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VistaGen Therapeutics Enters Strategic Drug Screening Collaboration With Vala Sciences

SOUTH SAN FRANCISCO, CA--(Marketwire -03/21/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA.OB - News) (OTCQB: VSTA.OB - News), a biotechnology company applying stem cell technology for drug rescue and cell therapy, and Vala Sciences, Inc., a biotechnology company developing and selling next-generation cell image-based instruments, reagents and analysis software tools, have entered into a strategic collaboration. Their goal is to advance drug safety screening methodologies in the most clinically relevant human in vitro bioassay systems available to researchers today.

Cardiomyocytes are the muscle cells of the heart that provide the force necessary to pump blood throughout the body, and as such are the targets of most of the drug toxicities that directly affect the heart. Many of these drug toxicities result in either arrhythmia (irregular, often fatal, beating of the heart) or reduced ability of the heart to pump the blood necessary to maintain normal health and vigor.

"Our collaboration with Vala directly supports the core drug rescue applications of our Human Clinical Trials in a Test Tube platform," said Shawn K. Singh, JD, VistaGen's Chief Executive Officer. "Our high quality human cardiomyocytes combined with Vala's high throughput electrophysiological assessment capabilities is yet another example of how we are applying our stem cell technology platform within a strategic ecosystem of complementary leading-edge companies and technologies. We seek to drive our drug rescue programs forward and generate a pipeline of new, cardiosafe drug candidates."

Through the collaboration, Vala will use its Kinetic Image Cytometer platform to demonstrate both the suitability and utility of VistaGen's human pluripotent stem cell derived-cardiomyocytes for screening new drug candidates for potential cardiotoxicity over conventional in vitro screening systems and animal models. VistaGen's validated human cardiomyocyte-based bioassay system, CardioSafe 3D, will permit Vala to demonstrate the quality, resolution, applicability and ease of use of its new instrumentation and analysis software to make information-rich, high throughput measurements and generate fundamentally new insights into heart cell drug responses. Accurate, sensitive and reproducible measurement of electrophysiological responses of stem cell-derived cardiomyocytes to new drug candidates is a key element of VistaGen's CardioSafe 3D drug rescue programs. VistaGen's strategic collaboration with Vala is directed towards this goal.

About VistaGen Therapeutics

VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy. VistaGen's drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, with modern medicinal chemistry to generate new chemical variants (Drug Rescue Variants) of once-promising small-molecule drug candidates. These are drug candidates discontinued due to heart toxicity after substantial development by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans, bringing human biology to the front end of the drug development process.

Additionally, VistaGen's small molecule drug candidate, AV-101, is in Phase 1b development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S. alone. VistaGen is also exploring opportunities to leverage its current Phase 1 clinical program to enable additional Phase 2 clinical studies of AV-101 for epilepsy, Parkinson's disease and depression. To date, VistaGen has been awarded over $8.5 million from the NIH for development of AV-101.

About Vala Sciences

Vala Sciences is a San Diego-based biotechnology company that develops and sells cell-image-based instrumentation, reagents and analysis software tools to academic, pharmaceutical and biotechnology scientists. Vala's IC 200 class of instrumentation, and CyteSeer Automated Image Cytometry software convert labor-intensive qualitative observations of biological changes that can take from days to months, into accurate measurements delivered automatically in minutes.

Cautionary Statement Regarding Forward Looking Statements

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Autism risk gene linked to differences in brain structure

Public release date: 21-Mar-2012 [ | E-mail | Share ]

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 x2156 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, March 21, 2012Healthy individuals who carry a gene variation linked to an increased risk of autism have structural differences in their brains that may help explain how the gene affects brain function and increases vulnerability for autism. The results of this innovative brain imaging study are described in an article in the groundbreaking neuroscience journal Brain Connectivity, a bimonthly peer-reviewed publication from Mary Ann Liebert, Inc (http://wwwliebertpub.com). The article is available free online at the Brain Connectivity (http://www.liebertpub.com/brain) website.

"This is one of the first papers demonstrating a linkage between a particular gene variant and changes in brain structure and connectivity in carriers of that gene," says Christopher Pawela, PhD, Co-Editor-in-Chief and Assistant Professor, Medical College of Wisconsin. "This work could lead to the creation of an exciting new line of research investigating the impact of genetics on communication between brain regions."

