No evidence to support stem cell therapy for pediatric optic nerve hypoplasia

PUBLIC RELEASE DATE:

22-Oct-2013

Contact: Eileen Leahy e.leahy@elsevier.com 732-238-3628 Elsevier Health Sciences

San Francisco, CA, October 22, 2013 A study performed at Children's Hospital Los Angeles found no evidence that stem cell therapy improves vision for children with optic nerve hypoplasia (ONH). Their results are reported in the Journal of the American Association for Pediatric Ophthalmology and Strabismus (AAPOS).

ONH, an underdevelopment of optic nerves that occurs during fetal development, may appear either as an isolated abnormality or as part of a group of disorders characterized by brain anomalies, developmental delay, and endocrine abnormalities. ONH is a leading cause of blindness in children in North America and Europe and is the only cause of childhood blindness that shows increasing prevalence. No treatments have been shown to improve vision in these children.

With no viable treatment options available to improve vision, ophthalmologists are becoming aware that families with children affected by ONH are travelling to China seeking stem cell therapy, despite lack of approval in the United States and Europe or evidence from controlled trials. The American Association for Pediatric Ophthalmology and Strabismus has also expressed its concern about these procedures. In response to this situation, pediatric neuro-ophthalmologist Mark Borchert, MD, Director of both the Eye Birth Defects and Eye Technology Institutes in The Vision Center at Children's Hospital Los Angeles, realized that a controlled trial of sufficient size was needed to evaluate whether stem cell therapy is effective at improving optic nerve function in children with ONH. He agreed to conduct an independent study when asked by Beike Biotech, a company based in Shenzhen, China, that offers treatment for ONH using donor umbilical cord stem cells injected into the cerebral spinal fluid.

Beike Biotech agreed to identify 10 children with bilateral ONH (ages 7-17 years) who had volunteered to travel to China for stem cell therapy and who agreed to participate in the study; Children's Hospital was to find case matched controls from their clinic. However, only two case-controlled pairs were evaluated because Beike Biotech was only able to recruit two patients. Treatments consisted of six infusions over a 16-day period of umbilical cord-derived mesenchymal stem cells and daily infusions of growth factors. Visual acuity, optic nerve size, and sensitivity to light were to be evaluated one month before stem cell therapy and three and nine months after treatment.

No therapeutic effect was found in the two case-control pairs that were enrolled. "The results of this study show that children greater than 7 years of age with ONH may have spontaneous improvement in vision from one examination to the next. This improvement occurs equally in children regardless of whether or not they received treatment. Other aspects of the eye examination included pupil responses to light and optic nerve size; these did not change following treatment. The results of this research do not support the use of stem cells in the treatment of ONH at this time," says lead author Cassandra Fink, MPH, program administrator at The Vision Center, Children's Hospital Los Angeles.

Confounding the trial was that subjects received additional alternative therapies (acupuncture, functional electrical stimulation, and exercise) while receiving stem cell treatments, which was contrary to the trial protocol. The investigators could not determine the effect of these additional therapies.

"This study underscores the importance of scientifically testing these procedures to validate them and also to ensure their safety. Parents of afflicted children should be aware that the science behind the use of stem cell technology is unclear. This study takes a step toward testing this technology and finds no beneficial effect," says William V. Good, MD, Senior Associate Editor, Journal of AAPOS and Clinical Professor of Ophthalmology and Senior Scientist at the Smith-Kettlewell Eye Research Institute.

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Life Stem Genetics Has New Stock Symbol and New Financing Commitment

LOS ANGELES--(BUSINESS WIRE)--

Life Stem Genetics Inc. (the Company), an emerging innovator in the advancement of Adult Stem Cell therapy announces that the Company's new stock symbol, LIFS, is now active.

The Company is also pleased to release the general details of its recent financing commitment. This financing is for $1 million (the Private Placement) of 1,000,000 units (each, a Unit) at a price of $1 per Unit. Each Unit will consist of one common share of the Company and one warrant to purchase an additional common share of the Company (each, a Warrant Share) at $1 per Warrant Share for a period of one year. The Company is to close the Private Placement within 45 calendar days of this press release.

