Showing posts with label Histogen. Show all posts
Showing posts with label Histogen. Show all posts

Saturday, October 12, 2013

Stratus Media Group and Histogen Execute Letter of Intent for Biotechnology Merger

Stratus Media Group and Histogen Execute Letter of Intent for Biotechnology Merger

Source: histogen.com
LOS ANGELES, October 07, 2013 - Stratus Media Group, Inc. (OTCQB:SMDI) announced today that it was planning to expand its entrance into the biotechnology industry with the execution of a letter of intent between the Company and Histogen, Inc., a regenerative medicine company developing innovative therapies for conditions including hair loss and cancer.
The non-binding letter of intent outlines the primary terms of a merger of San Diego-based Histogen into Stratus, to be renamed Restorgenex Corporation. The letter of intent has been approved by the board of directors of both companies, and the parties are engaged in completing a formal merger agreement.
Histogen's solutions are based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. The technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of proteins that have been shown to support stem cell growth and differentiation. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process can be found in skincare products including ReGenica, which is distributed by Suneva Medical in partnership with Obagi Medical Products.
"Histogen's technology platform opens a spectrum of potential product opportunities in both aesthetics and therapeutics, an ideal fit with our vision for Restorgenex," said Sol J. Barer, Ph.D., who will assume the position of Chairman of the Board of Restorgenex effective November 1, 2013. "The expertise of the Histogen team in developing regenerative products from concept to market, along with the success Histogen has already found in skincare partnering, will add significant value to our Company."
Following successful completion of this proposed merger, the company's goal is to build Restorgenex into a world-class cosmeceutical and pharmaceutical company in the large and expanding fields of dermatology and hair restoration. The parties intend to move toward a formal merger agreement in which Histogen would become a wholly-owned subsidiary, Histogen founder Gail K. Naughton, Ph.D. would assume the position of Chief Executive Officer of Restorgenex, and the corporate headquarters of Restorgenex would be located in San Diego. The merger will require, among other things, the satisfaction of customary closing conditions including the approval of Histogen's shareholders.
"I am very excited about the potential of a merger between Histogen and Restorgenex, and look forward to moving into the next stage," said Dr. Naughton. "It is an honor to be working with biotechnology visionaries Dr. Sol Barer and Isaac Blech, and to have them recognize the promise of Histogen's products is a true testament to the unique and exciting nature of our technology."
Dr. Naughton has spent more than 25 years extensively researching the tissue engineering process, holds more than 95 U.S. and foreign patents, and has been honored for her pioneering work in the field by prestigious organizations including receiving the Intellectual Property Owners Association Inventor of the Year Award.
Prior to founding Histogen in 2007, Dr. Naughton oversaw the design and development of the world's first up-scaled manufacturing facility for tissue engineered products, was pivotal in raising over $350M from the public market and corporate partnerships, and brought four human cell-based products from concept through FDA approval and market launch as President of Advanced Tissue Sciences.
"I believe the potential acquisition of Histogen, and the expertise and vision Dr. Naughton will bring as Chief Executive Officer will be a tremendous asset in ushering the Company into the biotechnology industry," said Jerold Rubinstein, current Chairman and Chief Executive Officer of Stratus.
Forward-Looking Statements
Statements in this press release relating to plans, strategies, projections of results, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Securities Acts of 1933 and 1934. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors. Although the company's management believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, performance or achievements. The company has no obligation to update these forward-looking statements.
Contacts
Histogen, Inc.
Eileen Brandt, (858) 200-9520
ebrandt@histogeninc.com
Stratus Media Group, Inc.
Tim Boris, 310-526-8700
timb@stratusmediagroup.com

Friday, April 26, 2013

Men And Balding: Why We May Be The Last Men To Go Bald

Men And Balding

Why We May Be The Last Men To Go Bald

By Jeremy Berger
Source: uk.askmen.com
Jeremy Berger is a writer living in New York.








"There has never been a clinical treatment specifically developed for hair loss that worked."

Balding is the hoverboard of medical research. If someone had told me in 1989 that, more than 20 years later, my Birdhouse deck wouldn't float, I'd have told the butthead to get lost. But here we are in 2012. Hoverboardless. Dinosaurs.