Although carriers of the common gene variant CNTNAP2identified as an autism risk genemay not develop autism, there is evidence of differences in brain structure that may affect connections and signaling between brain regions. These disruptions in brain connectivity can give rise to functional abnormalities characteristic of neuropsychological disorders such as autism.

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Emily Dennis and coauthors from UCLA School of Medicine and UCLA (Los Angeles, CA) and University of Queensland and Queensland Institute of Medical Research (Brisbane, Australia), used a sophisticated imaging technique to study the brains of healthy young adults who are carriers of CNTNAP2. They report their findings in "Altered Structural Brain Connectivity in Healthy Carriers of the Autism Risk Gene, CNTNAP2." (http://online.liebertpub.com/doi/abs/10.1089/brain.2011.0064)

About the Journal

Brain Connectivity (http://www.liebertpub.com/brain) is the journal of record for researchers and clinicians interested in all aspects of brain connectivity. The Journal is under the leadership of Founding and Co-Editors-in-Chief Christopher Pawela, PhD and Bharat Biswal, PhD, Associate Professor, University of Medicine and Dentistry of New Jersey. It includes original peer-reviewed papers, review articles, point-counterpoint discussions on controversies in the field, and a product/technology review section. To ensure that scientific findings are rapidly disseminated, articles are published Instant Online within 72 hours of acceptance, with fully typeset, fast-track publication within 4 weeks. Complete tables of content and a sample issue may be viewed online at the Brain Connectivity (http://www.liebertpub.com/brain) website.

About the Company

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Individual Rights to Genetic Information—Issues for Medicine and Government – Video

21-03-2012 13:09

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Individual Rights to Genetic Information—Issues for Medicine and Government - Video

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Research Spots Potential New Target in Fight Against Baldness

WEDNESDAY, March 21 (HealthDay News) -- Men worried about encroaching baldness, take heart: A genetic analysis of tissue taken from both bald and hairier spots on men's scalps has identified a protein involved in male pattern hair loss.

The researchers note that drugs that inhibit the protein are already in development, and it's possible those drugs could one day be used to help men preserve their head of hair.

In the study, researchers from the Perelman School of Medicine at the University of Pennsylvania did an analysis of more than 25,000 genes and honed in on one that produces an enzyme that produces a protein known as PGD2. That protein is present in much higher levels in bald spots.

When scientists placed PGD2 on hair follicles in a petri dish, they found the protein inhibited hair growth.

Researchers then tested the protein on mice genetically engineered to lack a receptor for PGD2, and found that hair growth was unaffected. But when PGD2 was applied to mice that have a different receptor (GPR44), the mice grew less hair.

PGD2 is a type of prostaglandin, or a hormone-like substance known to be involved in many body functions, including regulating the contraction and relaxation of smooth muscle tissue. Drugs that inhibit PGD2, for example, are being studied for use in preventing airway constriction in asthma.

"Several companies have compounds in development that block the receptor for PGD2. Those compounds are being studied to treat asthma," said senior study author Dr. George Cotsarelis, chair and professor of dermatology at University of Pennsylvania School of Medicine in Philadelphia. "We think using these compounds topically . . . could slow down and possibly reverse baldness."

The study is published in the March 21 issue of the journal Science Translational Medicine.

About 80 percent of white men have some degree of hair loss before age 70, according to background information in the study. In balding men, hair follicles don't disappear, but they shrink and produce very small, even microscopic hairs, Cotsarelis explained.

The belief is that something is inhibiting the follicle from growing a normal hair. One of those factors seems to be PGD2, which was found near stem cells in the follicle, which are important in hair growth, Cotsarelis explained.

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Genetic mutation found in familial chronic diarrhea syndrome

Public release date: 21-Mar-2012 [ | E-mail | Share ]

Contact: Chris Gunter or Holly Ralston cgunter@hudsonalpha.org 256-327-0400 HudsonAlpha Institute for Biotechnology

HUNTSVILLE, Ala. -- When the intestines are not able to properly process our diet, a variety of disorders can develop, with chronic diarrhea as a common symptom. Chronic diarrhea can also be inherited, most commonly through conditions with genetic components such as irritable bowel syndrome. Researchers in Norway, India, and at the HudsonAlpha Institute for Biotechnology have identified one heritable DNA mutation that leads to chronic diarrhea and bowel inflammation.

