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

[chrome]

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

...and here is the TV show today:

AZ-TV
06 Dec 08
21st Century Breakthroughs for Biomedical Research

http://www.histogeninc.com/downloads/histogen4.mpg

 

[chrome]

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

As has already been posted on this thread, the Regenica hair growth compound has only just begun trials and isn't available until around 2015.

However, as also posted earlier, Histogen are releasing 3 new Cosmetic formulas in the first 3 months of 2009 containing the same "Regenica" as used in the Hair Growth formula. Obviously, they will be a weaker version than the hair growth formula under trials.....but atleast it DOES contain the same material.

As mentioned in the news clip above, Regenica stimulates new stem cells which form new follicles.

Hopefully, some of these new cosmetic formulas will have some effect on hairloss as well as the skin .

Fingers crossed for a great New Year anyway.

cheers, chrome

 

[chrome]

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

Here is a 37 page official Histogen presentation which includes such info as the suggested $5,000 treatment cost for the hair growth product when its finally released and a few other snippets:

Histogen 37 page Investor Presentation:
http://www.histogeninc.com/downloads/hisotgenforinvestor.pdf

Here is the Regen HGEN-001 Hair Growth section:

Hair Growth Product
•Hair loss affects 35 million men and 21 million women in the United States
•Hair growth product (HGEN-001) has an estimated revenue of $2.8 billion (represents 1% of the market)
•Suggested price for treatment is $5k versus $4-12k (2 procedures)
•Strong scientific data suggests potential homerun product
•Potential to capture 25% of market (revenue of $70 billion = 56 million x .25 x $5,000)
•Net Potential Revenue is $49 billion (70% of gross)
•Strategy: secure global corporate partner after Phase I data is available

Competition
•Surgical–Hair Transplant
•Surgical procedure in which hair follicles are transplanted–Costs $4k-12k per procedure –usually 2 procedures
•Can leave an unnatural looking hairline–Scalp Reductions–Flap Surgery
•Drugs–Rogain–Propecia–helps but overtime effect decreases, possible side effects
•Hair Pieces

Hair Growth Data
•HGEN-001 has demonstrated a significant increase in new hair follicle creation and hair growth in preclinical trials
•Preclinical toxicology studies are underway and Histogenplans to file an IND in Q1 2008, with phase 1 clinical trials commencing in Q3 2008
•In May 2007, Dr. Naughton’s previous findings were substantiated in an article by George Cotsarelis -offered evidence that growth factors and wnt proteins lead to increase in creation of new hair follicles

 

[dertim]

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

Thanks for all the info chrome!
Sounds pretty good to me. Aside from that launch date.
If it's 7 years now, it's probably more like 8-10 in the long run. Such a long time. :/
Hopefully those other Cosmetic formulas will be helpful too. Maybe help maintaining? That'd be great .

 

[SoThatsLife]

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

They are marketing a little heavy, a bit to much.

Follica, that is probably our best chance, is quiet and STILL doing research! Biotech is the new future of medicine and I really don't hope this is another investor scam, but when they have such extravagance marketing I really hope they can back it up with some proof when their phase 1 trials end this summer.

 

[chrome]

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

An email reply from Histogen, 06 Dec 08:


Dear sir,,

Thank you for your inquiry, and for your interest in Histogen.

In follow-up to your question, we are launching 3 skin care products in the first quarter of 2009 – a post-resurfacing facial rejuvenation complex, advanced day repair (anti-aging) and advanced night repair (anti-aging). More information about these products and trials can be found at http://www.histogenaesthetics.com.

Although they come from the same process, the formulations of ReGenica for skin care are quite different from the ReGenica formulation for hair regrowth – the products should not be used interchangeably. The first human evaluation of ReGenica for hair regrowth began on November 20th, and we look forward to sharing the results of this study in the first half of 2009.

If we can provide any further information, please feel free to contact me directly at the email below.

Thank you,
Histogen, Inc.

 

[khali]

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

They are marketing a little heavy, a bit to much.

Follica, that is probably our best chance, is quiet and STILL doing research! Biotech is the new future of medicine and I really don't hope this is another investor scam, but when they have such extravagance marketing I really hope they can back it up with some proof when their phase 1 trials end this summer.

Phase 1 is just to test if the product is safe. Its cannot be used as proof.

