that we should feel reassured because Shiseido believes in their technology is wrong. Shiseido paid Replicel $4,200,000 upfront to use their technology - which is a joke in the biotechnology world. The bulk of Shiseido's investment ($31,500,000) is milestone-based, so if the product doesn't work and doesn't sell - Shiseido pays nothing additional.

Replicel's treatment is going to fail. However - as others have highlighted - Shiseido is a legitimate company with substantial financial resources and teams of great scientists that are working on a solution. It is Shiseido's dedication to developing a cure - and NOT Replicel's technology - that makes me feel optimistic. And who knows - maybe they'll pull it off by 2018 like they claim.

Meanwhile - I think there's a reasonable possibility that in 2018, Replicel's Phase 2 trial in Germany will still be "coming soon"...

WHAT?! They only paid 4.2 million? Ok, that is terrible what a joke.

It's more complicated then taking dsc cells multiplying and injecting. If that was the cure clinics in mexico would already be offering this treatment.

I agree it just seems way too easy.. way too easy. Hopefully we will be surprised though.

[Renee]

It's more complicated then taking dsc cells multiplying and injecting. If that was the cure clinics in mexico would already be offering this treatment.

[xyz123]

I suspect Replicel doesn't want this phase II hair trial to happen too soon. They probably already have an idea that their results are going to disappoint and want to draw this out as much as possible to buy time to get their other pipeline projects advancing. It's been 5 years since phase I, which is ridiculous by any measure. I've heard their excuses for the delay, but i don't believe it's the whole truth . My guess, If the hair trial flops and they don't yet have anything else significantly advanced, it could be lights out for them.

I also feel that there are other reasons for Shesheido licensing their technology other than intending to commercialize it directly. There may be some synergies with their IPS research they're conducting that they can take advantage of. At least that's what i'm hoping, because i just don't see much chance for Replicel's technology to work as it exists now.

I agree completely. No company that believes they have an effective therapy (let alone a cure...) takes this long between Phase 1 and Phase 2 trials. And as soon as their Phase 1 results were released, they made it clear that they were diversifying into skin and tendinosis ventures - not a coincidence...

And the notion that we should feel reassured because Shiseido believes in their technology is wrong. Shiseido paid Replicel $4,200,000 upfront to use their technology - which is a joke in the biotechnology world. The bulk of Shiseido's investment ($31,500,000) is milestone-based, so if the product doesn't work and doesn't sell - Shiseido pays nothing additional.

Replicel's treatment is going to fail. However - as others have highlighted - Shiseido is a legitimate company with substantial financial resources and teams of great scientists that are working on a solution. It is Shiseido's dedication to developing a cure - and NOT Replicel's technology - that makes me feel optimistic. And who knows - maybe they'll pull it off by 2018 like they claim.

Meanwhile - I think there's a reasonable possibility that in 2018, Replicel's Phase 2 trial in Germany will still be "coming soon"...

[luiza]

@Floyd: Really I can't understand judging Replicel's technology by Phase 1 results, which was projected mainly to show safety on humans. It's not suprising that small dose in one injection didn't give outstanding results. But it gave some results, it works, so think about much more bigger doses and multiple sessions. It's useless to create now sophisticated theories about intentional delaying phase II. Wait plz until the end of this year, as both Replicel and Shiseido say that it will begin this year. I think that only after that phase, in which diffrent doses will be tested, talking about its efficacy will be reasonable.

The safety trial was actually done with a really high dosage :/ but only one injection.

The Phase II trial will be done with different dosages and multiple injections. Hopefully it will give better results.

I will only get excited about replicel/shiseido if they prove they can be a full cure and give hair back to NW7.
I am a girl and my hair loss is not THAT bad but I am so sick of treatments. I will only get really happy the day someone tells me it is possible to get pretty much all my hair back.
If they can do it (even if it costs a lot and takes more time) I will be the happiest person in the world.

[Arieux]

@Floyd: Really I can't understand judging Replicel's technology by Phase 1 results, which was projected mainly to show safety on humans. It's not suprising that small dose in one injection didn't give outstanding results. But it gave some results, it works, so think about much more bigger doses and multiple sessions. It's useless to create now sophisticated theories about intentional delaying phase II. Wait plz until the end of this year, as both Replicel and Shiseido say that it will begin this year. I think that only after that phase, in which diffrent doses will be tested, talking about its efficacy will be reasonable.

[Hairismylife]

I always dunno why you guys like to speculate base on your own guessing while official announcement definitely says 2018. Some delays may happen but there's no point to doubt their effectiveness. Japanese won't say something without supporting especially such a large corp.

[Renee]

I agree with floyd, very we'll said. Shishiedo paid pennies to access the science behind replicel technology, which has been researched since 2004.

[FloydButterworth]

I have a feeling that Replicel does a far better job at hyping them self and raising money than growing hair. Just a bunch of guys earning money by playing financial games with quick and smooth talk. But we'll see.

I suspect Replicel doesn't want this phase II hair trial to happen too soon. They probably already have an idea that their results are going to disappoint and want to draw this out as much as possible to buy time to get their other pipeline projects advancing. It's been 5 years since phase I, which is ridiculous by any measure. I've heard their excuses for the delay, but i don't believe it's the whole truth . My guess, If the hair trial flops and they don't yet have anything else significantly advanced, it could be lights out for them.

I also feel that there are other reasons for Shesheido licensing their technology other than intending to commercialize it directly. There may be some synergies with their IPS research they're conducting that they can take advantage of. At least that's what i'm hoping, because i just don't see much chance for Replicel's technology to work as it exists now.

[Renee]

There are a lot of biotech venture capital firms that will throw money at anybody who has developed a better treatment or cure. If what hellouser is saying is true that lauster got funding denied then his method doesn't work. However, I remember Desmond saying that the lauster team is working on solving the final step and funding is not a problem for them.