Histogen

[BALDIE42]

Updates from Histogen... http://www.sddt.com/news/artic...urceCode=20091029crd

 

Full article for all those who are having problems retrieving this article, here it is:

 

Histogen exec sees growing promise in stem cell technology

By ELIZABETH MALLOY

Thursday, October 29, 2009

 

For Gail Naughton, one of the most exciting things about her company Histogen's recent clinical trial is just how fast they're seeing results.

The trial, conducted in South America, is for a hair re-growth treatment. Looking at pictures of patient samples, the before and after differences are easy to see.

"You don't have to be a hair expert to see there are hairs where there were not (before) and they're thicker hairs," Naughton said, looking at photos of patients who received Histogen's hair re-growth treatment in South America. "One injection, we were able to increase it by 100 new hairs."

Hair regrowth is just one of the possible treatments Histogen hopes to generate with its stem cell technology. The company also has the potential to grow new organ cells, nerve cells in the spine, even treat cancer. But Naughton said hair treatments would have a huge initial market, which can bring in funding for other more serious conditions.

"Hair can really generate a lot of excitement and help us raise the cash we need to develop the other products," she said.

Histogen's chairwoman and chief executive, Naughton is somewhat of a rarity in that she is both a scientist and a businesswoman. She is working to make this less of a rarity in her other job -- as dean of San Diego State University's College of Business Administration. There, she has helped develop a joint Ph.D. and MBA program that will teach more scientists business skills, and vice versa.

 

Gail Naughton

A native of Brooklyn, N.Y., Naughton was a scientist first, only learning the business side when she started her first company, Advanced Tissue Sciences Inc., in 1991. The technology Histogen is based on is from Naughton's own research.

While Histogen can be considered a stem cell company, the treatments the company is working on uses a protein secreted by stem cells, rather than the actual cells themselves. The company gets the protein using a unique strategy.

"The whole premise of Histogen is that if you go and grow human cells under conditions that are embryonic-like, the cells will revert back, and become embryonic," she explained.

One of the advantages scientists have long seen with embryonic stem cells is that they secrete a kind of protein called WNT proteins. These are the proteins that signal to cells how to differentiate, or turn into the various muscle, bone, organ and blood cells they should grow into.

Researchesr believed that they could isolate WNT proteins and use them to stimulate tissue growth and regrow things like organs, skin and hair.

Naughton's discovery with Histogen, which was based on other researchers' work, was that by growing cells in an embryonic environment -- low-gravity and low-oxygen -- within a few days, the cells would revert to their embronic state. This means the company could get WNT proteins without having to drestroy actual embryoes.

"We're not the basic, 'A-ha!' discovery research (company)," she explained. "We're there saying, 'We know the composition of what we have, we know what's unique about it, let's go to the literature and see what other people have found to be important with these and let's go after the therapuetic areas, which are our greatest need right now.'"

While it conducts research on different therapuetic treatments, Histogen has products on the market which help generate some cashflow, though not enough to fully fund the company yet. The company sells a stem cell product, and is awaiting FDA approval for a wound care product.

The hair product could be on the market in Asia within the next two years.

Histogen has suffered some setbacks in the last year. The company had 38 employees until last January, when it was hit with a lawsuit over patent infrigement. Histogen had to lay most of the staff off, but still has 11 full-time employees. Naughton said that after another round of fundraising, they hope to begin rehiring.

The company is currently raising money to expand its hair re-growth trial in Asia.

As both the executive officer of Histogen and the dean of SDSU's business school, Naughton acknowledged that she's a very busy woman. She works about seven days a week, whether it's raising venture funding for the company, reading up on new possibilities for WNT proteins or creating international studies programs for her business students. Still, she said, she wouldn't have it any other way.

"By being able to be involved with both, I keep myself at a good balance," she said. "I love what I do."

[Crashul]

Excellent news!!! A hell of a woman this Naughton! Two years seems too good to be true!

I'm keeping my hopes alive.

[Pale_Rider]

Another update from Histogen, video format. Dated Nov. 17th 2009

 

http://www.thebaldtruth.com/ar...%9D-as-soon-as-2013/

[CuriousJungleGeorge]

Is this the sort of transplanted hair that would eventually fall out, or the kind resistant to thinning/loss?