Gloria Simov, CEO of Life Stem Genetics, commented, "Our new trading symbol and recent financing are key components to provide future value to our shareholders and to our fulfillment of our long term objectives in the emerging Adult Stem Cell therapy industry."

All shareholders of the Company are encouraged to view the Company's complete filings at the following link:

http://www.sec.gov/cgi-bin/browse-edgar?company=Life+Stem+Genetics HYPERLINK "http://www.sec.gov/cgi-bin/browse-edgar?company=Life+Stem+Genetics&owner=exclude&action=getcompany"& HYPERLINK "http://www.sec.gov/cgi-bin/browse-edgar?company=Life+Stem+Genetics&owner=exclude&action=getcompany"owner=exclude HYPERLINK "http://www.sec.gov/cgi-bin/browse-edgar?company=Life+Stem+Genetics&owner=exclude&action=getcompany"& HYPERLINK "http://www.sec.gov/cgi-bin/browse-edgar?company=Life+Stem+Genetics&owner=exclude&action=getcompany"action=getcompany

About Life Stem Genetics

Life Stem Genetics (LSG) is a progressive health care company that focuses on healing with a patients own Stem Cells. Stem Cells for years have been known to heal a variety of ailments successfully and now it is being offered as an efficient and painless way to treat many different illnesses ranging from orthopedic Injuries, neurological disorders such as Parkinsons, and Alzheimers, Cancer, Plastic Surgery, Age Management, Arthritis, Diabetes, Cardiology, COPD, MS, Urology, and many more. Stem Cell Therapy and LSGs proprietary techniques have experienced some of the best results in the industry, helping to repair or re-program damaged or diseased tissues and organs.

LSGs stem cell specialist has performed thousands of stem cell treatments, including the top names in PGA golf, NFL football, NBA basketball, and Major League Baseball. LSG will offer their proprietary treatments through a series of affiliate doctors, and medical clinics, with 60 affiliated clinics so far.

LSGs mission is to create a solid comprehensive approach to the treatment and maintenance of diseases and to break free from the medical insurance world by tapping into an affordable private- pay sector delivering exceptional healthcare free from the medical insurance maze.

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Molecule Increases Growth of Stem Cells, Research Suggests

Recently published results from the Harvard Stem Cell Institutes first-ever clinical trials have identified a molecule that could increase the success rates of umbilical cord blood transplants in cancer patients.

The trials found that umbilical cord blood cells treated with 16, 16-dimethyl prostaglandin E2, a molecule derived from fatty acids and also called dmPGE2, grew more stem cells than untreated umbilical cord blood.

Stem cell growth is particularly promising in the treatment of cancer, which is marked by rapid proliferation of mutated cells and the death of functional, important tissue. Stem cell transplants usually face stringent blood type matching requirements, which can often hinder a patients ability to find a viable donor.

Umbilical cord transplants improve flexibility and safety, however, since blood does not need to be exactly matched and has had less exposure to viruses. Successful implementation of the dmPGE2 molecule could help the approximately 50 to 60 percent of stem cell transplant patients who do not have siblings with a matching blood type.

Led by Leonard I. Zon, chairman of the Harvard Stem Cell Institute Executive Committee and professor of stem cell and regenerative biology, researchers at the HSCI discovered that dmPGE2 spurred stem cell growth through laboratory experiments on zebrafish and then mice. Zon and his team then approached the Dana-Farber Cancer Institute and Massachusetts General Hospital to conduct clinical trials.

The HSCI has several ongoing projects, but researchers work on the dmPGE2 molecule is one of the special projects in the lab, Zon said, adding that the work is one of the most exciting things he has ever done.

Corey S. Cutler, an associate professor of medicine at Harvard Medical School who spearheaded the clinical trials, echoed Zons enthusiasm about the projects potential. The exciting part [about this project] is that its really home-grown technology that was discovered right down the hall, he said. He added that while it may still be many years before the technology is ubiquitously accessible to patients, the fact that we could potentially change the field entirely; its quite amazing.

