BrainStorm Cell Therapeutics Expands Pipeline with the Initiation of a Study for Multiple Sclerosis

NEW YORK & PETACH TIKVAH, ISRAEL--(BUSINESS WIRE)--

BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI.OB - News), a developer of adult stem cell technologies and CNS therapeutics, announces plans to initiate a preclinical study assessing the efficacy of its NurOwn stem cell technology in patients with Multiple Sclerosis (MS). Positive proof-of-concept results for MS have been confirmed in a set of in-vitro and in-vivo experiments, and the Company is working to advance MS into preclinical development in Q2 2012.

Based on initial promising pre-clinical data published by the Company's Chief Scientist, Prof. Daniel Offen of Tel Aviv University, BrainStorm has decided to explore MS as an additional indication for its NurOwn technology. The Company will draw plans to initiate pre-clinical safety trials, after which it will seek a leading medical center specializing in MS for clinical trials.

We have been focused on growing our pipeline of indications using our NurOwn stem-cell technology, commented Dr. Adrian Harel, Acting CEO of BrainStorm Cell Therapeutics. As we continue our ongoing trials to evaluate the safety, tolerability and therapeutic effects of NurOwn in ALS patients, we have determined through positive preliminary animal data that MS will be the next indication to pursue using our technology.

About NurOwn BrainStorms core technology, NurOwn, is based on the scientific achievements of Professor Eldad Melamed, former Head of Neurology, Rabin Medical Center, and Tel-Aviv University, and Professor Daniel Offen, Head of the Neuroscience Laboratory, Felsenstein Medical Research Center at the Tel-Aviv University.

The NurOwn technology processes adult human mesenchymal stem cells that are present in bone marrow and are capable of self-renewal as well as differentiation into many cell types. The research team is among the first to have successfully achieved the in-vitro differentiation of adult bone marrow cells (animal and human) into cells capable of releasing neurotrophic factors, such as glial-derived neurotrophic factor (GDNF), by means of a specific differentiation-inducing culture medium.

About Multiple Sclerosis (MS) Multiple sclerosis (MS) is believed to be an autoimmune disorder that affects the central nervous system (CNS). Autoimmune means that the bodys immune system mistakenly attacks its own tissue, in this case, the tissues of the CNS. With MS, autoimmune damage to neurons disrupts the bodys ability to send and receive signals, thus causing MS-related symptoms. Symptoms may vary due to the location and extent of the damage. Worldwide, MS may affect more than 2 million individuals, including approximately 400,000 people in the United States.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of adult stem cell therapeutic products derived from autologous bone marrow cells and intended for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel-Aviv University. For more information, visit the companys website at http://www.brainstorm-cell.com.

Safe Harbor Statement Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. The potential risks and uncertainties include risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. The Company does not undertake any obligation to update forward-looking statements made by us.

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BrainStorm Cell Therapeutics Expands Pipeline with the Initiation of a Study for Multiple Sclerosis

UCLA scientists find insulin, nutrition prevent blood stem cell differentiation in fruit flies

Public release date: 11-Mar-2012 [ | E-mail | Share ]

Contact: Kim Irwin kirwin@mednet.ucla.edu 310-206-2805 University of California - Los Angeles Health Sciences

UCLA stem cell researchers have shown that insulin and nutrition keep blood stem cells from differentiating into mature blood cells in Drosophila, the common fruit fly, a finding that has implications for studying inflammatory response and blood development in response to dietary changes in humans.

Keeping blood stem cells, or progenitor cells, from differentiating into blood cells is important as they are needed to create the blood supply for the adult fruit fly.

The study found that the blood stem cells are receiving systemic signals from insulin and nutritional factors, in this case essential amino acids, that helped them to maintain their "stemness," said study senior author Utpal Banerjee, professor and chairman of the molecular, cell and developmental biology department in Life Sciences and a researcher with the Eli and Edythe Broad Center of Regenerative Medicine at UCLA.

"We expect that this study will promote further investigation of possible direct signal sensing mechanisms by mammalian blood stem cells," Banerjee said. "Such studies will probably yield insights into chronic inflammation and the myeloid cell accumulation seen in patients with type II diabetes and other metabolic disorders."

The study appears March 11, 2012 in the peer-reviewed journal Nature Cell Biology.

In the flies, the insulin signaling came from the brain, which is an organ similar to the human pancreas, which produces insulin. That insulin was taken up by the blood stem cells, as were amino acids found in the fly flood, said Ji Won Shim, a postdoctoral fellow in Banerjee's lab and first author of the study.

