Goed nieuws Histogen!

[maart84]

Hoi!
Goed nieuws van Histogen! Nu hopen dat ze snel (genoeg) investeerders vinden dat de phase 2 trials eind dit jaar kunnen beginnen! Ik heb dit overigens van een ander fora (hairsite).

I received this email from Histogen Inc (guess I'm on a list of people to update for some reason).

There is a press release being published tomorrow that gives the 1 year updated results. I have attached the 2 images that were on the email, and reproduced the text in its entirety...

Histogen is excited to share the one year results of our pilot clinical trial of HSC for hair growth, which we will be announcing tomorrow. Please find the news release below. Particularly interesting and exciting that the new growth was not only rapid (significant growth at 3 months), but has continued over time without additional treatments. A statistically significant increase in hair count was seen at the one year follow-up.

Please feel free to share the announcement with friends, family and/or your local news outlets. As always, if I can answer any questions please contact me directly at the email below.

Hope you are well, and look forward to being in touch with further news soon!

Eileen

Eileen Naughton Brandt

Director of Communications

Histogen, Inc.

619.318.7821

enaughton@histogeninc.com

PS – You are receiving this email as a member of Histogen’s HSC interest list. If you no longer wish to receive news from Histogen, please reply to this email and we would be happy to remove you from our list.


HSC Trial Shows Continued Significant Hair Growth at One Year Follow-up

Histogen to present one year clinical trial data at Society for Investigative Dermatology Annual Meeting

SAN DIEGO, April 13, 2010 – Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, today announced the one year data findings of its Hair Stimulating Complex (HSC) pilot clinical trial. Statistically significant new hair growth was seen in HSC-treated subjects at this follow-up timepoint, one year after their single treatment with HSC.

In addition to the number of new hairs, a statistically significant (p<0.05) increase in hair density, which is directly related to hair count over the treatment areas, was also seen at the one-year timepoint. Other efficacy factors, such as hair thickness and terminal hair density, showed an upward trend at this timepoint as well. The pilot trial tested two formulations of HSC and, although one formulation was determined to be superior, significant new hair growth was seen in both groups. (p=0.032)

This new data indicates that a single HSC treatment not only results in rapid hair growth (statistically significant increases in the number of terminal hairs, hair thickness density and hair shaft diameter was seen at three months), but that these results persist over time.

“Seeing continued hair growth at this one year follow-up is truly groundbreaking,” said Dr. Craig Ziering, Founder of Ziering Medical and Principal Investigator on the HSC clinical trial. “Not only do currently available non-surgical treatments show limited hair regrowth, but any new hair is lost shortly after discontinued use. We now have preliminary evidence that HSC significantly increases hair counts, and that the effects of a single treatment are lasting.”

The pilot 24 subject clinical trial of HSC was a double-blind, placebo-controlled evaluation of safety in the clinical application of the product as an injectable for hair growth. Quantitative analysis of clinical macrophotography and subject biopsies were utilized to evaluate treatment safety and efficacy. No adverse events were seen at any timepoint, including the one year follow-up.

HSC is a proprietary formulation of naturally secreted embryonic-like proteins and growth factors. In addition to Wnt 7a, which is recognized to be critical in the induction and maintenance of hair follicle growth, the complex contains a wide variety of factors typically produced by embryonic cells and which are important to the hair cycle, such as follistatin. While these embryonic-like materials are amplified under Histogen’s unique manufacturing conditions, undesirable proteins and growth factors, including Wnt 5a, which has been shown to be associated with cancer, are eliminated.

“The development of hair follicles is the consequence of a complex interplay of factors that is still being unraveled,” said Dr. Jonathan Mansbridge, Histogen’s Chief Scientific Officer. “However, several factors critical to hair growth, such as Wnt 7a, follistatin, VEGF and KGF, are present in HSC, and their secretion by the cells is stimulated by the culture conditions we use. The embryonic conditions under which our cells are manufactured not only upregulates genes associated with hair growth, but induces significantly more production of these critical factors than seen with other culture conditions.”

HSC is a unique composition resulting from growing newborn cells under embryonic conditions. The hypoxia/microgravity results in large amounts of follistatin (41.6 ng/ml in HSC versus 6.75 ng/ml in normal culture conditioned media), VEGF (9.1 ng/ml versus 2 ng/ml), KGF (5.4 ng/ml versus 2.1 ng/ml), and a lack of the scar-related TGF beta (0 ng/ml versus 1.7 ng/ml in normal cultures). This composition is covered by pending US patent #2010/0047305.

The full results of the HSC clinical trial will be presented at the Society for Investigative Dermatology (SID) Annual Meeting, taking place in Atlanta, May 5-8, 2010. Presentation abstracts have been published by SID are now available for review at http://sid.abstractcentral.com/login.

Histogen is currently in planning stages for the next clinical trial of HSC, which is scheduled to begin in late 2010. This next trial will further examine the safety and efficacy of the HSC product as an injectable for hair growth, and will also evaluate optimum treatment dosing and delivery. Histogen is currently seeking a Series B investment round, which will be utilized to finance these next stages of HSC development and trials.

