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"Is Histogen Hair to Stay?" - Article


#1

The following is a direct copy and paste / quote from xconomy.com:

"Is Histogen Hair to Stay? Amid Patent Lawsuit That Is Mane Event, CEO Updates Plans to Advance its Hair Regrowth Treatment
Bruce V. Bigelow 1/15/10

San Diego-based Histogen became something of a high-wire act on the local biotech scene last year after a cross-town rival filed a patent infringement lawsuit against the startup—upending Histogen’s plans to develop a variety of regenerative medical treatments.

The patent suit, which was filed a year ago by Carlsbad, CA-based SkinMedica, hit just as Histogen was preparing to report early results of its experimental treatment to stimulate hair regrowth among 24 men with male-pattern baldness. As we reported at the time, the prospect of costly litigation prompted a group of angel investors to withdraw their planned $2.4 million investment, and Histogen was forced to lay off all 36 employees.

At that time, it seemed likely that the teetering startup was headed for a fall, and Histogen would soon be history.

That still could be the outcome. Lawyers for Histogen filed a request for a summary judgment last August that would dismiss the case. Lawyers for SkinMedica filed their response in September, arguing to keep the lawsuit on track and headed for trial. I reviewed the filings in San Diego federal court yesterday, and U.S. District Judge Thomas J. Whelan has yet to rule on the arguments over Histogen’s bid for an early dismissal.

Meanwhile, as I reported in an end-of-the-year summary, many Xconomy readers continue to root for success in Histogen’s experimental treatment for male pattern baldness.

But we haven’t heard much from Histogen since July, when the startup reported final results of its early study. In the experiment, a single injection of the company’s hair regrowth product—formerly known as ReGenica, now called Hair Stimulating Complex, or HSC—was made just beneath the scalp. Histogen says nearly 85 percent of the two dozen balding men had more hair three months after being treated, and they experienced an increase in hair thickness and density.

To get an update, I recently spoke by telephone with Histogen CEO Gail Naughton, who highlighted the company’s latest plans for carrying on development of its hair regrowth treatment. The short version, for all the readers out there hoping for better treatments, is that Histogen (if it can survive) is planning to conduct additional clinical trials of its hair regrowth product in Singapore. Those experiments are expected to take about two more years. But even if regulators approve this particular treatment, it will only be available in parts of Asia—not the United States.

In our conversation, Naughton highlighted these key points:

—The initial experiment testing the HSC treatment was done in Honduras. Naughton says there were no safety issues “clinically or histologically.” She says Histogen is expected to report results from a 1-year follow-up of the Honduras study by the end of this month, and the one-year data will be submitted to the International Society of Hair Restoration Surgery’s professional journal.

—Histogen plans to enroll 50 patients in another HSC experiment that will be done in Singapore. This study will begin “no later than June,” according to Naughton, who notes that Singapore has become a mecca for aesthetic and cosmetic medical treatments.

—Providing that the Singapore study is successfully completed, Naughton says Histogen plans to conduct a late-stage clinical trial of its hair regrowth treatment that will enroll between 200 and 250 patients from Hong Kong, India, South Korea, and Singapore. She says the trial is scheduled to begin in spring 2011. “If everything goes well,” Naughton says, “we expect to get pan-Asian approval [for the HSC treatment] everywhere but Japan.”

—Histogen plans to begin two additional pilot trials of HSC as a topical treatment (with no injections below the skin) in the United States over the next six months. Dr. Craig Ziering, a Southern California hair transplant surgeon, will oversee the tests. Ziering, an osteopath who has offices in Beverly Hills, Newport Beach, La Jolla, Las Vegas, NV, and Salt Lake City, UT, also sits on Histogen’s scientific advisory board. Naughton says one of the studies will apply HSC to transplanted hair follicles and is intended to test its suitability in preventing hair loss. The other U.S. study calls for applying HSC on scar tissue from previous hair transplant procedures.