 

[goata007]

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

They are marketing a little heavy, a bit to much.

Follica, that is probably our best chance, is quiet and STILL doing research! Biotech is the new future of medicine and I really don't hope this is another investor scam, but when they have such extravagance marketing I really hope they can back it up with some proof when their phase 1 trials end this summer.

Phase 1 is just to test if the product is safe. Its cannot be used as proof.

for the love of God...it's been said over and over again that what they did in summer was a Research Study NOT a phase-I.

 

[SoThatsLife]

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

I probably misplaced my words, I was pointing to Histogen's Phase 1.

 

[chrome]

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

http://www.earthtimes.org/articles/...e-secret-action-against-histogen,689573.shtml

SkinMedica Files Patent and Trade Secret Action Against Histogen

23 Jan 2009

SAN DIEGO - SkinMedica®, Inc. announced that it has initiated a patent and trade secret action against Histogen, Inc., Histogen Aesthetics, LLC and Dr. Gail Naughton, founder, President and Chief Executive Officer of Histogen and Histogen Aesthetics. Dr. Naughton was a co-founder of

SAN DIEGO - (Business Wire) SkinMedica®, Inc. announced that it has initiated a patent and trade secret action against Histogen, Inc., Histogen Aesthetics, LLC and Dr. Gail Naughton, founder, President and Chief Executive Officer of Histogen and Histogen Aesthetics. Dr. Naughton was a co-founder of Advanced Tissue Sciences or ATS, which initiated bankruptcy proceedings in 2002. SkinMedica acquired several assets from ATS, including intellectual property encompassing its NouriCel® technology. The complaint seeks damages and an injunction against the defendants for the development and manufacture of aesthetic and therapeutic products using SkinMedica’s patented conditioned cell culture media technology.

The complaint, filed in the United States District Court for the Southern District of California, seeks relief against the defendants for infringing SkinMedica’s U.S. Patents No. 6,372,494 and/or 7,118,746. The ‘494 and ‘746 patents, which were filed in 1999 and 2000, respectively, relate to methods and uses of SkinMedica’s proprietary conditioned cell media technology. The complaint also seeks relief for the misappropriation of SkinMedica trade secrets and confidential information by Histogen, Inc., Histogen Aesthetics, LLC and Dr. Naughton.

SkinMedica is a privately held company marketing both prescription and aesthetic products to dermatologists and other health care professionals. The company's full line of products, which is sold through physicians, includes TNS Recovery Complex® with NouriCel® to help improve the appearance of the skin. SkinMedica is based in Carlsbad, California. For more information, visit www.skinmedica.com.

SkinMedica, Inc.
Mary Fisher, Chief Executive Officer
760-448-3680

 

[chrome]

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

http://www.prweb.com/releases/Histogen/Hairtrial/prweb2069524.htm

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 (PRWEB) 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.

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 ReGenicaTM, Histogen's proprietary liquid formula. For more information, please visit http://www.histogeninc.com.

###

Histogen
Eileen Naughton
619.318.7821

BEFORE

12 WEEKS

 

[chrome]

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

Also, the 3 HGEN-001 related products that Histogen have been saying they will be introducing in the first 3 months of 2009 will be officially launched on 04 Mar 08 !

However, on their contact page you can apply to become one of the first to use their new products, presumably before the launch date on 04 Mar 09.

I have just applied anyway to see what they say as i want to try this as its based on HGEN-001 technology and may be worth a shot now rather than wait till 2015. It might help and it might not. Lets face it, history tells us it won't do anything but who knows - its new. We'll see. Even maintaining would be a huge achievement.

See their website at:
http://www.histogenaesthetics.com/


PS -Just to remind everyone of Histogens email in December confirming that these 3 new products "come from the same process," (as HGEN-001) but also add "the products should not be used interchangeably." Of course they will say that. They haven't been tested for any possible hair growth abilities so simply cannot make that claim.

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

"An email reply from Histogen, 06 Dec 08:


Dear sir,,

Thank you for your inquiry, and for your interest in Histogen.

In follow-up to your question, we are launching 3 skin care products in the first quarter of 2009 – a post-resurfacing facial rejuvenation complex, advanced day repair (anti-aging) and advanced night repair (anti-aging). More information about these products and trials can be found at http://www.histogenaesthetics.com.

