Cassiopea Announces First Patient To Be Enrolled In Phase Ii Trial For The Treatment Of Androgenetic

[bekeero]

CASSIOPEA ANNOUNCES FIRST PATIENT TO BE ENROLLED IN PHASE II TRIAL FOR THE TREATMENT OF ANDROGENETIC ALOPECIA IN FEMALES WITH CLASCOTERONE SOLUTION
https://www.cassiopea.com/2019/11/1...opecia-in-females-with-clascoterone-solution/

 

[MrJolly26]

Women only :S

 

[irishlad8787]

FDA meeting today about how to proceed with the mens trials, i jumped the gun and thought this was a bad sign that the trial was only for women.

 

[FilthyFrancis]

FDA meeting today about how to proceed with the mens trials, i jumped the gun and thought this was a bad sign that the trial was only for women.

I thought Cassiopea launched Phase 2 trial for women just because they figured out their solution was as viable for women as for men.

They will most likely keep pushing the phase 3 men trial results to FDA approval and try to catch up with women in the meantime.

 

[irishlad8787]

Yes thats now my understanding after reading the article.

 

[Rho Gain]

Yes thats now my understanding after reading the article.

Yeah, they seem to be signaling that they're going to Phase III. Considering that about 70% of compounds that get a Phase III trial end up going to market, that's pretty exciting. Probably 3-4 years out, and considering Follica will be out before then, this will be another arrow in the near-term quiver. This is the most active period for anti-Androgenetic Alopecia protocols in about a decade.

 

[irishlad8787]

Doubt it will take 3-4 years, more like 2 i think to come to market.

 

[Rho Gain]

Doubt it will take 3-4 years, more like 2 i think to come to market.

"Meeting with FDA scheduled on November 13, 2019, to discuss the Androgenetic Alopecia Phase III Program in males with clascoterone solution."

The average length of a Phase III trial is 17 months. They haven't even begun recruiting yet, much less established a testing methodology that has been approved by the FDA. Then they actually have to conduct the study, do a data readout, and submit it to the FDA for review and approval. There is zero chance that a novel compound study that literally just began discussions with the FDA today will be commercially available in two years.

 

[FilthyFrancis]

"Meeting with FDA scheduled on November 13, 2019, to discuss the Androgenetic Alopecia Phase III Program in males with clascoterone solution."

The average length of a Phase III trial is 17 months. They haven't even begun recruiting yet, much less established a testing methodology that has been approved by the FDA. Then they actually have to conduct the study, do a data readout, and submit it to the FDA for review and approval. There is zero chance that a novel compound study that literally just began discussions with the FDA today will be commercially available in two years.

I must agree on this. 2 years seems far too optimistic. SM04554 is estimated for 2022 with phase 3 trial initiated in 2018.

However, just to put it into perspective, Cassiopea has stated their phase 3 trial would only last for 6 months, which could save us some time. Let's just hope that given the molecule is already known by the FDA (with the facial 1% cream) and with the short phase 3 trial, Cassiopea could hasten the process.

Tbh, I am not a strong believer in CB. HairLossTalk.com users who have been experimenting this drug have had limited results so far, and while I agree the product purity and Cassiopea's final vehicle could be game changers, the phase 2 trial results were too underwhelming to me.

As Rho Gain puts it, it's just an arrow in the quiver, not a cure.

 

[irishlad8787]

Is it not the same compound as the acne cream which is going to be released soon i thought, and if that is the case that will speed up the release of this, safety is the biggest concern with the fda so if its demonstrated safely for the acne cream that will expedite the marketing of the Androgenetic Alopecia product.

 

[Janko]

I must agree on this. 2 years seems far too optimistic. SM04554 is estimated for 2022 with phase 3 trial initiated in 2018.

However, just to put it into perspective, Cassiopea has stated their phase 3 trial would only last for 6 months, which could save us some time. Let's just hope that given the molecule is already known by the FDA (with the facial 1% cream) and with the short phase 3 trial, Cassiopea could hasten the process.

Tbh, I am not a strong believer in CB. HairLossTalk.com users who have been experimenting this drug have had limited results so far, and while I agree the product purity and Cassiopea's final vehicle could be game changers, the phase 2 trial results were too underwhelming to me.

As Rho Gain puts it, it's just an arrow in the quiver, not a cure.

It is good, that new things are not 5 years away, but rather 3-4 years and already commiting to the phase 3. Samumed, Follicum and Cassiopea will most likely come quite close to each other and maybe even RCH will get released at similar time. Wouldn't that be the perfect paradox for hairloss users, that after many decades without any new treatment they would get 3-4 new treatments almost at the same time?

