From the Hands of Angels: Brainstorm Cell Therapeutics Inc.

BOSTON, MA--(Marketwire -06/25/12)- When it comes to disease, few are crueler than ALS. Approximately 5,600 people in the U.S. are diagnosed with ALS each year. Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. The motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. The progressive degeneration of the motor neurons in ALS eventually leads to their death. The life expectancy is 2-5 years from the time of diagnosis. When the motor neurons die, the ability of the brain to initiate and control muscle movement is lost. Most ALS patients expire from suffocation while suffering no cognitive depreciation.

Brainstorm Cell Therapeutics Inc., trading on the Over the Counter Bulletin Board in the United States, is leading the fight to finding a cure for ALS with its NurOwn proprietary technology. The NurOwn technology is changing the field of regenerative medicine by reprogramming bone marrow derived from mesenchymal stem cells into neuron-supporting cells. The axon terminals (nerve cells ending) will take up neurotrophic factors secreted by the transplanted cells into the muscles or the spinal cord and transport them back into cell bodies within the spinal cord. This will prevent further degeneration of the neuronal cells. Although the primary purpose of the Phase I/II trial being conducted at the prestigious Hadassah Medical Center in Jerusalem is to ensure safety and tolerability, initial data has shown efficacy. Professor Eldad Melamed, the lead investigator of the trial, said, "There have been no significant side effects in the initial patients we have treated with BrainStorm's NurOwn technology. In addition, even though we are conducting a safety trial, the early clinical follow up of the patients treated with the stem cells shows indications of beneficial clinical effects, such as an improvement in breathing and swallowing ability as well as in muscular power. I am very excited about the safety results, as well as these indications of efficacy, we are seeing. This may represent the biggest hope in this field of degenerative diseases, like ALS." Dr. Adrian Harel, CEO of Brainstorm, indicated trial data from the first cohort of 12 patients with ALS will be made available to the public sometime in July 2012.

Sai Rosen, Director for Stem Cell Media, LLC, observed, "Brainstorm's early clinical results showed a marked improvement in breathing. An arterial blood gas (ABG) test measures the levels of oxygen and carbon dioxide in the blood to determine how well the lungs are working and according to the initial data the patients showed improved ABG."

It is expected that a Phase II/III ALS trial application will be filed with the FDA in the United States in the second half of 2012. Brainstorm recently received FDA Orphan Drug Designation for its NurOwn cell therapy for ALS in the U.S. The trial site in the U.S. will be conducted at Massachusetts General Hospital (MGH) and is expected to begin late 2012.

The Company is well positioned financially to see the ALS trial through proof of concept. Dr. Harel has arranged a $10MM stock purchase agreement along with non-dilutive grant monies from the Office of the Chief Scientist (OCS) in the amount of approximately $350,000. The yearly grant for 2012 is $1,100,000 (~4.2 M NIS). Dr. Harel commented, "We are thankful to the OCS for its continued support of our Research and Development program. The non-dilutive capital that we are receiving from the OCS will help move forward our NurOwn technology as a potential new treatment standard for patients with Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS)."

Brainstorm's flagship NurOwn technology is also being applied to adult stem cell therapies to treat a variety of debilitating neurodegenerative diseases, such as Parkinson's Disease (PD), Multiple Sclerosis (MS) and spinal cord injuries.

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From the Hands of Angels: Brainstorm Cell Therapeutics Inc.

Notre Dame establishes professorships in adult stem cell research

Public release date: 22-Jun-2012 [ | E-mail | Share ]

Contact: William Gilroy gilroy.6@nd.edu 574-631-4127 University of Notre Dame

Alumnus Michael Gallagher and his wife, Elizabeth, have made a $5 million gift to establish the Elizabeth and Michael Gallagher Family Professorships in Adult Stem Cell Research at the University of Notre Dame.

Their gift, which will fund three new endowed professorships in adult and all forms of non-embryonic stem cell research, will strengthen Notre Dame's leadership in the field of stem cell research and enhance the University's effective dialogue between the biomedical research community and the Catholic Church on matters related to the use and application of stem cells and regenerative medicine.

"As a Catholic university, Notre Dame carries a mantle of responsibility to use our scholarship and resources to help alleviate human suffering, and, in this area of research in particular, to do so with deep respect for the sanctity of all human life," said Rev. John I. Jenkins, C.S.C., the University's president. "These new professorships will enable us to effectively build upon an already strong foundation in this critically important field. We are tremendously grateful to the Gallaghers for making this possible with their transformative gift."

Despite years of research, there are no known cures for a large number of degenerative diseases, such as Type 1 diabetes, Parkinson's disease, cardiovascular disease, macular degeneration and spinal cord injuries. Stem cell research has the potential to contribute to the discovery of new and successful treatments for these and other diseases because it holds the unique promise of regenerating damaged cells and tissues, fully restoring tissues and organs to their normal function.

