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HISTOGEN (Regenica HGEN-001) - Launch date 2015.

Discussion in 'New Research, Studies, and Technologies' started by chrome, Oct 20, 2008.

  1. chrome

    chrome Member

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    http://www.histogeninc.com/products/hgen_001.htm

    HGEN-001 HGEN-001 is a proprietary liquid formula created by infusing the soluble chemicals secreted by the newborn fibroblasts with the liquid media. It is the first naturally stabilized and bioactive formulation of wnt proteins and growth factors, offering exceptional opportunities for applications including research tools and biologics products.

    [*]...The formula contains naturally stabilized and bioactive wnt proteins and activity
    [*]...The formula contains naturally secreted growth factors
    [*]...HGEN-001 is soluble and injectable
    [*]...The formula requires no purification process
    [*]...Capabilities for Hair growth

    Hair loss affects 35 million men and 21 million women in the United States.

    One of Histogen's significant applications for HGEN-001 is its utilization as an injectable for hair growth. The combination of wnt proteins and growth factors making up HGEN-001 has been shown to both stimulate resting hair follicles and induce new follicle formation.

    In May 2007, these findings were substantiated by research performed by Dr. George Cotsarelis, which offered further evidence that these growth factors and proteins in combination lead to a significant increase in the creation of new hair follicles in mice.

    Histogen's injectable for hair growth will be undergoing clinical trials, and launch is planned for 2015.

    [​IMG]
    [​IMG]
     
  2. chrome

    chrome Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    http://www.histogeninc.com/products/regenica.htm

    ReGenicaTM ReGenicaTM is a proprietary liquid formula created by the culturing of newborn fibroblasts in an embryonic-like environment and then harvesting the naturally secreted growth factors, anitoxidants and other synergistic bioproducts that are produced. It is the first naturally stabilized and bioactive formulation of wnt proteins and natural cofactors - offering exceptional opportunities for applications including research tools and as a natural additive in products.

    The formula contains naturally stabilized and bioactive wnt proteins with activity
    The formula contains naturally secreted growth factors
    ReGenicaTM is soluble and can be in both a topical or injectible format. injectible
    The formula requires no purification process
    Capabilities for Skin & Hair Care

    ReGenicaTM is currently being researched as an additive to cosmeceutical products, with applications from post-resurfacing treatments to commercial anti-aging products.

    The liquid formulation contains a complex mixture of actives, including human growth factors such as Keratinocyte Growth Factor, soluble human ECM such as collagen, and natural cellular antioxidants which supports the epidermal stem cells that renew skin throughout life.

    In May 2008, an evaluation of ReGenicaTM's as a treatment for post-laser patients was completed. Preliminary 'proof of concept' results from this first evaluation suggest that topical application of a skin gel supplemented with ReGenicaTM can provide overall improved visible re-epithelialization of post ablative laser facial skin, and thereby accelerate patient recovery, keeping superficial cutaneous side effects to a minimum. More details can be found within the news announcement at: http://www.histogeninc.com/aboutus/news_events.htm#8"

    Additional studies are planned for late 2008, including further evaluation of ReGenicaTM as a treatment for post-resurfacing as well as preliminary evaluation of ReGenicaTM for anti-aging applications.

    Histogen is also evaluating ReGenicaTM as an active ingredient for hair care products such as shampoos and conditioners. The Company anticipates ReGenicaTM's interaction with hair follicles will help hair to grow thicker, stronger and more flexible.

    Capabilities for Hair growth

    Hair loss affects 35 million men and 21 million women in the United States.

    [​IMG]

    One of Histogen's significant applications for ReGenicaTM is its utilization as an injectable for hair growth. The combination of wnt proteins and growth factors making up ReGenicaTM has been shown to both stimulate resting hair follicles and induce new follicle formation.

    In May 2007, these findings were substantiated by research performed byDr. George Cotsarelis, which offered further evidence that these growth factors and proteins in combination lead to a significant increase in the creation of new hair follicles in mice.

    Histogen's injectible ReGenicaTM for hair growth will begin clinical trials in Q4 2008, and launch is planned for 2015.
     
  3. chrome

    chrome Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    http://www.azcentral.com/arizonarepublic/business/articles/2008/10/19/20081019biz-skinco1019.html

    Company picks Valley to develop skin products
    Oct. 19, 2008

    The Arizona Republic

    Sunshine and skin damage have prompted a San Diego biotechnology company to expand in Arizona to develop a line of anti-aging skin products.

    Histogen Inc. has opened a Tempe office and plans to begin selling three new skin-care products in the first quarter of 2009.

    The company said it uses a stem-cell-like technology to foster a skin product derived from skin discarded from infants after circumcisions.

    The company wants to parlay revenue collected from the sale of aesthetic products to fund research in areas such as cardiovascular and wound healing.