[why oh why]

it's supposed to be resistant... however when she says something about possibly having to get more injections at six months... that makes me wonder

[dying curls]

nowhere it is say it will be resistant.

 

But, i guess if you get the procedure done

then stick to minox and propecia, you can keep the hair for a good amount of time.

 

I am a girl i have AGA due to an hormonal imbalance and my dad's bad genes. I take a treatment to keep my hormones in check. When my hormones(androgens... )are in check i dont loose hair anymore.

So in my case the new hair from the stem cells would be resistant as long as i keep my hormones in check.

 

And let me tell you i would not mind going on taking my treatment all my life and getting the stem cells procedure done if it means i ll have georgeous hair.

 

I would not even lind getting the procedure done several times in my lifetime. i drather pay for that than for a car!!!

[hairmee]

My wish list at 39 is for this company to show real signs of a cure for this mentally challenged problem we all hairloss sufferers face. Someday this will be a breakthrough but I hope it's sooner rather than later.

[dying curls]

yeah me too i dont wanna be a bald lady. i used to have the most meautiful curls. Everybody would tell me how thick and beautiful was my hair. i got nicknames because of my hair... i got the curls from my mom and my mom'd dad and the hair loss from my dad and his mom...

i have a bad relationship with my dad and knowing i inherited this from him made me very angry

[HaiRisWhere]

i haven't really gone through this thread completely.I don't even know whether its promising.But I wonder why aren't the active members on this forum giving any input on this future treatment.

[dying curls]

yes i wonder too....

[wtb_hair]

This forum is the hairtransplantnetwork, which most of the users here talk about the proven methods that have helped changed their lives. The people in this community have seen many "miracle cures" in their lifetime and are slow to join up on something until it is proven.

 

I'm sure everyone here has an optimistic hope for a better cure in the future, but no one wants to create too much of a buzz on something that is not yet proven.

 

But, as a person who has not gotten to the point of needing/wanting a hair transplant, I have hope that I can hold on to the rest of my hair until one of these new cures come out. There is a lot more hope now than ever before, with the advancement in technology and the lift on the research ban, we may be closer than ever to finding the solution.

[brentipold]

I have to agree with wtb, most people on this site have been through it all and seen it all, so they don't get too excited about anything. Especially something thats 3 or 4 years before ever coming to the States. Althought I am pretty excited about it being someone who is in the early stages of hairloss.. It does give me some comfort knowing that something is hopefully not to far off.

[dying curls]

yes i understand...but being a girl this potential futur stem cells treatment are like..the light in the end of the tunnel.

I obsess over my hair and the day i will have a kid. Having a kid is a great thing but for me it will come along with more hair loss....i dont want that. I dont want to chose between my hair and a kid it's not fair.

I miss the days when i had the thicker hair in high school...but then around 17 things started to change...very slowly so slowly that it took me 6 years to notice really (before the first signs were there but not obvious and people thought it was all in my head.)

 

 

Anyway I really really want this to work.

[Shyguy]

it seems that they are trying to raise $2.4MM for funding their operations. if it was that promising that this amount of money would be easily raised don't you think?

 

of course i hope that it is the real deal. i'm just playing devils advocate.

 

thoughts?

[why oh why]

yeah if it were the case that full heads of hair were just a 2.4 mil investment away, it would have happened instantly

[Shyguy]

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

 

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.

[Pale_Rider]

Histogen updates: http://www.prweb.com/releases/2010/05/prweb3953054.htm

 

Hypoxia Induces Stem Cell Gene Expression, Protein Production and Cell Surface Markers

 

Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, will present new findings today at the International Conference on Stem Cell Engineering (ICSCE). Analysis of the cells grown under Histogen's proprietary conditions of hypoxia and low gravity show the expression of specific markers associated with embryonic stem cells.

San Diego, CA (PRWEB) May 3, 2010 -- Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, will present new findings today at the International Conference on Stem Cell Engineering (ICSCE). Analysis of the cells grown under Histogen's proprietary conditions of hypoxia and low gravity show the expression of specific markers associated with embryonic stem cells.

Different cell types can be identified by unique profiles based on the genes they express, the proteins they produce, and markers that they have on their cell surface. Histogen has discovered that, under growth conditions of 2-5% oxygen (hypoxia) and low gravity, safe and non-controversial newborn skin cells (fibroblasts) acquire the profile of pluripotent stem cells.

