CB-03-01 - new antiandrogenic

[Thinning@30]

Work on Proof of Concept trial for CB-03-01 in alopecia continues. It is target to be completed in 2015

I'm confused. I thought proof of concept was something that happened prior to Phase I. On Cosmo's website, there is a bar chart showing the alopecia formulation of CB 03 01 as being in the middle of Phase II, with the abbreviation "POC" next to it. I thought the drug approval pipeline went something like this:

POC/preclinical -> Phase I (safety) -> Phase IIa (safety & efficacy) -> Phase IIb (dose ranging) -> Phase III (large scale safety) -> approval.

Can anyone clarify the approval process for me?

[efedrez]

I'm confused. I thought proof of concept was something that happened prior to Phase I. On Cosmo's website, there is a bar chart showing the alopecia formulation of CB 03 01 as being in the middle of Phase II, with the abbreviation "POC" next to it. I thought the drug approval pipeline went something like this:

POC/preclinical -> Phase I (safety) -> Phase IIa (safety & efficacy) -> Phase IIb (dose ranging) -> Phase III (large scale safety) -> approval.

Can anyone clarify the approval process for me?

I'm also confused, In Cosmos reports submitted today (http://www.cosmopharma.com/~/media/F..._Half_2014.pdf) it appear that they are conducting the POC for alopecia which will be completed by 2015 and it looks like this is also the end of phase 2 (120 patients against minoxidil and placebo)

If this is correct maybe we are looking at a potential phase 3 by 2016 and something that we can use by 2017.

Something is sure, Cosmo is making progress with CB (both acne and alopecia) and will try to get return over their investment as soon as possible, so the future might give us a good alternative to fin before someone else comes up with a more definitive cure

[joel203]

Anyone have any idea roughly when this will come out?

[burtandernie]

Anyone have any idea roughly when this will come out?

Yeah it seems no one really knows for sure except for some vague guesswork. So maybe 2017? I might need to give propecia a try soon to keep my hair until then so that would only be about 3 years of having to be on propecia. I guess you can always hope its sooner than 2017 but I have my doubts that if anything it will take longer

[joel203]

Yeah it seems no one really knows for sure except for some vague guesswork. So maybe 2017? I might need to give propecia a try soon to keep my hair until then so that would only be about 3 years of having to be on propecia. I guess you can always hope its sooner than 2017 but I have my doubts that if anything it will take longer

I hope it comes out soon and is effective! I am a NW2 at the moment, my hairs quite thick atm (maybe thinning slightly at the crown but nothing noticeable) but hairlines receeded a bit noticeably, although it can be covered up. I really hope this comes out soon and is effective for many years so I can maintain- I got on finasteride last month to hopefully maintain for the next few years if possible (only 23 atm)

[Pate]

I'm also confused, In Cosmos reports submitted today (http://www.cosmopharma.com/~/media/F..._Half_2014.pdf) it appear that they are conducting the POC for alopecia which will be completed by 2015 and it looks like this is also the end of phase 2 (120 patients against minoxidil and placebo)

If this is correct maybe we are looking at a potential phase 3 by 2016 and something that we can use by 2017.

Something is sure, Cosmo is making progress with CB (both acne and alopecia) and will try to get return over their investment as soon as possible, so the future might give us a good alternative to fin before someone else comes up with a more definitive cure

The POC will be a combined Phase I/IIa trial. After that they still need to do a Phase IIb trial. I assume that is why in the Pipeline Update chart in the presentation, the line for CB alopecia only goes halfway through Phase II, while the acne line goes to the end of Phase II. Acne will be ready for Phase III but alopecia will need a IIb trial first.

The weird thing is that IIa is usually the dose-ranging study, but they seem to already decided on the dose to use (5% anhydrous), so they seem to have done their dose-ranging in pre-clinicial. So I don't know what they will do with their Phase IIb trial.

[TwoInchCircle]

FROM COSMO:
Acne: Phase III to target to be completed H2 2016
Alopecia: POC targeted to be competed end 2015

I'm confused by the phrasing in the acne section: "Phase III to target to be completed H2 2016."

Does it mean that their target is to be done Phase III by H2 2016 or are they insinuating that Phase Three + commercialization is targeted by second half 2016?

[deuce]

Bottom Line is CB for Hair will be out in 2018 or later and most of us will be bald by then.

[joely]

Desmond seems to think when the Acne version is out he will be able to come up with a vehicle for hair! I hope it's soon just quit propecia after three years because of sides! Needs something soon I don't think my array of natural supplements and I grow are gonna hold me

[burtandernie]

How do you buy the acne solution and get just the CB and then enough of it to make the MPB version? It sounds hard to do that if its even possible. I dont think anyone would use propecia if they had a choice of something safer everyone uses it because its the only good option. I thought bryan one time said that merk asked if men wanted topical or oral and everyone picked oral so there it is. Now everyone complains about it being oral because of sides. I guess people dont know what they want

[burtandernie]

Little off topic but what happened with ascj 9 that was similar to CB is that still coming out or did they stop because CB is going to do the same thing?

[Swooping]

Little off topic but what happened with ascj 9 that was similar to CB is that still coming out or did they stop because CB is going to do the same thing?

Same thing what happens with 70%+ of drugs in phase 2 mate. God knows what reason, could be from financial reasons to effectiveness. Nobody knows. The literature is really scarce on ascj-9 though. People have tried it and had very mixed results (not good generally), stained like hell too.

[burtandernie]

Ah okay just wondered. Thats my biggest worry about CB is that it wont get funded and seen through to the finish line. There are lots of good things that never made it and its just never the same trying to make it yourself these things are just too hard to do your on own

[Haircure]

Ah okay just wondered. Thats my biggest worry about CB is that it wont get funded and seen through to the finish line. There are lots of good things that never made it and its just never the same trying to make it yourself these things are just too hard to do your on own

I doubt funding will be an issue since Cosmo pharmaceuticals seems to be doing very well, especially in their stock, which has increased dramatically over the past 5 years or so. And it's most likely the same for other treatments, because if they worked, then there would definitely be investors involved. So most likely treatments that have been postponed or canceled have likely been done so due to issues with effectiveness.

[Duke]

Cosmo has more than enough funds...so as long as THEY decide to push CB for hair loss, funding will not be an issue!