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I am waiting for Histogen\'s final results


#1

Just a reminder:
Histogen said they would present final results of the hair regeneration trial on first half of 2009…


#2

» Just a reminder:
» Histogen said they would present final results of the hair regeneration
» trial on first half of 2009…

Hey I forgot about that. I guess by July (seventh month) we can start emailing them telling them they have led us on and owe us an explanation.


#3

http://www.histogeninc.com/aboutus/news_events.htm#20

News<< BackHistogen Aesthetics Launches ReGenica Rejuvenation System
Natural embryonic-like human proteins stimulate skin cells to combat aging and help support healing

SAN DIEGO, April 27, 2009 - Histogen Aesthetics, a division of Histogen focused on providing unique, clinically proven, human skin cell-derived products for aesthetics medicine, today announced the launch of the ReGenicaTM Rejuvenation System for anti-aging and post-resurfacing.

Histogen Aesthetics utilizes a proprietary manufacturing process in which newborn dermal fibroblast cells are grown on beads in controlled bioreactors that maintain an embryonic-like environment, including low oxygen and low gravity conditions. During this process, the cells secrete growth factors such as Keratinocyte Growth Factor and Vascular Endothelial Growth Factor, and soluble extracellular matrix proteins such as collagens, laminin and decorin, which are associated with skin renewal and scarless healing. In addition, factors associated with scarring, such as TGFbeta, are decreased or nonexistent.

The resulting product is ReGenica, a complex made up of the naturally produced cell signaling materials and embryonic-like proteins which support the epidermal stem cells that renew skin throughout life.

Through Histogen’s unique and proprietary technology process, Histogen Aesthetics is able to produce a skincare system that differentiates itself from other growth factor-containing skin products on the market. ReGenica:

does not contain any plant-derived growth factors or phytoestrogens which can be subject to seasonal variability and pesticide contamination
does not contain genetically-engineered growth factors (recombinant proteins)
does not contain fetal bovine or other animal serum, so no animal hormones are present
"Our patients undergoing cosmetics procedures are very interested in minimizing their downtime as well as minimizing their risk, and I believe the Histogen formulations do both," said Dr. Garth Fisher, renowned plastic surgeon and primary investigator on the first ReGenica post-resurfacing clinical study. “In addition, they have the added benefit of minimizing the risks associated with allergic responses from using animal products.”

The ReGenica products are formulated based upon the results of randomized double-blind, placebo-controlled clinical studies, in which independent dermatologists both collected and blind-reviewed the data. In addition to before and after photographs, assessment of product efficacy was determined by instrumental assessment of transepidermal water loss (TEWL), viscoelasticity measurements and three dimensional image analysis of silicon replicas.

“As a participant in a ReGenica clinical study, I was impressed to see the rigorous and controlled trial process Histogen Aesthetics’ products undergo,” said Stephanie Parker, a patient in the ReGenica post-resurfacing clinical study. “I feel comfortable in knowing that any products released by the Company have been tested and proven safe and effective, and am excited that the anti-aging and post-resurfacing products will now be available. ReGenica products aren’t just making claims - I saw real results.”

Initial product launches in the ReGenica rejuvenation system include the ReGenica Facial Rejuvenation Complex for post-resurfacing, ReGenica Advanced Rejuvenation Day Repair with sunscreen and ReGenica Advanced Rejuvenation Overnight Repair. The system is now available at special introductory pricing through dermatologists, plastic surgeons and other aesthetic medicine professionals, and can also be purchased online through www.histogenaesthetics.com.

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 - ExceltrixTM, Histogen’s human Extracellular Matrix (ECM) and ReGenica, Histogen’s proprietary liquid formula.


Histogen Hair Regrowth Clinical Trial Results to be Presented at AAD Annual Meeting

SAN FRANCISCO, March 7, 2009 - Attendees of the American Academy of Dermatology Annual Meeting, taking place March 6-10, 2009 in San Francisco, will receive a peek of Histogen’s preliminary hair regrowth clinical trial results in two presentations during the event. Data will be shared within an electronic poster from Histogen throughout the event, as well as within a podium presentation being given by Dr. Kenneth Washenik on advances in the treatment of hair loss on Sunday, March 8th.

Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts grown under embryonic conditions, has recently released data from the 12 week timepoint of the Company’s first human clinical evaluation of ReGenicaTM for hair regrowth. This clinical trial is the first time that a single application of a treatment has shown an increase in new follicles, thickness of existing hairs, and number of hairs in pre-existing follicles, in a human study.

ReGenica, a proprietary liquid containing naturally secreted embryonic proteins and growth factors, is the first naturally stabilized and bioactive formulation of Wnt proteins and natural cofactors, which have been implicated in the formation of new hair follicles.

“It is definitely exciting to see the laboratory promise of Wnt’s effect on hair growth successfully translated into a clinical study,” said Dr. Washenik, who is the Medical Director of Bosley, the nation’s largest hair restoration group, and a faculty member in the Department of Dermatology at NYU’s School of Medicine.