 

Over 5,000 genes are differentially expressed by these cells, as compared to fibroblasts grown under traditional conditions

What we are seeing is a shift in the profile of these cells to one that is more embryonic-like, more similar to stem cells than fibroblasts.

Reprogramming adult, differentiated somatic cell types through chemical manipulation or genetic transfection to transform the cells into a dedifferentiated, pluripotent stem cell phenotype has been the focus of many recent studies

Induction of Stem Cell Marker Expression in Human Dermal Fibroblasts in Hypoxic Culture Conditions

"Over 5,000 genes are differentially expressed by these cells, as compared to fibroblasts grown under traditional conditions," said Dr. Gail K. Naughton, CEO and Chairman of the Board at Histogen. "What we are seeing is a shift in the profile of these cells to one that is more embryonic-like, more similar to stem cells than fibroblasts." DNA microarray analysis revealed that, under hypoxic culture conditions, fibroblasts upregulate the expression of key embryonic stem cell markers including Oct4, Nanog, and Sox2. These specific genes are known to be critical in the generation of induced pluripotent stem cells. A number of other stem cell-associated markers, such as Brachyury, Gata4, CCR4, LIN28 and Nodal FGF5 were also expressed at higher levels in the hypoxic cultures as compared to fibroblasts grown under normal oxygen levels.

These studies suggest hypoxic culture of somatic cells in large-scale bioreactor systems is a potentially feasible and efficient method for obtaining and producing adequate amounts of pluripotent stem cells and associated factors for clinical regenerative medicine applications.

"Reprogramming adult, differentiated somatic cell types through chemical manipulation or genetic transfection to transform the cells into a dedifferentiated, pluripotent stem cell phenotype has been the focus of many recent studies," said Dr. Jonathan Mansbridge, Chief Scientific Officer at Histogen. "Although these experiments have demonstrated the ability to induce cells back to a pluripotent state, the methods used have raised considerable issues regarding mutagenicity and clinical safety. We now have preliminary evidence that, by altering the oxygen levels under which neonatal fibroblasts are cultured, there is potential for a viable pluripotent stem cell source that would be free of these issues."

 

Human extracellular matrix (hECM) compositions produced under the hypoxia/microgravity conditions discussed here are covered by pending US patent #2010/0047305. "Induction of Stem Cell Marker Expression in Human Dermal Fibroblasts in Hypoxic Culture Conditions" will be presented by Dr. Mansbridge at the ICSCE event, taking place May 2-5, 2010 in Boston, Mass.

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 cells 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. For more information, please visit http://www.histogen.com.

[Pale_Rider]

Fresh updates from Histogen. http://financewests.com/ears/r12e6517027273n52mi/in9852291033

 

 

 

Histogen Welcomes Dr. Hyma Gollamudi as Chief Business Officer

 

Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, announced today that Dr. Hyma Gollamudi has joined the Company as Chief Business Officer. Gollamudi's business and product development expertise will be invaluable as Histogen begins seeking strategic alliances nationally and internationally.

 

"With our early-stage product launches underway, and exciting projects coming quickly down the pipeline, Histogen is increasingly examining relationships with companies, physicians and investors," said Dr. Gail Naughton, Histogen CEO and Chairman of the Board. "I am excited to welcome Hyma Gollamudi to Histogen, and look forward to seeing the Company's business development and strategic planning efforts flourish through her oversight and experience."

 

Dr. Gollamudi brings more than 10 years of experience from the healthcare and financial industries to Histogen. Most recently, she served as a Product Director in the healthcare division of Fair Isaac Corporation, a leading provider of analytics and decision management technology. In this position, Dr. Gollamudi oversaw alliances and partnerships and grew the Company's government (Medicare and Medicaid) and commercial business through dedicated attention to client relationships and client managements.

 

Dr. Gollamudi has authored a number of papers, presented at various healthcare conferences and working groups, and is the co-inventor on two patents. She holds a doctorate in Agricultural Economics from the Ohio State University.

 

"Histogen's broad range of product applications from a single technology platform is intriguing, and offers almost limitless opportunities in markets from research tools to cosmetics," said Gollamudi. "I am excited to work toward forming alliances, navigating products through reimbursement hurdles, and contributing to the Company's success in various markets."

