CB-03-01 - new antiandrogenic

[hellouser]

How long does phase 3 lasts?

God knows.... but couldn't this stuff hit the market already in Asia? I'd buy the stuff by the cases...

[breakbot]

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.

How long does phase 3 lasts?

[hellouser]

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.

[deuce]

My advice if you are worried about fin would see a cardiologist. Preferably someone who is familiar with your family history, and talk to him about minoxidil for you. As for the fin goes all you can do is try it. More people do not get sides than those who do.

[Allowme]

Don't be so foolish , jump on fin and Minox first

I am wary of minox due to family history. Some of those studies on minox and the heart sound worrisome. And it also sounds as though minox gains hair cosmetically not actually combatting androgen alopecia. I can't tell if I am being irrational or not due to sudden of hair loss. I am more convinced of trying cb than fin. Sorry for straying away from topic. All your inputs are appreciated. I spent so much tine reading through the forum I am having hard time digesting the info and decide what is the best course of action.

[lilpauly]

I could hold off for another week I suppose. I feel iffy about fin and minox though. The whole systemic thing and minox's effect on the heart.

Don't be so foolish , jump on fin and Minox first

[Allowme]

Cosmo is giving a update in a week, right now I would not purchase cb because if the expense , ha e u considered find and Minox?

I could hold off for another week I suppose. I feel iffy about fin and minox though. The whole systemic thing and minox's effect on the heart.

[lilpauly]

Cosmo is giving a update in a week, right now I would not purchase cb because if the expense , ha e u considered find and Minox?

[Allowme]

Hello,


5% once a week ? It's a bad idea....
You need to use 5% / Day.

As far as I know, cosmo study showed cb is good for a week? Are you suggesting daily usuage because cosmo used iontophoresis? But isn't cosmo also developing topical cb that you only have to use once a week? I don't know what vehicle cosmo is using, but I doubt efficacy is so far off from the study. Perhaps twice a week? I know nothing of chemistry though. I cant afford daily use of cb 5%. In that case I will have to try ru instead. Please let me know what you guys think.

[Seuxin]

Hello,


5% once a week ? It's a bad idea....
You need to use 5% / Day.

[Allowme]

I can't hold off any longer. I am going to go with 5% cb once a week. Does anyone have a recommendation for a vehicle? How harsh is oleyl? I'm thinking of 9:1 oleyl and pg. Also, should I mention that I am going use cb to my doctor? Will I be ridiculed and forced to be on propecia instead?

[TravisB]

It better not fail, because if it fails we're ****ed.

It's our only chance for a better treatment in the near future.

The good thing is that CB-03-01 comes from well estabilished company - Cosmo Pharmaceuticals. They already managed to succesfully release several drugs on the market.

Also, CB will be licensed worldwide to another big pharma company - Valeant, so it's likely that Valeant knows that it works so they bought the rights and are pumping cash into research.

This is the latest statement about CB-03-01 from Cosmo (from March 27th 2014):

CB-03-01
Together with Intrepid Therapeutics we initiated the dose escalating phase II
trial for acne. The trial is progressing as planned and is expected to end in the
first half of 2014 with the end of phase III meeting scheduled late in the second
half.

During 2013 we completed additional formulation and stability tests for
CB-03-01 lotion for the treatment of alopecia. In late Q4 we had a pre IND meeting with the FDA with no additional requests being filed by the regulator. The proof of concept trial is scheduled to be started in the first half of 2014.

They will end (or have already ended) Phase II acne trials in H1 2014, and will probably start phase III in H2 2014, or 2015. So I think we can expect CB for acne on the market in 2017-2018. I wonder if acne cream will work for MPB?

Also, they plan to start (or have already started) Proof of Concept (also known as Phase I/IIa I believe) trial for alopecia in H1 2014. They say that they will be testing lotion CB in lotion for alopecia, so they already have some vehicle for it.

So if everything goes well, I think we'll have acne version on the shelves in 2017-2018, and MPB version 2-3 years later (or faster if CB will prove to be safe for acne, and maybe they will be able to speed up the process).

So 2020-2021 is probably when we'll have CB for MPB.

Well, I know that 6-7 years is not that near at all, but it's still better than to wait decades for promised "cures".

[deuce]

I think they release results at their quarterly report. I am pretty sure it is at the end of this month. Man we really need this soon. Especially now that it does not look like there will be a full blown cure for a while.

[Pate]

I can't find any reference to that, which presentation was it in?

So this also means then, that they don't even know it will work in a chemical solution - as all the results are only about iontophoresis?

Correct. This is the first human phase 2 trial to use a topical solution.

As for the vehicle, all I have seen them say is it's anhydrous, which means not water based. The acne treatment is cream based.

Anhydrous is not very informative as it covers a wide range of possibilities as to what the primary ingredients are.

[maomao]

They actually trying a gel formula right now in trials

I can't find any reference to that, which presentation was it in?

So this also means then, that they don't even know it will work in a chemical solution - as all the results are only about iontophoresis?