Shawn Levy, Ph.D., faculty investigator at HudsonAlpha said, "Based on the effects seen from this one mutation, we are hopeful that the work will aid in understanding of much more common diseases like Crohn's and irritable bowel syndrome, which also have inflammation and diarrhea as symptoms."

The Norwegian family studied for the paper published today in The New England Journal of Medicine has 32 living members with a number of related inflammatory bowel conditions. Such a large family allowed scientists in Norway to use traditional genetic linkage methods to narrow down the potential DNA mutation to one portion of chromosome 12, and then to a specific gene called GUCY2C.

The Norway group asked Levy and his group at HudsonAlpha to confirm initial findings on this mutation as well as determine if there were other mutations that could contribute to the disorder. "Our exome sequencing was able to rule out other mutations and demonstrate that the one change in the GUCY2C gene was common to the disease," commented Levy.

The protein made from the GUCY2C gene is involved in transmitting specific chemical signals from food consumed to the cells inside our bowels. But the family members with chronic diarrhea have a mutation that makes the protein constantly "on," or transmitting much more signal than it should. Based on this new understanding, the scientists are now evaluating possible drug treatments based on the function of the affected protein. They can also recommend that GUCY2C be reexamined in more common bowel inflammation syndromes, as it may contribute to pathology for thousands of people worldwide.

###

The article "Familial Diarrhea Syndrome Caused by an Activating GUCY2C Mutation," by Fiskerstrand et al. can be found at the website http://www.nejm.org.

The HudsonAlpha Institute for Biotechnology in Huntsville, Alabama, is the cornerstone of the Cummings Research Park Biotechnology Campus. The campus hosts a synergistic cluster of life sciences talent - science, education and business professionals - that promises collaborative innovation to turn knowledge and ideas into commercial products and services for improving human health and strengthening Alabama's progressively diverse economy. The non-profit institute is housed in a state-of-the-art, 270,000 square-ft. facility strategically located in the nation's second largest research park. HudsonAlpha has a three-fold mission of genomic research, economic development and educational outreach.

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Drosophila meeting poster award recipients announced

Public release date: 21-Mar-2012 [ | E-mail | Share ]

Contact: Phyllis Edelman pedelman@genetics-gsa.org 301-634-7302 Genetics Society of America

BETHESDA, MD -- The Genetics Society of America (GSA) and the Drosophila community are pleased to announce the nine award recipients for their poster presentations at the 53rd Annual Drosophila Research Conference held March 7-11, 2011 in Chicago, IL.

Poster awards were presented to scientists at three career stages: undergraduate students, graduate students, and postdoctoral researchers. Each category offered a first prize for $500, second for $300 and third for $200.

"The poster awards are just one way that we highlight the contributions of early-career researchers, recognizing these talented individuals not only for their science, but on the effective communication of their results," said Adam Fagen, Ph.D., executive director of GSA. "We look forward to following the careers of these students and postdocs and expect great things as they continue in science."

"Winning a poster award is a true honor," said Elizabeth Gavis, Ph.D., past president of the Drosophila community's Board of Directors. "Although the poster presenters span all career stages, these awards are designated specifically for students and postdocs and recognize the intellectual and experimental contributions of the winners as well as their ability to convey their research to other scientists," she added.

The nine recipients of the awards were selected from among 500 student and postdoc posters, which represent more than half of the nearly 1,000 poster presentations at the conference. The awardees, research institution, poster titles and principal investigators (PI) who worked with them are listed below.

Undergraduate Awardees:

1st Place: Kathryn Landy, Rutgers University, Piscataway, NJ Poster Title: Chromosome axis proteins regulate synapsis and recombination in female meiosis (#322) PI: Kim S. McKim, Ph.D.

2nd Place: Balint Z. Kacsoh, Emory University, Atlanta, Georgia Poster Title: High hemocyte load is associated with increased resistance against parasitoids in Drosophila suzukii, a relative of D. melanogaster (#459) PI: Todd A. Schlenke, Ph.D.

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Response Genetics, Inc. to Release Fourth Quarter and Full-Year 2011 Financial Results and Host Conference Call on …

LOS ANGELES--(BUSINESS WIRE)--

Response Genetics, Inc. (Nasdaq:RGDX - News), a company focused on the development and commercialization of molecular diagnostic tests for cancer, will announce its fourth quarter and full-year 2011 financial results and an operational update in a press release to be issued before the market opens on Tuesday, March 27, 2012. The company will host a conference call that same day at 10:00 a.m. EDT to discuss its financial results.