The study was published online in the weekly medical journal Blood in late August and received support from biopharmaceutical company Fate Therapeutics. Phase II of the clinical testing is designed to evaluate the treatments efficacy in about 60 patients. According to Zon, results should be expected after 18 months.

The HSCI was established nine years ago to translate stem cell technology advances made in the laboratory into clinical applications.

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Molecule Increases Growth of Stem Cells, Research Suggests

Stem Cell Therapeutics Strengthens CD47 Franchise With Acquistion of Complementary Antibody Program

TORONTO, ONTARIO--(Marketwired - Oct 17, 2013) - Stem Cell Ther apeutics Corp. (TSX VENTURE:SSS)(SCTPF), a biopharmaceutical immuno-oncology company developing cancer stem cell-related therapeutics, today announced that it has entered into an option agreement to exclusively license worldwide rights to a panel of fully human monoclonal antibodies targeting the SIRPa protein (CD172a). The technology was developed by scientists at the University Health Network, the University of Toronto, through the Toronto Recombinant Antibody Centre (TRAC), and The Hospital for Sick Children (SickKids), in Toronto, Ontario.

SIRPa is the ligand of CD47, a molecule upregulated on many hematological and solid tumors. CD47 delivers a "do not eat" signal that su ppresses macrophage phagocytosis, allowing cancer cells, including cancer stem cells, to escape immune-mediated destruction. Stem Cell Therapeutics (SCT) is currently developing a CD47 antagonist, using a modified version of the native SIRPa protein fused to an immunoglobulin Fc region. This SIRPaFc fusion protein has shown remarkable anti-leukemic activity both in vitro and in human xenograft models, and SCT recently announced that the program has entered the IND-enabling phase of drug development. The company expects to report further updates at the upcoming annual meeting of the American Society of Hematology (December 7-10, 2013).

"Targeting the CD47/SIRPa pathway can eliminate bot h bulk cancer cells and cancer stem cells, and engages both the innate and the adaptive arms of the immune system," commented SCT's Chief Scientific Officer, Dr. Bob Uger. "Antibody blockade of SIRPa is a promising approach to activate the anti-tumor activity of macrophages against both liquid and solid tumors, and has the potential as both a monotherapy and combination therapy with other anti-cancer antibodies."

"The CD47/SIRPa axis is one of the most promising a nd compelling next-generation immunotherapy targets in the fight against cancer," remarked SCT's Chief Executive Officer, Dr. Niclas Stiernholm. "Having recently an nounced the advancement of our SIRPaFc program into formal IND-enabling studies, a program we believe is the best-in-class CD47 antagonist currently in development, reinforcing our industry-leading position in this pathway with a complementary antibody program against the SIRPa protein makes eminent sense."

The execution of the definitive license agreement is subject to final due-diligence and certain conditions being met by SCT over the next nine months. The license agreement will contain customary terms and provisions for assets at this stage of development, including an initial license consideration, milestone payments, royalties on sales and sublicensing terms.

SCT Annual and Special Meeting

The company's Annual and Special Meeting of shareholders will be held today at 3:00 pm in the company's offices at 96 Skyway Avenue, Toronto, Ontario, M9W 4Y9. The meeting will include an audio broadcast. To access, please use the following details:

About Cancer Stem Cells:

The cancer stem cell (CSC) concept postulates that the growth of tumors is driven by a rare population of dedicated cells that have stem cell-like properties, including self- renewal. While the bulk of a tumor consists of rapidly proliferating cells and differentiated cells, neither of which is capable of self-renewal, a small population of CSCs provides for long-term maintenance of the cancer. Although the CSC concept was first postulated in the 1960s, it wasn't until 1994 that proof of their existence was demonstrated, when Dr. John Dick and colleagues in Toronto isolated CSCs (known as leukemic stem cells, or LSCs) from bulk acute myeloid leukemia cells. More recently, CSCs have been identified in many other human malignancies, including solid tumors such as bladder, brain, breast, colon, ovarian and prostate cancers. There is accumulating evidence that CSCs are resistant to conventional chemotherapies and radiation. Thus, CSCs are thought to be responsible for a phenomenon well known to oncologists: most patients will experience an initial response to conventional chemotherapies but will ultimately relapse. To cure cancer CSCs need to be destroyed, but the current armament of therapies is poorly equipped to do so.

