Thanks! I wonder if this time they will really start the trial, last year it was the same for Q1, then Q2 then second half of 2014, and now H1 2015.
I believe there were dealing with a few bureaucratic issues that were resolved list year.
Also we should pay attention to Shiseido trial also starting this year
01-15-2015 10:30 AM
hellouser
Could they AT LEAST get the ball rolling with the japanese trials from Shiseido??
01-15-2015 12:12 PM
brocktherock
I really think that now since their partnership is more settled they won't be so slow with trials. Im sure there will be some delays though, I understand its not like going to the dmv and getting a new licence.
01-15-2015 02:20 PM
Sogeking
I think they will definitely start in first half of this year, however this Phase 2 is make it or break it for Replicel.
This is an excerpt from the pdf:
Quote:
160 participants
396 RCH-01 treatment group sites (vs. 16 in P1), with 244 placebo sites
Designed to measure dosing and treatment frequency
Primary commercial endpoint –efficacy at 52 weeks after final injection
efficacy measured as total density, hair thickness, cumulative hair and treatment response rate
Secondary endpoints –52 weeks
local tolerance, systemic safety
Notice the bolded part: after 52 weeks (1 year) we will get the results for the Phase 2 data. That is when we will know how good RCH-01 really is. This is good. At least we won't be kept in the dark.
So expect results in H2 of 2016.
As for Shiseido I don't expect they will be forthcoming with news for the international scene. I think they will conduct their trials away from the public eye.
01-15-2015 03:04 PM
brocktherock
Quote:
Originally Posted by Sogeking
I think they will definitely start in first half of this year, however this Phase 2 is make it or break it for Replicel.
This is an excerpt from the pdf:
Notice the bolded part: after 52 weeks (1 year) we will get the results for the Phase 2 data. That is when we will know how good RCH-01 really is. This is good. At least we won't be kept in the dark.
So expect results in H2 of 2016.
As for Shiseido I don't expect they will be forthcoming with news for the international scene. I think they will conduct their trials away from the public eye.
Why do do think they won't be forthcoming? They could have kept it quiet but lately they've been very transparent and don't give vague answers in interviews like Cots did. They've been doing a lot of presentations and interviews and David Hall seems genuinely passionate and for once he is using the word cure without using verbal ju jitsu. I sincerely believe if this isn't a full on cure then it will at least stop further loss which would give people like me the option of an HT without longterm risks.
01-15-2015 06:23 PM
Hairismylife
Quote:
Originally Posted by Sogeking
I think they will definitely start in first half of this year, however this Phase 2 is make it or break it for Replicel.
This is an excerpt from the pdf:
Notice the bolded part: after 52 weeks (1 year) we will get the results for the Phase 2 data. That is when we will know how good RCH-01 really is. This is good. At least we won't be kept in the dark.
So expect results in H2 of 2016.
As for Shiseido I don't expect they will be forthcoming with news for the international scene. I think they will conduct their trials away from the public eye.
No hope to get it in H1 2016?
Little bit disappointed.
01-19-2015 01:05 PM
brocktherock
The presentation said that the cells grow for 5 to 8 weeks. The more I know about this the more I think this is a cure. If its as good or better than fin in the first 6 months of the pilot study then Im impressed.
01-23-2015 02:57 PM
Kudu
Even if Shiseido completes phase 2 trials, then what? Are they going to be able to set up clinics that can do the procedure? How are they going to handle the massive number of people that want this? And how can we think this will be affordable? This just seems so far away still.
01-23-2015 04:34 PM
brocktherock
Quote:
Originally Posted by Kudu
Even if Shiseido completes phase 2 trials, then what? Are they going to be able to set up clinics that can do the procedure? How are they going to handle the massive number of people that want this? And how can we think this will be affordable? This just seems so far away still.
In the last presentation they use procedures like botox to show how profitable it can be to mark it up. I don't think it'll be cheap but this isn't labor intensive like hair transplants are. You pay for biopsy, the labor it takes to culture, the matierials and the labor to give you the injections. I'm sure even if they mark it up 500% it should still be comparable to a hair transplant. Sheseido mearly licenced this, I think this will be like breast implants. Doctors will be able to form a career from this alone. There should be no shortage of labor. These are just my predictions but I really don't see how it could vary too much. Also Japan now allows you to commercialize DURING phase 2 as long as it has been given the proper testing. There is a lot of aggressive movement from the 4th largest cosmetic company in the world simply to get it out sooner.