CONFERENCE CALL DETAILS

To access the conference call by phone on March 27 at 10:00 a.m. EDT, dial (800) 537-0745 or (253) 237-1142 for international participants. A telephone replay will be available beginning approximately two hours after the call through April 3, and may be accessed by dialing (855) 859-2056, (404) 537-3406, or (800) 585-8367. The reply passcode is 64520370.

To access the live and archived webcast of the conference call, go to the Investor Relations section of the Company's Web site at http://investor.responsegenetics.com. It is advised that participants connect at least 15 minutes prior to the call to allow for any software downloads that might be necessary.

About Response Genetics, Inc.

Response Genetics Inc. (RGI) is a CLIA-certified clinical laboratory focused on the development and sale of molecular diagnostic tests for cancer. RGIs principal customers include oncologist, pathologists and hospitals. In addition to diagnostic testing services, the Company generates revenue from the sales of its analytical testing services of clinical trial specimens to the pharmaceutical industry. RGI was founded in 1999 and its principal headquarters are located in Los Angeles, California. For additional information, please visit http://www.responsegenetics.com.

Forward-Looking Statement Notice

Except for the historical information contained herein, this press release and the statements of representatives of RGI related thereto contain or may contain, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995.

Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Companys plans, objectives, projections, expectations and intentions, such as the ability of the Company to announce its financial results and provide a conference call, to continue to provide clinical testing services to the medical community, to continue to expand its sales force, to continue to build its digital pathology initiative, to attract and retain qualified management, , to continue to provide clinical trial support to pharmaceutical clients, to enter into new collaborations with pharmaceutical clients, to enter into new areas such as companion diagnostics, and to continue to execute on its business strategy and operations, to continue to analyze cancer samples, the potential for using the results of this research to develop diagnostic tests for cancer, the usefulness of genetic information to tailor treatment to patients, and other statements identified by words such as projects, may, could, would, should, believes, expects, anticipates, estimates, intends, plans or similar expressions.

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Response Genetics, Inc. to Release Fourth Quarter and Full-Year 2011 Financial Results and Host Conference Call on ...

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Myriad Genetics slips on patent concerns

NEW YORK (AP) Shares of Myriad Genetics Inc. fell Wednesday after a Supreme Court ruling started a new round of concerns about the company's intellectual property, which includes patents on genetic mutations related to breast cancer.

THE SPARK: On Tuesday the Supreme Court threw out patent claims belonging to Prometheus Laboratories, a subsidiary of Nestle SA. The 9-0 ruling overturned patents that were used in a blood test that helps doctors determine the dosage of a drug used to treat autoimmune diseases.

The test involved administering the drug, called thiopurine, to patients and then determining the levels of thiopurine metabolites in the patient's red blood cells. The court ruled that the patents were based on the laws of nature, which can't be patented.

Myriad has faced challenges to some of the patents supporting its BRACAnalysis test, which looks for mutations on a gene that indicates an increased risk for inherited breast cancer. In March 2010 a New York district court ruled that genes could not be patented, but a federal appeals court reversed that decision in July.

THE BIG PICTURE: The U.S. Patent and Trademark Office has been awarding patents on human genes for decades, and the federal court said the BRACAnalysis patents were valid because they concern "isolated DNA," which has a different chemical structure from DNA within the body. The case could come before the Supreme Court.

THE ANALYSIS: Analysts said Wednesday that it's not clear if the Supreme Court will accept the Myriad Genetics case or how it would rule if it did. Jefferies & Co. analyst Jon Wood said the ruling in the Prometheus Laboratories case does not contradict the federal court's findings from July. However he said that even if the Myriad Genetics patents are overturned, the BRACAnalysis test is supported by many other patents.

William Blair & Co. analyst Amanda Murphy said the decision "introduces some uncertainty related to method patents in general, particularly correlation claims in diagnostics" for Myriad Genetics and Genomic Health Inc., but she said the Prometheus Labs and the Myriad case involve different types of patents.

Genomic Health's Oncotype DX test is designed to predict the risk that a patient's breast or colon cancer will recur.