Although this vital area of research could accelerate the ability to alleviate much human suffering, it has generated extensive ethical debate with the use of embryonic versus non-embryonic stem cells. The Catholic Church affirms the dignity of all human life at every stage and vigorously opposes the destruction of human embryos for the harvesting of stem cells. At the same time, the Church strongly endorses the use of adult and non-embryonic stem cell research as a potential therapy for individuals suffering from these debilitating diseases. Research has demonstrated that adult stem cells, including all forms of non-embryonic stem cells, such as induced pluripotent stem cells and umbilical cord stem cells, can be harvested and programmed to achieve pluripotency the same characteristic that enables embryonic stem cells to differentiate into any type of cell.

An urgent need exists to increase the number of faculty experts performing adult stem cell research at Notre Dame. Doing so will expand upon the strong foundation the College of Science holds in these areas and will help create an environment for excellence in which faculty and students can learn, grow, collaborate and ultimately affect human health.

"We are overwhelmed with gratitude at the generous gift from Mike and Liz Gallagher," said Gregory P. Crawford, dean of the College of Science. "The impact of this gift is truly beyond measure. It will play a crucial role in attracting three more of the best faculty in the field of adult stem cell research to Notre Dame. Furthermore, this gift will equip our existing talented group of adult stem cell researchers at Notre Dame to take the next great leap toward ultimately forming a premier center in adult stem cell research."

Michael Gallagher is a 1991 graduate of Notre Dame, and his wife, Elizabeth, is a 1992 graduate of Saint Mary's College. They have two sons, Brock and Jack, and currently live near Denver.

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Notre Dame establishes professorships in adult stem cell research

VIDEO: Stem cell research facility to open at Rensselaer Polytechnic Institute

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Some of the automated sampling equipment in the Rensselaer Stem Cell Research Center in Troy. Some of the automated sampling equipment in the Rensselaer Stem Cell Research Center in Troy. (Mike McMahon / The Record)

By Danielle Sanzone dsanzone@troyrecord.com Twitter.com/DanielleSanzone

State Department of Health Commissioner Nirav Shah, left, and Rensselaer Polytechnic Institute President Dr. Shirley Ann Jackson, right, announce the opening of the Rensselaer Center for Stem Cell Research during a forum at the colleges Troy campus Friday. (Mike McMahon / The Record)

TROY During a Rensselaer Polytechnic Institute forum on Friday, dozens were able to see their first baby picture: a single cell that eventually multiplied, in part due to stem cells, into an organism with trillions of cells.

That, to me, is the most amazing thing in the study of biology, said Glenn Monastersky, director of the Rensselaer Center for Stem Cell Research.

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VIDEO: Stem cell research facility to open at Rensselaer Polytechnic Institute

Rensselaer and New York State Launch New Stem Cell Research Center

Newswise Troy, N.Y. Ground-breaking research to advance the application of stem cells to address critical injuries and diseases will be taking place at Rensselaer Polytechnic Institute, in a new center funded by New York state and opened today (June 22, 2012).

The Rensselaer Center for Stem Cell Research was launched officially by Rensselaer President Shirley Ann Jackson, New York State Department of Health Commissioner Nirav Shah, and Jonathan Dordick, director of the Rensselaer Center for Biotechnology and Interdisciplinary Studies (CBIS) and the Howard P. Isermann 42 Professor of Chemical and Biological Engineering. They were joined at the ribbon cutting by Glenn Monastersky, CBIS operations director and biomedical engineering professor of practice. Monastersky is also principal investigator under the $2.45 million grant awarded to fund the new center, from the New York State Stem Cell Science Program (NYSTEM).

The opening of the Rensselaer Center for Stem Cell Research marks a milestone on the path toward this important area of exploration, which promises so much in terms of alleviating disease and improving health, said Jackson. At the center we will work at the frontiers of this promising discipline in collaboration with New York state and investigators from across the region.

This research complements stem cell research, sponsored by New York and the National Institutes of Health, that is already in progress at Rensselaer, Jackson added. Due to our commitment to biotechnology that began over 10 years ago under The Rensselaer Plan, we are able to link engineering with the life and physical sciences in ways that allow us to explore new possibilities. We are grateful to Dr. Shah and the state of New York for their leadership in this important research area, and for providing the funding to launch this center.

Governor Cuomo recognizes that stem cell research is a vital and growing industry that helps create jobs here in the Capital Region and around the state, said Nirav R. Shah, M.D., M.P.H., New York State Commissioner of Health. Targeting our investment in results-oriented research enterprises like this center will lead to medical advances as well as expand our economy and make New York the place to be for 21st century health and science research.

According to Dordick, the new center continues to place CBIS and the research conducted there on the leading edge of efforts to harness advances in biotechnology to address 21st century health challenges.

Ranging from our work on the blood anti-coagulant drug heparin to solutions to fighting some of todays super bugs to important advances in understanding Alzheimers disease, we are focusing our efforts on scientific advances that will ultimately open the doors to new cures for traumatic injuries or treatments for long-term conditions and diseases, Dordick said. Now, working with our partners at New York state and other researchers in the region, we will expand our work on stem cells to help the medical and scientific research communities advance efforts to better understand those cells and how they can be used in medicine.