    It's the same playbook sketched out by other Arizona biotechnology companies such as Tucson-based Niadyne Development: develop anti-aging skin products backed by science to raise cash while focusing on a bigger prize of health research.

    The Tempe division is called Histogen Aesthetics.

    President Lawrence Rheins said the company chose Arizona to launch its aesthetics business due to the Phoenix-area's large network of dermatologists and plastic surgeons focused on cosmetic and anti-aging procedures as well as the state's growing biotechnology hub.

    "Everybody who lives here gets photo (sun) damage," said Rheins, who previously served as a director at Hill Top Research in Scottsdale and an assistant dermatology professor at the University of Cincinnati. "There is a real need for these types of products because of the desert climate and the intense sun."

    Histogen CEO Gail Naughton was the co-founder of Advanced Tissue Sciences, a former San Diego biotech company that had a promising skin-patch technology to treat burns and wounds.

    The company eventually filed bankruptcy amid heavy debt and a struggle to get Food and Drug Administration approval for a key product.

    Naughton, now a dean of the college of business administration at San Diego State University, has reloaded with Rheins and several of her former Advanced Tissue colleagues.

    Of Histogen's first 25 employees, 18 worked together at Advanced Tissue, Rheins said.

    "It is clearly the reason we were able to start as fast as we were able to," he said.

    Histogen's Tempe office has four employees, with plans to expand to about 20 workers as the company launches its line of skin products targeting baby boomers and others. The positions will mainly be sales and marketing.

    Rheins said the company expects its non-prescription products will be sold by plastic surgeons and dermatologists and distributed by a Tempe company, Secure Medical. Secure Medical CEO John Rao also sits on the board of Histogen, and Secure Medical is an investor.

    Histogen's products will be made from an ingredient the company calls ReGenica, which can be used for skin, hair and nail care.

    The company said its technology mimics the embryo, allowing the growth of protein-rich material that is similar to what is found in young skin.

    Rheins said the company's initial products will include a gel that can be applied to skin after laser resurfacing. It also will unveil anti-aging lotions that are applied day and night.

    Earlier this year, Histogen unveiled a kit to grow stem cells, called BioNuesis.

    The Tempe division expects to expand with other skin offerings such as dermal fillers or treatments for skin conditions such as acne or rosacea.

    Rheins said Histogen has no plans to conduct research at its Tempe office, but the company may conduct clinical trials here.

    The parent company, which formed last year, believes the technology can be used to eventually have many beneficial therapeutic uses, including regenerating cells that can help treat cardiovascular patients and heal wounds.
     
  4. hairsucks

    hairsucks Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    Great post, another treatment in the pipeline. The more the better, one of them has to work, one day!

    Cheers Chrome, where the hell do you find all this stuff?
     
  5. chrome

    chrome Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    hairsucks,

    In the newspaper article above it says:

    "Histogen Inc. has opened a Tempe office and plans to begin selling three new skin-care products in the first quarter of 2009."

    I have emailed Histogen to ask if this is true and,more importantly, will these include the same/similar technology. If its the same/similar then we only have to wait a few months to try a topical that *may* help. Obviously it won't be as effective as the hairloss injections due in 7 years time, but atleast we can try it with "needling" and, you never know, we may have a decent treatment out of this within a few months. Will be interesting to see their reply anyway. Worth an email anyway imho - just in case :)

    cheers, chrome.
     
  6. hairsucks

    hairsucks Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    Could be very interesting, Keep us posted with your email Chrome, thanks again!
     
  7. sphlanx2006

    sphlanx2006 Experienced Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    chrome thx for keeping us up to date! As for histogen...the more products on the line, the better thats a sure thing!
     
  8. bornthisway

    bornthisway Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    They have a product launched already - BioNuesis. viewtopic.php?f=32&t=48526
     
  9. hairsucks

    hairsucks Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    bornthisway,

    I read that link and I still have no idea what that product is? well, I know it's the "Only All-Human Stem Cell Culturing Kit" but how does it help with hairloss? by stem cell growth?

    I think I need to read up on stem cells.
     
  10. rusty_y2k2

    rusty_y2k2 Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    Your posts are all awesome chrome - cheers for taking the time to post things like this.
     
  11. ChrisJ

    ChrisJ Junior Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    Good news but 7 years? :sobbing:
     
  12. debris

    debris Junior Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    only 7-10% of all drugs & treatments that enter FDA phase I actually reach the market. So don't hold your breath for too long.
     
  13. goata007

    goata007 Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    All their claims are based on data collected by Dr. Cotsarelis, if Follica fails there is no chance in hell that Histogen will work. And if Follica works, we will have a working treatment in 2-3 years and would have NO need for Histogen. Regenica is nothing but a gimmick to attract investors.
     