So how is Histogen going to pay for all these clinical trials? Naughton says the startup also has made progress on that front, but she’s not ready to talk about it just yet. Standby for more news from Histogen in the weeks to come."

http://www.xconomy.com/san-die…-regrowth-treatment/


#2

There’s more to that story beyond this article:

Apparently they have raised $4.4 million in series A funding (amidst the lawsuit) and are looking for another $2.3 million in series A. Then they will immediately start raising series B funding.

The series A cash was intended to keep things moving and design an Asian clinical trial.

The series B funding is intended to create a manufacturing facility and to conduct the Asian trial which would consist of ~300 subjects.

If the Asian trial is successful, they can go directly to market in Asia, excluding Japan…no more waiting. Then they will look to the US. They showed 2 photos at the 5 month mark (to investors) with the average increase in hair being over 20% with a single injection…some over 40%. The photos, like those seen on their website, are of an area the size a nickel. A 20% increase in this nickel sized area was equivalent to 100 additional hairs.

They say there were absolutely no safety issues and they feel like they can increase the effectiveness with multiple injections or by increasing the dosage.

I’m not sure what’s happening with the lawsuit motion for Summary Judgment, but HSC is not a subject of the lawsuit.


#3

I wanna know about the new hair cycling and longer term androgen resistance.

If it works and comes to market, would this be a functional cure? Or just a much better maintinence drug, like a hair-oriented botox that must be repeated constantly? I don’t hear anything about these issues in the stories about the stuff.


#4

» I wanna know about the new hair cycling and longer term androgen
» resistance.
»
» If it works and comes to market, would this be a functional cure? Or just
» a much better maintinence drug, like a hair-oriented botox that must be
» repeated constantly? I don’t hear anything about these issues in the
» stories about the stuff.

A botox-like injection every 3-5 years doesn’t sound so bad to me.

It’s more important to know whether or not the results are compoundable or increase with higher dosage injections. If they are, they probably really got something.


#5

thanks both for the info.

I am amazed by how fast this company is able to move forward with trials. This by itself deserves attention.
They plan to have soon 1-year data from the Honduras study.
Apparently the new hairs have no direction issues, and this makes me think that they are rejuvenated follicles.
20% average increase at 5 months is quite soso. I want to know what happens in a totally bald spot.
We don’t know if the hairs cycle, or if they will be DHT resistant (other poster has risen this concern too).

The 50 subjects-Singapore trial is a decent one (PhaseI and II)
The 300 men trial (Phase III) is very impressive.
These are real tials, not phoney ones like ICX’s.
Also, we know that Histogen has good photographic equipment and good analysis of the data, and the design of the tests seem quite rational.

The fact that they are again rising funds is also good news.

well, lets see what happens. Its worth the wait, because they are so fast and expeditive!!

Doing the trials abroad permits blazing fast timings. We will l see if these trials are trustworthy like the US-ones (are these trustworty?).

» There’s more to that story beyond this article:
»
» Apparently they have raised $4.4 million in series A funding (amidst the
» lawsuit) and are looking for another $2.3 million in series A. Then they
» will immediately start raising series B funding.
»
» The series A cash was intended to keep things moving and design an Asian
» clinical trial.
»
» The series B funding is intended to create a manufacturing facility and to
» conduct the Asian trial which would consist of ~300 subjects.
»
» If the Asian trial is successful, they can go directly to market in Asia,
» excluding Japan…no more waiting. Then they will look to the US. They
» showed 2 photos at the 5 month mark (to investors) with the average
» increase in hair being over 20% with a single injection…some over 40%.
» The photos, like those seen on their website, are of an area the size a
» nickel. A 20% increase in this nickel sized area was equivalent to 100
» additional hairs.
»
» They say there were absolutely no safety issues and they feel like they
» can increase the effectiveness with multiple injections or by increasing
» the dosage.
»
» I’m not sure what’s happening with the lawsuit motion for Summary
» Judgment, but HSC is not a subject of the lawsuit.


#6

Having to get the injections redone every 3-5 years wouldn’t bother me either. But needing to boost it every 3-5 weeks would be a different story.

