Hisogen form e-mail (for what its worth)

Just received this e-mail from Histogen as I am sure a lot of you have.

HSC Question & Answer Session with Histogen CEO Dr. Gail K. Naughton

Q: The Phase I/II clinical trial of HSC will begin in Singapore this Spring. How will the design of this trial differ from the pilot clinical trial?

A: Like the pilot trial, the Phase I/II will focus on safety and efficacy in the application of HSC as an injectable for hair growth, but this trial will also begin to examine dosing and delivery. As such, the trial design includes a larger number of injections per treatment site, as well as a second treatment timepoint, to determine if this further enhances the results.

In addition, the Phase I/II will be a dual-site trial with a larger number of subjects (50), which will provide us will more significant safety and efficacy data.

Q: Why has Histogen chosen to perform this clinical trial in Singapore? Will there be trials in other countries as well?

A: A number of countries in Asia, including Singapore, have become leading global centers for advanced aesthetic medicine. By performing the trial in Singapore, we are able to work with experts in the hair restoration industry while pursuing opportunities to bring HSC to market sooner.

After a successful Phase I/II trial, we plan to conduct a 250 patient study in 5 countries in Asia, which can lead to Pan-Asian (excluding Japan) approval.

Regulatory requirements for clinical trials and approval in Singapore and Pan-Asia are very similar to the US and Europe, and their regulatory agencies are highly regarded worldwide. Histogen continues to work with the FDA in parallel to the Singapore trial, and hopes to be able to utilize the data gained from the Phase I/II within its US FDA Investigational New Drug (IND) submission.

Future clinical studies of HSC in other countries are also likely. We look forward to getting the upcoming trial underway, and to further evaluating potential design and locations for studies including a pilot evaluation of HSC for diffuse hair loss in women.

Q: How does HSC work?

A: When grown under proprietary conditions of very low oxygen and suspension, human newborn dermal cells act as they would in the embryonic environment, becoming stem cell-like and producing proteins that are embryonic in nature. The soluble complex of cell-signaling proteins produced through this process becomes HSC.

HSC contains a number of proteins, including follistatin, VEGF and KGF, which have been shown by leading research to be involved in hair growth, maintenance, and in the development of new hair follicles. These proteins signal existing follicles to produce new hair, and stimulate stem cells in the scalp to become brand new hair follicles.

Q: How does Histogen plan to bring HSC to market?

A: As with all of its product applications, Histogen seeks to bring HSC to market through partnerships and licenses with global industry leaders. While HSC continues to be Histogen’s lead product application, the embryonic-like soluble proteins and insoluble extracellular matrix produced through our technology process have numerous therapeutic applications. Research to date in areas such as cancer and medical device coatings have yielded very exciting results, and Histogen’s expertise lies in the development of products to meet medical needs.

Q: Histogen has recently opened a Series B financing round. What will this financing be used for, and who are Histogen’s investors?

A: Histogen’s $23M Series B round of financing was opened in December 2010, and will be utilized to fund clinical trials of HSC through market launch in Asia, continue development of our oncology program, and upscale manufacturing to meet regulatory requirements and future commercial needs. As with our first round of financing, Histogen is seeking a limited number of accredited investors for the Series B, which we hope to bring to a close this Spring.

» After a successful Phase I/II trial, we plan to conduct a 250 patient study
» in 5 countries in Asia, which can lead to Pan-Asian (excluding Japan)
» approval.
»

So they plan to go through phase 2, phase 3 and then go on market in asia by 2014? All that in three years time? That will be the fastest phase 2+3 in the history of clinical trials. It took them 2,5 years from starting phase 1 to start phase 2 this may. I thought they only needed phase 2 in asia? Oh well, it will still be interesting to see how well phase 2 turn out.

» So they plan to go through phase 2, phase 3 and then go on market in asia
» by 2014? All that in three years time? That will be the fastest phase 2+3
» in the history of clinical trials.

The last thing we need is a 10 year saga to this problem.

The whole point of not doing it straight to the american FDA’s plan is to be able to speed up the process in Asia. They might be trying to use the Asian data as part of the data for future FDA approval without being directly aimed at FDA approval as the first step.

If you’re not willing to get the procedure done after Asian trials, and you’re only willing to wait for an american FDA approval, then Histogen was never gonna happen in less than a decade for you. This should come as no surprise to you now as long as you have been using common sense when looking at the Histogen situation during the last several years.

Thanks. Best explanation of Histogen I’ve ever seen.

» While HSC continues to be Histogen’s lead product application, the
» embryonic-like soluble proteins and insoluble extracellular matrix produced
» through our technology process have numerous therapeutic applications.

Call me crazy, but this sounds like the more advanced cousin of PRP + Acell.