  14. chrome

    chrome Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    More confirmation today of imminent skin care product launches in the first 3 months of 2009. Its not the HGEN-001 hairloss treatment.However, if they are based on similar technology then we may get a similar product on the market within months which may help. Looking forward to seeing what these 3 new products are.


    -----------------------------------------------------------


    Company picks Valley to develop skin products
    Oct. 19, 2008
    http://www.azcentral.com/arizonarepublic/business/articles/2008/10/19/20081019biz-skinco1019.html

    Histogen Inc. has opened a Tempe office and plans to begin selling three new skin-care products in the first quarter of 2009.

    +

    Recognized Dermatology Expert Dr. Zoe Draelos Joins Histogen Scientific Advisory Board
    13 Nov 2009
    http://news.yahoo.com:80/s/prweb/20081113/bs_prweb/prweb1609104

    "We are excited to have the opportunity to utilize her insight and clinical expertise as we prepare for product launches in post-resurfacing and anti-aging in early 2009, and continue development of additional skin, hair, and nail care products in the aesthetic medicine arena."
     
  15. chrome

    chrome Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    Histogen Announces Start of Hair Regrowth Clinical Evaluation - 20 Nov 2008
    http://www.prweb.com/releases/Histogen/HairStudy/prweb1643564.htm


    San Diego, CA (PRWEB) November 20, 2008 -- Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced the start of the Company's first human clinical evaluation of ReGenicaTM for hair regrowth. The primary objective of the study is to evaluate safety in the clinical application of the ReGenica product.

    ReGenica is a proprietary liquid formula created by the culturing of newborn fibroblasts in an embryonic-like environment, and then harvesting the naturally secreted growth factors, anitoxidants and other synergistic bioproducts that are produced. It is the first naturally stabilized and bioactive formulation of wnt proteins and natural cofactors, which are thought to act in the formation of new hair follicles.

    Histogen's in-vitro and preclinical research to date has shown ReGenica to be safe, and has indicated the complex's ability to increase hair growth and new follicle formation. Based on the results of preliminary research, and the potential of ReGenica as a hair regrowth treatment, Histogen has moved forward with this outside-U.S. study to more rapidly obtain human safety data which will allow the Company to progress with product development.

    "We are excited to be on schedule with the initiation of our first human clinical evaluation of ReGenica for hair growth," said Dr. Gail Naughton, CEO and Chairman of the Board for Histogen. "We look forward to the results of this preliminary safety evaluation, which we can parlay into further studies."

    The ReGenica study, which began today, will be a double-blind, placebo-controlled, randomized single site study. Dr. Craig Ziering, renowned hair transplant surgeon and founder of Ziering Medical, is serving as Principal Investigator on the study with Dr. David Perez-Meza as Sub-Investigator. Results of this first human hair regrowth product clinical evaluation will be released by Histogen in the first half of 2009.

    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, Histogen's human Extracellular Matrix (ECM) and ReGenica, Histogen's proprietary liquid formula. For more information, please visit http://www.histogeninc.com.

    Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced the start of the Company's first human clinical evaluation of ReGenica for hair regrowth. ReGenica is the first naturally stabilized and bioactive formulation of wnt proteins and natural cofactors, which are thought to act in the formation of new hair follicles. We are excited to be on schedule with the initiation of our first human clinical evaluation of ReGenica for hair growth
     
  16. chrome

    chrome Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    In the above it says Histogens products are "based on the products of newborn fibroblasts".

    This sounds very similar to Intercytex's Vavelta, which is ALSO based on "newborn fibroblasts" and is already available in the UK. Actually, Intercytex "Vavelta" use fibroblasts from newborn babies penis's...so if i try this treatment on my scalp i will never be able to argue ever again if someone calls me a Dickhead :)

    Daily Mail article - 19 Nov 2008 (UK newspaper - has a before/after pic of facial treatment as well - very good results)
    Would you undergo anti-ageing treatment using cells from circumcised newborn babies?
    http://www.dailymail.co.uk/femail/a...t-using-cells-circumcised-newborn-babies.html

    Intercytex Vavelta website:
    http://www.vavelta.com/vavelta/consumers/what/

    Recent Vavelta stories in the news:
    http://news.google.com/news?q=vavel...F-8&sourceid=ie7&rlz=1I7PCTA&um=1&sa=N&tab=wn
     
  17. Night

    Night Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    " Results of this first human hair regrowth product clinical evaluation will be released by Histogen in the first half of 2009."

    Good.
     
  18. LookingForAnswers

    LookingForAnswers Junior Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    You gotta be kidding! This is being run by Dr. Ziering, snake oil salesman of the year! He is well known in conjunction with his partner, Dr Levitt, of HairMax fame, as being a con artist. He has numerous lawsuits pending against him already. Just another high priced scam.
     
