CB probably is not that great

[sdsurfin]

This is an email i received from restoregenex. Unfortunately it doesn't sound too good for CB. It doesn't sound like the product pipeline is too hot for AGA (big surprise), but maybe that will change It really sucks that they do acne trials first, but maybe there's some way for kane to get a hold of restoregenex's patent and you guys can give that a shot. it seems like it will be very safe and more effective than CB. if i were going to drop a lot of money I would go with that route rather than CB, and if there is a demand then I'm sure kane would stet producing this stuff.


"What I know about Cosmo is that they licensed that compound to a company called Intrepid Pharmaceuticals. I believe Valeant acquired those assets. Valeant is known to hold onto assets and not develop them so I don't know what the development status of that compound is. I do know they claim it's an anti androgen but the reality is that it's a glucocorticoid with some anti-androgen activity. It is also not designed, as ours is, to avoid systemic exposure. Following successful acne Phase I/IIa trials in a few years we will utilize the same safety data and may explore alopecia as another market. Hard to put a timeline on it.

Best,

Yael

Yael Schwartz, Ph.D.
President"

[macbeth81]

What I know about Cosmo is that they licensed that compound to a company called Intrepid Pharmaceuticals. I believe Valeant acquired those assets. Valeant is known to hold onto assets and not develop them so I don't know what the development status of that compound is.

"Consequently both Cosmo and Valeant agreed to unwind the present agreement and replace it with an agreement granting Valeant a right of first refusal should Cosmo decide to license out the drug after completing its development."

I cannot remark on the rest.

http://www.cosmopharmaceuticals.com/news/press/2014/2014-07-08.aspx

[sdsurfin]

i think the best thing is to accept the sad reality that we are probably not going to get a topical that works in the next ten years. replicel is pretty much the only thing worth hoping for.

[lilpauly]

It could reach Asian very very fast ! Let's just wait and see the results from cosmo

[sdsurfin]

"Consequently both Cosmo and Valeant agreed to unwind the present agreement and replace it with an agreement granting Valeant a right of first refusal should Cosmo decide to license out the drug after completing its development."

I cannot remark on the rest.


http://www.cosmopharmaceuticals.com/...014-07-08.aspx

what does this mean??

[macbeth81]

The existing license was terminated and replaced with right of first refusal. Cosmo gave up $20 million in milestones to regain full rights to CB-03-01. In other words Valeant will no interfere with the development of CB-03-01 as Dr. Schwartz implied.

http://www.cosmopharmaceuticals.com/~/media/Files/C/Cosmo-Pharmaceuticals/140730_Cosmo_HYR2014.pdf

[sdsurfin]

well that's good. now that phase II for acne is complete, does anyone know what those results were??

[Justinian]

well that's good. now that phase II for acne is complete, does anyone know what those results were??

I don't think they've released anything, other than saying it was "successfully completed". As for the next step, Phase 2 alopecia trials just started and for acne "The FDA meeting for discussion of the phase III design is expected end of 2014/beginning of 2015" according to the their website.

[burtandernie]

It doesnt sounds like anyone knows much more than we did before just some guy guessing at how well it would work. Yes CB not being licensed is not a good thing though. That Valeant company dropping it is not going to help things happen any faster. I still think its possible CB works well but we have to wait to see. If they drop it or it dies like RU then we can assume it didnt work that well. The huge list of dead AAs will continue to grow and I guess everyone can take finasteride another 10 years
People constantly talk crap about fin but no one ever offers any alternatives. Just bashing on the one thing that exists and they wonder why people take it.

[KO1]

Why are they (Intrepid) doing a clinical trial then?

http://clinicaltrials.gov/ct2/show/NCT02279823?term=cb-03-01&rank=2

Btw, CB is an antiandrogen, so it should be something similar to finasteride I assume...still defense, not offense...but defense wins you championships brahs.

[KO1]

This is an email i received from restoregenex. Unfortunately it doesn't sound too good for CB. It doesn't sound like the product pipeline is too hot for AGA (big surprise), but maybe that will change It really sucks that they do acne trials first, but maybe there's some way for kane to get a hold of restoregenex's patent and you guys can give that a shot. it seems like it will be very safe and more effective than CB. if i were going to drop a lot of money I would go with that route rather than CB, and if there is a demand then I'm sure kane would stet producing this stuff.


"What I know about Cosmo is that they licensed that compound to a company called Intrepid Pharmaceuticals. I believe Valeant acquired those assets. Valeant is known to hold onto assets and not develop them so I don't know what the development status of that compound is. I do know they claim it's an anti androgen but the reality is that it's a glucocorticoid with some anti-androgen activity. It is also not designed, as ours is, to avoid systemic exposure. Following successful acne Phase I/IIa trials in a few years we will utilize the same safety data and may explore alopecia as another market. Hard to put a timeline on it.

Best,

Yael

Yael Schwartz, Ph.D.
President"

Can you ask them why are they pursuing acne before MPB?

[Illusion]

Can you ask them why are they pursuing acne before MPB?

sdsurfin already adressed this in another thread. Here you go:

This company is also developing a topical anti-androgen (they used to be called Hygeia), and is also doing acne trials first. they will initiate phase 1-2 in 2016, so we're looking at some time before anything comes of it. but for young guys, this is another option in the works for the next decade. Sounds better than CB and also side effect free theoretically. I asked them why they do acne trials first and here is the answer:

Good question. While there appears to be a lot of acne medications, there really hasn't been anything new in a very long time. Mostly reformulations of older drugs.
There are no topical anti androgens on the market for acne and we would be the first. Proof of concept in acne for an anti-androgen opens up the market for other topical anti-androgens. The clinical trials for acne are quicker, and, thus, less expensive, because you'll see regression of an acne lesion in less than 4 weeks. On the contrary, clinical trials for alopecia take significantly longer because of the long growth cycle of hair. So, you can see the decision to see if we have a good anti-androgen signal in the pilosebaceous unit by going after the acne indication first, is an economic one.
I hope this answers your question.

Best,
Yael

Yael Schwartz, Ph.D.

(https://www.baldtruthtalk.com/showthread.php?t=18077)

[KO1]

Good, that's what I thought, thanks for the update. Good to know the reason and not a conspiracy against balders.

[macbeth81]

Why are they (Intrepid) doing a clinical trial then?

Maybe Dr. Schwartz has companies confused. Medicis Pharmaceutical had the license and was acquired by Valeant Pharmaceuticals. His assessment of Valeant is accurate. Intrepid Therapeutics agreed to perform the Phase II trials in the US for CB-03-01.

In other words, Cosmo is paying Intreprid to conduct the trials, but Medicis/Valeant was paying Cosmo to license the drug. Intreprid was not acquired to my knowledge.

http://intrepidthera.com/press/

[lilpauly]

Agree 100% fin and dut are king! Cb must be used 2x a day , 5% strength . Btw cosmo is using a gel! Cosmo coould release cb to the Asian market fast ! Europe will take a few years and tbe usa forever !