RepliCel - Spencer Kobren's Follow Up Interview With CEO David Hall

[Pate]

I'm guessing the wnt proteins are being multiplied as a side effect of the dermal cup cells being multiplied, correct? This is probabably the only thing I haven't fully grasped yet about Replicel's treatment.

It's more that the DC cells are going to pump out growth factors which will include the wnt proteins and all the others we hear about. My understanding of the major difference between Histogen and Replicel is that Replicel will inject the cells and let them express the genes and growth factors in vivo, whereas Histogen will culture the cells in the lab where gene expression and production of growth factors happens in vitro, then they inject the growth factors directly.

But as far as Replicel is concerned, basically there is going to be a hyper-expression of genes and growth factors in vivo such as hasn't been seen in the scalp since you were a developing embryo. Who knows what that might do? It SHOULD be okay but there might be unknown processes going on that nobody yet knows about. Better safe than sorry.

The other big unknown is the purity of the stem cells. We know that the cells have to go through several generations to make enough cells to be useful, and we know that in previous work the stem cells at the end of the process were not the same as the original stem cells - in particular they lost their inductive ability to generate hair, which is one major reason the original 10-year estimate blew out.

So what happens if there are mutations along the line? What if a mutation happens early on and carries down through billions of daughter cells? What if those cells now hyper-express a protein that causes cancer?

I'm not saying that's likely or even possible because I don't know, I'm not an expert (I am a scientist but not a bioscientist). All I'm saying is we are talking about a process that is associated with both embryo development and cancer. And even if there's no known pathway by which cancer could result (as the Replicel guys have said), that doesn't mean one doesn't exist, because this is brand new science - we need to go through the trials and Replicel obviously agree.

Even if some of us are desperate enough to take the risk we need to remember that any serious breach of safety standards could get Replicel into big trouble and send them out of business as well as get the whole industry under extra regulation - and then nobody gets treatment.

[Pate]

Just wanted to clarify that Replicel and Histogen of course use different cells - Replicel use DSC cells and Histogen use fibroblasts - but they both rely on the cells producing growth factors to achieve new hair growth.

Here is an abstract from a presentation by Hoffman and McElwee in 2010: http://www.hair2010.org/abstract/10.asp

It explains nicely both how they need to consider cancer during the process and how their results show that so far all evidence points to DSCs being safe.

[Kampung101]

Thanks Pate for the synopsis on that specific area of this treatment.

So would you say Histogen has the possibility of being maybe more safer due to the gene expression and the growth factor production happening in vitro?

[Dasani]

4-5 more months and we'll know a lot more after the results from histogen, replicel, and aderans come out. Waiting is not fun.

[RichardDawkins]

The results will be good there is no doubt, from all of them. Why i say this? Because all of them have secretly or not get in touch with clinics and dermatologist, like Gho did.

This is actually a good sign.

The bad sign in 5 months : PRICE TAG and AVAILABILITY (is this even a word)

Mark my words in 5 months a lot of us will say " Goddammit this will be expensive"

[CVAZBAR]

4-5 more months and we'll know a lot more after the results from histogen, replicel, and aderans come out. Waiting is not fun.

It'll be worse if they fail.

[Follicle Death Row]

It'll be worse if they fail.

I saw something in college today that said that most treatments and drugs don't get anywhere near 'the potential' we see in animal models. Made me sad. Plus they said it can take 14 years to go from animal tests to on the shelf and about $350mil. For every 20,000 chemicals created only one makes an effective treatment. Wanted to block my ears.

However perhaps we can consider cell based solutions a new paradigm.

[DepressedByHairLoss]

I saw something in college today that said that most treatments and drugs don't get anywhere near 'the potential' we see in animal models. Made me sad. Plus they said it can take 14 years to go from animal tests to on the shelf and about $350mil. For every 20,000 chemicals created only one makes an effective treatment. Wanted to block my ears.

However perhaps we can consider cell based solutions a new paradigm.

I disagree with those statistics. Nothing against you Follicle Death Row (you seem like a good guy), I just think that those statistics that were brought up at college sound like 'alarmist' statistics created by people who are trying to create lots of alarm and hype by putting forth astounding numbers. When I was in college, I heard plenty of so-called statistics that were brought up by professors and others who manipulated data to use it back up their own point of view. I don't believe that 20,000 chemicals statistic but I do agree that there are far too many chemicals that are not even bothered to be tested on humans, chemicals that could have great potential to cure this hair loss curse. I don't buy the statistic about 14 years and $350 million; there are plenty of drugs and treatments that don't fit into that category. Perhaps some treatments are not delivered to the public as quickly as they should because they've got various regulatory agencies and pharmaceutical special interests that very often unnecessarily hold them up. But that's why Replicel, Follica, and Histogen are conducting their trials outside of North America, so that they won't need to deal with any bureaucratic red tape. I just don't think that these statistics are true, so I don't think we have anything to be pessimistic about (at least related to those stats).