SHARE ACTION: Myriad shares lost 94 cents, or 3.9 percent, to $23.37 in afternoon trading. The stock is up 16 percent this year.

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Seattle Genetics Appoints Dr. Nancy Simonian to Board of Directors

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (Nasdaq: SGEN - News) announced today that Nancy A. Simonian, M.D. has been appointed to the companys Board of Directors. Dr. Simonian is a biotechnology veteran with more than 16 years of global drug development experience, most recently as Chief Medical Officer at Millennium: The Takeda Oncology Company.

Nancy brings significant experience in all aspects of clinical development, regulatory affairs and medical research, as well as program management and strategic prioritization of product portfolios, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. She is a valuable addition to our Board as we continue executing on our broad clinical development program for ADCETRIS and advancing our pipeline of clinical and preclinical products aimed at improving treatments for people with cancer.

This is an exciting time at Seattle Genetics, with the August 2011 FDA approval of ADCETRIS in two relapsed lymphomas, the many ongoing and planned clinical trials to evaluate ADCETRIS in a wide range of CD30-positive malignancies and a robust pipeline of other oncology assets, said Dr. Simonian. I look forward to working with the Board and the management team to maximize the potential of Seattle Genetics antibody-drug conjugate technology, collaborations and value to patients.

NancySimonian is currently an independent consultant to the biotechnology industry. From 2001 to 2011 she was at Millennium where she led clinical and regulatory activities supporting the development and product approvals for all oncology programs, including Velcade as well as drugs for inflammation and cardiovascular diseases. She also chaired the portfolio review committee responsible for all development investments. Before Millennium, she was Vice President of Clinical Research at Biogen (now Biogen Idec) where she was responsible for clinical development and medical affairs of the neurology and oncology pipeline, including Avonex and Tysabri. Dr. Simonian currently serves on the board of directors of the Personalized Medicine Coalition. Prior to joining the pharmaceutical industry, Dr.Simonian was on the faculty of Massachusetts General Hospital and Harvard Medical School as an assistant professor of neurology. She received a B.A. in Biology from Princeton University and an M.D. from the University of Pennsylvania Medical School.

About Seattle Genetics

Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. The FDA granted accelerated approval of ADCETRIS in August 2011 for two indications. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC programs: SGN-75, ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at http://www.seattlegenetics.com.

Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the companys plans for clinical trials with ADCETRIS and other programs. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, among others, that adverse events adversely affect the ability to successfully conduct planned clinical trials. More information about the risks and uncertainties faced by Seattle Genetics is contained in the companys Form 10-K for the year ended December 31, 2011 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Bioheart Labs and Stemlogix Veterinary Products Featured in Media

SUNRISE, Fla., March 22, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (OTCBB:BHRT.OB - News), a company focused on developing stem cell therapies for heart disease, previously announced that they entered into an agreement with Stemlogix, LLC, a veterinary regenerative medicine company, to provide additional cellular products and services to the veterinary market. Under this agreement, the companies are offering stem cell banking for veterinary patients (pets). WPLG, channel 10 featured this exciting technology in a news segment which aired in the South Florida area. A small sample of tissue can be obtained from the animals during a routine procedure such as a spay or neuter. The stem cells are isolated and cryopreserved for future use as needed.

"We are excited to bring our expertise in stem cell therapy to the veterinary community," said Mike Tomas, Bioheart's President and CEO. "Stem cell therapies represent new opportunities for various types of patients and the ability to bank a pet's cells when they are young and healthy could be very valuable for future use."

WPLG, Channel 10 in Miami/South Florida featured this new technology in a news segment which aired March 15, 2012. Please see the link below:

http://www.local10.com/thats-life/health/Pet-stem-cells-frozen-banked-for-future-use/-/1717022/9285894/-/apcx9rz/-/index.html

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com.

About Stemlogix, LLC

Stemlogix is an innovative veterinary regenerative medicine company committed to providing veterinarians with the ability to deliver the best possible stem cell therapy to dogs, cats and horses at the point-of-care. Stemlogix provides veterinarians with the ability to isolate regenerative stem cells from a patient's own adipose (fat) tissue directly on-site within their own clinic or where a patient is located. Regenerative stem cells isolated from adipose tissue have been shown in studies to be effective in treating animal's suffering from osteoarthritis, joint diseases, tendon injuries, heart disorders, among other conditions. Stemlogix has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. For more information about veterinary regenerative medicine please visit http://www.stemlogix.com.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

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Bioheart Labs and Stemlogix Veterinary Products Featured in Media

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Proposition 71 stem cell research funds drying up

SACRAMENTO (KABC) -- Eight years ago voters agreed to fund California's stem cell agency, hoping it would yield new treatments for various conditions. Now the agency is running out of funds and any practical cures are still years away.

