7th World Congress for Hair Research (2013)

[Thinning87]

What about combining histogen with propecia!? i wish they would do a side study for those already on fin to see if it has any more or less benefit.

Overall 20-25% is massive, I'd be back to NW1 territory, especially considering I have alot of vellus hairs.

Make this stuff come faster! or at least widespread the trials!

well this is not "25% of all your hair" this is "increase what you have by 25%" so if you still have half the hair you used to have (which is your status when you first discoveer hair loss) you're only going to increase up to 62.5% of your full head of hair.... and again this is when you first noticed thinning, i.e. when you had 50% of your original hair...

To me if this is the results, Histogen will only be a stand alone option for those of us who are 15 years old today and have not started balding yet...

[Desmond84]

One more question, what is Phase 2b/III all about? what are they gonna get done? Seems like Phase I/II already shows it's safe and effective. So what are the extra phases for? More money for FDA or these phases are actually needed?

Phase I/IIa is the SAFETY trial.

Phase IIb will be the EFFICACY trial. They will increase the number of injections and treatment zone and might add 1-2 extra injection timelines. They will also be monitoring for safety.

Phase III will be IIb but in a much larger population (10x number of subjects)! They will be making sure it is effective & safe in most of the population.

[ANW]

Not necessarily .. for some the fact that they wont loose anymore hair is comfort in itself

[PatientlyWaiting]

Phase I/IIa is the SAFETY trial.

Phase IIb will be the EFFICACY trial. They will increase the number of injections and treatment zone and might add 1-2 extra injection timelines. They will also be monitoring for safety.

Phase III will be IIb but in a much larger population (10x number of subjects)! They will be making sure it is effective & safe in most of the population.

Okay, I see. I just searched what are each phases for and see you are right. It says Phase III takes 3 years, so by 2016 Histogen will be ready to use if gets FDA approved, or more like 2017?

[Thinning87]

Okay, I see. I just searched what are each phases for and see you are right. It says Phase III takes 3 years, so by 2016 Histogen will be ready to use if gets FDA approved, or more like 2017?

no one can answer for sure...

[john2399]

Does phase IIb and phase 3 run concurrently?

[Desmond84]

Unfortunately not!

To file for Phase 3, you must complete your Phase 2b trials!

Realistically, for Histogen to become readily available in US/Europe/Japan/Australia, we have to wait till 2017!

There are talks that South Korea and Singapore allow you to combine the number of patients from Phase 2a and 2b trial and make that a Phase 3! This way we may have Histogen available in these 2 countries by late 2015

[rdawg]

Okay, I see. I just searched what are each phases for and see you are right. It says Phase III takes 3 years, so by 2016 Histogen will be ready to use if gets FDA approved, or more like 2017?

I was under the assumption Phase III takes one year....

IIB starts by summer-fall ends by 2014 fall,phase III starts a few months after that so potentially end of 2015 or early 2016?

I mean if they have efficacy now, and simply plan to expand the injections I cant see them running into funding or product problems, so it should be a smooth trial if it really does work.

[rdawg]

Unfortunately not!

To file for Phase 3, you must complete your Phase 2b trials!

Realistically, for Histogen to become readily available in US/Europe/Japan/Australia, we have to wait till 2017!

There are talks that South Korea and Singapore allow you to combine the number of patients from Phase 2a and 2b trial and make that a Phase 3! This way we may have Histogen available in these 2 countries by late 2015

that is a major buzzkill! singapore and Korea aren't exactly close you know haha, pretty rough to spend 2000 bucks to fly over and try this stuff.

but still, why does phase III take longer? isnt it 1 year each?

[Thinning87]

that is a major buzzkill! singapore and Korea aren't exactly close you know haha, pretty rough to spend 2000 bucks to fly over and try this stuff.

but still, why does phase III take longer? isnt it 1 year each?

Oh whatever man if they had this tomorrow I'd spend 20 thousand to fly over to *****ing Korea

[Desmond84]

Phase 3 may take anywhere between 6 months to 3 years depending on what condition is being treated!

Hairloss trials generally last 12 months + 6 months to allow for patient recruitment and data analysis.

[ANW]

yes the trials run for about a year, but time is lost in between to get approval to start and recruit and approval once complete.

I believe Dr Zierling and Replicel CEO Hall said in Asia phase 2b/3 can be combined or run back to back. Cant remember which one, we shall know soon.

[PatientlyWaiting]

Okay, I always see 2b/III mentioned together, I was under the impression that they are done together or something. So 2b will take 1 year, and 3 will take another year and a half?

[Desmond84]

pretty much

+ 10-12 months for FDA/TGA/EMEA/Japanese approval

[john2399]

Talk bout being patient!!!! Phase 3 is so pointless. goddam.