[CVAZBAR]

I saw something in college today that said that most treatments and drugs don't get anywhere near 'the potential' we see in animal models. Made me sad. Plus they said it can take 14 years to go from animal tests to on the shelf and about $350mil. For every 20,000 chemicals created only one makes an effective treatment. Wanted to block my ears.

However perhaps we can consider cell based solutions a new paradigm.

To be honest, I don't even know what to think anymore. I'm trying to prepare for the worst. I really hope all this exceeds expectations but the more you learn about this problem, the more I lose confidence. It's hard to believe we haven't been able to crack this. In a way I feel we're just starting to learn from this. I want to be wrong but sometimes I feel we need a miracle at this point.

[Jundam]

I saw something in college today that said that most treatments and drugs don't get anywhere near 'the potential' we see in animal models. Made me sad. Plus they said it can take 14 years to go from animal tests to on the shelf and about $350mil. For every 20,000 chemicals created only one makes an effective treatment. Wanted to block my ears.

However perhaps we can consider cell based solutions a new paradigm.

Sounds to me like your teacher is just bending statistics to make a point by using the grandest and blandest of examples knowing full well that no student is going to argue them.

Statistics is such utter bullshit in almost any scenario, so easy to bend to your need. It's why politicians love them.

[Follicle Death Row]

Sounds to me like your teacher is just bending statistics to make a point by using the grandest and blandest of examples knowing full well that no student is going to argue them.

Statistics is such utter bullshit in almost any scenario, so easy to bend to your need. It's why politicians love them.

I hope so man. She didn't see to have the brightest outlook on the pharmaceutical industry. When I say up to 14 years that's the longest time frame. Shortest is supposedly 8 years from animal testing to market apparently. Then again Replicel probably started animal trials way way back so who knows.

As to what those stats are based on I have no idea. I was sitting there thinking balls, hope this isn't true. Hopefully the sample was taken to prove a point. I know what you mean about statistics. There are 3 kinds of lies: lies, damned lies and statistics. I love that quote. Still we might be exhausting solutions with traditional drugs that target receptors. We can't tar cell based solutions with that brush. We're talking about something completely different. Cell based solutions will hopefully explode and with that paradigm shift medicine will continue to advance.

Sometimes I think hmmm, 2016 we'll have this cracked, that's amazing! But then you have moments where you're like yeah right. It's probably best not to get too excited. As I always say, they will crack it but very hard to say when. The timeline for 2015/2016 makes sense but in reality it just never seems to go off without a hitch.

I did think it was healthy to hear that though. I don't want to set myself up for disappoint with Replicel but the signs are still good. Good to ground me. I think I'll take some time off the forums and revisit nearer March for the phase 1 results.

[Follicle Death Row]

I disagree with those statistics. Nothing against you Follicle Death Row (you seem like a good guy), I just think that those statistics that were brought up at college sound like 'alarmist' statistics created by people who are trying to create lots of alarm and hype by putting forth astounding numbers. When I was in college, I heard plenty of so-called statistics that were brought up by professors and others who manipulated data to use it back up their own point of view. I don't believe that 20,000 chemicals statistic but I do agree that there are far too many chemicals that are not even bothered to be tested on humans, chemicals that could have great potential to cure this hair loss curse. I don't buy the statistic about 14 years and $350 million; there are plenty of drugs and treatments that don't fit into that category. Perhaps some treatments are not delivered to the public as quickly as they should because they've got various regulatory agencies and pharmaceutical special interests that very often unnecessarily hold them up. But that's why Replicel, Follica, and Histogen are conducting their trials outside of North America, so that they won't need to deal with any bureaucratic red tape. I just don't think that these statistics are true, so I don't think we have anything to be pessimistic about (at least related to those stats).

Well the statistics are right. The question is what sample are they based on? Presumably a sample was taken to paint a pessimistic picture of the pharmaceutical industry today. So many mergers because of such few blockbuster drugs in the pipelines. Etc etc. I actually think it did me some good. I'm a little more grounded and have taken down my expectations a little so as not to set myself up for disappointment.

[uninformed]

Well the statistics are right. The question is what sample are they based on? Presumably a sample was taken to paint a pessimistic picture of the pharmaceutical industry today. So many mergers because of such few blockbuster drugs in the pipelines. Etc etc. I actually think it did me some good. I'm a little more grounded and have taken down my expectations a little so as not to set myself up for disappointment.

exactly, the 4 companies arent your everyday companies. theyre better. its like saying statistically speaking it takes the average man 14 seconds to run 100 metre, stat may be true but it doesnt mean no one can get there in 10 seconds

[wherediditgo]

Does anybody know/ think that the injections will be compoundable. So that over time through several sets of injections one could get unlimited density? Over months of years?

[NeedHairASAP]

Well the statistics are right. The question is what sample are they based on? Presumably a sample was taken to paint a pessimistic picture of the pharmaceutical industry today. So many mergers because of such few blockbuster drugs in the pipelines. Etc etc. I actually think it did me some good. I'm a little more grounded and have taken down my expectations a little so as not to set myself up for disappointment.

2016 is a best case scenario.... a lot of these companies still consider propecia and minox as competition.... that says something about their expectations for their products....