»
» I don’t think it hurts to ask. What’s the worst that could happen if we
» throw in that question? We are all speculating anyway, at least we will
» have something to work with if she does answer that question.
That’s my point. She can answer the question, and it still doesn’t mean we actually have anything to work with yet.
Medical researchers aren’t in the business of telling the truth about their timelines to market on things in development. Blatant underestimations of timelines in that industry have become like steriods in baseball - it’s so commonplace that you basically get penalized by NOT doing it.
exactly cal, I was thinking along your line when I posted.
After ALL previous timelines of previous companies in this forum have been proven wrong, I think it is ridiculous to ask Dr. Naughton about timelines.
» »
» » I don’t think it hurts to ask. What’s the worst that could happen if we
» » throw in that question? We are all speculating anyway, at least we
» will
» » have something to work with if she does answer that question.
»
» That’s my point. She can answer the question, and it still doesn’t mean
» we actually have anything to work with yet.
»
» Medical researchers aren’t in the business of telling the truth about
» their timelines to market on things in development. Blatant
» underestimations of timelines in that industry have become like steriods in
» baseball - it’s so commonplace that you basically get penalized by NOT
» doing it.
» Many people have suggested this product be released outside the US to
» avoid FDA regulation prior to the US launch, and in the past, Histogen has
» not been outright opposed to the idea; has a decision been made, or is
» management perhaps leaning towards one side or the other?
That’s a very good question to ask, as well as Rev’s about the 22 weeks result.
» exactly cal, I was thinking along your line when I posted.
» After ALL previous timelines of previous companies in this forum
» have been proven wrong, I think it is ridiculous to ask Dr. Naughton about
» timelines.
»
» » »
» » » I don’t think it hurts to ask. What’s the worst that could happen if
» we
» » » throw in that question? We are all speculating anyway, at least we
» » will
» » » have something to work with if she does answer that question.
» »
» » That’s my point. She can answer the question, and it still doesn’t
» mean
» » we actually have anything to work with yet.
» »
» » Medical researchers aren’t in the business of telling the truth about
» » their timelines to market on things in development. Blatant
» » underestimations of timelines in that industry have become like steriods
» in
» » baseball - it’s so commonplace that you basically get penalized by NOT
» » doing it.
I agree… dont waste precious interviewing time and questions asking questions which cannot and will not be answered acurately.
» » Dr. Gail Naughton of Histogen has agreed to do a small Q&A with our
» » community. The Q&A will be limited to approximately 10 questions. Forum
» » members are welcome to submit your questions in this thread, in an
» orderly
» » fashion. Kindly note that Dr. Naughton has NO OBLIGATION to
» answer
» » each and every question submitted here. Please be respectful with your
» » questions and stay on topic.
»
» I’d like to know:
» If they’ll release any 5month photos.
» What’s the deal with their lawsuit, and it’s effect on their product
» release.
» Are they still looking for investors/ individual donations?
» Are they still on track for a 2015 release, or do their recent findings
» indicate an earlier or later release?
I agree… the question about the lawsuit which has scared off investors is indeed a big deal and is definatly an issue. However i’m not sure how truthfully this question can be answered.
» Okay, would you think my question below is a legitimate and productive
» question?
» »
» » » But has ANYONE asked if this formula has been tested for side
» effects?
»
» So I will ask this one directly to Dr. Naughton.
»
» Dr. Naughton, has this drug been tested for side effects? Is there any
» knowledge of it causing side effects? Is it safe?
»
I would have been if it hadn’t already been answered in the press release in this very thread! It makes me wonder if you really read the original post, which is a press release about their efficacy and safety trial showing no signs of side effects. Wouldn’t it be rather unneccesary to waste one question when we already know the answer, an answer which was communicated directly by Histogen in a press release? Wouldn’t it make her wonder why we didn’t even have the courtesy to read up before asking questions? Anyway, I’m digressing and won’t waste more space by debating this. Suffice it to say I vote for not including this question.
» » Okay, would you think my question below is a legitimate and productive
» » question?
» » »
» » » » But has ANYONE asked if this formula has been tested for side
» » effects?
» »
» » So I will ask this one directly to Dr. Naughton.
» »
» » Dr. Naughton, has this drug been tested for side effects? Is there any
» » knowledge of it causing side effects? Is it safe?
» »
» I would have been if it hadn’t already been answered in the press
» release in this very thread! It makes me wonder if you really read the
» original post, which is a press release about their efficacy and safety
» trial showing no signs of side effects. Wouldn’t it be rather
» unneccesary to waste one question when we already know the answer, an
» answer which was communicated directly by Histogen in a press release?
» Wouldn’t it make her wonder why we didn’t even have the courtesy to read up
» before asking questions? Anyway, I’m digressing and won’t waste more space
» by debating this. Suffice it to say I vote for not including this question.
roger_that is a shill. You’ll notice a reoccurring theme among his posts - he undermines HM while promoting HTs.
» » » Okay, would you think my question below is a legitimate and productive
» » » question?
» » » »
» » » » » But has ANYONE asked if this formula has been tested for side
» » » effects?