Worse: Men have been losing their hair for thousands of years, and the best science has done is smoke and mirrors, ointment and wigs. Perhaps it's what we deserve for all our vanity, preening and grooming while the promises of liberal democracy smolder. Maybe we should shave our heads and rebuild America. But the truth is even the most stoic guys struggle with hair loss when it sets in, and it'll happen to about 50% of us by middle age. Only a much smaller percentage -- as low as 7% -- will ever seek medical treatment.

Understanding why this is boils down to the fact that there hasn't been a single groundbreaking treatment that permanently stopped or turned back the clock on hair loss. In fact, there has never been a clinical treatment specifically developed for hair loss that worked.

The options from recent history: wearing a wig; using a topical solution or foam with minoxidil, like Rogaine (developed initially to treat high blood pressure); taking finasteride, which is in Propecia and Proscar (first used to treat an enlarged prostate); or getting hair transplants. Each of these works in a piecemeal way, but they're all problematic. Wigs are a bit silly. Rogaine and Propecia have mixed results and must be used every day, for life. Transplants are limited by the amount of donor hair from the crown and back of the neck. None of them will bring back the flowing locks of your teenage years.

Some scientists and doctors think that could change in the next 10 years. Is it for real this time?

The best defense is a good offense


In recent years the theme of the balding conversation has changed from “maintenance” and “prevention” to actual regrowth. The reason? A better understanding of hair biology, including new knowledge of how cells communicate with the hair follicle. A study led by George Cotsarelis, M.D., chair of the Department of Dermatology at the University of Pennsylvania School of Medicine, that was published last year in the Journal of Clinical Investigation found that a bald scalp and one with hair both have the same number of stem cells, but in the bald scalp, the stems cells are sort of chilling out, just sitting there instead of going to work repairing and replenishing hair follicles and fibers. “However, the fact that there are normal numbers of stem cells in a bald scalp gives us hope for reactivating those stem cells,” Cotsarelis said in a news release issued by Penn Medicine. Get the stem cells working again and the hair comes back.

New Biotech: Follica, Histogen, Replicel


Cotsarelis declined to be interviewed for this story, but he's been hard at work as co-founder and member of the scientific advisory board of Follica, a privately held biotech company that has an exclusive license from Penn Medicine to develop technology based on the JCI study and another from 2007, which showed that mice with skin wounds regrew hair at the injured site in a process that mimicked embryonic development. This means that activated stem cells can grow new hair follicles. Little else is known of Follica's forthcoming balding treatment, except that it will likely include a drug compound and some sort of wounding of the skin akin to what went down with the mice.

Follica isn't the only biotech company trying to find a cure for hair loss and stake a claim in the multibillion dollar market for treatment, one that could conceivably balloon if a better treatment existed. San Diego-based Histogen, a privately held company headed by Gail Naughton, Ph.D., an expert in tissue engineering, also views Dr. Cotsarelis' work (along with studies at Rockefeller University by Elaine Fuchs and University of Southern California by Cheng-Ming Chuong) as the foundation of current biotech progress in hair restoration.

“Our approach is to take cells that are normally found in the scalp and grow them under embryonic conditions of very low oxygen and suspension culture to trick the cells into thinking they're back in the embryonic environment,” Naughton said.

“Within a couple of days they start acting like multipotent stems cells and secreting the growth factors that are necessary to stimulate stem cells in the body, including stem cells of the human hair follicle. We've basically learned how to manufacture a complex physiological group of growth factors that are normally responsible for stimulating stem cells to create new hairs. We simply mimic nature by figuring out how to make what the body makes to grow a new hair.”

Those growth factors, chemical signals produced by cells that induce more cell growth and maturation or differentiation, are what go into Histogen's Hair Stimulating Complex (HSC), an injectible liquid formula currently in clinical trials in Manila, Philippines.

Naughton believes she and her team have identified the four growth factors that are most important for the cycling of a hair follicle and for stimulating growth: Follistatin, Noggin (seriously), Vascular endothelial growth factor (VEGF), and Keratinocyte growth factor (KGF). So far, according to Histogen, patients have had statistically significant hair growth (including increases in hair count, hair thickness and hair density) at 12 weeks and at one year. Histogen aims to have a product on the market in Asia in 2015 and in the U.S. a year later. The actual procedure involves a one- or two-time set of injections in the scalp with a very fine 32-gauge needle, taking only several minutes rather than the hours required for a hair transplant.

"What we know for sure about the future is that there will be more robots."