 

Through the Company's proprietary bioreactor technology, Histogen is uniquely capable of simulating the embryonic environment, creating products that are embryonic in nature without containing embryonic stem cells or animal components. From two product families - ExCeltrixTM, Histogen's insoluble human Extracellular Matrix (ECM), and ReGenicaTM, Histogen's proprietary liquid complex - the Company has created a product portfolio which includes applications from stem cell culturing to skin care, tissue regeneration to hair regrowth.

 

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 recently launched its first product - BioNuesisTM Human Stem Cell Culturing Kits - and announced the creation of its cosmeceutical venture - Histogen Aesthetics. For more information, please visit http://www.histogeninc.com.

 

 

 

Author Information

 

Eileen Naughton Brandt

Histogen, Inc.

 

May 10th, 2010

[Blake Bloxham]

Pale_Rider,

 

Thank you for sharing this newest update. It's interesting to see such increased activity from Histogen!

[slowjo]

Does anyone know what they presented at the conference?

[1982UK]

(promotional link removed - sorry, but we don't allow link backs to this community)

 

This is another forum that is tracking Histogen also check this interview it's really good.

 

The second flash audio player down

 

Exclusive interview with Histogen Inc. CEO and Founder Dr. Gail Naughton: (promotional link removed - sorry, but we don't allow link backs to this community)

Edited June 13, 2010 by 1982UK

[Pale_Rider]

Fresh Histogen updates from July 13th(it was not Friday ) 2010

 

 

Histogen Announces Initial Close of Series A Financing Round

 

Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced the initial close of Series A financing at $5.35 million. The round was completed by private and corporate investors, including Secure Medical Inc., CellCeuticals Skin Care Inc., and Leonard H. Lavin, founder and Chairman Emeritus of the Alberto-Culver Company.

 

H 5a8 istogen will utilize the round to fund Phase 1 clinical trials for hair growth and complete 510k submissions for wound and hernia repair applications. The round will also enable the company to upscale manufacturing for ExceltrixTM, Histogen's human Extracellular Matrix product, and HGEN-001, Histogen's proprietary liquid formulation.

 

With the close of this financing, we look forward to bringing additional talent to our already seasoned team, and getting our first products to market within the next 12 months.

 

"We are pleased that we have exceeded our original target for the Series A round, and have added highly experienced investors to our list of shareholders," said Gail K. Naughton, Ph.D., CEO of Histogen. "With the close of this financing, we look forward to bringing additional talent to our already seasoned team, and getting our first products to market within the next 12 months."

 

The initial close of Series A financing will allow Histogen to maintain timelines for product introductions, including the company's first tissu 317 e engineering products, which are slated for launch in late 2008 and early 2009. From two product families, Exceltrix and HGEN-001, which are derived from a single manufacturing process, Histogen forsees a breadth of applications in a variety of markets, from research tools to cosmeceuticals.

 

About Histogen

 

Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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 -- ExceltrixTM, 1c1d Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula. For more information, please visit http://www.histogeninc.com.

 

 

 

Author Information

 

Eileen Naughton Posted on Tuesday, July 13th, 2010

 

Histogen Announces Initial Close of Series A Financing Round

[brentipold]

phase 1 clinical trials? huh?

[FinHairLoss]

I wrote histogen recently and asked when I could have my hair back......

 

 

"Thank you for your interest and message. Histogen's Hair Stimulating Complex (HSC) is currently in clinical trials as an injectable for hair regrowth. More information, and the latest news from our pilot clinical trial of HSC, can be found on the news section of our website at: Histogen - About Histogen - Latest news, upcoming events at Histogen.

 

Our next clinical trial is scheduled to begin in early 2011 in Singapore, with the next trials being a larger Pan-Asian clinical trial. 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 mid-2013.

 

I would be happy to add you to our hair interest list which provides HSC updates, including information about trials and subject recruiting. If I can answer any further questions, please feel free to contact me directly at the email below."

[TakingThePlunge]

FinHairLoss,

 

Thanks for continually updating us on Histogen's progress. Let's hope those clinical trials in Asia go well. We may have to negotiate a group rate on airfare to Singapore in three years.