Kythera Acquires Rights to PGD2 Blocking Setipriprant for New Hair Loss Treatment

[hellouser]

Cotsareli's involvement is not a guarantee of success. He also had some success with wounding and lithium almost a decade ago and that lead nowhere, any attempt from forum members to replicate those results failed

This is a lie.

His successes with wounding and lithium did not 'lead nowhere' as the clinical trials with Follica are still ongoing.

[bigentries]

This is NOT a new drug. It's been tested in 8 clinical trials, including a phase 3. If you want to mention Cotsarelis, this is HIS work. He sold global rights to a company so that they can run a trial, market, and distribute it.

It is a new drug, it has never been commercialised

Dutasteride has been commercialised, has been involved in several clinical trials, and it's widely prescribed off-label as a hair loss treatment because the medical community considers it safe and effective.

And still, it's not officially approved for hair loss, and it's been years since the approval process started. Why is this drug any different?

Cotsareli's involvement is not a guarantee of success. He also had some success with wounding and lithium almost a decade ago and that lead nowhere, any attempt from forum members to replicate those results failed

[beetee]

You guys have literally been missing all the signs. Both work on prostaglandins, one stops hair loss, the other will regrow. It is the holy grail of treatments. Bimatoprost finished up its phase 2b study back in Nov when Allergan was sold for $13 billion more than any company was willing to offer. They planned on releasing their info for their phase 2b study in January, are now saying you'll have to wait for those results until 2016. Also, setipiprant has an excellent safety profile with over 1,000 men and women being tested. Not to mention that it has passed 8 trials. It would only need to do a proof-of-concept to test the efficacy of the application. Even the optimal dose has already been determined.

All those years of research by Cotsarelis and Follica, are now being funneled into one proof-of-concept trial. Then we have new treatments. Holy crap.

I'm not missing the point. Why do you think I posted the information? However, we still don't know what if anything either will do, which is why no one else is acting like it's a done deal. But I think most agree this is a good thing and we are happier for the time being.

[It's2014ComeOnAlready]

People need to be realistic with timeline projections.

Dutasteride is considered safe, effective and it's widely prescribed off-label as a hair loss treatment, yet, it's still on it's way to be officially marketed as a hair loss treatment, keep in mind phase II ended in 2010

This is a new drug, and from clinical studies, its efficacy has never been proved in vivo. Remember that, even Aderans and Intercytex had good results in proof of concept and in vitro studies. They need to demonstrate it does something first.

The only thing that keeps me optimistic is Cotsareli's involvement

This is NOT a new drug. It's been tested in 8 clinical trials, including a phase 3. If you want to mention Cotsarelis, this is HIS work. He sold global rights to a company so that they can run a trial, market, and distribute it.

[walrus]

Dutasteride is considered safe, effective and it's widely prescribed off-label as a hair loss treatment, yet, it's still on it's way to be officially marketed as a hair loss treatment, keep in mind phase II ended in 2010

Dutasteride comes with similar disadvantages as finasteride. There is little to distinguish it to warrant pushing for a rapid release.

The PGD2 pathway will potentially avoid sexual side effects and the mechanisms have been demonstrated on ex-planted human follicles.

[finco]

People need to be realistic with timeline projections.

Dutasteride is considered safe, effective and it's widely prescribed off-label as a hair loss treatment, yet, it's still on it's way to be officially marketed as a hair loss treatment, keep in mind phase II ended in 2010

This is a new drug, and from clinical studies, its efficacy has never been proved in vivo. Remember that, even Aderans and Intercytex had good results in proof of concept and in vitro studies. They need to demonstrate it does something first.

The only thing that keeps me optimistic is Cotsareli's involvement

You make a very good point. Wait on the POC trials in 2015/2016 and take it from there.

[bigentries]

People need to be realistic with timeline projections.

Dutasteride is considered safe, effective and it's widely prescribed off-label as a hair loss treatment, yet, it's still on it's way to be officially marketed as a hair loss treatment, keep in mind phase II ended in 2010

This is a new drug, and from clinical studies, its efficacy has never been proved in vivo. Remember that, even Aderans and Intercytex had good results in proof of concept and in vitro studies. They need to demonstrate it does something first.

The only thing that keeps me optimistic is Cotsareli's involvement

[It's2014ComeOnAlready]

Regarding the link > page 7: P=0.001 means it's a concentration of 0.001%? (I'm sorry I'm absolutely not familiar with this lol)

It's the statistical significance. It would mean that their conclusion is with less than 1% chance that it is wrong.

[Illusion]

Regarding the link > page 7: P=0.001 means it's a concentration of 0.001%? (I'm sorry I'm absolutely not familiar with this lol)

[sdsurfin]

Can someone explain what I am missing?
- We know that setipiprant is safe
- The recognized Dr George Cotsarelis says it work and is better than Finansteride
- A big biopharmaceutical company believes in it and have put a lot of money in it
- They will start to sell it as soon as the paperwork/proof is done
- We can buy it today, eg here: http://www.keyorganics.net/bionet/se...19fn2o3-1.html

Why are we not all ordering this already? What are we missing. The dosage? Do we need other ingredients than Setiprant?

Well for starters it's 65 Bucks for 1 mg. Zyrtec has 10mg of pgd2 blocker per tablet. Maybe look into china to get it cheaper. I think the evidence that pgd2 pathways can stop hair loss is pretty damn conclusive. I'll be getting on centrifuge or ramatroban asap until this comes out in three years or so. My guess is they do a phase 2 and then a phase 3 and if it works it'll prob get released at the same time as bim. I'm hopeful about results the question is will the side effects be worth it. Bim has shown gnarly eye swelling even when not put in the eye, and these allergy mess cause serious withdrawal after a while and also make people drowsy and give headaches, and far more peeps get sides than with propecia. We should all be bugging kythera to consider this as a topical. If anyone has contact info for them pass it along. Or if you're in Cali plan a visit with their head of research, he's a dermatologist. Would be great to put a bug in his ear about reducing sides via topical application. And also ask him about bim eye swelling.

[It's2014ComeOnAlready]

Thanks but that's in vitro.

Can you tell me why that makes a difference? You don't know how this will even be delivered as a drug. If they can determine the proper molar concentration per hair follicle, they can probably determine the dose.

[finco]

Page 7 http://files.shareholder.com/downloa...0Deck%209FEB15

Thanks but that's in vitro.

[It's2014ComeOnAlready]

Yeah do we know what the optimal dosage actually is? If so could someone link me to this info.

Also the presentation said that there have been around 8 trials done on the drug, not of these study results are available as far as I know. And not mention of significant regrowth of hair has been noted in these trials, or not been reported.

Page 7 http://files.shareholder.com/downloa...0Deck%209FEB15

[finco]

Yeah do we know what the optimal dosage actually is? If so could someone link me to this info.

Also the presentation said that there have been around 8 trials done on the drug, not of these study results are available as far as I know. And not mention of significant regrowth of hair has been noted in these trials, or not been reported.

[Jonathan]

Can someone explain what I am missing?
- We know that setipiprant is safe
- The recognized Dr George Cotsarelis says it work and is better than Finansteride
- A big biopharmaceutical company believes in it and have put a lot of money in it
- They will start to sell it as soon as the paperwork/proof is done
- We can buy it today, eg here: http://www.keyorganics.net/bionet/se...19fn2o3-1.html

Why are we not all ordering this already? What are we missing. The dosage? Do we need other ingredients than Setiprant?