Histogen scientists reported on the upregulation of several Wnt genes in response to the embryonic conditions in the Company’s proprietary bioreactors. In addition, the data has confirmed the activity of these Wnt proteins, through the nuclear translocation of beta catenin in human keratinocytes, the downstream signaling of Wnt-responsive TCF/ Lef promoter, and the presence of secreted Wnt 7a through western blot analysis.

Histogen began its outside-U.S. clinical trial of ReGenica for hair regrowth in November, with the goal of more rapidly obtaining human safety data which will allow the Company to progress with product development. Dr. Craig Ziering, the principal investigator on the trial, is a leading hair transplant specialist and the founder of Ziering Medical.

“For the millions of men and women who grapple every day with their hair loss, the results of our early testing indicate the potential for a phenomenal treatment option, particularly for women and men presenting with diffuse hair loss who are not good candidates for hair transplant surgery,” said Dr. Ziering. “In addition to growing new hair, it increases the diameter of existing hair, creating more volume and coverage, which are the primary goals of those seeking help for their thinning or balding hair.”

The trial is currently in progress, with the final scheduled 5 month timepoint upcoming. The Company expects to release full results from this first clinical trial in the first half of 2009.

Histogens’ electronic poster presentation, entitled Tissue-engineered human embryonic-like conditioned media for therapeutic applications, will be available for viewing throughout the American Academy of Dermatology Annual Meeting.

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 - ExceltrixTM, Histogen’s human Extracellular Matrix (ECM) and ReGenica, Histogen’s proprietary liquid formula.


Histogen to Present Preliminary Hair Regrowth Clinical Results at Stem Cell Summit

Company will Share Sneak Peek at Safety and Efficacy Results from In Progress Clinical Trial

NEW YORK, February 16, 2009 - Dr. Gail Naughton, CEO of Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts grown under embryonic conditions, will address attendees tomorrow at the 4th Annual Stem Cell Summit in New York. Dr. Naughton will be presenting preliminary mid-trial results from Histogen’s first human clinical evaluation of ReGenicaTM for hair regrowth.

Baseline results

Hair Regrowth results after 12 weeks

The primary objective of this double-blind, placebo-controlled, randomized study is to evaluate safety in the clinical application of the ReGenica product for hair regrowth. Histogen is also examining product efficacy as a secondary objective, specifically looking at the same end-points the Company has seen in the animal model - new hair growth, and the thickness of new and existing hair. The study is in progress, but the Company has reviewed data from the scheduled 12 week time point and is pleased with the results to date.

“Histogen’s clinical trial was designed to assess the safety of its product over a five month period,” commented Dr. Craig Ziering, principal investigator of the study and founder of Ziering Medical. “In addition to seeing no adverse reactions, we were delighted to see more hair, thicker hair shafts, and what appears to be the growth of completely new hair follicles in the areas that received the ReGenica treatment.”

ReGenica is a proprietary liquid formula created by the culturing of newborn fibroblasts in an embryonic-like environment, and then harvesting the naturally secreted embryonic wnt proteins, growth factors, 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.

“Wnt signaling has been shown to be responsible for initiating epidermal stem cells to form new hair follicles in mice, and is also important in maintaining the hair inducing activity from existing follicles,” said Frank Zeigler, General Manager at Histogen. “We are excited to be the first group to show these effects in a clinical setting using human WNT proteins.”

Histogen began this outside-U.S. study of ReGenica for hair regrowth in November, with the goal of more rapidly obtaining human safety data which will allow the Company to progress with product development. The trial is currently ongoing, and Histogen expects to release full results from this first clinical study in the first half of 2009.

Dr. Gail Naughton has spent more than 15 years extensively researching the tissue engineering process, and holds more than 90 patents in the field. Dr. Naughton founded Histogen in 2007, and currently serves as Chief Executive Officer and Chairman of the Board for the Company, in addition to her position as Dean of the College of Business at San Diego State University.

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 - ExceltrixTM, Histogen’s human Extracellular Matrix (ECM) and ReGenica, Histogen’s proprietary liquid formula.


Histogen Welcomes Dr. Hyma Gollamudi as Chief Business Officer

Regenerative Medicine Company Poised for Business Growth

SAN DIEGO, December 03, 2008 - 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.


#4

It almost looks like a bad hair transplant, then the other pics are later of the transplanted hairs growing

odd


#5

» It almost looks like a bad hair transplant, then the other pics are later
» of the transplanted hairs growing
»
» odd

More meaningless pics. I expect a hair count from a three-stage trial.


#6

Those are the same pictures they showed earlier this year, 12 weeks after a single injection.
There is a PDF with more pictures from the same point in the trial that has before and after hair counts.

We are waiting on the 24 week results now I believe and if I recal correctly it’s the end of this phase of study, Supposedly to be presented at the IHRS in July.


#7

» Those are the same pictures they showed earlier this year, 12 weeks after a
» single injection.
» There is a PDF with more pictures from the same point in the trial that
» has before and after hair counts.
»
» We are waiting on the 24 week results now I believe and if I recal
» correctly it’s the end of this phase of study, Supposedly to be presented
» at the IHRS in July.