Although they come from the same process, the formulations of ReGenica for skin care are quite different from the ReGenica formulation for hair regrowth – the products should not be used interchangeably. The first human evaluation of ReGenica for hair regrowth began on November 20th, and we look forward to sharing the results of this study in the first half of 2009.

If we can provide any further information, please feel free to contact me directly at the email below.

Thank you,
Histogen, Inc.

 

[ComeOnPropy]

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

That picture with the 12 week update gives me something to be hopeful for it looks like there is new hair there and that most of the other hair is alot thicker or atleast thickening up. It would be good if that was just the beginning of the process. It seems that Follica is now on about the same timeline as Histogen so it will be interesting to see who gets to market first. I do however really like the photos of new hair, i think that would be the first time i ever seen it on a human.

 

[Smooth]

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

These are very exciting news! i belive that countdown about to start soon.... once they manage to actually safely GROW new follicles its only a matter of time for the nw7s to reverse the clock.... i dont want to be too optimstic tho, the thread does mention a pasemstic timeline after all (2015.......... :thumbdown2: )

 

[bababooey]

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

Well I hope the face stuff aint too expensive.

If it gets absorbed well topically, im puttin that sh*t on my head!

 

[yvakin]

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

Anyone, explain in normal language what a hek "BioNuesis" suppose to do. :dunno:

 

[chrome]

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

Biotech excited about hair-growth results
Experimental therapy is in early-stage trial
By Terri Somers
Union-Tribune Staff Writer
http://www3.signonsandiego.com...-about-hair-growth-r/

2:00 a.m. February 17, 2009

If your forehead is more like a fivehead, or you've started to see a lot more scalp at the crown of your head, the tiny San Diego biotechnology company Histogen has some promising news.

The company today is unveiling preliminary results from an early-stage clinical trial that showed its experimental hair regrowth therapy, ReGenica, increased new hair growth and the thickness of existing hair in men after 12 weeks.

"These results appear to be phenomenal, although this trial is still in the very early stages," said Los Angeles-based hair transplant specialist Dr. Craig Ziering.

"Wimpy hairs became thicker, which is pretty significant to the patient because even if you cannot increase the numbers of hairs, if you increase the diameter, you increase the volume. And preliminary hair counts show there was an increase in new hair of 15 to 20 percent in some patients," said Ziering, a paid member of the company's scientific advisory board.

ReGenica is made of a cocktail of proteins that are present in the early-stage embryo and help direct stem cells to become either hair, bone or blood, said Histogen Chief Executive Gail Naughton.

Although scientists have known about the role these proteins play, Histogen's aha moment was figuring out how to create them in a lab, said Naughton, who is also dean of San Diego State University's School of Business Administration.

Fibroblasts, early-stage stem cells that form connective tissue, are grown in the simulated low-oxygen and free-floating, low-gravity conditions of the embryo, Naughton said. The important Wnt proteins and growth factors then build up in that environment, she said.

The 18-person company, which opened in 2007, conducted research showing ReGenica stimulated hair growth in animals. It started its Phase 1 human trial to show the therapy was safe; no dangerous side effects were experienced, Ziering said.

Histogen was also hoping the trial would show ReGenica's effectiveness, which might give the company the buzz it needs to raise funding, build a manufacturing facility and then begin Phase 2 trials, Naughton said.

The Phase 1 trial involves 25 men ages 18 to 45 who have varying stages of male-pattern baldness.

Each of the balding spots was mapped into quadrants. Each quadrant received an injection of either the drug or a placebo. Some of the quadrants were also treated with microdermabrasion or lasers as well as the drug, to test previous medical theory that a wound helps to stimulate stem cells in the skin to regenerate hair follicles.

At 12 weeks, penny-size pieces of scalp were biopsied to observe the changes. Histogen staff even counted the follicles and hairs sprouting out of them. Once the trial is completed, an independent data-monitoring board will review the results after five months and make an assessment.

More than 50 million men in the United States alone suffer from hair loss, and about 35 million women are dealing with the problem, said Ziering, who has been treating patients for hair loss for 18 years.

"There's a tremendous need for something that can help people with their hair loss because there are many ramifications on people's lives," Ziering said.

Histogen's product shows promise to do multiple things, including slowing the progressive nature of hair loss, increasing the thickness of the follicles and actually getting new follicles to grow, the physician said.