» » »
» » » So I will ask this one directly to Dr. Naughton.
» » »
» » » Dr. Naughton, has this drug been tested for side effects? Is there
» any
» » » knowledge of it causing side effects? Is it safe?
» » »
» » I would have been if it hadn’t already been answered in the press
» » release in this very thread! It makes me wonder if you really read
» the
» » original post, which is a press release about their efficacy and
» safety
» » trial showing no signs of side effects. Wouldn’t it be
» rather
» » unneccesary to waste one question when we already know the answer, an
» » answer which was communicated directly by Histogen in a press release?
I hope you people realize this product is more than likely already on the market as a skin wrinkle cream…
» » Wouldn’t it make her wonder why we didn’t even have the courtesy to read
» up
» » before asking questions? Anyway, I’m digressing and won’t waste more
» space
» » by debating this. Suffice it to say I vote for not including this
» question.
»
» roger_that is a shill. You’ll notice a reoccurring theme among his posts -
» he undermines HM while promoting HTs.
» » I hope you people realize this product is more than likely already on
» the
» » market as a skin wrinkle cream…
»
» Do you mean this ? :
»
» http://www.histogenaesthetics.com/products.htm
Yes, the product uses the same growth factors. The hair trials however were done by injecting the growth factors. Don’t know the dalton size of the growth factors and there ability to penetrate to the follicles via topical non-injection application.
» I agree… dont waste precious interviewing time and questions asking
» questions which cannot and will not be answered acurately.
Sometimes I don’t understand the logic of this board. Does it mean that you guys don’t care even if Dr. Naughton thinks that it will take 10 years before it hits the market? I am with Hmorht on this one, if the product is not going to hit the market soon enough, I might get fue now while waiting for one of these companies to come through for us. I think this question is a must-have!
» I would like to know if the skin product that is currently for sale has the
» same growth factors as the hair product. My guess is yes but obviously in
» a different base.
I wouldn’t ask for growth factors but for the WNTs. that might be the reason why they are injecting it.
Sometimes I don’t understand the logic of this board. Does it mean that you guys don’t care even if Dr. Naughton thinks that it will take 10 years before it hits the market? I am with Hmorht on this one, if the product is not going to hit the market soon enough, I might get fue now while waiting for one of these companies to come through for us. I think this question is a must-have!
You’re saying “why don’t you guys care?”
We’re trying to tell you that we DO care, but we don’t think anything that comes out of their mouth about timelines will be reliable in any way whatsoever. It’s not the same thing as not caring.
» » I agree… dont waste precious interviewing time and questions asking
» » questions which cannot and will not be answered acurately.
»
» Sometimes I don’t understand the logic of this board. Does it mean that
» you guys don’t care even if Dr. Naughton thinks that it will take 10 years
» before it hits the market? I am with Hmorht on this one, if the product
» is not going to hit the market soon enough, I might get fue now while
» waiting for one of these companies to come through for us. I think this
» question is a must-have!
cannot and will not be answered acurately. If I knew i wld be getting an honest answer… ofcourse i would ask. But when have we ever gotten an honest answer when asking about timelines?
» cannot and will not be answered acurately. If I knew i wld be getting an
» honest answer… ofcourse i would ask. But when have we ever gotten an
» honest answer when asking about timelines?
Well, the answer will carry some information. Let’s put it this way: if she says 5 years, then we KNOW it wont be coming faster than that. The answer we get is likely going to be the theoretical best-case, if-all-goes-incredibly-well scenario, which we all know should be multiplied by 3, give or take, to yield a more likely timeline. That’s just the nature of any complicated project.
Although I personally don’t care that much about the timeline, I can see how it is important for others. Getting an optimistic estimate from someone who actually knows what she is talking about beats wild forum speculation.
We could perhaps ask what her opinion is regarding FDA trials and what she thinks they will have to do, should they go down that route. What phases, the number of subjects in the trials, etc. Also, what about the prospect of releasing it outside the US without FDA trials while simultanously doing FDA trials in the US. That way they can get the best of two worlds: the product can start generating some income abroad while they push ahead and get FDA approval in the US. Just her general thoughts on the subject, basically.
Regarding the GFs, I guess WNT is one of the secreted factors they extract from the fibroblasts, along with a number of other growth factors. The fact that their skin product also contains GFs from fibroblasts, neoither means it contains the same GFs nor the same concentrations. And then there’s the vehicle. But sure, we could ask about the difference. Do they contain the very same growth factors? In similar concentrations? If not, what is the difference?
I wonder if anyone is using it, I’m going to google it again but last time I couldn’t find anything, but I admit I didn’t try it very hard, there are a lot of skin forums out there with people using everything you can imagine… and more
» » » I hope you people realize this product is more than likely already on
» » the
» » » market as a skin wrinkle cream…
» »
» » Do you mean this ? :
» »
» » http://www.histogenaesthetics.com/products.htm
»
» Yes, the product uses the same growth factors. The hair trials however
» were done by injecting the growth factors. Don’t know the dalton size of
» the growth factors and there ability to penetrate to the follicles via
» topical non-injection application.
How do you know that? If that is true… We can try to use it with a dermaroller and the cream to see what happens.