Vancouver-based RepliCel is also working on an injectible treatment. Scientists there are banking on the dermal sheath cup cell, which they isolate from the root of the patient's hair follicle. That cell goes into a growth medium where it multiplies into the millions before being injected back into the patient's scalp and going to work growing new follicles and rejuvenating existing ones. “We believe that the dermal sheath cup cells are the progenitor cells that are necessary to instruct the rest of the cell population to form a follicle and to form a hair fiber,” David Hall, RepliCel CEO, said. “In layman's terms, we're doing a cellular transplant as opposed to a follicular transplant.”

RepliCel's phase one clinical trial is underway in Tbilisi, Georgia, and the company expects to have safety and efficacy data in early 2012. (Phase one of clinical trials primarily establishes the safety of the procedure. Phase 2 focuses on dosing and efficacy in a larger group of patients.) That means that a treatment in the U.S. would probably be available in the next five years.

Meanwhile, in New York...


In the meantime, hair transplant surgery has come a long way from obvious “plugs” -- large, clunky grafts -- to more precise implants in naturally occurring groups of 1-4 hairs called follicular units. Even RepliCel's Hall considers microtransplant surgery the gold standard for care in men. “In the hands of a gifted surgeon, it has a really good outcome,” he said. “The problem is that there are only so many gifted surgeons.”

The logic behind hair transplant surgery, aside from the obvious -- moving hair from once place to another -- is that the donor hair taken from the back of the head isn't sensitive to the androgen, or hormone, dihydrotestosterone (DHT). DHT is the culprit in male-patterned baldness that stops the follicle from cycling normally. (To the extent that Propecia works, it does so by blocking DHT.) In theory, a successful hair transplant should be relatively permanent. The other problem is that there are only so many hairs.

In the U.S. there are two new developments that could potentially improve the quality and availability of hair transplant surgery, which according to the American Society of Plastic Surgeons was the fifth most common cosmetic surgical procedure among men in 2010, behind nose reshaping, eyelid surgery, liposuction, and breast reduction.

One of these developments is being tested at the offices of Amiya Prasad, M.D., a cosmetic surgeon in New York City. Gary Hitzig, M.D., Medical Director of Prasad Cosmetic Surgery Hair Restoration Division, is banking on the same university studies cited by the biotech companies we interviewed. But instead of coming up with a proprietary injection -- like Histogen's HSC or RepliCel's dermal sheath cup cells -- he has sidestepped the research and FDA approval process by using ACell MatriStem, a product derived from pig bladder that has already been cleared by the FDA and is commonly used in regenerative medicine (including by Prasad in the other areas of his practice).

ACell MatriStem has been in the mainstream press for regenerating a woman's severed fingertip, healing a toddler's severed thumb and for its use in healing soldiers with significant battle wounds. It's made of collagen and other growth factors; when applied to wounds, it provides a sort of scaffolding for healing and simultaneously activates nearby adult stem cells to rebuild tissue.

Hitzig has experimented with several applications of ACell: Using it to accelerate the healing process and prevent scarring where donor hair was extracted, dipping hairs in it before they were transplanted into the top of the scalp, as an injection in non-transplant patients, and as an injection combined with platelet-rich plasma (PRP), blood plasma jacked up with even more growth factors than the ACell alone.

“It's amazing stuff,” he said. “We're at the stage now where I can take people who weren't candidates for transplants and we can go ahead and do them. We have a way of healing the area instead of scarring. And we have a way of getting a better result by multiplication of hairs growing on top.” He's especially excited about the injection, which he sees and as a way to slow down or stop hair loss.

“I equate it to a flu shot,” Hitzig said. “It may not stop you from getting the flu, but it sure as heck helps. We haven't had anything else like this.”

It's not a radically different concept than what the biotech companies are exploring: Create a nutrient- and growth-factor-rich environment to save dying hair follicles and grow new ones. The one problem is that Hitzig hasn't yet conducted a controlled clinical trial to prove that patients have statistically significant results with the ACell and PRP injection.

Thus, robots


The other development, naturally, is a robot. It turns out that extracting an implanting follicular units successfully is difficult and time-consuming, a procedure too tricky for many transplant surgeons. Restoration Robotics, a privately held medical device company, aims to democratize the procedure. Its first product, ARTAS, uses an image-guided robotic arm to harvest hair from the back of the patient's head.

Mohan Bodduluri, Ph.D, the founder and CTO of Restoration Robotics, said that he expects to roll out a product that can do even more in five years. “Internally, we call that 'hair transplantation in a box," Bodduluri said. “The expectation is that the follicles would be harvested, they would be stored and be implanted -- all by the machine. The technicians may never have to handle the graft.”