01-23-2015 05:15 PM
garethbale
The cost will be just so prohibitive. I've heard its going to be in the region of $30,000 for treatment.
01-24-2015 05:28 AM
sascha
Quote:
Originally Posted by Kudu
Even if Shiseido completes phase 2 trials, then what? Are they going to be able to set up clinics that can do the procedure? How are they going to handle the massive number of people that want this? And how can we think this will be affordable? This just seems so far away still.
a) they do not even have to complete phase 2
b) it was said 3000 - 5000 dollar per procedure
c) your doubts in term of space and number of customers are ridiculous
01-24-2015 05:51 AM
Kudu
Quote:
Originally Posted by sascha
a) they do not even have to complete phase 2
b) it was said 3000 - 5000 dollar per procedure
c) your doubts in term of space and number of customers are ridiculous
Thanks! That allays my fears a bit, and I hope I'm being ridiculous.
01-24-2015 08:07 AM
Sogeking
Quote:
Originally Posted by brocktherock
Why do do think they won't be forthcoming? They could have kept it quiet but lately they've been very transparent and don't give vague answers in interviews like Cots did. They've been doing a lot of presentations and interviews and David Hall seems genuinely passionate and for once he is using the word cure without using verbal ju jitsu. I sincerely believe if this isn't a full on cure then it will at least stop further loss which would give people like me the option of an HT without longterm risks.
Everything about Shiseido has been relayed by Replicel. Once the trials startthere is no guarantee that Shiseido will keep them in the loop until they are over, and that may last a year or two.
I hope for the same things you do. Effectiveness is the main problem, but as you say, if it could stop hair loss then it is still a game changer.
@Kudu
In every business seeking profitability, increased demand brings increased supply.
As for the price, yes it could be a bit steep especially if one will need repeated treatments. That is why we need to see its safety profile and effectivity.
01-24-2015 10:18 AM
sascha
Quote:
Originally Posted by Kudu
Thanks! That allays my fears a bit, and I hope I'm being ridiculous.
Sure man. Did you see this Kobe Research Cluster? It`s huge, they have money
01-24-2015 05:38 PM
brocktherock
Quote:
Originally Posted by sascha
a) they do not even have to complete phase 2
b) it was said 3000 - 5000 dollar per procedure
c) your doubts in term of space and number of customers are ridiculous
Where did you hear it'd be between 3 and 5k?
01-26-2015 06:13 PM
sdsurfin
"Thank you for your email and interest in the potential product we are developing and testing for the treatment of pattern baldness. We are as anxious as you to see this through the required development/testing stages and approvals to get the product available on the market. We did have, as you may know, some manufacturing issues to resolve which slowed down our progression to the phase 2 trial considerably. This has now been resolved and we are ready, once again, to go full speed ahead with clinical development and testing. We are also pleased that Shiseido now has their manufacturing facility ready and has validated their ability to manufacture the product meaning they anticipate also being able to proceed shortly with their own trial in Japan concurrent with ours. While 2014 was a year of re-tooling, 2015 will be all about moving forward as quickly as possible on both clinical trials for RCH-01 for pattern baldness in addition to our other clinical trials.
As for the phase 1 trial results, it is important to understand that the purpose of a phase 1 trial is to prove that your product is safe. We injected a very high dosage of RCH-01 into each patient and no adverse events were recorded. Now that we have proven the product is safe, the phase 2 trial is designed to determine the optimum dose and frequency. Our phase 2 trial will include approx. 160 patients. We will be injecting approx. 396 sites with RCH-01 and approx. 244 with placebo. This data will give us a clear indication of efficacy.
In our phase 1 trial only 18 patients were injected with a very high dose of RCH-01. The primary objective of our phase 1 study was to assess the local (at treatment sites) safety profile of injections of autologous dermal sheath cup cells (DSCC) at 6 months post-injection compared to control. Secondary objectives were to assess systemic (overall) safety, local safety, and efficacy at 24 months post-injection. The safety data collected from study participants 12-months after receipt of injections of verum and control revealed that the RepliCel™ treatment was very safe and well-tolerated. This data, coupled with positive increases in hair growth efficacy measured at 6-months post-injection, provided support for the Company to move forward with the development of its Phase 2 dosing trial. Safety only will continue to be monitored on these patients for a total of 5 years post injection.
We remain extremely optimistic about the potential of RCH-01 as a treatment for pattern baldness and expect to start our phase 2 trial this year."
01-26-2015 08:09 PM
efedrez
Thank you for shearing! I'm feeling very optimistic about replicel... Can't wait for phase 2 to begin
