Histogen Update - Spencer Kobren Speaks With Dr. Craig L. Ziering

[Losing_It]

It's not a matter of whether persons would be willing to participate (and, your own eagerness doesn't indicate whether they would); it's a question of whether those who volunteer are suitable to Histogen.

I'd still like to know whether recruitment has been completed and actual testing has commenced.

If I understood correctly, Phase 1 would enroll forty patients whilst Phase 2 would enroll 200 patients. There was some speculation that if all goes to plan they could launch the product after Phase 2, but I am not certain if this is actually the case or not. Anyways we will find out on their results in the next few months. All they need to do is build on their 57 cm2, and if they can prove that it reverses miniaturization in existing hair, than Bob's your Uncle. Reversing miniaturization with some regrowth even at 57cm2 is in my opinion ground breaking. For many people, maybe not for people on a high norwood scale, this will be enough. But you can supplement with transplants etc.

One thing is for sure, the race is on for a viable solution and the revenue in hair restoration

[MrRyan]

I think that they really should launch HSC after the phase II trials even if this product just keeps hair that would be enough for me at this stage, it will benefit them for so many reasons, the revenue generated would be massive and would give them more than enough money to get this thing FDA approved and available in the U.S, and we all know that is where the big money is for them. I mean after phase II we will know it's safe that's the main thing for them at the minute right, if they don't there will be so many like me just starting to lose their hair now, but by the time it would be ready after phase three trials my hair will most likely be a mess because i, like so many other people don't want to take Propecia or even apply minox, i'm just trying to stay healthy with vitamins diet and exercise.

I mean really they have a product that they could release right now that would make a difference to millions of men and women, i know it sounds impatient, but seriously is there any reason not to go to market with this it's a win win all round what could they possibly gain from holding out, at the end of the day they will say phase three will refine the product, but isn't that always going to be the case it's always going to be improved upon after trials have long gone, i just hope they have some empathy and listen to what we all want after all we are the ones that will be spending our hard earned cash on this thing.

[MrRyan]

And another thing why the hell is HSC not all over the media, i mean this is huge unprecedented news why are they not all over this thing, or do you think it will start to spark more interest after phase II trials, because to be honest i just don't get it. The more media attention the more money for Histogen i think they really need to start getting some interest in this thing if they do infact have what they say they have, it will fund their efforts and help get the result we are all hoping for.

And i do think that someone from Histogen should just come on here and give us a quick update as to what is happening it only takes a minute to be fair the silence worries me, some people are on these forums a lot i try not to come on here to often as it depresses me, we just need facts so we know where we stand not just us speculating what might or might not happen.

[Bronson]

I realize everyone is anxious about the release date but I'm far more worried about the safety. I wish they'd do trials with 1,000 people instead of 200. Remember, people have only recently discovered serious (and possibly irreversible) problems with Propecia and that's been out, what, 10 years? Not to mention hundreds of thousands of guys had to take that stuff before they discovered the 1-2% that were having major problems. It's not like we all have very similar genes, there's a lot of variation out there. If they find a 1-2% horrible side effects rate with histogen I'll probably pass.

[Losing_It]

Maybe, its best they not all over the media right now, since if they fail then its better for them. Imagine if they hype it up and fails then their would be less faith from investors to pump money into their other technologies. Well if they manage to get really positive Phase 2 data, then they could spend money on marketing the product, but for now the risk is to big to take. One thing for sure though even if they manage to halt further hair loss and you need to take an injection after every 3-5 years, that is still better than propecia.

85% of patients responded well in the pre-clinical so its a no brainer that they would reproduce this result.

I don't think we will get any feedback until they have results. They playing their cards close to their chest. We will have to wait till next year.

[Losing_It]

I realize everyone is anxious about the release date but I'm far more worried about the safety. I wish they'd do trials with 1,000 people instead of 200. Remember, people have only recently discovered serious (and possibly irreversible) problems with Propecia and that's been out, what, 10 years? Not to mention hundreds of thousands of guys had to take that stuff before they discovered the 1-2% that were having major problems. It's not like we all have very similar genes, there's a lot of variation out there. If they find a 1-2% horrible side effects rate with histogen I'll probably pass.

The only possible serious side effect HSC could have would be the development of cancer, but in my understanding of how HSC is engineered is that the Wnt 5a protein and growth factors, which has been associated with cancer development are eliminated. In the pre-clinical there were no adverse reactions at the 1 and 2 year follow up. With propecia who know the side effects within the first few days of taking it.

My only worry is whether they would be able to reproduce the pre-clinical results and improve on that. I wouldn't worry about side effects now, we live in such a polluted world anyways that we get exposed to pathogens on a daily basis. Just think of all those drug resistant bacteria, because of the overuse of antibiotics. Leading a healthy lifestyle won't guarantee that you won't die of some form of cancer that wasn't so prevalent 50 years ago.

[Follicle Death Row]

We really don't need to worry about cancer if it makes it through phase 2. I believe Histogen are more interested in developing a wnt protein approach to fighting cancer by inducing cell apoptosis than HSC. However HSC is an important product in the company pipeline which can help to fund further cancer research.

For sure it won't be released in the US (FDA) or Europe (EMA) until it has passed phase 3. Seems like Aderans Ji Gami could be out first in the US and Europe. They're still shooting for 2014 to be finished with phase 3 and on the market. Their timeline seems a little more realistic to me anyway.

[Samiam]

However HSC is an important product in the company pipeline which can help to fund further cancer research

If they're trying to cure cancer I'm all for them but you can't be telling me this is just some little side project. I mean there should be a company with their full focus on finding out how to cure the genetic defect in MPB, or make a treatment that lets you grow all your hairs back. But like I said if their main goal is getting rid of cancer I'm still rooting for them.

[Sogeking]

I realize everyone is anxious about the release date but I'm far more worried about the safety. I wish they'd do trials with 1,000 people instead of 200. Remember, people have only recently discovered serious (and possibly irreversible) problems with Propecia and that's been out, what, 10 years? Not to mention hundreds of thousands of guys had to take that stuff before they discovered the 1-2% that were having major problems. It's not like we all have very similar genes, there's a lot of variation out there. If they find a 1-2% horrible side effects rate with histogen I'll probably pass.

I agree with everything said here. There is a reason for phase III. However although cancer is the worst possible side effect the usage of proteins for fighting cancer by inducing cell apoptosis might have different reactions.

[UK_]

If they're trying to cure cancer I'm all for them but you can't be telling me this is just some little side project. I mean there should be a company with their full focus on finding out how to cure the genetic defect in MPB, or make a treatment that lets you grow all your hairs back. But like I said if their main goal is getting rid of cancer I'm still rooting for them.

The thing is, with baldness [lol]... the more you research the disorder the more you realise how complicated an issue it really is. I mean you're talking of trying to generate [create] in the lab or in human scalp tissue over 15,000 separate organs with a multitude of interconnected dynamics, a host of complex pathways that govern a cyclical pattern of growth/rest/shed like clockwork... organs that have been stated to be more complex than some of our more important ones.

It really is a tough road... and to be honest... I dont wish to be a downer here but the more I delve into the years of research the more I feel the 'better treatment' will come from an evolution of transplantation as opposed to a one-shot miracle injection like HST.

Regardless, for those of you who have just started thinning, count yourselves lucky, Samiam I believe you're still in your teens - when I was your age there was literally NOTHING and I mean NOTHING going on... it was a real dark age where one literally only had the choice of either turning to Minoxidil or a hair transplant surgeon you could never review properly.