Shim studied the flies while in the larval stage of development. To see what would happen to the blood stem cells, Shim placed the larvae into a jar with no food - they usually eat yeast or cornmeal and left them for 24 hours. Afterward, she checked for the presence of blood stem cells using specific chemical markers that made them visible under a confocal microscope.

"Once the flies were starved and not receiving the insulin and nutritional signaling, all the blood stem cells were gone," Shim said. "All that were left were differentiated mature blood cells. This type of mechanism has not been identified in mammals or humans, and it will be intriguing to see if there are similar mechanisms at work there."

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UCLA scientists find insulin, nutrition prevent blood stem cell differentiation in fruit flies

Insulin, nutrition prevent blood stem cell differentiation

LOS ANGELES UCLA stem cell researchers have shown that insulin and nutrition prevent blood stem cells from differentiating into mature blood cells in Drosophila, the common fruit fly, a finding that has implications for studying inflammatory response and blood development in response to dietary changes in humans.

Keeping blood stem cells, or progenitor cells, from differentiating into blood cells is important as blood stem cells are needed to create the blood supply for the adult fruit fly.

The study found that the blood stem cells are receiving systemic signals from insulin and nutritional factors, in this case essential amino acids, that helped them to maintain their "stemness," said study senior author Utpal Banerjee, the Irving and Jean Stone Professor and chairman of molecular, cell and developmental biology in the UCLA Division of Life Sciences and a researcher with the Eli and Edythe Broad Center of Regenerative Medicine at UCLA.

"We expect that this study will promote further investigation of possible direct signal sensing mechanisms by mammalian blood stem cells," Banerjee said. "Such studies will probably yield insights into chronic inflammation and the myeloid cell accumulation seen in patients with type II diabetes and other metabolic disorders."

The study appeared Sunday (March 11) in the peer-reviewed journal Nature Cell Biology.

In the flies, the insulin signaling came from the brain, which is an organ similar to the human pancreas, which produces insulin. That insulin was taken up by the blood stem cells, as were amino acids found in the fly blood, said Ji Won Shim, a postdoctoral fellow in Banerjee's lab and first author of the study.

Shim studied the flies while in the larval stage of development. To see what would happen to the blood stem cells, Shim placed the larvae into a jar with no food they usually eat yeast or cornmeal and left them for 24 hours. Afterward, she checked for the presence of blood stem cells using specific chemical markers that made them visible under a confocal microscope.

"Once the flies were starved and not receiving the insulin and nutritional signaling, all the blood stem cells were gone," Shim said. "All that were left were differentiated mature blood cells. This type of mechanism has not been identified in mammals or humans, and it will be intriguing to see if there are similar mechanisms at work there."

In the fruit fly, the only mature blood cells present are myeloid cells, Shim said. Diabetic patients have many activated myeloid cells that could be causing disease symptoms. It may be that abnormal activation of myeloid cells and abnormal metabolism play a major role in diabetes.

"Metabolic regulation and immune response are highly integrated in order to function properly dependent on each other. Type II diabetes and obesity, both metabolic diseases, are closely associated with chronic inflammation, which is induced by abnormal activation of blood cells," Shim said. "However, no systemic study on a connection between blood stem cells and metabolic alterations had been done. Our study highlights the potential linkage between myeloid-lineage blood stem cells and metabolic disruptions."

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Insulin, nutrition prevent blood stem cell differentiation

New approach to treating type 1 diabetes? Transforming gut cells into insulin factories

ScienceDaily (Mar. 11, 2012) A study by Columbia researchers suggests that cells in the patient's intestine could be coaxed into making insulin, circumventing the need for a stem cell transplant. Until now, stem cell transplants have been seen by many researchers as the ideal way to replace cells lost in type I diabetes and to free patients from insulin injections.

The research -- conducted in mice -- was published 11 March 2012 in the journal Nature Genetics.

Type I diabetes is an autoimmune disease that destroys insulin-producing cells in the pancreas. The pancreas cannot replace these cells, so once they are lost, people with type I diabetes must inject themselves with insulin to control their blood glucose. Blood glucose that is too high or too low can be life threatening, and patients must monitor their glucose several times a day.

A longstanding goal of type I diabetes research is to replace lost cells with new cells that release insulin into the bloodstream as needed. Though researchers can make insulin-producing cells in the laboratory from embryonic stem cells, such cells are not yet appropriate for transplant because they do not release insulin appropriately in response to glucose levels. If these cells were introduced into a patient, insulin would be secreted when not needed, potentially causing fatal hypoglycemia.