» Just received this e-mail from Histogen as I am sure a lot of you have.
»
»
»
»
»
» HSC Question & Answer Session with Histogen CEO Dr. Gail K.
» Naughton
»
»
»
» Q: The Phase I/II clinical trial of HSC will begin in Singapore this
» Spring. How will the design of this trial differ from the pilot clinical
» trial?
»
»
»
» A: Like the pilot trial, the Phase I/II will focus on safety and efficacy
» in the application of HSC as an injectable for hair growth, but this trial
» will also begin to examine dosing and delivery. As such, the trial design
» includes a larger number of injections per treatment site, as well as a
» second treatment timepoint, to determine if this further enhances the
» results.
»
»
»
» In addition, the Phase I/II will be a dual-site trial with a larger number
» of subjects (50), which will provide us will more significant safety and
» efficacy data.
»
»
»
»
»
» Q: Why has Histogen chosen to perform this clinical trial in Singapore?
» Will there be trials in other countries as well?
»
»
»
» A: A number of countries in Asia, including Singapore, have become leading
» global centers for advanced aesthetic medicine. By performing the trial in
» Singapore, we are able to work with experts in the hair restoration
» industry while pursuing opportunities to bring HSC to market sooner.
»
»
»
» After a successful Phase I/II trial, we plan to conduct a 250 patient study
» in 5 countries in Asia, which can lead to Pan-Asian (excluding Japan)
» approval.
»
»
»
» Regulatory requirements for clinical trials and approval in Singapore and
» Pan-Asia are very similar to the US and Europe, and their regulatory
» agencies are highly regarded worldwide. Histogen continues to work with the
» FDA in parallel to the Singapore trial, and hopes to be able to utilize the
» data gained from the Phase I/II within its US FDA Investigational New Drug
» (IND) submission.
»
»
»
» Future clinical studies of HSC in other countries are also likely. We look
» forward to getting the upcoming trial underway, and to further evaluating
» potential design and locations for studies including a pilot evaluation of
» HSC for diffuse hair loss in women.
»
»
»
»
»
» Q: How does HSC work?
»
»
»
» A: When grown under proprietary conditions of very low oxygen and
» suspension, human newborn dermal cells act as they would in the embryonic
» environment, becoming stem cell-like and producing proteins that are
» embryonic in nature. The soluble complex of cell-signaling proteins
» produced through this process becomes HSC.
»
»
»
» HSC contains a number of proteins, including follistatin, VEGF and KGF,
» which have been shown by leading research to be involved in hair growth,
» maintenance, and in the development of new hair follicles. These proteins
» signal existing follicles to produce new hair, and stimulate stem cells in
» the scalp to become brand new hair follicles.
»
»
»
»
»
» Q: How does Histogen plan to bring HSC to market?
»
»
» A: As with all of its product applications, Histogen seeks to bring HSC to
» market through partnerships and licenses with global industry leaders.
» While HSC continues to be Histogen’s lead product application, the
» embryonic-like soluble proteins and insoluble extracellular matrix produced
» through our technology process have numerous therapeutic applications.
» Research to date in areas such as cancer and medical device coatings have
» yielded very exciting results, and Histogen’s expertise lies in the
» development of products to meet medical needs.
»
»
»
»
»
» Q: Histogen has recently opened a Series B financing round. What will this
» financing be used for, and who are Histogen’s investors?
»
»
»
» A: Histogen’s $23M Series B round of financing was opened in December 2010,
» and will be utilized to fund clinical trials of HSC through market launch
» in Asia, continue development of our oncology program, and upscale
» manufacturing to meet regulatory requirements and future commercial needs.
» As with our first round of financing, Histogen is seeking a limited number
» of accredited investors for the Series B, which we hope to bring to a close
» this Spring.

I recently heard that drug companies are able to shave many, many months off the time needed to complete a trial, if they perform that trial in Asia or Russia. I think the time saved is six to nine months over doing the same single trial in the USA.

So for two trials, that could mean getting a drug to market up to a year and a half faster, more than two years faster if all three trials are done.

I forget the reason for the time savings, probably less red tape or something.

» HSC contains a number of proteins, including follistatin, VEGF and KGF,
» which have been shown by leading research to be involved in hair growth,
» maintenance, and in the development of new hair follicles. These proteins
» signal existing follicles to produce new hair, and stimulate stem cells in
» the scalp to become brand new hair follicles.

IF this company really has what it claims to have, they will be rich beyond anyone’s imagination.

I put IF in bold because its a huge assumption given what they are claiming.

I will keep my hopes low but my attitude positive until I see the holy grail evidence of a NW6 to NW2 transition.

I hope to God they have what they claim to because what they have is essentially the cure.

Right on Freddie - If it works it will be absolutely amazing. When I enquired about Series B investment they were looking for USD$50k-100k amounts and were happy for international investors to apply. Unfortunately I’m not in a position to contribute/invest that much, but hopefully they raise the capital shortly and have a very successful set of trials & results.

» IF this company really has what it claims to have, they will be rich
» beyond anyone’s imagination.