Histogen also sees ReGenica as a means toward lifesaving therapies that trigger stem cells to generate new tissue in damaged heart muscle and new neurons in damaged spinal cords, Naughton said.

"We wanted to go after a market where there is really an unmet need and a large patient population, which could help us generate the cash flow to fund longer-term projects that would be more of a regulatory and reimbursement hurdle," she said.

 

[decro435]

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

Man , 2015 is way too far away. I'm losing my hai rapidly enough now at 19 years old. I think we can safely say for a lot of us this won't help because we will have lost most of our hair by then. For people who begin to thin out around 2015 they will have a much better chance with this product.

 

[bababooey]

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

Biotech excited about hair-growth results
Experimental therapy is in early-stage trial
By Terri Somers
Union-Tribune Staff Writer
http://www3.signonsandiego.com...-about-hair-growth-r/

2:00 a.m. February 17, 2009

If your forehead is more like a fivehead, or you've started to see a lot more scalp at the crown of your head, the tiny San Diego biotechnology company Histogen has some promising news.

The company today is unveiling preliminary results from an early-stage clinical trial that showed its experimental hair regrowth therapy, ReGenica, increased new hair growth and the thickness of existing hair in men after 12 weeks.

"These results appear to be phenomenal, although this trial is still in the very early stages," said Los Angeles-based hair transplant specialist Dr. Craig Ziering.

"Wimpy hairs became thicker, which is pretty significant to the patient because even if you cannot increase the numbers of hairs, if you increase the diameter, you increase the volume. And preliminary hair counts show there was an increase in new hair of 15 to 20 percent in some patients," said Ziering, a paid member of the company's scientific advisory board.

ReGenica is made of a cocktail of proteins that are present in the early-stage embryo and help direct stem cells to become either hair, bone or blood, said Histogen Chief Executive Gail Naughton.

Although scientists have known about the role these proteins play, Histogen's aha moment was figuring out how to create them in a lab, said Naughton, who is also dean of San Diego State University's School of Business Administration.

Fibroblasts, early-stage stem cells that form connective tissue, are grown in the simulated low-oxygen and free-floating, low-gravity conditions of the embryo, Naughton said. The important Wnt proteins and growth factors then build up in that environment, she said.

The 18-person company, which opened in 2007, conducted research showing ReGenica stimulated hair growth in animals. It started its Phase 1 human trial to show the therapy was safe; no dangerous side effects were experienced, Ziering said.

Histogen was also hoping the trial would show ReGenica's effectiveness, which might give the company the buzz it needs to raise funding, build a manufacturing facility and then begin Phase 2 trials, Naughton said.

The Phase 1 trial involves 25 men ages 18 to 45 who have varying stages of male-pattern baldness.

Each of the balding spots was mapped into quadrants. Each quadrant received an injection of either the drug or a placebo. Some of the quadrants were also treated with microdermabrasion or lasers as well as the drug, to test previous medical theory that a wound helps to stimulate stem cells in the skin to regenerate hair follicles.

At 12 weeks, penny-size pieces of scalp were biopsied to observe the changes. Histogen staff even counted the follicles and hairs sprouting out of them. Once the trial is completed, an independent data-monitoring board will review the results after five months and make an assessment.

More than 50 million men in the United States alone suffer from hair loss, and about 35 million women are dealing with the problem, said Ziering, who has been treating patients for hair loss for 18 years.

"There's a tremendous need for something that can help people with their hair loss because there are many ramifications on people's lives," Ziering said.

Histogen's product shows promise to do multiple things, including slowing the progressive nature of hair loss, increasing the thickness of the follicles and actually getting new follicles to grow, the physician said.

Histogen also sees ReGenica as a means toward lifesaving therapies that trigger stem cells to generate new tissue in damaged heart muscle and new neurons in damaged spinal cords, Naughton said.

"We wanted to go after a market where there is really an unmet need and a large patient population, which could help us generate the cash flow to fund longer-term projects that would be more of a regulatory and reimbursement hurdle," she said.

Has it started phase I for hair already?
I thought it was still pre clinicals stage.

BTW I am sooo trying the Regenica face cream when it comes out in March. I might even inject that ish! Ofcourse I would need to find out how exactly they did it in their pre-clinicals first...

 

[casperz]

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

Judging from the picture at the very least this is a minoxidil killer especially if it works on all areas of the scalp.