The study, conducted by Chutima Talchai, PhD, and Domenico Accili, MD, professor of medicine at Columbia University Medical Center, shows that certain progenitor cells in the intestine of mice have the surprising ability to make insulin-producing cells. Dr. Talchai is a postdoctoral fellow in Dr. Accili's lab.

The gastrointestinal progenitor cells are normally responsible for producing a wide range of cells, including cells that produce serotonin, gastric inhibitory peptide, and other hormones secreted into the GI tract and bloodstream.

Drs. Talchai and Accili found that when they turned off a gene known to play a role in cell fate decisions -- Foxo1 -- the progenitor cells also generated insulin-producing cells. More cells were generated when Foxo1 was turned off early in development, but insulin-producing cells were also generated when the gene was turned off after the mice had reached adulthood. "Our results show that it could be possible to regrow insulin-producing cells in the GI tracts of our pediatric and adult patients," Dr. Accili says.

"Nobody would have predicted this result," Dr. Accili adds. "Many things could have happened after we knocked out Foxo1. In the pancreas, when we knock out Foxo1, nothing happens. So why does something happen in the gut? Why don't we get a cell that produces some other hormone? We don't yet know."

Insulin-producing cells in the gut would be hazardous if they did not release insulin in response to blood glucose levels. But the researchers say that the new intestinal cells have glucose-sensing receptors and do exactly that.

The insulin made by the gut cells also was released into the bloodstream, worked as well as normal insulin, and was made in sufficient quantity to nearly normalize blood glucose levels in otherwise diabetic mice.

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New approach to treating type 1 diabetes? Transforming gut cells into insulin factories

A new approach to treating type I diabetes? Gut cells transformed into insulin factories

Public release date: 11-Mar-2012 [ | E-mail | Share ]

Contact: Karin Eskenazi ket2116@columbia.edu 212-342-0508 Columbia University Medical Center

NEW YORK, NY -- A study by Columbia researchers suggests that cells in the patient's intestine could be coaxed into making insulin, circumventing the need for a stem cell transplant. Until now, stem cell transplants have been seen by many researchers as the ideal way to replace cells lost in type I diabetes and to free patients from insulin injections.

The researchconducted in micewas published 11 March 2012 in the journal Nature Genetics.

Type I diabetes is an autoimmune disease that destroys insulin-producing cells in the pancreas. The pancreas cannot replace these cells, so once they are lost, people with type I diabetes must inject themselves with insulin to control their blood glucose. Blood glucose that is too high or too low can be life threatening, and patients must monitor their glucose several times a day.

A longstanding goal of type I diabetes research is to replace lost cells with new cells that release insulin into the bloodstream as needed. Though researchers can make insulin-producing cells in the laboratory from embryonic stem cells, such cells are not yet appropriate for transplant because they do not release insulin appropriately in response to glucose levels. If these cells were introduced into a patient, insulin would be secreted when not needed, potentially causing fatal hypoglycemia.

The study, conducted by Chutima Talchai, PhD, and Domenico Accili, MD, professor of medicine at Columbia University Medical Center, shows that certain progenitor cells in the intestine of mice have the surprising ability to make insulin-producing cells. Dr. Talchai is a postdoctoral fellow in Dr. Accili's lab.

The gastrointestinal progenitor cells are normally responsible for producing a wide range of cells, including cells that produce serotonin, gastric inhibitory peptide, and other hormones secreted into the GI tract and bloodstream.

Drs. Talchai and Accili found that when they turned off a gene known to play a role in cell fate decisionsFoxo1the progenitor cells also generated insulin-producing cells. More cells were generated when Foxo1 was turned off early in development, but insulin-producing cells were also generated when the gene was turned off after the mice had reached adulthood.

"Our results show that it could be possible to regrow insulin-producing cells in the GI tracts of our pediatric and adult patients," Dr. Accili says.

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A new approach to treating type I diabetes? Gut cells transformed into insulin factories

Osiris Therapeutics Reports Fourth Quarter and Full Year 2011 Financial Results

COLUMBIA, Md.--(BUSINESS WIRE)--

Osiris Therapeutics, Inc. (NASDAQ: OSIR - News), the leading stem cell company focused on developing and commercializing products to treat medical conditions in inflammatory, cardiovascular, orthopedic, and wound healing markets, announced today its results for the fourth quarter and full year ended December 31, 2011.

Recent and Full Year Highlights

We are very pleased with the commercial performance of our two Biosurgery products, Grafix and Ovation, said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. As interest in stem cell products for surgical applications intensifies, Osiris remains uniquely positioned as the clear leader in this space. Additionally, with Prochymal being used around the world to treat patients with life-threatening GvHD through our Expanded Access program, our Therapeutic and Biosurgery units are carrying out our mission of bringing Smart Medicine, to patients, Right Now.