Still don’t understand why no serious firm (like L’Oreal, etc) are involved in this game, nor do others kick their asses to bring something before 10 years. The only real players are R&D firms although the one who find something DECENT will be rich as hell in the second the product is released.

Why do you think Histogen will be rich beyond anyone’s imagination freddie? The salenumbers on propecia have proved that most men who go bald don’t care enough to take medication for it. Propecia was not the big winner in sales that was expected. That’s the main reason why it’s very hard to find investors in hairlossmedicines and that’s the main reason why there still is no “cure”.
Because most men just don’t care enough to spend money on their hairloss.

» » HSC contains a number of proteins, including follistatin, VEGF and KGF,
» » which have been shown by leading research to be involved in hair
» growth,
» » maintenance, and in the development of new hair follicles. These proteins
»
» » signal existing follicles to produce new hair, and stimulate stem cells
» in
» » the scalp to become brand new hair follicles.
»
»
» IF this company really has what it claims to have, they will be rich
» beyond anyone’s imagination.
»
» I put IF in bold because its a huge assumption given what they are
» claiming.
»
» I will keep my hopes low but my attitude positive until I see the holy
» grail evidence of a NW6 to NW2 transition.
»
» I hope to God they have what they claim to because what they have is
» essentially the cure.

» Why do you think Histogen will be rich beyond anyone’s imagination freddie?
» The salenumbers on propecia have proved that most men who go bald don’t
» care enough to take medication for it. Propecia was not the big winner in
» sales that was expected. That’s the main reason why it’s very hard to find
» investors in hairlossmedicines and that’s the main reason why there still
» is no “cure”.
» Because most men just don’t care enough to spend money on their hairloss.

Well, it’s cost-benefit. If Propecia gave you a full head of hair, men would be all over it. As it is, it kind of sort of works for some people, to a moderate extent, for an unknown amount of time. This is before you get into the possibility of side effects.

A drug that cured hairloss would be a blockbuster. Propecia isn’t that drug, though.

<>

What does this mean? Don’t existing follicles already produce hair?

» A drug that cured hairloss would be a blockbuster. Propecia isn’t that
» drug, though.

Most guys who start balding out there don’t even understand the difference between keeping the hair you have (which is what propecia does) and regrowing hair you lost (which is what propecia does not do).

Had I known what I know today, I would have got on propecia at the very onset of my hair loss.

Anyway a cure would be every man’s dream.

I’ve got one important question. Maybe someone here in contact with Histogen can email them.

The graph they put up shows hair count increasing after just one injection of their product even at the 1 year mark. Have they tracked these results to see if hair counts continue to increase even AFTER the one year mark ?

If i just draw a line-of-best-fit through the vertical bars, it would appear within roughly 2 years of the initial shot, a bald person could get back one-third of his hair density! And that includes thickness of all follicles not just hair count which is cosmetically pretty significant.

I hope the graph is exponential rather than linear :wink:

» I hope the graph is exponential rather than linear :wink:

There is nothing on the graph to even remotely indicate that it is exponential, in my reading of it. I think if it were exponential, they would have indicated something along the x or y axis about units changing by various orders of magnitude.

Don’t get your hopes up, there’s nothing exponential here.

What I see is a VERY meager set of results – hair count increase from 230 (baseline, before treatment) to 260 (after 1 year).

I’ve seen better results in clinical trials of placebos for different drugs.

Is this what people are getting all excited about?

This is like the “Laser Comb” – all marketing hype, and no real results.

» » I hope the graph is exponential rather than linear :wink:
»
» There is nothing on the graph to even remotely indicate that it is
» exponential, in my reading of it. I think if it were exponential, they
» would have indicated something along the x or y axis about units changing
» by various orders of magnitude.

It registered a surprising jump towards the end. Here’s to hoping that graph goes vertical in year 2 :slight_smile: but we’re probably hoping against all hope here.

I wonder if its just a case of seasonal variation, that is more hairs just happen to be in anagen when they took their readings towards the end when it was summer or something.

» What I see is a VERY meager set of results – hair count increase from 230
» (baseline, before treatment) to 260 (after 1 year).

Yes I noticed that too. Well at least its not decreasing which was what placebo patients in the study were undergoing.

But one thing that the graph does not show is increase in thickness. Propecia’s greatest effect is not hair count per say but increase in hair shaft diameter. That is what gives the cosmetic appearance of a fuller head of hair. That’s also why it makes more sense to take it when you first notice hair loss rather than when you’re NW6.

To be fair, this is with a single shot of their stuff without knowing the optimal dosage for efficacy. They really should do a parallel study with the effects of DHT blocked + their stuff. I’m not expecting the cure from them but if they can even muster 15% extra density, its worth it.

Laser comb is snake oil to me because the science behind it makes no sense. There is no light activated molecule identified in hair to my knowledge that causes it to grow. So I fail to see the point of shooting it with a laser.