ARTAS is currently being used at hair transplant facilities in New York, Los Angeles, Dallas, and Denver. It looks a bit like a cross between a massage chair and Optimus Prime. Like most hair transplants, the cost of a procedure with ARTAS costs $10,000 and up, depending on the number of grafts and the reputation of the surgeon.

The future: Hairy


What we know for sure about the future is that there will be more robots. What we sort of know is that there will be a brief period of time when people in Asia and the Caucuses are walking around with pompadours while we're still in recession (both kinds). And what we can only speculate about is that Chinese President Hu Jintao and Vice-President, Xi Jinping did not get such exceptional hair through genetics alone. Somebody got his hands in the cell transplant injection jar.

Prasad said something interesting when I spoke to him about hair transplants and his work with Hitzig: “Hair transplant surgeons, kind of like chefs who cook chili, talk about how the other guys are not as good as I am because I do this that and the other thing. When you get down to it, no matter what doctor is doing the work, the quality of the transplant has an upper limit. It's a strategy to frame your face, create the illusion of more hair than you think someone has.”

He's confident that ACell will be a breakthrough, but his comments have broader implications: chili cooks are a pain in the ass. Also, framing the face is about more than just about the number of follicles in a scalp. It's about how we see ourselves and whether we really can, and want to, reverse-engineer the building blocks of nature for cosmetic purposes. Whether it's better to live generally within the bounds of nature or to live with an illusion of youth.

Common procedures are becoming less invasive and less costly. Botox was the most popular minimally invasive cosmetic procedure for men in 2010, up 10% over the previous year. There's a very good chance that we're less than 10 years away from a similarly quick and painless injectible treatment to stop or reverse hair loss.

When it happens, when we decide to use it, make no mistake: The treatment may go under the radar, but everything we do frames the face.

Sunday, April 7, 2013

Histogen Announces Initial Results from Phase I/II Clinical Trial of HSC

Histogen Announces Initial Results from Phase I/II Clinical Trial of HSC

Source: histogen.com

Data shows significant efficacy at all time points and all treated hair loss regions
SAN DIEGO, October 19, 2012 - Histogen, Inc., a regenerative medicine company developing innovative therapies based on the products of cells grown under simulated embryonic conditions, will present preliminary data from the ongoing clinical trial of its Hair Stimulating Complex (HSC) today at the International Society of Hair Restoration Surgery (ISHRS) Annual Meeting. Statistically significant improvement was seen across all targeted hair growth parameters in this Phase I/II clinical trial, with an 86% responder rate.
 
The double-blind Phase I/II clinical trial was undertaken to further examine the safety and efficacy of intradermal injections of HSC in 56 men with androgenetic alopecia. In addition to other safety outcome measures, clinical evaluation of blood serum chemistry, hematology and urinalysis showed no indication of toxicity over 12 weeks. The treatment was well-tolerated and no study-related adverse events have been reported.
In this second clinical trial of HSC, which was designed with an additional treatment timepoint, the increase in total hair count was 46.5% above that seen in the pilot HSC trial at 12 weeks. Statistical significance was noted in all efficacy endpoints, which include increases in total hair count (p=0.0013), terminal hairs (p=0.0135), and hair thickness (p=0.026). A significant increase in vellus hair count (p=0.033) was seen for the first time, supporting the hypothesis that the HSC treatment rescues dying follicles, in addition to converting vellus to terminal hairs and increasing the number of hairs per follicle. Statistical significance continued to be seen at the 24 week time point.
"We are excited that HSC has not only continued to show unprecedented results, but that the addition of a second treatment time point in the Phase I/II clinical trial has resulted in even greater hair growth than the pilot study," said Gail K. Naughton, Ph.D., Histogen CEO and Chairman of the Board. "Particularly compelling is the growth seen in more difficult types and stages of hair loss. Without limitations to treatment area, age or stage of balding, HSC has the potential to expand the hair restoration market by offering a successful option to those that currently have none."
Available non-surgical treatment options for alopecia focus on younger patients in the earlier stages of hair loss, with a primary purpose of retaining existing hair and supporting limited hair regrowth. This is not the trend seen in the clinical trials of HSC. In both the pilot and Phase I/II clinical trial, HSC treatment has shown efficacy across age groups, with subjects age 40-59 seeing cosmetically significant results beginning at 12 weeks, including a mean increase of 39% in terminal hairs and 19.4% in total hair count in this age group in the current trial.
Importantly, the efficacy of HSC is not limited by hair loss region. The Phase I/II clinical trial has shown noted new hair growth in subjects treated in all regions of the scalp, including temporal recession, mid-scalp and vertex. Subjects receiving HSC in the temporal recession, which is known to be more difficult to treat than other areas of hair loss, saw marked improvement in terminal hair count, with a mean increase of 22.6% at 12 weeks and 25.2% at the 24 week time point.
In addition to the Phase I/II data, Dr. Naughton will present results from a Physician-sponsored IND of HSC conducted by Dr. Craig Ziering, an ISHRS member and leading hair restoration surgeon. Five men and five women received up to four treatments of HSC, with all subjects showing positive hair growth. Increased hair growth was seen as early as 6 weeks, with clinically and cosmetically relevant results seen as early as 18 weeks.
"The clinical data seen to date with HSC is very compelling," said Dr. Craig Ziering, Founder and CEO of Ziering Medical. "Not only is the strong safety profile clinically important, but we have seen cosmetically significant results, with coverage of thinning areas, in a clinical setting. In addition, the response seen in women treated with HSC is unprecedented."
HSC is a complex of proteins and growth factors naturally secreted by multipotent cells under Histogen's proprietary growth conditions. The proteins within HSC, such as KGF, VEGF, and follistatin, are involved in signaling stem cells in the body, and have been shown to be key in hair formation and the stimulation of resting hair follicles.
"Scalp Injection of Active Embryonic-like Cell-secreted Proteins and Growth Factors" will be presented by Dr. Naughton at the ISHRS Annual Meeting, taking place October 17-20, 2012, in the Bahamas.