Fourth Quarter Financial Results

Net income for the fourth quarter of 2011 increased to $5.0 million, compared to $4.4 million for the fourth quarter of 2010. Revenues were $11.0 million in the fourth quarter of 2011, consisting primarily of the amortization of license fees from our collaboration agreements. Our fourth quarter Biosurgery product revenues were $0.8 million. Revenues during the fourth quarter of 2010 were $10.8 million. As of December 31, 2011, Osiris had $48.0 million of cash, receivables, and short-term investments.

Research and development expenses for the fourth quarter of 2011 were $4.2 million, compared to $5.0 million incurred in the fourth quarter of 2010. General and administrative expenses were $1.5 million for the fourth quarter of 2011 compared to $1.8 million for the same period of the prior year. Net cash used in operations for the quarter was $4.6 million.

Full Year 2011 Financial Highlights

Net income was $14.9 million for the fiscal year ended December 31, 2011 compared to $13.1 million in fiscal 2010. Revenues of $42.4 million were recognized in 2011, including $40.0 million from the Genzyme collaboration agreement, $1.0 million from the research, development and commercialization agreement with the JDRF and $1.3 million of revenues from our Biosurgery products. Revenues in 2010 were $43.2 million, which included $40.0 million from the Genzyme collaboration agreement, $0.5 million from the U.S. Department of Defense contract, $1.2 million from the JDRF agreement and a $1.0 million milestone earned on our license agreement with JCR Pharmaceuticals.

R&D expenses for the 2011 fiscal year were $19.2 million compared to $23.5 million in the prior year. G&A expenses in fiscal 2011 were $7.9 million, which include $2.4 million of non-cash share based payments. G&A expenses in fiscal 2010 were $6.5 million, including $0.7 million of share-based payments.

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Osiris Therapeutics Reports Fourth Quarter and Full Year 2011 Financial Results

Eastday-Student who twice backed out of cell donation divides opinion

A SHANGHAI student who registered as a stem cell donor but then twice backed out of donating at the last moment has found herself at the center of public debate.

The would-be recipient, a leukemia patient in neighboring Jiangsu Province, had already received medication to stop blood-forming functions in preparation for the transplant when the intended donor pulled out.

It was said that the would-be donor, who has not been named, had faced pressure from her family not to go ahead with the procedure.

The incident has stirred up discussion online, with some web users accusing the student of putting the patient's life in danger through her actions.

Some argued that donors should be legally prevented from backing out once the intended recipient has been given preparatory medication.

However, local medical officials said that donations should be based on freewill and that a donor must be allowed to change his or her mind.

The 23-year-old leukemia patient, Jiang Jing, is being treated in a hospital in Suzhou. As an emergency solution, a partial match was found yesterday using a sample from the Shanghai Stem Cell Blood Bank and cells from Jiang's mother. The success rate is likely to be around 60 percent, local doctors told Shanghai Daily.

Jiang was diagnosed with leukemia last April and a full match was found with the Shanghai college student who had registered as a donor with the Red Cross in the city.

The transplant had been scheduled for Tuesday and the patient had been receiving medication since late last month to stop her body forming blood cells.

But last Thursday, the donor said she did not want to proceed.

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Eastday-Student who twice backed out of cell donation divides opinion

Nimer named new director for University of Miami’s cancer center

Medical breakthroughs discovered in the laboratory can take a long time to be put into practice in the examination room, often because there is little communication between research scientists and clinical physicians.

Dr. Stephen D. Nimer, a renowned researcher and physician named Wednesday as director of the University of Miamis Sylvester Cancer Center, is vowing to bring equal emphasis to leading-edge scientific research and quality patient care. His goal: to make Miami a worldwide destination for cancer treatment.

I am going to devote my energies toward bringing the center to the next level, said Nimer, 57, who has pioneered novel therapies for cancer and advocated for more compassionate care of patients. I want to build on the greatness that exists here.

Nimers appointment comes nearly 18 months after the Sylvester Centers board launched a global search for a new director to succeed Dr. W. Jarrard Goodwin, who stepped down after 14 years at the helm to become chief medical officer for the center.

Joan Scheiner, board chair of the Sylvester Center, said Nimer is the perfect candidate to lead the 20-year-old center into the next stage.

Hes going to help us build the kind of cancer center we deserve, said Scheiner, who beat metastatic soft tissue sarcoma with the help of Sylvester Center doctors in the late 1990s. It validates our past and ensures a future with no limits.

