Histogen Update from Ziering Medical

[hellouser]

They had a lawsuit in 2010.

They finished 2A end of 2012, after showing results which looked positive, they went silent for rest of 2013, until that little comment on facebook.

everyone thought they'd be almost done 2B by now, but they havent even started.

What is the reason for splitting phase 2 trials into 2A and 2B? Why couldnt they just have done both in one run instead of slacking off for so long?

[rdawg]

What is the reason for splitting phase 2 trials into 2A and 2B? Why couldnt they just have done both in one run instead of slacking off for so long?

no idea, I think 2A is dosing trial, but 2B is used for when they want to test a higher dosage like Bimataprost is doing in 2B right now.

So they could go straight to 3, but it would have to be at the dose they used, and because they probably want better results, they have to take another phase(2B) just to test a slightly higher dosage. FDA is a ridiculously long and tedious process, I really dont understand why they cant shorten the phases and then just do a controlled release(I.e two phases for safety/dosing, then a 3rd limited public release in select cities) once safety is proven.

[hellouser]

no idea, I think 2A is dosing trial, but 2B is used for when they want to test a higher dosage like Bimataprost is doing in 2B right now.

So they could go straight to 3, but it would have to be at the dose they used, and because they probably want better results, they have to take another phase(2B) just to test a slightly higher dosage. FDA is a ridiculously long and tedious process, I really dont understand why they cant shorten the phases and then just do a controlled release(I.e two phases for safety/dosing, then a 3rd limited public release in select cities) once safety is proven.

My god, why is every biotech relying on the FDA for trials? I realize USA has a population of 300 million, but its not like there isn't a world beyond its borders. FDA has been more of a burden than anything for these treatments. I really hope that the next set of clinical trials for ANY treatment will completely disregard USA and do it elsewhere. If guys are willing to pay thousands of dollars for HTs to improve their hair, I'm sure they'll pay a little more to get a vacation and a PROPER treatment in one shot.

[Dav7]

Any updates on what year Histogen will be released in Asia?

[Desmond84]

To be honest guys, I dont think Histogens HSC will be coming out in the next 5 years in any country. They seem to have moved on to other projects which is a shame.

By the time they release their product there'll be very strong therapies in the pipeline that will make HSC obsolete.

Cell therapy will revolutionize medicine in the near future. By 2020 I'm more than certain there'll subjects who are in human trials gaining back several norwoods using a germ method or something even more ground breaking. I lost hope in histogen in January when they still remained silent and refused to reply to our emails.

[Kiwi]

What the hell is stopping them from continuing!!!?

Ziering medical is NOT Histogen. Ziering participated in a small clinic based trial - nothing to do with 2a or 2b FDA trials.

Unless you already knew that you probably don't know enough to be commenting about Histogen.

I think sciencetalk is right though. Goto a trendy hair dresser and get the best cut you can. Accept yourself

[Hair Bear]

Yep, I'm just waiting for them to pull an Aderans on us.

[joely]

I don't get it,, according to their web site, they were getting good results for safety and efficacy, I don't get why they appear to have lost interest in it now

[HairBane]

I don't get it,, according to their web site, they were getting good results for safety and efficacy, I don't get why they appear to have lost interest in it now

They haven't lost interest. They don't have enough money to do the next trial phase.

[joely]

So we have to wait until they have funding for 2b and then 3 then everything else they need, once again we are waiting Pissing years for something

[Kiwi]

They haven't lost interest. They don't have enough money to do the next trial phase.

HairBane stop speculating - it's like you're trying to get a rise from them

When a company goes from 2A to 2B it generally means they are going to attempt to increase the dosage to get even better results.

Unfortunately for us this means Histogen needs to do more work. I've read cases where the drug company has to even go so far as to test these new dosages on animals again before humans.

I suspect in this case it's not money related but time and even more bullshit FDA processes getting in the way.