So much depends on whether the results are compoundable or not. IMHO that is the million-dollar question right now.


#7

» Having to get the injections redone every 3-5 years wouldn’t bother me
» either.

well, that would bother me, but if I have no better option, then lets do it.

But needing to boost it every 3-5 weeks would be a different
» story.
»
»
» So much depends on whether the results are compoundable or not. IMHO that
» is the million-dollar question right now.


#8

n/t


#9

If it actually produced decent density, I would be ok with topping up every 5 or 6 months even. Not that big of a deal, but they’d have to take pricing into consideration.

3-5 weeks is pretty quick for hair to just fall out/go away even if its not DHT resistant.


#10

Topping it off again every 6 months won’t seem so minor if you’re living in the USA or europe and this stuff is only legal in asia for several more years to come.

Seriously, we don’t know jack squat right now except that it has produced good pics.

If Aderans produced good pics then we would probably be trusting the technology to beat the androgen problem just because of the core method it employs. But we don’t really know that about Histogen yet. I have the feeling it will either work very well or very temporarily/poorly.


#11

» Topping it off again every 6 months won’t seem so minor if you’re living in
» the USA or europe and this stuff is only legal in asia for several more
» years to come.
»
»
»
» Seriously, we don’t know jack squat right now except that it has produced
» good pics.
»
» If Aderans produced good pics then we would probably be trusting the
» technology to beat the androgen problem just because of the core method it
» employs. But we don’t really know that about Histogen yet. I have the
» feeling it will either work very well or very temporarily/poorly.

I really doubt that it won’t be compundable. If it’s not compounable then they have a mediorce (if anything) treatment. If they didn’t think their single injection results weren’t compoundable I very much doubt they’d be where they are today and pushing forward as they are. The big money, imo, is in a compundable result.


#12

posted by mj2003 , Toronto, 03.02.2010, 00:40
I really doubt that it won’t be compundable. If it’s not compounable then they have a mediorce (if anything) treatment. If they didn’t think their single injection results weren’t compoundable I very much doubt they’d be where they are today and pushing forward as they are. The big money, imo, is in a compundable result.
One could argue that our current treatments are compoundable to a certain, albeit very limited, extent (that includes HTs as well). The real question is what will be Histogen’s actual product threshold.

posted by cal, 03.02.2010, 00:15
Topping it off again every 6 months won’t seem so minor if you’re living in the USA or europe and this stuff is only legal in asia for several more years to come.
Histogen does claim HSC is soluble which makes it a solid candidate for topical applications (in the form a of a shampoo - something Histogen is actually considering), so theoretically, if you could achieve hair growth with HSC, you could probably maintain it with their topical


#13

It all sounds good. I just hope it pans out anything like as well (and as soon) as it sounds.

Right now you can turn on mainstream shows like Oprah Winfrey and listen to doctors tell you that current MPB treatments “can generally stop the continued loss” and they are “virtually side effect free.”

Of course that stuff is bullsh*t, but that’s still the mainstream story on the current existing products. Unfortunately I expect a similar set of small to medium letdowns with any new HM method too. So I don’t get excited unless the early press is pretty dynamite.


#14

» It all sounds good. I just hope it pans out anything like as well (and as
» soon) as it sounds.
»
»
» Right now you can turn on mainstream shows like Oprah Winfrey and listen
» to doctors tell you that current MPB treatments “can generally stop the
» continued loss” and they are “virtually side effect free.”
»
» Of course that stuff is bullsh*t, but that’s still the mainstream story on
» the current existing products. Unfortunately I expect a similar set of
» small to medium letdowns with any new HM method too. So I don’t get
» excited unless the early press is pretty dynamite.

so hold on, somehow i lost track of info. histrogen is going to start phase 3 or they are already process of it? d@mn it would be nice to have this now.


#15

I am curious about this product as well.