About Stem Cell Therapeutics:

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Stem Cell Therapeutics Strengthens CD47 Franchise With Acquistion of Complementary Antibody Program

Desperate Family Turns To Controversial Stem Cell Treatment To Help Toddler

MIAMI (CBS4) When Vicky Bonilla looks into her 3-year-old son Andrews eyes, she sees his desire to communicate like he used to.

The neurologist and therapists tell me that he is more aware than what he is able to express and at times he gets frustrated because he cannot express what he wants, Vicky told CBS4s Natalia Zea.

When his older siblings play peekaboo with him they see glimmers of who Andrew used to be.

Andrew was born with digestive issues, but functioned like any other toddler.

He would walk, talk, play like a regular little boy did, said Bonilla through tears.

And he was his dad Tito Bonillas sidekick.

He would do everything with me. He knew everybodys names. He knew mommy, pappi, he knew the color of your car. He knew everything. It was just amazing, he was so smart, said Tito.

Everything changed in January of 2012. At 2 years old, Andrew went into an emergency room, one of many visits for his digestive problems. But this time, he went into septic shock. Infection took over his body and he flat lined in front of his mom.

I had him on his side, I had his hand on his chest and I felt his heart stop, that denial of No, this is not happening, this is really not happening, Vicky recalled.

Medical staff revived Andrew, but the lack of oxygen caused brain damage and left him severely impaired.

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Desperate Family Turns To Controversial Stem Cell Treatment To Help Toddler

Church: Don’t use human embryos for stem cell cure

Archbishop Socrates Villegas: Killing an embryo is killing a human being (cbcpforlife.com photo)

DAGUPAN CITY, PhilippinesArchbishop Socrates Villegas said the Catholic Church is not against stem cell treatment but is wary that human embryos taken from aborted fetuses have been used in the controversial therapy.

In his pastoral guidance issued Thursday on queries about the morality of the treatment, Villegas said there was nothing generally objectionable about stem cell therapy.

Stem cell research and therapy that use adult human stem cells and stem cells from umbilical cord blood are acceptable as long as they are proven safe and are approved by regulating bodies, Villegas said.

What the Church fears are incidences when such therapy abets directly or indirectly the practice of abortion, he said. [This] is not only morally objectionable [but also] morally repugnant as the use of human embryo means killing a human being in order to save another human being.

We have always believed that a human embryo or fertilized ovum is a (complete) human being although in its primitive form, he said, adding that this entity is irreplaceable.

Killing an embryo in any of its stage of development is killing a human being. This makes it morally repugnant, the bishop said.

Villegas issued the statement in response to requests by the Union of Catholic Physicians for moral guidance regarding the medical issue of stem cell therapy and the ethical dimensions in the practice of their profession.

The dangers and potentials of stem cell therapy, which has become available in the country, have prompted the Church to provide pastoral guidelines for those procuring, providing or regulating such treatment, he said.

He also cautioned people against stem cell therapy that uses plant cells, animal cells and genetically modified human stem cells.

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Church: Don’t use human embryos for stem cell cure

Rewinding the biological clock

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Francis Leroy / Biocosmos / Science Photo Library

Reproductive biologists have been working for decades to solve one of the great mysteries of human fertility: why do women produce all the eggs they will ever have while still in the womb, only to have most of those eggs die off before birth, and many more before the woman reaches puberty?

Jonathan Tilly, chair of the biology department at Northeastern University in Boston, was among those drawn to studying this enduring puzzle. But what he found instead was evidence of a fundamental flaw in the basic tenets that govern our understanding of the female reproductive system. If successful, his research could open the door to the most radical advancement in infertility treatment since in vitro fertilization was invented nearly 40 years ago.

