Replicel Question - DSC Cell Specific

[hellouser]

I think there is definitely a possibility that hair count did surpass the results @ 6 months mark! I'm more than certain Shiseido got to see the 12 month results before giving Replicel US $3 million.

IDK if you remember but Replicel initially had plans to provide 6 monthly updates on their Phase 1/2a results but after the public dissatisfaction with their interim (6 months) results, they withdrew that comment and announced that their next update will be the 24 month results.

Now Dec 2013 will mark the end of Phase 1/2a results (i.e. 24 months). Considering it takes 4-5 months to process the final data, we can be more than certain they'll make an announcement by April 2014.

We should also get a 6 month interim results update on Phase 2b by July 2014!

2014 will most definitely be filled with Replicel...Let's hope its promising news

Wait, are you saying Replicel is ALREADY in Phase IIa trials and going into Phase IIb in Q4 of 2013 (essentially in a few or so months)?

Would that mean by the end of 2014 they'll essentially be done and ready to roll out a treatment in two years in 2015 in Asia?

[FearTheLoss]

Wait, are you saying Replicel is ALREADY in Phase IIa trials and going into Phase IIb in Q4 of 2013 (essentially in a few or so months)?

Would that mean by the end of 2014 they'll essentially be done and ready to roll out a treatment in two years in 2015 in Asia?

RepliCel states on their website they are following a strict schedule to release a product in nonwestern countries before end of 2015.

[Thinning87]

Wait, are you saying Replicel is ALREADY in Phase IIa trials and going into Phase IIb in Q4 of 2013 (essentially in a few or so months)?

Would that mean by the end of 2014 they'll essentially be done and ready to roll out a treatment in two years in 2015 in Asia?

RepliCel states on their website they are following a strict schedule to release a product in nonwestern countries before end of 2015.

Well the timeline chart on the Replicel website shows phase 2B starting in the latter part of this year (although I remember reading on the website contradicting info that it will start in early 2014) and lasting two years, I don't recall reading that they are officially aiming for a release in Asia immediately after that, although the funding from the Japanese in exchange for rights in Asia pretty much indicates that intention.

Happy to be proved wrong though...

[FearTheLoss]

Well the timeline chart on the Replicel website shows phase 2B starting in the latter part of this year (although I remember reading on the website contradicting info that it will start in early 2014) and lasting two years, I don't recall reading that they are officially aiming for a release in Asia immediately after that, although the funding from the Japanese in exchange for rights in Asia pretty much indicates that intention.

Happy to be proved wrong though...

scroll all the way to the bottom of the page

http://www.replicel.com/hair-regeneration/cause-of-hair-loss/faqs/

[hellouser]

scroll all the way to the bottom of the page

http://www.replicel.com/hair-regener...air-loss/faqs/

That page doesnt say anything about Phase IIa or IIb as Desmond mentioned. Neither does the pipeline page:

http://www.replicel.com/product-pipeline/rch-01-hair-regeneration/

They only mention Phase II as a single trial.

[Thinning87]

That page doesnt say anything about Phase IIa or IIb as Desmond mentioned. Neither does the pipeline page:

http://www.replicel.com/product-pipeline/rch-01-hair-regeneration/

They only mention Phase II as a single trial.

but at thebeginning of that article they mention their results from a phase 1/2A so it makes sense to assume all they have left is two B

scroll all the way to the bottom of the page

http://www.replicel.com/hair-regener...air-loss/faqs/

yeah that's the chart I was referring to earlier... how can we assume at the end of the arrow comes commercialization, instead of something else e.g. phase 3 in NA

[Desmond84]

Yeah unfortunately Phase 2b is 2 years and then you need to at least give it 6 months for data analysis and another 3-4 months for an Asian country to approve the product.

This makes Asian release somewhere between November 2016 and January 2017!

Sad but true

P.S. Don't forget that they may never reach the market if they can't out-perform finasteride! If only they knew how many of us would pay anything to use their therapy instead!

[mari0s]

Yeah unfortunately Phase 2b is 2 years and then you need to at least give it 6 months for data analysis and another 3-4 months for an Asian country to approve the product.

This makes Asian release somewhere between November 2016 and January 2017!

Sad but true

P.S. Don't forget that they may never reach the market if they can't out-perform finasteride! If only they knew how many of us would pay anything to use their therapy instead!

In a previous post i was thinking about 2018 (with a year to analyze the results) but in their investor relation (which is being made this year they still pointing at 2015 i don't know how they possible make it.

What i don't like: i was thinking that phase IIb was about multiple treatments to find the low useful dosage, so i was expected 1 injection at months or every 3 months o even 6 months if the effect would been extended so far.

Instead... 1 injection the first day, another at day 91 and stop. I really don't know nothing about pharmaceutical trials and its protocols but seems to me completely illogical.

Here are the details

Primary endpoints: Efficacy (density, hair thickness, cumulative hair),
treatment response rate
Secondary endpoints: Local tolerance, systemic safety

120 male patients:
– 3 injection sites, 1 shaved site per patient as reference
– Treatment group (96 patients)
• 48 treated with single injections (3 different doses)
• 48 treated with repeat injections at day 1 and 91 (3 different doses)

– Placebo group (24 patients)
• 12 treated with single injection (carrier vehicle only)
• 12 treated with repeat placebo at day 1 and 91

– 288 treated data sites (Compared to 16 in Phase I)

– 72 placebo data sites

– Primary Institution: Charité-Universitätsmedizin, Berlin

Proposed Phase II Design
RCH-01Phase II Status
Advisory meetings with EU Regulators (Paul-Ehrlich-Institut):
• Product manufacturing presentation (Nov 2, 2012) 
– Minimal changes - must add certain process validations protocols
• Clinical design presentation (Feb 2013) 
– Feedback on proposed clinical treatment protocol
• Clinical trial application (Mid-2013)
• Ethics Review Board - Charité-Universitätsmedizin, Berlin (Mid-2013)
• Phase II trial initiation Mid-2013

[Desmond84]

In a previous post i was thinking about 2018 (with a year to analyze the results) but in their investor relation (which is being made this year they still pointing at 2015 i don't know how they possible make it.

What i don't like: i was thinking that phase IIb was about multiple treatments to find the low useful dosage, so i was expected 1 injection at months or every 3 months o even 6 months if the effect would been extended so far.

Instead... 1 injection the first day, another at day 91 and stop. I really don't know nothing about pharmaceutical trials and its protocols but seems to me completely illogical.

Here are the details

Yeah...it seems a bit rushed BUT at least there is a second injection timepoint which is great...we'll see if it is compoundable. In 3 months, you can impact follicles that may have been in Telogen phase during the previous session.

At the end of the day, if it was compoundable, they might add a third session in their Phase 3 trials! It has happened before with other therapies.

2015 seems unlikely though unless their target asian country is somewhere with VERY loose regulatory approval process! Thailand, Philippines or Indonesia could be where they are planning to release it first.