Sunday, March 3, 2013

Histogen’s Hair Stimulating Complex (HSC): Revolutionary Hair Loss Treatment for Males with Androgenic Alopecia?

Histogen’s Hair Stimulating Complex (HSC): Revolutionary Hair Loss Treatment for Males with Androgenic Alopecia?


David / Fri 20 Jul 2012
Source: regrowhair.com

histogen.com
Over the past year, regenerative medicine company Histogen, Inc. has continued to test its highly anticipated hair loss treatment known as HSC (Hair Stimulating Complex). The latest phase in HSC’s ongoing trials began in Pasig City, Manila, Philippines on December 22, 2011 and will conclude in December 2012.

Androgenic alopecia (genetic baldness) affects an estimated 40 million men and 21 million women in the United States alone with many millions more worldwide. Approximately 7% of these hair loss sufferers, from the early stages of thinning hair to completely bald, currently seek medical and/or surgical hair restoration treatments to slow the progression of further balding and regrow hair. Though a relatively small number, this amounts to a highly competitive, multi-billion dollar industry.

Today’s most effective hair loss treatments are the clinically proven and FDA approved drugs Rogaine (minoxidil) and Propecia (finasteride) as well as state of the art follicular unit hair transplantation (FUT). However, a number of balding men and women also seek alternatives like low level laser therapy (LLLT) and herbal treatments among others. Each of these treatments has its own benefits and limitations but Histogen, Inc. hopes to add its new and potentially revolutionary injectable treatment to the list.

How HSC Works
According to the literature, “HSC consists of proteins secreted by human dermal cells under proprietary culture conditions that include reduced oxygen and bioreactors. Under these conditions, the cells secrete soluble proteins that include both growth factors and soluble precursors to the deposited extracellular matrix. Several of these proteins are known to be important in the control of the hair cycle and will stimulate resting hair follicles to resume hair formation”.

Interestingly, the importance of a low oxygen environment (hypoxia) has been cited as an important factor in reawakening dormant hair follicles by other researchers like French cosmetics giant L’Oreal whose upcoming hair growth lotion Neogenic also aims to revolutionize the hair restoration industry.

To learn more about Histogen’s Hair Stimulating Complex including the results of its pilot study see the article, Histogen Inc. Makes Headway in Pursuit of a Revolutionary Hair Loss Treatment

Conclusion
Only time will tell if HSC can deliver on its promise to stimulate new hair growth but, even if it lives up to its hype, it does not represent the fabled “hair loss cure” and will likely takes its place as an adjunct to the existing and proven hair loss treatments mentioned above.

For more on Histogen and to stay abreast of their progress, you are encouraged to add your comment to the discussion topic “Histogen” on our hair loss forum.