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

[JJacobs152]

Seems like Histogen has had good results. They just released their latest press release article online. However, they're results are best seen between the age groups of 40-59.

Histogen Announces Initial Results from Phase I/II Clinical Trial of HSC
Data shows significant efficacy at all time points and all treated hair loss regions
SAN DIEGO, October 19, 2012 - Histogen, Inc., a regenerative medicine company developing innovative therapies based on the products of cells grown under simulated embryonic conditions, will present preliminary data from the ongoing clinical trial of its Hair Stimulating Complex (HSC) today at the International Society of Hair Restoration Surgery (ISHRS) Annual Meeting. Statistically significant improvement was seen across all targeted hair growth parameters in this Phase I/II clinical trial, with an 86% responder rate.
The double-blind Phase I/II clinical trial was undertaken to further examine the safety and efficacy of intradermal injections of HSC in 56 men with androgenetic alopecia. In addition to other safety outcome measures, clinical evaluation of blood serum chemistry, hematology and urinalysis showed no indication of toxicity over 12 weeks. The treatment was well-tolerated and no study-related adverse events have been reported.

In this second clinical trial of HSC, which was designed with an additional treatment timepoint, the increase in total hair count was 46.5% above that seen in the pilot HSC trial at 12 weeks. Statistical significance was noted in all efficacy endpoints, which include increases in total hair count (p=0.0013), terminal hairs (p=0.0135), and hair thickness (p=0.026). A significant increase in vellus hair count (p=0.033) was seen for the first time, supporting the hypothesis that the HSC treatment rescues dying follicles, in addition to converting vellus to terminal hairs and increasing the number of hairs per follicle. Statistical significance continued to be seen at the 24 week time point.

"We are excited that HSC has not only continued to show unprecedented results, but that the addition of a second treatment time point in the Phase I/II clinical trial has resulted in even greater hair growth than the pilot study," said Gail K. Naughton, Ph.D., Histogen CEO and Chairman of the Board. "Particularly compelling is the growth seen in more difficult types and stages of hair loss. Without limitations to treatment area, age or stage of balding, HSC has the potential to expand the hair restoration market by offering a successful option to those that currently have none."

Available non-surgical treatment options for alopecia focus on younger patients in the earlier stages of hair loss, with a primary purpose of retaining existing hair and supporting limited hair regrowth. This is not the trend seen in the clinical trials of HSC. In both the pilot and Phase I/II clinical trial, HSC treatment has shown efficacy across age groups, with subjects age 40-59 seeing cosmetically significant results beginning at 12 weeks, including a mean increase of 39% in terminal hairs and 19.4% in total hair count in this age group in the current trial.

Importantly, the efficacy of HSC is not limited by hair loss region. The Phase I/II clinical trial has shown noted new hair growth in subjects treated in all regions of the scalp, including temporal recession, mid-scalp and vertex. Subjects receiving HSC in the temporal recession, which is known to be more difficult to treat than other areas of hair loss, saw marked improvement in terminal hair count, with a mean increase of 22.6% at 12 weeks and 25.2% at the 24 week time point.

In addition to the Phase I/II data, Dr. Naughton will present results from a Physician-sponsored IND of HSC conducted by Dr. Craig Ziering, an ISHRS member and leading hair restoration surgeon. Five men and five women received up to four treatments of HSC, with all subjects showing positive hair growth. Increased hair growth was seen as early as 6 weeks, with clinically and cosmetically relevant results seen as early as 18 weeks.

"The clinical data seen to date with HSC is very compelling," said Dr. Craig Ziering, Founder and CEO of Ziering Medical. "Not only is the strong safety profile clinically important, but we have seen cosmetically significant results, with coverage of thinning areas, in a clinical setting. In addition, the response seen in women treated with HSC is unprecedented."

HSC is a complex of proteins and growth factors naturally secreted by multipotent cells under Histogen's proprietary growth conditions. The proteins within HSC, such as KGF, VEGF, and follistatin, are involved in signaling stem cells in the body, and have been shown to be key in hair formation and the stimulation of resting hair follicles.

"Scalp Injection of Active Embryonic-like Cell-secreted Proteins and Growth Factors" will be presented by Dr. Naughton at the ISHRS Annual Meeting, taking place October 17-20, 2012, in the Bahamas.

[534623]

Seems like Histogen has had good results. They just released their latest press release article online. However, they're results are best seen between the age groups of 40-59.

This is the original source/press release:

http://www.prweb.com/releases/2012/10/prweb10032346.htm

Female result (before/after):
http://ww1.prweb.com/prfiles/2012/10...0-%2019wks.jpg

Male result (before/after):
http://ww1.prweb.com/prfiles/2012/10...20-%2024wk.jpg

Convincing? Impressed? Let me know ...

The male patient -I think- is more than 40 years. Does it mean a young patient will see -0 result?

[JJacobs152]

This is the original source/press release:

http://www.prweb.com/releases/2012/10/prweb10032346.htm

Female result (before/after):
http://ww1.prweb.com/prfiles/2012/10...0-%2019wks.jpg

Male result (before/after):
http://ww1.prweb.com/prfiles/2012/10...20-%2024wk.jpg

Convincing? Impressed? Let me know ...