 

[Rho Gain]

As Rho Gain puts it, it's just an arrow in the quiver, not a cure.

What's exciting, however, is the potential synergies any new compound may have with Follica's procedure. Follica's initial release will probably only utilize minoxidil, and they have started investigating other novel compounds to add to the protocol. As other competitors release new drugs, they have the potential to be added to the Follica "stack." There's never been a good time to lose your hair, but today is by far the best time in history to suffer from Androgenetic Alopecia, and I truly believe that we are going to see real progress within the next "five year" (for real this time); there are at least three new compounds and procedures that are very likely to commercialize within the next 2-4 years.

 

[MeDK]

What's exciting, however, is the potential synergies any new compound may have with Follica's procedure. Follica's initial release will probably only utilize minoxidil, and they have started investigating other novel compounds to add to the protocol. As other competitors release new drugs, they have the potential to be added to the Follica "stack." There's never been a good time to lose your hair, but today is by far the best time in history to suffer from Androgenetic Alopecia, and I truly believe that we are going to see real progress within the next "five year" (for real this time); there are at least three new compounds and procedures that are very likely to commercialize within the next 2-4 years.

Replicel is planning to get their injector approved and released next year in the EU and hong kong, and it almost does the same as follica device without the massage function. I don't remember when follica is planning to release their device.

but the whole "synergies" doesn't really work that well. Look at all the user here that uses LOADS of compounds and its not like its working for those people.

 

[Rho Gain]

Replicel is planning to get their injector approved and released next year in the EU and hong kong, and it almost does the same as follica device without the massage function. I don't remember when follica is planning to release their device.

but the whole "synergies" doesn't really work that well. Look at all the user here that uses LOADS of compounds and its not like its working for those people.

You're joking - you're actually comparing a device designed to ablate with an injector? Please explain how a device that needles the skin hundreds (thousands?) of times at precise depths is comparable to a dermal injector that is designed to pierce the skin one insult at a time and distribute fillers, etc. subcutaneously.

Honestly, if you don't know what you're talking about, you just shouldn't post.

 

[jamesbooker1975]

Is it not the same compound as the acne cream which is going to be released soon i thought, and if that is the case that will speed up the release of this, safety is the biggest concern with the fda so if its demonstrated safely for the acne cream that will expedite the marketing of the Androgenetic Alopecia product.

"safety is the biggest concern with the fda "
Lol, they approve Finasteride for Androgenetic Alopecia, so, I doubt it.

 

[MrJolly26]

Just saw this pop up when I hash tagged propecia, didn't check who the poster was but since I posted you guys should investigate and let me know!

It is good, that new things are not 5 years away, but rather 3-4 years and already commiting to the phase 3. Samumed, Follicum and Cassiopea will most likely come quite close to each other and maybe even RCH will get released at similar time. Wouldn't that be the perfect paradox for hairloss users, that after many decades without any new treatment they would get 3-4 new treatments almost at the same time?

If so, which one do you think will be the most effective? Not going to go with the lotions, but pills I guess.

 

[Janko]

If so, which one do you think will be the most effective? Not going to go with the lotions, but pills I guess.

It depends. Cassiopea seems to have a faith in CB. They are pushing further to phase 3 quite fast. Phase 2 showed even some finasteride like regrowth, but quite big drop between the months, so we really need the phase 3 to see, how good it really is. But it will most likely replace finasteride.
Both Follicum and Samumed looks to have improval about 10%. Which is already decent. Again, we need the longer study to see its full efect. If we will be lucky, they will be able to have synergic effect. What scares me a little is Samumeds statement: We have not yet had an end-of-phase 2 meeting with the FDA. Based on the data from the trial, we would determine whether to have such a meeting ... etc. They are not sure whether or not try to push it with the FDA, so they might not have exactly high trust in it.
We will see, but we should not also forget, that those treatments won't be exactly cheap. We can just wait, but overall of what I expect from first to last regarding regrowth is: 1)Samumed 2)Follicum 3)CB

 

[irishlad8787]

"safety is the biggest concern with the fda "
Lol, they approve Finasteride for Androgenetic Alopecia, so, I doubt it.

If you think any drug is 100% safe you dont know much about pharmaceuticals. Whether you believe it or not is irrelevant but the vast majority of people taking finasteride do not suffer sides.

 

[Rho Gain]

It’s because finasteride is a save medication outside of these forums where everyone has ocd

This. A million times this.

 

[jamesbooker1975]

It’s because finasteride is a save medication outside of these forums where everyone has ocd

Hahahahahahaha. Yes, sure , you are just an ignorant idiot.