terrapin12
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What's his website?
Hair Multiplication Update:Histogen!
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terrapin12
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I wouldn't say he particularly endorses them one way or another on there, it seems more like an acknowledgement of their existence. Tricomin hasn't been proved one way or another as far as I know.
for the record, ICX didnt fail after phase 2. They sold their findings to Aderans. The idea that retains my hope for Histogen is that we are seeing stem cells used in other medicine, like wound healing. when they made their claims years ago about Hair regeneration, stem cells were being studied, and not used.
bigentries
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For what I remember, ICX went bankrupt because of a skin graft product that failed horribly, not the HM product
Of course, we can safely presume the HM product didn't work or was very mediocre, because, unlike what the conspiracy nuts think, if the product was working, it could had easily got more funding
Sad we haven't heard any good news about HM in a while
I find it frustrating that the hopes for a cure have changed from hair multiplication to simple hair transplants with unlimited hair grafts
Of course, we can safely presume the HM product didn't work or was very mediocre, because, unlike what the conspiracy nuts think, if the product was working, it could had easily got more funding
Sad we haven't heard any good news about HM in a while
I find it frustrating that the hopes for a cure have changed from hair multiplication to simple hair transplants with unlimited hair grafts
Well, even so, if there was indeed such a solution at reasonable prices, you can bet that baldness would start disappearing at fast pace. At least among men in the 25-45 age range.bigentries said:
Even NW3 is not bald, so a NW6 --> NW3 would be a good compromise for advanced Norwood-ers who have no the cash.
I dont know how old this is, but histogen emailed it to me.
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.
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.
dimitar_berbagod
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I don't really find that frustrating at all. HM does seem a bit too good to be true at this stage. The unlimited supply seems much more viable IMO. Hopefully the trials will warrant further funding.
terrapin12
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I don't really think the hopes for HM have failed, no? Seems like Histogen is still an injectable treatment, not a surgery.
Unlimited donor was probably always going to be the first thing discovered. You're trying to undo the genetic process of the body, versus just making a copy of already existing cells and doing a procedure which has been around for decades.
that being said it's good because the germans already cloned a follicule. and you dont need the unlimited donor now, you only need it when you run out of hair.
which means once it's done the waiting list for people like armani and other doctors who will transplant to nw1 is going to EXPLODE.
that being said it's good because the germans already cloned a follicule. and you dont need the unlimited donor now, you only need it when you run out of hair.
which means once it's done the waiting list for people like armani and other doctors who will transplant to nw1 is going to EXPLODE.
Some of your information about cancer is a little bit wonky; but their is indeed a new wave of research like you are talking about: check out www.sens.org for example
scoobysnacks
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Been reading on a few different forums that Histogen is recruiting in June for 50 candidates, so it looks like Phase II of the trials could be getting underway in the near future.
And Gail Naughton (Histogen CEO) has quit her post at San Diego SU to focus on Histogen. Read into that what you will, but I feel it can only be a positive sign.
And Gail Naughton (Histogen CEO) has quit her post at San Diego SU to focus on Histogen. Read into that what you will, but I feel it can only be a positive sign.
scoobysnacks
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Bombarie said:
My reading of that is that it has finished the "Pre-Clinical" stage with Phase II beginning sometime towards the end of this year. I'm definitely not holding my breath on this though, I'll at least need to see what Histogen present at the upcoming WDC in late May before I even think about getting excited.
Histogen also have plenty of other areas which seem to be progressing into the market, so that could very easily be the motivating factor for Naughton to focus solely on the company. But i'm also sure she realises the huge market potential for a relatively unintrusive hair regrowth treatment, which is what Histogen seem to be aiming for.
terrapin12
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from a Histogen e-mail this week:
"Our next clinical trial is scheduled to begin Summer 2011 in Singapore. While we don’t expect our product to be launched in the US until the 2015 timeframe, Histogen hopes that we can launch sooner outside the US if our international trials go well. However, that timeframe would also be a few years out. As an estimation, Histogen hopes to get product approval in Asia by late-2013/early-2014. Histogen expects that launching the HSC product in the EU will be around the same time as a US product in 2015. As the product progresses through development, Histogen will identify whether trials in the UK/EU are necessary."
I had a anesthetic injected into my scalp for a biopsy this week. It's not particularly painful, but goddamn is that an uncomfortable and awful feeling to have a needle in your scalp. Not that I would mind if it meant regrowing hair.
"Our next clinical trial is scheduled to begin Summer 2011 in Singapore. While we don’t expect our product to be launched in the US until the 2015 timeframe, Histogen hopes that we can launch sooner outside the US if our international trials go well. However, that timeframe would also be a few years out. As an estimation, Histogen hopes to get product approval in Asia by late-2013/early-2014. Histogen expects that launching the HSC product in the EU will be around the same time as a US product in 2015. As the product progresses through development, Histogen will identify whether trials in the UK/EU are necessary."
I had a anesthetic injected into my scalp for a biopsy this week. It's not particularly painful, but goddamn is that an uncomfortable and awful feeling to have a needle in your scalp. Not that I would mind if it meant regrowing hair.
terrapin12
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It wasn't from a mailing list, I only asked a question on their website.
dimitar_berbagod
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Our next clinical trial is scheduled to begin Summer 2011 in Singapore. While we don’t expect our product to be launched in the US until the 2015 timeframe, Histogen hopes that we can launch sooner outside the US if our international trials go well. However, that timeframe would also be a few years out. As an estimation, Histogen hopes to get product approval in Asia by late-2013/early-2014. Histogen expects that launching the HSC product in the EU will be around the same time as a US product in 2015. As the product progresses through development, Histogen will identify whether trials in the UK/EU are necessary.
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Just reading this, and what does 'However, that timeframe would also be a few years out' mean? I don't understand.
Are they suggesting they haven't got a clue when it will ready for the market despite several dates given? Appears to be a contradiction...
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Just reading this, and what does 'However, that timeframe would also be a few years out' mean? I don't understand.
Are they suggesting they haven't got a clue when it will ready for the market despite several dates given? Appears to be a contradiction...
andrei_eremenko
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So the things are moving guys...check the clinical status!