Found this link

They said:
…it plans to release at the end of this month the results of a one-year follow up to an earlier study that showed hair growth in 85 percent of patients. posted on the 22-01-2010

It looks like having a lawsuit speeds things up, and causes photos/results to come out faster. :slight_smile:

Don’t know what phase either.

PS: Very sorry if i am not the first one posting this link.


#16

Hey guys
do you have some news about histogen?
the result in January had to exit!


#17

Did you see?
There are some little news!

Upcoming Events

Hilton Head - "Regenerative Medicine: Advancing to Next Generation Therapies"
March 10-14. 2010
Hilton Head Island, SC
Histogen to present: “Clinical Evaluation of Fibroblast-Secreted Proteins to Induce Hair Growth in Humans”, “Evaluation of a Bioengineered Human Extracellular Matrix for Wound Healing Applications”, “Hypoxic Culture Conditions Induce Stem Cell Marker Expression in Human Dermal Fibroblasts”


#18

» Did you see?
» There are some little news!
»
»
» Upcoming Events
»
» Hilton Head - “Regenerative Medicine: Advancing to Next Generation
» Therapies”
» March 10-14. 2010
» Hilton Head Island, SC
» Histogen to present: “Clinical Evaluation of Fibroblast-Secreted Proteins
» to Induce Hair Growth in Humans”, “Evaluation of a Bioengineered Human
» Extracellular Matrix for Wound Healing Applications”, “Hypoxic Culture
» Conditions Induce Stem Cell Marker Expression in Human Dermal Fibroblasts”

Yeh, good find. Here’s the link http://www.histogen.com/aboutus/news.htm

Upcoming Events

Hilton Head - "Regenerative Medicine: Advancing to Next Generation Therapies"
March 10-14. 2010
Hilton Head Island, SC
Histogen to present: “Clinical Evaluation of Fibroblast-Secreted Proteins to Induce Hair Growth in Humans”, “Evaluation of a Bioengineered Human Extracellular Matrix for Wound Healing Applications”, “Hypoxic Culture Conditions Induce Stem Cell Marker Expression in Human Dermal Fibroblasts”

American Association for Cancer Research (AACR) Annual Meeting
April 17-21, 2010
Washington, D.C.
Emmett Pinney to present poster entitled “Coating polymers with a human extracellular matrix (hECM) significantly improves implant biocompatibility”

Society for Investigative Dermatology (SID) Annual Meeting
May 5-8, 2010
Atlanta, Georgia
Dr. Jonathan Mansbridge to present poster entitled “Clinical Evaluation of Embryonic-like Fibroblast Secreted Proteins to Induce Hair Growth”


#19

» Did you see?
» There are some little news!
»
»
» Upcoming Events
»
» Hilton Head - “Regenerative Medicine: Advancing to Next Generation
» Therapies”
» March 10-14. 2010
» Hilton Head Island, SC
» Histogen to present: “Clinical Evaluation of Fibroblast-Secreted Proteins
» to Induce Hair Growth in Humans”, “Evaluation of a Bioengineered Human
» Extracellular Matrix for Wound Healing Applications”, “Hypoxic Culture
» Conditions Induce Stem Cell Marker Expression in Human Dermal Fibroblasts”

I don’t think any of this will be new information. Sounds like it’s just a presentation to gain more funding.

Either way, Histogen started or is starting soon clinical trials in Asia. We should know more towards the end of 2010.


#20

» Either way, Histogen started or is starting soon clinical trials in Asia.
» We should know more towards the end of 2010.

Post by buckerine11:
http://www.hairsite.com/hair-loss/posting-id-60211-page-2-category-1-order-last_answer-descasc-DESC-view-board.html
» Dr. Naughton addressed this question in one of the other forums. She said
» that Histogen is starting another set of clinical trials in early 2010 in
» Singapore. If those results are favorable, then they are going to set up
» pan-Asian Phase III trials. If all goes well, it’s possible to have a
» product available in Asia (sans Japan) by 2013, and a product available in
» the US a year later.

Anyway, that’s what Dr. Naughton (Histogen) said to Spencer Kobrein, Nov 17, 2009.