(CB-03-01 Vehicle Research) PhD Student in Chemistry

[HairBane]

Today`s cosmo-presentation is a bit disappointing...

Only info about cb for alopecia is this:

Pre clinical:
- Pre-clinical development on mini-pigs (6 and 9 months) to obtain the chronic use of the drug;
- last tolerability test ongoing

clinical:
- phase I clinical study in EU completed
- PK results: ˂1% API absorption into the blood = topical drug
- Phase II POC: design with 3 arms (drug, placebo, comparator), 6 months treatment + follow up, male pts only

regulatory:
- Pre-IND meeting held on 18 Dec 13, full FDA agreement on development program

http://www.cosmopharma.com/~/media/F...ainate2014.pdf

Yes there's a lack of info, but at least it seems like they're getting good safety and efficacy with acne and progressing to phase 3. I wasn't really expecting vehicle info, the most they've said so far is that PG/OL gave like 100x penetration, so why not use that?

Also, what does the 'phase i clinical study in EU completed' part mean?

[UK_]

checking this forum everyday isn't helping me either. My hairloss is slow and minox is the only thing i got that has kept me steady and that doesn't say much. especially, since we are now in 2014 and i'm using the best treatment now that was available in the damn 80's. it's disgusting.

Wish you the best everyone. I'm done with this forum. Time to move on with my life and with the hair i got. My rant is done.

Peace guys.

lol!

[TravisB]

Today`s cosmo-presentation is a bit disappointing...

Only info about cb for alopecia is this:

Pre clinical:
- Pre-clinical development on mini-pigs (6 and 9 months) to obtain the chronic use of the drug;
- last tolerability test ongoing

clinical:
- phase I clinical study in EU completed
- PK results: ˂1% API absorption into the blood = topical drug
- Phase II POC: design with 3 arms (drug, placebo, comparator), 6 months treatment + follow up, male pts only

regulatory:
- Pre-IND meeting held on 18 Dec 13, full FDA agreement on development program

http://www.cosmopharma.com/~/media/F...ainate2014.pdf

What's so disappointing in this? At least we know that they are moving forward.

Also the acne version phase III trials will probably start this year.

I think acne version has the chance to hit the market in 2016-2017, but I'm not sure about alopecia version. Maybe it will hit the market before 2020, if ever.

But if acne version turns out to be also effective for MPB, then we're all good

[cookies]

There are no big revelations, but no bad news either.

They mention that their vehicle for acne treatement is QD or BID, but I have no idea what these abbrevations stand for, but it will be a cream. I'm not sure if you can put that on your head.

[cookies]

Also, what does the 'phase i clinical study in EU completed' part mean?

That they completed phase 1 of their clinical study in the EU? Which I find a bit confusing, since their other data seem to indicate that they're in an earlier stage of their clinical study, but I'm no expert.

[TravisB]

Also quote from Cosmo website:

An IND was granted in the US for CB-03-01 for acne in Q1 2012. Phase II dose escalating clinical trials were initiated in the US in H2 2012 and are scheduled to be completed in H1 2014. An IND is planned to be filed for alopecia in H1 2014.

And quote from CB alopecia presentation

Pre-IND meeting held on 18 Dec 13, full FDA agreement on
development program

So now let's look at that - in Q1 2012 an IND (Investigational New Drug) was granted for CB for acne, and 2 years later (this year) they will probably be starting Phase III.

This year an IND will also be granted for CB for alopecia, so if everything went same way, phase III trials would be starting in 2016. This IMO would make year 2018-2019 very realistic for the release of CB for alopecia. Perhaps the things could be speeded up even more if acne CB went on the market and was proven to be a safe and well studied substance.

I'm positive about Cosmo because from their pipeline I see they meet their deadlines and don't delay things.

Actually according to their pipeline, Phase II POC (proof of concept) stage for CB for alopecia is going to end in H1/2015. But does anyone know how POC stage differs from an ordinary Phase II? Because looking at their pipeline it's the same

[Pentarou]

straight up, who cares about the alopecia version. when the acne version hits shelves, damn straight we reverse engineering that bitch and making our own super powerful shit.

but until then its fin + ru.

such is life.

True! The acne version of CB-03-01 hitting the market will be a Big Deal, that will indicate that 99.99% of the battle is already won. At worst then, that will mean that CB will be widely available off-licence/off-label for hair loss treatment purposes like Avodart has been for the last decade.

[mikeswick]

True! The acne version of CB-03-01 hitting the market will be a Big Deal, that will indicate that 99.99% of the battle is already won. At worst then, that will mean that CB will be widely available off-licence/off-label for hair loss treatment purposes like Avodart has been for the last decade.

is CB for maintenance of what you already have? or does it regrow hair?

[Dan26]

is CB for maintenance of what you already have? or does it regrow hair?

will depend on the person...like fin/dut, mostly for maintanence but could get regrowth. Preliminary trials (iontophereis ones) showed good regrowth

[Alias123]

so the treatment for acne is expected this year or what? if you say that we can trust their pipeline...

[TravisB]

so the treatment for acne is expected this year or what? if you say that we can trust their pipeline...

No

Cosmo will start phase III trials this year.

Phase III should take up to 2 years I think, and if CB passes Phase III, then FDA must review and approve the drug (it also takes up to 2 years), and then it can be marketed.

I think we will see CB for acne on the shelves in 2018 max, and 1-2 years later the MPB version.

It's not that far really if you think about it. 2018 is only 4 years away . And IMO it's the worst case because it can come in 2017 or even 2016.

But again I don't know shit and it's just my opinion + a bit of wishful thinking

[TravisB]

There are no big revelations, but no bad news either.

They mention that their vehicle for acne treatement is QD or BID, but I have no idea what these abbrevations stand for, but it will be a cream. I'm not sure if you can put that on your head.

I imagine that you can and it will be effective for MPB (at least to some extent). The main problem is it will probably be hard to apply if you don't have very short hair

[rdawg]

Why is everyone worrying about the CB release date?

We really just need to know the vehicle then we can purchase the stuff ourselves.

[locke999]

Why is everyone worrying about the CB release date?

We really just need to know the vehicle then we can purchase the stuff ourselves.

Why are so many people on this forum under the assumption that we can just replicate anything so easily.

Oh follica is damaging skin to induce growth of hair follicles, herp derp ill just hurt my head with a dermaroller.

Oh Cosmo has a hair producing consisting of main ingredient CB0301, herp derp, i'll just order some chemical from some random Chinese dude with a website that makes a bunch of money off of desperate dudes with hair loss.

Its like a child thinking they can imitate a hundred dollar bill by scanning and printing it with a lexmark printer. All this "we just need the ingedient huehueheue and we can do the cure ourselves is delusional.

[rdawg]

Why are so many people on this forum under the assumption that we can just replicate anything so easily.

Oh follica is damaging skin to induce growth of hair follicles, herp derp ill just hurt my head with a dermaroller.

Oh Cosmo has a hair producing consisting of main ingredient CB0301, herp derp, i'll just order some chemical from some random Chinese dude with a website that makes a bunch of money off of desperate dudes with hair loss.

Its like a child thinking they can imitate a hundred dollar bill by scanning and printing it with a lexmark printer. All this "we just need the ingedient huehueheue and we can do the cure ourselves is delusional.

Follica's wounding process is much more complicated as it includes FGF9 which we have no idea the damage that can do nor can we get our hands on that actual chemical i believe.

all we need to use CB is the dosage and the vehicle, there's nothing complicated to it. It's the same thing with RU.

It's a little risky, but most say that CB has a safe profile, so this is exactly the kind of drug you can use on the grey market.