The male patient -I think- is more than 40 years. Does it mean a young patient will see -0 result?

You fail to comprehend that Histogen's method is a completely new and innovative method of helping BOTH sexes with andro. alopecia. An injection form of medium, that hasn't showed any side effects as of yet. Lets run through history real quick and see what the current treatments and their side effects are, shall we?

Minoxidil - potent vasodilator that can make you hypotensive, causing tachycardia, and other array of symptoms.
Finasteride - people have talked about ED, to the point where they've fallen into depression.
RU - nothing about this can even be said, since there is hardly any data.

I'm not sure, but can females with andro aloopecia take fin - no they can't, especially if they plan on having children, since the drug is a teratogen.

I'd say the results from those pictures is pretty good, taking into consideration what is currently available on the market. Not sure why you're trying to bash their results.

Atleast, unlike a certain HT physician overseas, they're providing well documented pictures, protocols, and willing to let the rest of the world see their plans and future outlook on hair "regeneration".

[rdawg]

This is great news IMO, a true help to those with moderate hairloss including in the temples. So far(not sure if they may tinker with it to make it better) it seems perfect for those in the NW1-4 range.

I suppose this means Phase III is going to be approved?

I do have to ask how long these hairs last though? do they just get lost without something like Fin being used?

quite excited to see a product that actually causes noticeable growth, even if it's not a fullout cure, combining this with Minoxidil+Fin may get a NW3-4 back to a NW1-2.

A little glimmer of hope came out today, I'll be getting some of my hair back with this stuff within a few years!

[The Alchemist]

I'd say the results from those pictures is pretty good, taking into consideration what is currently available on the market. Not sure why you're trying to bash their results.

Atleast, unlike a certain HT physician overseas, they're providing well documented pictures, protocols, and willing to let the rest of the world see their plans and future outlook on hair "regeneration".

Think you answered your own question here. Ironman's posting frequency peaks whenever news comes out that indicates the future of his employers business may not be in such great shape. With results like Histogen just presented, i expect his posting to reach a fevered pitch and level of hysteria that hasn't been seen before.

A mean of 40% new terminals is phenomenal! And with a response rate of nearly 90%. That is great news!

[UK_]

Some people know me as a huge sceptic.

However, I have never heard a legitimate company in 20 years of hair loss research make a statement like this that I actually believed:

"Importantly, the efficacy of HSC is not limited by hair loss region. The Phase I/II clinical trial has shown noted new hair growth in subjects treated in all regions of the scalp, including temporal recession, mid-scalp and vertex. Subjects receiving HSC in the temporal recession, which is known to be more difficult to treat than other areas of hair loss, saw marked improvement in terminal hair count, with a mean increase of 22.6% at 12 weeks and 25.2% at the 24 week time point."

I remember a few months ago we were all wondering if Histogen (HSC) would even work in the temporal regions - and there we have it, our first clinical study showing a treatment being effective on the most difficult area to treat... the temples!!

[Ted]

I got very disappointed from the pics.
The first pic of the woman are overexposed probably taken with a flash. In the same lightning conditions the hair would probably look exactly the same.

The first pic of the man have his hairs brushed to the sides to reveal the thin areas, whereas in the second pic the hair is brushed to cover the thin areas.

I really high hope for Histogen but these pics have made me loose all trust in them.
This ****ing industry stinks!

Edit. The angels are also different in the pics which makes the hair look thicker

[Artista]

@JJacobs152 Thank you for posting this my friend

[The Alchemist]

Some people know me as a huge sceptic.

However, I have never heard a legitimate company in 20 years of hair loss research make a statement like this that I actually believed:



I remember a few months ago we were all wondering if Histogen (HSC) would even work in the temporal regions - and there we have it, our first clinical study showing a treatment being effective on the most difficult area to treat... the temples!!

Agreed - the temples are the first to go. Most balding men lose them in their 20s. So those patients in this study being at least 40 yrs of age and getting growth in an area have most likely been skin bald in that area for at least a decade, maybe more. That takes a sledge hammer to the theory of follicles reaching a "point of no return", which was being tossed around on the various forums.

Hopefully they can push this through and get it released into Asian markets early.

[rdawg]

I got very disappointed from the pics.
The first pic of the woman are overexposed probably taken with a flash. In the same lightning conditions the hair would probably look exactly the same.

The first pic of the man have his hairs brushed to the sides to reveal the thin areas, whereas in the second pic the hair is brushed to cover the thin areas.

I had really high hope for Histogen but these pics have made me loose all trust in them.
This ****ing industry stinks!

I dont know what you're looking at but the mans hair is clearly thicker and he definitely has more hair. That is not simply 'brushing' it to cover up spots.

dont expect the first actual growth product to give you a full head of hair within a few months, the fact that this gives NOTICEABLE growth at all is fantastic, there's nothing on the market it like it. Especially in the temple region.

Is this gonna help a NW7? I'm not sure, what happens if they repeat the dose again at one year? what if they did it monthly? questions that could be answered. Maybe it gets even better as more time goes by?

either way, perfect as is for moderate hairloss sufferers.