  19. chrome

    chrome Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    Life Sciences, startups, Fibroblast
    Human Tissue Startup ‘Putting the Band Together Again’
    25 Nov 2008

    San Diego’s Advanced Tissue Sciences tried for 14 years to develop living-tissue patches for healing burns, wounds and chronic sores. But the business went into bankruptcy liquidation in late 2002, a victim of regulatory delays and more than $300 million in debt.

    Since then, former CEO Gail Naughton says she’s been invited to speak many times about the hurdles that Advanced Tissue Sciences was unable to overcome and what she would have done differently. “After talking about what I would do differently a number of times,â€￾ Naughton says, “I decided to go out and actually do it.â€￾

    The result is Histogen, a San Diego-based life sciences company that Naughton founded last year. Naughton says the technology underlying Advanced Tissue Sciences has been reborn—with significant advances—and that Histogen intends to avoid the business pitfalls that crippled the predecessor company.

    “Many of us worked for Gail at Advanced Tissue Sciences,â€￾ says Robert Kellar, Histogen’s vice president of research and development. “So we joke around by saying ‘We’re putting the band together again.’ â€￾

    After raising more than $5.3 million from private investors in May, Naughton says Histogen plans to raise another $1.4 million from investors by the end of the year. The startup also has secured a $1.4 million loan.

    A key difference at the new company is the creation of a subsidiary, Histogen Aesthetics, which is adapting the in-house expertise in fibroblasts, the cells that form connective tissue, to develop skin and hair care products. By focusing at the outset on the cosmetics, dermatology, and plastic surgery industries, Naughton says Histogen can generate immediate revenue to support the long-term development of living tissue skin grafts and other medical products that require a protracted regulatory approval process.

    The company’s first cosmetics product is called ReGenica, a liquid made from fibroblast-secreted proteins, growth factors, and other products. It is intended for use in anti-aging skin treatments and to promote healing after cosmetic laser skin resurfacing.

    Last week, Histogen said it also plans to evaluate whether ReGenica injected into the scalp will stimulate hair regrowth in a clinical trial of 24 patients. “Our hypothesis is that it helps to stimulate resident stem cells to become hair follicles,â€￾ Kellar says.

    Naughton says Histogen already has used its expertise in culturing and growing fibroblast cells to develop products derived from human tissue cells that can be used as a growth medium by stem cell researchers. With such products already generating sales, she says Histogen can generate cash to offset at least some losses it expects to endure while it spends years working toward getting approval to sell its therapeutics products.

    It was that prolonged march through the desert that eventually killed Advanced Tissue Sciences, which endured a three-year FDA delay amid mounting debts in getting the company’s Dermagraft skin patch for diabetic ulcers to market. Even after getting regulatory approval, Naughton said the reimbursement rate that insurers set for the treatment covered only a fraction of the company’s actual cost to make the patch. Today reimbursement rates are more favorable, Naughton says.

    Histogen intends to use its same proprietary human “extra-cellular matrixâ€￾ to develop a variety of other medical products—coatings for orthopedic implants and stents, patches for repairing torn shoulder ligaments and other tissue, and even “retentiveâ€￾ enemas for treating sores in the large intestine and Crohn’s Disease.

    “So basically we’ve learned and we’ve brought the best and brightest people back at Histogen,â€￾ Naughton says. “The team that did it before is back together again, with decades of experience.â€￾
     
  20. chrome

    chrome Member

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    Re: REGENICA (Histogen HGEN-001) - Launch date 2015.

    December 5, 2008

    Histogen Featured on Economic Report Television Series

    Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, will be featured in an upcoming segment of The Economic Report as part of the 21st Century Breakthroughs for Biomedical Research series.

    Phoenix, AZ (PRWEB) December 5, 2008 -- Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, will be featured in an upcoming segment of The Economic Report as part of the 21st Century Breakthroughs for Biomedical Research series. Airings of the segment will begin on AZ-TV, local channel 7, on Saturday, December 6th, at 6:00am.

    Through Histogen's proprietary bioreactor process which mimics 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, Histogen's human Extracellular Matrix (ECM) and ReGenicaTM, Histogen's proprietary liquid complex - which address areas from research tools to tissue repair, skin rejuvenation to hair growth.

    The Economic Report segment featuring Histogen focuses on the Company's unique ability to support stem cell research, while developing products that do not contain embryonic stem cells or animal components. In addition, the segment shares the results of Histogen's first clinical evaluation of ReGenica as a post-resurfacing treatment, as well as the potential for a ReGenica formulation in the area of hair regrowth.

    For more information about Histogen, or to view the segment online, please visit http://www.histogeninc.com. Further information about Histogen Aesthetics upcoming line of skin, hair and nail care products can be found at http://www.histogenaesthetics.com.
     

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