» Dr. Gail Naughton of Histogen has agreed to do a small Q&A with our
» community. The Q&A will be limited to approximately 10 questions. Forum
» members are welcome to submit your questions in this thread, in an orderly
» fashion. Kindly note that Dr. Naughton has NO OBLIGATION to answer
» each and every question submitted here. Please be respectful with your
» questions and stay on topic.
»
» For those who are not familiar with Histogen’s Hair Stimulating Complex
» (HSC) clinical trial, please read the following press release.
»
» ===========================================================
»
» Histogen Hair Regrowth Clinical Trial Presented at ISHRS Annual
» Meeting
» Data shows statistical significance at three key efficacy
» endpoints
»
» SAN DIEGO, July 27, 2009 - Histogen, Inc., a regenerative medicine company
» developing solutions based on the products of newborn fibroblasts grown
» under embryonic conditions, shared the results of the Company’s preliminary
» clinical trial of Histogen’s HSC human hair regrowth product for the first
» time at the International Society of Hair Restoration Surgeons (ISHRS)
» Annual Scientific Meeting. Dr. Craig Ziering, founder of Ziering Medical
» and principal investigator on the clinical trial, addressed attendees on
» July 25th, 2009 during the conference, taking place in Amsterdam July
» 22-26, 2009.
»
» Patients treated with Histogen’s Hair Stimulating Complex (HSC)
»
»
» 3 months
» Hair count + 22.4%
» Terminal hair + 27.8%
» Thickness + 23.9%
»
»
»
» ==============================
»
» 3 months
» Hair count + 23.7%
» Terminal hair + 24.2%
» Thickness + 22.2%
»
»
»
» HSC is a proprietary formulation of naturally secreted embryonic proteins,
» growth factors and contains the first naturally stabilized, bioactive
» solution of Wnt proteins and their cofactors, which have been implicated in
» the induction of new hair follicle formation and growth.
»
» The five-month double-blind, placebo-controlled clinical trial was focused
» on evaluation of safety in the clinical application of Histogen’s Hair
» Stimulating Complex (HSC), formerly known as ReGenica. The 24 subject
» clinical trial was designed to examine the safety and efficacy of a single
» injection of HSC alone, as well as in combination with three different
» perturbation methods. Quantitative analysis of clinical macrophotography
» and subject biopsies were utilized to evaluate treatment safety and
» efficacy.
»
» Efficacy at 12 weeks with one Application of HSC
»
» cumulative thickness density (mm/cm2) p=0.0249
» thickness mean (um) p=0.0402
» terminal hair density (n/cm2) p=0.0029
»
»
»
» 84.6% of the patients receiving one injection of Histogen’s serum-free HSC
» showed an increase in terminal hair 12 weeks post-injection, with a
» statistically significant (p<0.05) increase in the number of terminal
» hairs, cumulative hair thickness density and hair thickness mean.
» Perturbation did not enhance the results seen with HSC. There were no
» adverse reactions seen in any of the treated 24 patients at baseline, 12
» weeks, or the 22 week endpoint.
»
» “We are excited that our trial demonstrated safety and efficacy of our HSC
» product, which contains Wnt proteins and other growth factors important to
» hair follicle maintenance and growth,” said Dr. Gail K. Naughton, CEO of
» Histogen. “Wnt signaling has been shown by a number of experts in the field
» to be responsible for initiating epidermal stem cells to form new hair
» follicles in mice, and to be important in maintaining the hair inducing
» activity from existing follicles. Histogen’s trial is the first
» demonstration that compounds containing bioactive Wnt increase hair growth
» in humans.”
»
» While additional clinical evaluation is needed to further examine product
» safety, efficacy and treatment specifications, the preliminary clinical
» trial of HSC represents a potentially significant new treatment option for
» the millions suffering from hair loss. Of the 87 million people in the
» United States that suffer from hair loss, it is estimated that only 2-7%
» seek surgical or pharmacological treatment. The same is true
» internationally due to the general lack of effective medical options for
» this widespread condition.
»
» “Hair restoration treatments range in effectiveness and invasiveness. All
» of the current treatment options share the common goal of saving and
» redistributing existing hairs,” said Dr. Craig Ziering. “For the millions
» of men and women who grapple every day with their hair loss, the results of
» our HSC trial indicate the potential for a phenomenal treatment option that
» stimulates growth of new hairs along with increasing the thickness of
» existing hairs. Histogen’s HSC represents a potentially major paradigm
» shift from conventional treatment options to one that can promote the
» growth of new or dormant hairs using principles of the body’s own
» regenerative mechanisms.”
»
» About Histogen
»
» Histogen, launched in 2007, seeks to redefine regenerative medicine by
» developing a series of high value products that do not contain embryonic
» stem cells or animal components. Through Histogen’s proprietary bioreactors
» that mimic the embryonic environment, newborn fibroblasts are encouraged to
» naturally produce the vital proteins and growth factors from which the
» Company has developed its rich product portfolio. Histogen has two product
» families - a proprietary liquid complex of embryonic-like proteins and
» growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.
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That’s just the nature of any complicated project.