Research on stem cells offers promise in an array of health areas, ranging from trying to regenerate damaged nerve cells following spinal cord injuries to offering potential cures for autoimmune diseases such as multiple sclerosis, lupus, rheumatoid arthritis, and Type 1 diabetes. According to the National Institutes of Health (NIH), stem cells are important because unlike other cells in the human body they are capable of dividing and renewing themselves for long periods. In addition, because stem cells are unspecialized meaning that they are not associated with any tissue-specific functions early research has shown that under the right circumstances these cells can give rise to cells associated with specific functions, under a process called differentiation. Today, according to NIH, scientists are just beginning to understand the so-called triggers that can start stem cell differentiation into, for example, nerve, muscle, or bone cells.

The new state-of-the-art center is housed on the ground floor of the Rensselaer biotechnology center. In addition to advanced cell biology research equipment, new lab equipment acquired with funding from New York state includes an Olympus VivaView microscopy/incubation system and a Thermo Fisher Arrayscan cell-imaging system that utilizes advanced optics and analytical software to guide the analysis of stem cell development.

The Rensselaer Center for Stem Cell Research and its associated scientific staff, will enable collaborations with several New York partners including the New York Neural Stem Cell Institute, Albany Medical College, the University at Albany, the University of Rochester Medical School, and the Trudeau Institute. The main focus of the center is the basic science critical to development of stem cell-based therapies for human diseases and traumatic injuries.

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Rensselaer and New York State Launch New Stem Cell Research Center

Study Shows Most Commonly Mutated Gene in Cancer may have a Role in Stroke

Reported in CELL, Stony Brook pathologist uncovers new p53 mechanism triggering necrosis

Newswise STONY BROOK, N.Y., June 22, 2012 The gene p53 is the most commonly mutated gene in cancer. p53 is dubbed the guardian of the genome because it blocks cells with damaged DNA from propagating and eventually becoming cancerous. However, new research led by Ute M. Moll, M.D., Professor of Pathology at Stony Brook University School of Medicine, and colleagues, uncovers a novel role for p53 beyond cancer in the development of ischemic stroke. The research team identified an unexpected critical function of p53 in activating necrosis, an irreversible form of tissue death, triggered during oxidative stress and ischemia. The findings are detailed online in Cell.

Ischemia-associated oxidative damage leads to irreversible necrosis which is a major cause of catastrophic tissue loss. Elucidating its signaling mechanism is of paramount importance. p53 is a central cellular stress sensor that responds to multiple insults including oxidative stress and is known to orchestrate apoptotic and autophagic types of cell death. However, it was previously unknown whether p53 can also activate oxidative stress-induced necrosis, a regulated form of cell death that depends on the mitochondrial permeability transition pore (PTP) pore.

We identified an unexpected and critical function of p53 in activating necrosis: In response to oxidative stress in normal healthy cells, p53 accumulates in the mitochondrial matrix and triggers the opening of the PTP pore at the inner mitochondrial membrane, leading to collapse of the electrochemical gradient and cell necrosis, explains Dr. Moll.

"p53 acts via physical interaction with the critical PTP regulator Cyclophylin D (CypD). This p53 action occurs in cultured cells and in ischemic stroke in mice."

Of note, they found in their model that when the destructive p53-CypD complex is blocked from forming by using Cyclosporine-A type inhibitors, the brain tissue is strongly protected from necrosis and stroke is prevented.

The findings fundamentally expand our understanding of p53-mediated cell death networks, says Dr. Moll. The data also suggest that acute temporary blockade of the destructive p53-CypD complex with clinically well-tolerated Cyclosporine A-type inhibitors may lead to a therapeutic strategy to limit the extent of an ischemic stroke in patients.

p53 is one of the most important genes in cancer and by far the most studied, says Yusuf A. Hannun, M.D., Director of the Stony Brook University Cancer Center, Vice Dean for Cancer Medicine, and the Joel Kenny Professor of Medicine at Stony Brook. Therefore, this discovery by Dr. Moll and her colleagues in defining the mechanism of a new p53 function and its importance in necrotic injury and stoke is truly spectacular.

Dr. Moll has studied p53 for 20 years in her Stony Brook laboratory. Her research has led to numerous discoveries about the function of p53 and two related genes. For example, previous to this latest finding regarding p53 and stroke, Dr. Moll identified that p73, a cousin to p53, steps in as a tumor suppressor gene when p53 is lost and can stabilize the genome. She found that p73 plays a major developmental role in maintaining the neural stem cell pool during brain formation and adult learning. Her work also helped to identify that another p53 cousin, called p63, has a critical surveillance function in the male germ line and likely contributed to the evolution of humans and great apes, enabling their long reproductive periods.

Dr. Molls Cell study coauthors include: Angelina V. Vaseva and Natalie D. Marchenko, Department of Pathology, Stony Brook University School of Medicine; Kyungmin Ji and Stella E. Tsirka, Department of Pharmacological Sciences, Stony Brook University School of Medicine; and Sonja Holzmann, Department of Molecular Oncology, University of Gottingen in Germany.

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Study Shows Most Commonly Mutated Gene in Cancer may have a Role in Stroke