CB-03-01 - When will it come to market? Will it be a stand alone treatment?

[ammin]

Could the veterans answer the above questions and also the possible long term sides from the topical. The studies suggest there are none.

Incidentally, decade two on hair loss help was quoted as saying that it will be as effective as RU. That would be phenomenal. Can some of you opine on these matters?

[ammin]

Bump Bump Bump

[Follicle Death Row]

According to their presentation on their site (presume it's still there), the preliminary trials have shown it to be more effective than finasteride but we'll have to wait and see. I could be wrong but I thought it was going to be developed as a once a week application. Will be interesting to see what comes of it.

[the_dude78]

Originally Posted by ammin

Could the veterans answer the above questions and also the possible long term sides from the topical. The studies suggest there are none.

Incidentally, decade two on hair loss help was quoted as saying that it will be as effective as RU. That would be phenomenal. Can some of you opine on these matters?

This has a long way to go before it hits the market, trials have only just begun.

Taken from the website:

"CB-03-01 CB-03-01, a molecule patented by Cosmo, is a steroidal ester, androgen antagonist derived from 11-deoxycortisone, which tightly mimics the profile of an ideal anti-androgen for topical use. The objective is to create a product for topical application to treat acne, male pattern baldness, and seborrhoea that does not have the side effects of products currently being taken in tablet form. An IND was filed in the US for CB-03-01 for acne. Clinical trials are planned to start in the USA in Q2 2012."

[Pate]

Clinical trials are already well advanced, they only just started in the US but earlier trials happened in Europe. The big downer for CB is that they are focusing on acne first, which seems bizarre since the acne market is already well supplied with viable treatments while MPB of course isn't.

The other downer is the indicative timeline keeps slipping. I think 2017 is a realistic goal for market now.

But in terms of efficacy and sides it's looking great. Should be a big improvement on Fin with no systemic sides, and only needs to be used once or max twice a week. And while trials are slow, at least Cosmo is making progress and getting deals done. They are also a profitable company in their own right so no worries about them going out of business if they meet delays.

[Pate]

It's also interesting that Cosmo STILL haven't revealed who their "US specialty pharmaceutical company" is that bought the licence for CB worldwide. We know Intrepid is conducting the US phase 2 but who coughed up $25M to Cosmo for the licencing deal? I actually wonder if it might be Allergan. They definitely fit the bill.

[ammin]

I think 2015 is a more likely release date than 2017. The molecule for acne and AA topicals is the same . So the approval for AA would not take long once the approval for acne has been obtained.

heres an email received by a hair loss help member from the Chief Medical officer at Cosmo:

http://www.hairlosstalk.com/interact...Cosmo-CB-03-01


"Dear Mr. xxx,

I am glad to inform you that Phase II US clinical study on acne vulgaris (NCT01631474) started as planned on June 2012, and it is proceeding regularly.
A previous Phase II European study in facial acne vulgaris (EudraCT 2008-004335-37) was completed in July 2009, and the results have been published on British Medical Journal 2011;165:177-83.
As concerns the possible US launch, we maintain our deadline for 2015.
Kind regards


Giuseppe Celasco, MD
Chief Medical Officer

"

[Pate]

2015 for acne is still possible, 2016 for hair loss. I am giving it an extra year to 2017 because these things ALWAYS slip. Unfortunately they still need to do the trials for hair loss, they can't just piggyback off the acne. FDA approval requires dedicated hair loss trials. We may be able to use the acne stuff off-label but it might not be a high enough dose. It'll probably also be a cream instead of a lotion which will be hard to apply on longer hair.

The current plan from Cosmo seems to be to finish Phase 2 for hair loss by H1/2014. Then it'll be at least 18 months to do phase 3 and get it approved. So I won't hold my breath for 2015. Will be awesome if I'm wrong though. I am really hopeful for CB, I think it has great potential to consign fin to the scrap heap.

[Desmond84]

Originally Posted by Pate

2015 for acne is still possible, 2016 for hair loss. I am giving it an extra year to 2017 because these things ALWAYS slip. Unfortunately they still need to do the trials for hair loss, they can't just piggyback off the acne. FDA approval requires dedicated hair loss trials. We may be able to use the acne stuff off-label but it might not be a high enough dose. It'll probably also be a cream instead of a lotion which will be hard to apply on longer hair.

The current plan from Cosmo seems to be to finish Phase 2 for hair loss by H1/2014. Then it'll be at least 18 months to do phase 3 and get it approved. So I won't hold my breath for 2015. Will be awesome if I'm wrong though. I am really hopeful for CB, I think it has great potential to consign fin to the scrap heap.

Yeah, hopefully by 2016 we'll have the NEW big 3 which will be:

Histogen + CB (Twice Weekly topical) + Nizoral (Twice weekly)

That should keep everyone side effect free and happy (to an extent)

[Pate]

Yep! I'd even say the Big 4:

HSC every 6-12 weeks for 1-2 years
CB twice a week
Nizoral twice a week
Bimatoprost once a day

It mightn't be a cure but it will crap all over what we have today.