RepliCel Reports Progress on Shiseido Technology

[Thinning87]

Folks you clearly have not been paying attention if you think this is the problem.

1 replicel had results in their phase 1/2A trials that cannot be marketed

2 however, in an episode of the bald truth last year, spencer declared he had a call with Hall, replicel CEO, in which the latter declared they are moving along with different approaches. Furthermore, they had results relating to a later time point from the original trials that were promising

3 the bottom line is they are likely to be doing phase 2B with improved knowledge acquired in phase 1/2A. They will release initial results from 2B at some point in 2015 or 2016 (I can't remember but it's on the website).

4 In the meantime the Japanese will do their own trial in japan subject to Japanese regulation. This is what we have to look forward if we can find more information about it. I don't know if the Japanese of Sheiseido have to start over from phase 1 but if they are intentioned to make progress they are probably about to be starting (or have already started, more likely) their own trials. They have all tube money and research power to carry on serious efforts so I assume they would want to go to commercialization ASAP

[hellouser]

The title of Replicel's post about their Japanese expansion is "A new course of action" - I do not think anyone, besides the people who are in the company, can guess what that means besides that they are moving down another path hence the phrase "new course of action." Furthermore, as to my understanding of the Japanese Regenerative Medicine Law, according to Market Watch - "Conditional approval by no means implies that regulatory approval process is over. It simply allows the therapy to be made available to patients earlier in the process, and for the sponsor company to begin commercialization and obtain reimbursement." Conditional approval can be obtained after completing phase 1 - so Replicel has completed phase 1, hence I believe that they are eligible to apply for conditional approval. They can continue doing trails but my understanding is that it will enable them to start administering it to patients during this process.

HMM!

In that case I've got cash set aside right now thats ready to be spent on a treatment.... enough for a hair transplant but would rather NOT use donor hair.

[Gremlin142]

Interesting. Perhaps this could be a question for Tammy George at Replicel?

Furthermore, the only real way to tell efficacy/safety is when people actually use the treatments at their intended dosage and frequency... for this you really need either large scale trials (tens of thousands of people which isn't possible) or simply push it out to the public but with conditions (accepting the risks and potential unknown side effects).

Still, theyre going to do their Phase II trials over the course of the next 3.25 years. I have a feeling that if their culturing method is 2D, those DSC cells may prove Replicel to be a flop like Aderans. If done in 3D... then we could see serious results. Others have already mentioned that it may be necessary for repeat treatments, but I don't think many of us will really care if thats necessary. I do recall someone pointing out that something with Replicel's method was 'altered' after Phase I results... this would have been over a year ago and coincidentally falls in line with what Desmond from the hair congress said about culturing cells in 3D was solved by many teams around the same time.

The title of Replicel's post about their Japanese expansion is "A new course of action" - I do not think anyone, besides the people who are in the company, can guess what that means besides that they are moving down another path hence the phrase "new course of action." Furthermore, as to my understanding of the Japanese Regenerative Medicine Law, according to Market Watch - "Conditional approval by no means implies that regulatory approval process is over. It simply allows the therapy to be made available to patients earlier in the process, and for the sponsor company to begin commercialization and obtain reimbursement." Conditional approval can be obtained after completing phase 1 - so Replicel has completed phase 1, hence I believe that they are eligible to apply for conditional approval. They can continue doing trails but my understanding is that it will enable them to start administering it to patients during this process.

[Jazz1]

Let's hope America don't stick their noses in Japan with regulations!

[Thinning87]

Yeah and it makes sense that replicel would be paying attention to these developments too.

On the bright side, Sheiseido are also doing their own trial with the same technology in Japan. Let's hope they are trying to take advantage of the new regulations passed in Japan.

[hellouser]

Now I was reading about this specific law Replicel is using to speed the delivery of their product in Japan and according to Market Watch - a reputable site dealing with business news "Japan's new policy requires an early stage clinical trial (call it a Phase I or small Phase II) at the minimum to confirm safety of the therapy and provide some plausible evidence of efficacy. Rather than requiring that the therapy then be evaluated in subsequent trials before making it available to patients, Japan's new law will allow for a "conditional approval" enabling the product to be brought to market, and for the product to obtain reimbursement in an accelerated manner."

So if I understand this correctly, does this not mean that they can start testing it on patients right away since they have already completed their phase 1 trial?

http://www.marketwatch.com/story/jap...-be-2014-03-03

Interesting. Perhaps this could be a question for Tammy George at Replicel?

Furthermore, the only real way to tell efficacy/safety is when people actually use the treatments at their intended dosage and frequency... for this you really need either large scale trials (tens of thousands of people which isn't possible) or simply push it out to the public but with conditions (accepting the risks and potential unknown side effects).

Still, theyre going to do their Phase II trials over the course of the next 3.25 years. I have a feeling that if their culturing method is 2D, those DSC cells may prove Replicel to be a flop like Aderans. If done in 3D... then we could see serious results. Others have already mentioned that it may be necessary for repeat treatments, but I don't think many of us will really care if thats necessary. I do recall someone pointing out that something with Replicel's method was 'altered' after Phase I results... this would have been over a year ago and coincidentally falls in line with what Desmond from the hair congress said about culturing cells in 3D was solved by many teams around the same time.

[Gremlin142]

Japanese Regenerative Medicine Law

Now I was reading about this specific law Replicel is using to speed the delivery of their product in Japan and according to Market Watch - a reputable site dealing with business news "Japan's new policy requires an early stage clinical trial (call it a Phase I or small Phase II) at the minimum to confirm safety of the therapy and provide some plausible evidence of efficacy. Rather than requiring that the therapy then be evaluated in subsequent trials before making it available to patients, Japan's new law will allow for a "conditional approval" enabling the product to be brought to market, and for the product to obtain reimbursement in an accelerated manner."

So if I understand this correctly, does this not mean that they can start testing it on patients right away since they have already completed their phase 1 trial?

http://www.marketwatch.com/story/japans-bold-initiative-in-regenerative-medicine-and-who-the-big-winners-might-be-2014-03-03

[Thinning@30]

so they're going to start phase 2B? where are the results of 2A then? i thought the results i was looking at on their website were from phase 1.

I was under the impression Replicel did a combined Phase 1/2a trial. I might have confused them with Histogen.

[joachim]

Those are the Phase I results on their site.

artista, can you ask them when phase 2 results will be ready then?
is it possible for us to get an earlier insight into it? numbers and percentages about regrowth would be interesting. if they were able to increase the 14% average regrowth through different dosing this would be great already.

[JZA70]

It's another Aderans in the making.

[hellouser]

so they're going to start phase 2B? where are the results of 2A then? i thought the results i was looking at on their website were from phase 1.

Those are the Phase I results on their site.

[joachim]

It would be great if we could get confirmation that they have actually started the phase IIb trial that was supposed to start during the first half of 2014.

so they're going to start phase 2B? where are the results of 2A then? i thought the results i was looking at on their website were from phase 1.

[hellouser]

3 years, really?

damn it. this is so faaaar away.

3.25 years actually (39 months, specifically).... so 2017. And 2018 for a treatment if they plan on releasing it in Asian jurisdictions after Phase II trials. So 4 more years. Phase II should have started at least a year ago.

[Thinning@30]

Any news about the progression?

It would be great if we could get confirmation that they have actually started the phase IIb trial that was supposed to start during the first half of 2014.

[Artha]

I had spoken with Tammey George of Replicel last night (US time)
We have had a few talks in the past so it was great to speak with her again.
It was a very nice conversation- basically what we have been reading online here.
This is very positive advancement of theirs and not just with hair.

Any news about the progression?