CB-03-01 - new antiandrogenic

[joachim]

shouldn't we try to contact cosmo and ask if an early release in asia is an option?
i mean, 2 phases are really enough to see safety and efficiency, so why not throw it on the market already and make some cash? at least they could sell it off-label or under a different name if they are afraid of some marketing complications or whatever.

would be worth a try, there's nothing to lose... is someone already in contact with them by email?

[tommy e]

Good news:

ClinicalTrials.gov Identifier: NCT01631474
Study Title: A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris
First Received: June 27, 2012
Last Updated: May 29, 2014

Source:

http://clinicaltrials.gov/ct2/archive/NCT01631474

http://clinicaltrials.gov/archive/NCT01631474/2014_05_29/changes

Looks like Phase II trials are done.

Acne PII trials are done, but what about AA?
I can't find the Cosmo's presentation of the recent conference in NY.

[Samsonite]

Could this be the the compound of CB cream:

excipients of CB-03-01 1% cream (cetyl alcohol, glyceryl
monostearate, liquid paraffin, propylene glycol, tocopherol,
sodium edetate, polysorbate 80, water).

http://intrepidthera.com/wp-content/uploads/2012/02/CB-03-01-Publication-BJD-2011-Trifu-et-al-.pdf

page 2 Study design and treatment

[hellouser]

Could this be the the compound of CB cream:

excipients of CB-03-01 1% cream (cetyl alcohol, glyceryl
monostearate, liquid paraffin, propylene glycol, tocopherol,
sodium edetate, polysorbate 80, water).

http://intrepidthera.com/wp-content/uploads/2012/02/CB-03-01-Publication-BJD-2011-Trifu-et-al-.pdf

page 2 Study design and treatment

Looks like the vehicle for acne.

[efedrez]

Looks like the vehicle for acne.

Even if the vehicle was designed for acne, would it make sense to use it for baldness?

I imagine that it will a creamy solution that will give us a hard time on the scalp with hairs but hopefully it will work anyway

[yan]

Another small update from cosmo:

CB-03-01:
• Only topical antiandrogen for treatment of acne and alopecia in
development
• Outlicensed to Medicis/Valeant with $ 25m signing fee plus milestones
and low double digit royalties
• Phase II completed in acne:
• no major adverse event ocurred
• data report available shortly
• $ 20m milestone is due upon successful EOP II meeting with
FDA scheduled for September
• POC in alopecia to start H2 2014: $ 10m milestone at completion
(6 months treatment; overall one year trial)

[hellouser]

Even if the vehicle was designed for acne, would it make sense to use it for baldness?

I imagine that it will a creamy solution that will give us a hard time on the scalp with hairs but hopefully it will work anyway

Ingredient needs to sink underneath the skin. I can't see the cream working at all.

[Sogeking]

Another small update from cosmo:

CB-03-01:
• Only topical antiandrogen for treatment of acne and alopecia in
development
• Outlicensed to Medicis/Valeant with $ 25m signing fee plus milestones
and low double digit royalties
• Phase II completed in acne:
• no major adverse event ocurred
• data report available shortly
• $ 20m milestone is due upon successful EOP II meeting with
FDA scheduled for September
• POC in alopecia to start H2 2014: $ 10m milestone at completion
(6 months treatment; overall one year trial)

Nice man, one year phase 2 trial. They could be finished with Phase 2 alopecia trial by end of next year. Then if they enter phase 3 thats it.

[rdawg]

Another small update from cosmo:

CB-03-01:
• Only topical antiandrogen for treatment of acne and alopecia in
development
• Outlicensed to Medicis/Valeant with $ 25m signing fee plus milestones
and low double digit royalties
• Phase II completed in acne:
• no major adverse event ocurred
• data report available shortly
• $ 20m milestone is due upon successful EOP II meeting with
FDA scheduled for September
• POC in alopecia to start H2 2014: $ 10m milestone at completion
(6 months treatment; overall one year trial)

It's a very good sign when the treatment is approved for a different situation. If anything, we can possibly use it and modify it slightly to use it on our hair which is helpful.

Usually that means not having to go through a long phase II process, they could do Phase II within a year(arent they in Pre-clinical for the MPB treatment?)

So sounds like BIM and CB will be our near future options as of now.

[maomao]

Another small update from cosmo:

CB-03-01:
• Only topical antiandrogen for treatment of acne and alopecia in
development
• Outlicensed to Medicis/Valeant with $ 25m signing fee plus milestones
and low double digit royalties
• Phase II completed in acne:
• no major adverse event ocurred
• data report available shortly
• $ 20m milestone is due upon successful EOP II meeting with
FDA scheduled for September
• POC in alopecia to start H2 2014: $ 10m milestone at completion
(6 months treatment; overall one year trial)

Great! So this means the IND must have been accepted then - Phase 1 I assume will be pretty short as they already did the testing for the Acne treatment.

Once Phase 2 starts - is this when we will be able to find out what the vehicle is?

[hellouser]

Once Phase 2 starts - is this when we will be able to find out what the vehicle is?

Good point! Maybe so. Hopefully Mark will have some info for us.

[sdsurfin]

Great! So this means the IND must have been accepted then - Phase 1 I assume will be pretty short as they already did the testing for the Acne treatment.

Once Phase 2 starts - is this when we will be able to find out what the vehicle is?

Last I talked to them they said that the cream cannot be used on the scalp because the delivery vehicle and formula and concentration are all different.

There is no way they are going to tell people what the vehicle and recipe are. they are trying to sell it. we're gonna have to wait. we also don't even know if this stuff works or how well it will work, people on here hype shit up so much it's ridiculous. androgens are only part of the problem, as has been proved by finasteride. this might be a nice treatment, but a POC will take a year, phase one another, phase two another, phase three another etc. it takes 8 years to go through trials, maybe take two off if we're lucky because it's proven safe for acne. and then still I'm sure it will have side effects if it does work. everything has side effects, which is why stem cell treatments are exciting, because they di not use foreign drugs.

[burtandernie]

I still think CB 03 01 is one of the nearest and most promising things because we know it will work. Propecia did the dirty work already we know what an AA can do and since this would be the first topical I think the sides will be minimal compared to propecia. I just hope its powerful and the vehicle gets the job done.
Of course, we have to wait and see. There are no sure things here and its going to be a long wait.

[Swooping]

CB-03-01 is just as , or just a bit less powerful than RU58841. So whoever has hope for him miraculously regrowing all his hair with it, forget about it. 1% will be to weak to use for alopecia, just as RU58841 doesn't perform at 1%.

Prevention is key though, and cb-03-01 will really be extremely nice for young people (and everyone) who can hop on it and don't have to deal with possible anti-androgenic side effects.

[maomao]

Last I talked to them they said that the cream cannot be used on the scalp because the delivery vehicle and formula and concentration are all different.

There is no way they are going to tell people what the vehicle and recipe are. they are trying to sell it. we're gonna have to wait. we also don't even know if this stuff works or how well it will work, people on here hype shit up so much it's ridiculous. androgens are only part of the problem, as has been proved by finasteride. this might be a nice treatment, but a POC will take a year, phase one another, phase two another, phase three another etc. it takes 8 years to go through trials, maybe take two off if we're lucky because it's proven safe for acne. and then still I'm sure it will have side effects if it does work. everything has side effects, which is why stem cell treatments are exciting, because they di not use foreign drugs.

POC is phase one and phase two. (Unless I'm mistaken)

As for the vehicle, the acne one is known, which is why I'm guessing the alopecia one would become known when trials start.