When Tilly examined the ovaries of mice, he noticed that their eggs were dying much faster than the overall egg count would suggest. The mice appeared to be producing new eggs, and were doing so by a process that no one really understood.

Tillys team began researching the role that stem cells play in the process. Chinese researchers later identified a specific type of stem cell located in the ovarian tissue.

Last year, Tillys team published evidence that the same process happening in mice was occurring in humans. He isolated human ovarian stem cells and then implanted them into mice to produce an immature egg called an oocyte.

The implications are huge. If a woman continues to produce eggs into adulthood, then menopause doesnt happen because her body has exhausted its lifetime supply of eggs, but because the process to make new ones has stopped working. It also means that infertility problems in older women arent happening because the eggs she is born with have grown too old, but because the bodys quality-control process has broken down so that it is pumping out poor-quality new eggs.

Theres not a lot you can do about an egg that is 40 years old and has gone bad because of 40 years of accumulated damage, says Tilly. But there is something very much one can do if the egg quality really reflects not eggs going stale, but a production pipeline thats run amiss.

More importantly, if researchers could find a way to somehow kick-start the ovarian stem cells in older women who had stopped producing viable eggs, they could potentially rewind the biological clock.

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INVESTOR INTEREST STRONG FOR STEM CELL COMPANIES

By Bradley J. Fikes U-T 12:01 a.m.Oct. 16, 2013

Good stem cell companies will get the funding they need to bring their products to market, financial and medical executives said at this years Stem Cell Meeting on the Mesa.

Biotech companies continue to attract investor interest, speakers said at the meeting this week in La Jolla, pointing to a stream of biotech initial public offerings as well as purchases of biotechs by large pharmaceutical companies.

However, theres a catch: Companies may get a lower value than they seek.

The field of stem cell therapies, also known as regenerative medicine, is making the transition from pure science to clinical medicine. San Diegos Cytori Therapeutics is testing a device to harvest a patients stem cells for treating heart diseases and repairing tissue defects. And in a much-watched trial, a cure for HIV infection is being tested by Sangamo BioSciences, based in Richmond.

The challenge for stem cell companies is to convince investors that their science is actually geared toward products that can be sold, said Ted Roth, president of Newport Beach-based Roth Capital Partners. Compared with 20 years ago, investors are much more sophisticated and arent dazzled by technology, he said.

How can you convince me this is not a science project? is the question these companies need to answer, Roth said.

Those that convince investors can do very well, Roth said, citing recent examples. Stemline Therapeutics, for example, held its IPO at $10 a share in January. At the close of trading on Monday, Stemline shares closed at $36.52. Stemline is developing treatments to eliminate cancer stem cells.

On a smaller scale, Roth Capital helped Carlsbad-based International Stem Cell Corp. raise $3 million this summer, Roth said. International Stem Cell is developing a Parkinsons treatment derived from parthenogenetic, or unfertilized, human egg cells.

Roth spoke at a Monday afternoon discussion on financing. His colleague on the panel, Karl Handelsman, concurred.

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INVESTOR INTEREST STRONG FOR STEM CELL COMPANIES

Stem cell businesses keep growing

Good stem cell companies will get the funding they need to bring their products to market, financial and medical executives said at this year's Stem Cell Meeting on the Mesa.

Biotech companies continue to attract investor interest, speakers said at the meeting this week in La Jolla, pointing to a stream of biotech initial public offerings as well as purchases of biotechs by large pharmaceutical companies.

However, there's a catch: Companies may get a lower value than they seek.

The field of stem cell therapies, also known as regenerative medicine, is making the transition from pure science to clinical medicine. San Diego's Cytori Therapeutics is testing a device to harvest a patient's stem cells for treating heart diseases and repairing tissue defects. And in a much-watched trial, a cure for HIV infection is being tested by Sangamo BioSciences, based in Richmond.

The challenge for stem cell companies is to convince investors that their science is actually geared toward products that can be sold, said Ted Roth, president of Newport Beach-based Roth Capital Partners. Compared with 20 years ago, investors are much more sophisticated and aren't dazzled by technology, he said.