A key member of one of the nations leading cancer centers Memorial Sloan-Kettering in New York Nimer is considered one of the worlds premier leukemia and stem cell transplant researchers and physicians.

During nearly two decades at Sloan-Kettering, Nimer established an inpatient program for patients with blood disorders, and a blood stem cell transplant program for adults with malignant blood diseases, focusing primarily on patients with non-Hodgkin and Hodgkin lymphoma, or multiple myeloma, a cancer of the plasma cells in the bone marrow.

Among Nimers notable achievements in the laboratory: developing a bone marrow transplant treatment using stem cells to eliminate cancer cells from the blood and coaxing tumor-reducing proteins out of stem cells, then using those proteins to help enhance the effects of chemotherapy and radiotherapy for cancer patients.

A prolific researcher who has authored more than 200 scientific publications in numerous medical journals, Nimer also has made important discoveries in the field of pre-cancerous oncogenes, which can mutate and trigger cancer.

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Nimer named new director for University of Miami’s cancer center

Tonsils make t-cells, too, Ohio State study shows

Public release date: 5-Mar-2012 [ | E-mail | Share ]

Contact: Darrell E. Ward Darrell.Ward@osumc.edu 614-293-3737 Ohio State University Medical Center

COLUMBUS, Ohio A new study provides evidence that a critical type of immune cell can develop in human tonsils. The cells, called T lymphocytes, or T cells, have been thought to develop only in the thymus, an organ of the immune system that sits on the heart.

The study, led by researchers at the Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC James), could improve the understanding of T-cell cancers and autoimmune diseases, and how stem-cell transplantation is done.

The study identified T cells at five distinct stages of development in the tonsil. These stages, identified using molecular signposts on the cells, were very similar to the stages of T-cell development in the thymus, although some differences were found as well.

The study also discovered that the cells develop in a particular region of the tonsil, in areas near the fibrous scaffold of the tonsil.

The findings are published in the Journal of Clinical Investigation.

"We've known for a long time that a functional thymus is necessary to develop a complete repertoire of T-cells, but whether a T-cell factory existed outside the thymus has been controversial," says principal investigator Dr. Michael A. Caligiuri, director of Ohio State's Comprehensive Cancer Center and CEO of the James Cancer Hospital and Solove Research Institute.

"I believe our study answers that question. It is the first report to describe a comprehensive, stepwise model for T-cell development outside the thymus."

It also raises a number of questions. Caligiuri notes that it's still unclear whether T-cells that develop in the tonsil also mature there or whether they leave the tonsil to mature elsewhere.

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Tonsils make t-cells, too, Ohio State study shows

Tonsils make T-cells, too

ScienceDaily (Mar. 5, 2012) A new study provides evidence that a critical type of immune cell can develop in human tonsils. The cells, called T lymphocytes, or T cells, have been thought to develop only in the thymus, an organ of the immune system that sits on the heart.

The study, led by researchers at the Ohio State University Comprehensive Cancer Center -- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC -- James), could improve the understanding of T-cell cancers and autoimmune diseases, and how stem-cell transplantation is done.

The study identified T cells at five distinct stages of development in the tonsil. These stages, identified using molecular signposts on the cells, were very similar to the stages of T-cell development in the thymus, although some differences were found as well.

The study also discovered that the cells develop in a particular region of the tonsil, in areas near the fibrous scaffold of the tonsil.

The findings are published in the Journal of Clinical Investigation.

"We've known for a long time that a functional thymus is necessary to develop a complete repertoire of T-cells, but whether a T-cell factory existed outside the thymus has been controversial," says principal investigator Dr. Michael A. Caligiuri, director of Ohio State's Comprehensive Cancer Center and CEO of the James Cancer Hospital and Solove Research Institute.

"I believe our study answers that question. It is the first report to describe a comprehensive, stepwise model for T-cell development outside the thymus."

It also raises a number of questions. Caligiuri notes that it's still unclear whether T-cells that develop in the tonsil also mature there or whether they leave the tonsil to mature elsewhere.

"The complete implications of this phenomenon for human health and disease are not entirely known," adds first-author Susan McClory, a graduate fellow in Caligiuri's laboratory. "It could be important in the development of T-cell cancers and autoimmune diseases, or it might suggest a location for T-cell development when thymus function is poor. We hope to do additional studies to explore these possibilities," she says.

Caligiuri, McClory and their colleagues conducted the study using tonsil tissue obtained from children undergoing routine tonsillectomy at Nationwide Children's Hospital in Columbus, and thymic tissue obtained from children undergoing thoracic surgery.

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Tonsils make T-cells, too