Histogen is legit, whether or not they succeed.
“Histogens’ electronic poster presentation, entitled Tissue-engineered human embryonic-like conditioned media for therapeutic applications, will be available for viewing throughout the American Academy of Dermatology Annual Meeting.”

American Academy of Dermatology isn’t some bull like the Hair Restoration Surgeon Society. Academy of Dermatology is an actual academic group that publishes a peer reviewed journal. Histogen is going the legit scientific route.


#8

http://www.hairsite.com/hair-loss/forum_entry-id-48403-page-0-order-time-descasc-DESC-category-all.html

animated before-after gif:

http://www.hairsite.com/hair-loss/forum_entry-id-48425.html


#9

» http://www.hairsite.com/hair-loss/forum_entry-id-48403-page-0-order-time-descasc-DESC-category-all.html
»
» animated before-after gif:
»
» http://www.hairsite.com/hair-loss/forum_entry-id-48425.html
Thank you for your message and interest. The preliminary clinical trial of ReGenica for hair regrowth has been completed, and the data is currently under evaluation. The current expected timeframe for market introduction is 2015, based upon the timelines for clinical trials and regulatory approval within the United States. Bringing the product to market outside the US within a shorter timeframe is a possibility we are examining, however no plans have been made in this area.

If I can answer any further questions, please feel free to contact me directly at the email below.

Thank you,

Eileen Naughton Brandt

Director of Corporate Communications

Histogen, Inc.

619.318.7821

enaughton@histogeninc.com


#10

Can we get a update?


#11

“Bringing the product to market outside the US within a shorter timeframe is a possibility we are examining, however no plans have been made in this area.”

no plans :frowning:
If only.


#12

» “Bringing the product to market outside the US within a shorter timeframe
» is a possibility we are examining, however no plans have been made in this
» area.”
»
» no plans :frowning:
» If only.

How much shorter are we talking? 2014 instead of 2015?-it’s still a long way off:-(


#13

» » “Bringing the product to market outside the US within a shorter
» timeframe
» » is a possibility we are examining, however no plans have been made in
» this
» » area.”
» »
» » no plans :frowning:
» » If only.
»
» How much shorter are we talking? 2014 instead of 2015?-it’s still a long
» way off:-(

I don’t know why you guys get your hopes up - it takes many years to bring a product to market. “6 years” really is becoming the new “5 years”.


#14

:slight_smile:


#15

» Just a reminder:
» Histogen said they would present final results of the hair regeneration
» trial on first half of 2009…

what about the lawsuit? It’s over now?


#16

Geeeeeeeeeee!!!

» Just a reminder:
» Histogen said they would present final results of the hair regeneration
» trial on first half of 2009…


#17

» Geeeeeeeeeee!!!
»
» » Just a reminder:
» » Histogen said they would present final results of the hair regeneration
» » trial on first half of 2009…

Another Intercytex/Follica/Neosil/Androscience type of company? :expressionless:


#18

» » Geeeeeeeeeee!!!
» »
» » » Just a reminder:
» » » Histogen said they would present final results of the hair
» regeneration
» » » trial on first half of 2009…
»
» Another Intercytex/Follica/Neosil/Androscience type of company? :expressionless:

Hello,

maybe the answer is on this post:

http://www.hairsite.com/hair-loss/forum_entry-id-55249-page-0-category-1-order-last_answer.html

And here is the program of the 17th ISHRS Scientific Meeting. They will talk about interesting things:

  • Phase III of Dutasteride for AGA

  • LLLT

  • Platelet

  • Adipose Stem Cells for hair restoration surgery

  • Dr Gho and hair stem cell transplantation (?¿?¿)

  • Science and Early Clinical Trial Data on Regenica

There are other interesting topics, but it don’t mean nothing. Maybe we will have the trial data at the end of this month… (we hope they show pictures!!).


#19

anyone knows in what day will Histogen speak?
Histogen doesn’t appear in this document:

http://www.ishrs.org/PDF/Prelim02_2009ASM_FULL.pdf

» » » Geeeeeeeeeee!!!
» » »
» » » » Just a reminder:
» » » » Histogen said they would present final results of the hair
» » regeneration
» » » » trial on first half of 2009…
» »
» » Another Intercytex/Follica/Neosil/Androscience type of company? :expressionless:
»
» Hello,
»
» maybe the answer is on this post:
»
» http://www.hairsite.com/hair-loss/forum_entry-id-55249-page-0-category-1-order-last_answer.html
»
» And here is the program of the 17th ISHRS Scientific Meeting. They will
» talk about interesting things:
»
» - Phase III of Dutasteride for AGA
»
» - LLLT
»
» - Platelet
»
» - Adipose Stem Cells for hair restoration surgery
»
» - Dr Gho and hair stem cell transplantation (?¿?¿)
»
» - Science and Early Clinical Trial Data on Regenica
»
»
» There are other interesting topics, but it don’t mean nothing. Maybe we
» will have the trial data at the end of this month… (we hope they show
» pictures!!).


#20

Regenica
Saturday 25 12:23 pm