"How can you convince me this is not a science project?" is the question these companies need to answer, Roth said.

Those that convince investors can do very well, Roth said, citing recent examples. Stemline Therapeutics, for example, held its IPO at $10 a share in January. At the close of trading on Monday, Stemline shares closed at $36.52. Stemline is developing treatments to eliminate cancer stem cells.

On a smaller scale, Roth Capital helped Carlsbad-based International Stem Cell Corp. raise $3 million this summer, Roth said. International Stem Cell is developing a treatment for Parkinson's derived from parthenogenetic, or unfertilized, human egg cells.

Roth spoke at a Monday afternoon discussion on financing regenerative medicine. His colleague on the panel, Karl Handelsman, concurred.

"If you can make a strong quality business case, you can always raise money," said Handelsman, founder of Codon Capital.

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Stem cell businesses keep growing

Amy Wagers receives New York Stem Cell Foundation-Robertson Stem Cell Prize

Public release date: 15-Oct-2013 [ | E-mail | Share ]

Contact: David McKeon dmckeon@nyscf.org 212-365-7440 New York Stem Cell Foundation

NEW YORK, NY (October 15, 2013) The New York Stem Cell Foundation (NYSCF) announced today that Amy Wagers, PhD, Professor at Harvard University, will be the 2013 recipient of the NYSCF Robertson Stem Cell Prize, which has been awarded since 2011 for extraordinary achievements in translational stem cell research by a younger scientist.

Dr. Wagers is the Forst Family Professor of Stem Cell and Regenerative Biology at Harvard University and an Early Career Scientist of the Howard Hughes Medical Institute. At Harvard, she leads an independent research program that focuses on the regulation and therapeutic potential of blood and muscle stem cells.

"Dr. Wagers' groundbreaking research on the biology of blood and muscle forming stem cells has opened up an avenue for cures of degenerative diseases of the aged," said Susan L. Solomon, CEO and Co-founder of NYSCF. "Her work has the potential to impact treatment of diabetes, cancer, and muscular dystrophy among many other devastating conditions."

As the population ages, therapies that delay or reverse degenerative changes associated with age are increasingly important. To date, few interventions show promise, but exciting work from Dr. Wagers' lab has uncovered a role for blood-borne factors. Her discovery of a hormone, GDF11, that regulates aging through stem cell "rejuvenation" has the potential to provide transformative new therapies for aging and chronic degenerative diseases.

"I am delighted that the NYSCF-Robertson Prize, which honors the most important research conducted by a young stem cell scientist, will this year recognize Dr. Amy Wagers. Her path-breaking work in understanding blood-forming and muscle-forming stem cells is precisely the kind of translational science that the NYSCF-Robertson Prize was created to encourage," said Julian Robertson, whose foundation underwrites the $200,000 prize. The terms of the prize require that the $200,000 stipend be used, at the recipients' discretion, to further support their research.

The NYSCF Robertson Stem Cell Prize was presented to Dr. Wagers at a ceremony in New York City by Susan L. Solomon on October 15.

The jury that selected Dr. Wagers consisted of Fiona Watt, DPhil, from King's College London in the United Kingdom; Lorenz Studer, MD, Director of the Sloan-Kettering Center for Stem Cell Biology; Irving Weissman, MD, Director of the Institute for Stem Cell Biology and Regenerative Medicine at the Stanford School of Medicine; and inaugural recipient of the NYSCF Robertson Stem Cell Prize, Peter J. Coffey, DPhil, Co-Executive Director of Translation UC Santa Barbara's Center for Stem Cell Biology and Engineering and Director of the London Project to Cure Blindness, University College London.

Dr. Wagers' current work focuses on defining the factors and mechanisms that modulate the migration, expansion, and regenerative potential of aging stem cells. Her work on GDF11, a circulating hormone that declines with age in mice and humans, has shown that restoring "youthful" levels of GDF11 in mice produces a striking reversal of age-related disease in multiple systems, especially skeletal muscle.

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Amy Wagers receives New York Stem Cell Foundation-Robertson Stem Cell Prize