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.

[wesley1982]

nu maar hopen dat ze geldschieters vinden he...

1 jaar later zonder iets van middelen , dat lijkt me zeker de moeite...

best gewoon met de huidige meds doorgaan tot dit beschikbaar word...

[martindeman]

Is dit een goede reden om enthousiast te worden? Ik bedoel, het werkt na een jaar nog altijd, wat zeer goed nieuws is! Maar is het resultaat er ook naar? Die foto's zijn mij wat nietszeggend!

[wesley1982]

ik zie veel meer haartjes staan na 1 jaar zelfs nog , en de diameter is ook veel dikker

van dichtbij lijkt het weinig, maar op een volledige bovenkant van een hoofd zou het wel nog redelijk wat verschil kunnen uitmaken hoor
hopelijk verbeteren ze de toepassing/formule nog wat en hebben ze een echt wondermiddel in handen , van alle produkten is dit blijkbaar wel het beste...
nu maar hopen dat ze het ooit op de markt brengen , begin maar te sparen want het zal waarschijnlijk niet goedkoop zijn
ze moeten de ontwikkelingskosten ergens uithalen

[millie]

heeft iemand vertrouwen dat dit iets gaat worden in de toekomst?

[wesley1982]

waarschijnlijk een beter middel dan de minoxidils dat we nu gebruiken , dat is zeker....

het zal zeker nog paar jaar duren voor er een officieel product van beschikbaar komen, tussen 2013 e 2015.... 2013 , daarvoor als het dan klaar geraakt , wat nog niet zeker is, zal je er wel naar china ofzo moeten voor gaan.... in europa was de voorspelde datum 2015...

[anais anais]

Dit ziet er wel goed uit ,hadden ze mij maar gevraagd als testpersoon

Zou je soms moeten truggaan voor injecties en zou dit niet eerder verkrijgbaar zijn als 2015?

Groetjes

[wesley1982]

volgens info van de contactpersoon bij histogen is het in 2013 zeker beschikbaar in china....

dure behandeling dus (elke keer reis naar china) , maar ik zou het geld er wel voor overhebben...

[millie]

klopt het dat ze bij deze methode géén gebruik maken van embryonale of dierlijke bestanddelen?zie laatste stukje van de engelse tekst.
en hoe willen ze dit dan gaan doen in de toekomst,met een lotion of met injecties?
laatste vraag zou je dit elk jaar moeten uitvoeren of zijn de resultaten blijvend?DAT zou natuurlijk GEWELDIG zijn!!
jee ben zo slecht in engels en wil dit zo graag willen weten!

[AnthonieH]

Oorspronkelijk geplaatst door millie

klopt het dat ze bij deze methode géén gebruik maken van embryonale of dierlijke bestanddelen?zie laatste stukje van de engelse tekst.
en hoe willen ze dit dan gaan doen in de toekomst,met een lotion of met injecties?
laatste vraag zou je dit elk jaar moeten uitvoeren of zijn de resultaten blijvend?DAT zou natuurlijk GEWELDIG zijn!!
jee ben zo slecht in engels en wil dit zo graag willen weten!

Ze kunnen alleen gebruik maken van je eigen stamcellen. Die zullen in de huid moeten worden gebracht, lijkt me. Dus injecties of sneetjes.

Mijn grote vrees zou zijn dat die stamcellen op hol slaan. Bij eerder testen met stamcellen in China zaten de proefpersonen onder de tumoren. Maar ik neem aan dat Intercytex daar een remedie tegen heeft.

[millie]

he bah, dat klinkt wel eng anthonie,maar stel dat het middel op de markt komt,dan mogen we toch aannnemen dat het veilig is,of niet?
ik hoop het toch zo!

[wesley1982]

ik dacht dat het niet te maken had met menselijk stamcellen toch ?

[millie]

iemand?

[AnthonieH]

Oorspronkelijk geplaatst door millie

iemand?

Als het door alle trials komt, dan mag je gerust aannemen dat het veilig is. Als ze het in China gaan aanbieden, dan zou ik me er minder zeker over voelen. Maar voorlopig is het middel er dus niet, dus praten we over luchtkastelen.

Over die tumoren, Wesley, volgens mij gebruikten ze in dat geval embrionale stamcellen (dus niet van de patient zelf). Een van de problemen met embrionale stamcellen is om ze het signaal te geven dat ze nu toch echt ver genoeg zijn gegaan en dat ze moeten stoppen met delen. Doet ie dat niet, dan vormt zich een tumor.

Ik heb overigens flink gezocht, maar ik kan de bron van het verhaal nergens meer vinden. In dit artikel (pagina 2 onderaan) kun je wel teruglezen dat het een bekend risico is.

[anais anais]

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


Hier staat 12 maanden maar dit zal niet over het haar gaan zeker