The California Institute for Regenerative Medicine (CIRM) is about to enter a crucial stage in stem cell research: going to clinical trials. The most promising experiments could cure diabetes, HIV, sickle-cell anemia and blindness in the elderly.

"You don't really get to find out whether the potential of the treatment is really going to be effective until you start to treat the patients," said Alan Trounson, president of the California Institute for Regenerative Medicine.

CIRM's board is discussing how much to allocate for that trial phase. Through voter-approved bonds under Proposition 71 (The California Stem Cell Research and Cures Act), it has already given out or spent half of the $3 billion, but despite the medical promise, there's little to show for it beyond basic research and several high-tech laboratories.

But the agency says the breakthroughs will come over the next few years, way ahead of the rest of the world.

"This would all be happening in California, all driven by this Proposition 71 money," said Trounson.

The bond money is expected to last only several more years. One option is to ask voters to approve more bonds, something taxpayer groups oppose.

"When people think about bond financing, they think about a bridge, a school, a canal," said Jon Coupal, president of the Howard Jarvis Taxpayers Association. "But stem cell research is just kind of out there."

Rancher Diana Souza says it would be a shame to stop public funding of stem cell research. Through trials at UC Davis Medical Center not financed by Prop. 71 money, she says stem cells helped restore full use of her severely fractured arm.

"I hope they can continue doing this because it is a miracle. It does work. And I have a good arm to prove it," said Souza.

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Proposition 71 stem cell research funds drying up

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California institute fights to continue stem cell research

Written by Nannette Miranda, ABC7

SACRAMENTO, CA - The California Institute for Regenerative Medicine, CIRM, is about to enter a crucial stage in stem cell research: going to clinical trials.

The most promising experiments could cure: diabetes, HIV, sickle cell and blindness in the elderly.

"You don't really get to find out whether the potential of the treatment is really going to be effective until you start with patients, the human subjects," CIRM's Alan Trounson said.

CIRM's board is discussing how much to allocate for that trial phase.

Through voter-approved bonds under Proposition 71, it has already given out or spent half of the $3 billion, but despite the medical promise, there's little to show for it beyond basic research and several high-tech labs.

But the agency said the breakthroughs will come over the next few years, way ahead of the rest of the world.

"This would all be happening in California, all driven by this Proposition 71 money," Trounson said.

The bond money is expected to last only several more years.

One option is to ask voters to approve more bonds, something taxpayer groups oppose.

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California institute fights to continue stem cell research

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Key to immune system disease could lie inside the cheek

Public release date: 21-Mar-2012 [ | E-mail | Share ]

Contact: Stephen Rouse RouseS@cardiff.ac.uk 44-292-087-5596 Cardiff University

Powerful new cells created by Cardiff University scientists from cheek lining tissue could offer the answer to disorders of the immune system.

While the body's immune system protects against many diseases, it can also be harmful. Using white blood cells (lymphocytes), the system can attack insulin-producing cells, causing diabetes, or cause the body to reject transplanted organs.

A team from Cardiff's School of Dentistry led by Professor Phil Stephens, with colleagues from Stockholm's Karolinska Institute, have found a new group of cells with a powerful ability to suppress the immune system's action.

The team took oral lining cells from the insides of patients' cheeks and cloned them. Laboratory tests showed that even small doses of the cells could completely inhibit the lymphocytes.

The breakthrough suggests that the cheek cells have wide-ranging potential for future therapies for immune system-related diseases. Existing immune system research has focussed on adult stem cells, particularly those derived from bone marrow. The cheek tissue cells are much stronger in their action.

Dr Lindsay Davies, a member of the Cardiff team, said: "At this stage, these are only laboratory results. We have yet to recreate the effect outside the laboratory and any treatments will be many years away. However, these cells are extremely powerful and offer promise for combating a number of diseases. They are also easy to collect bone marrow stem cells require an invasive biopsy, whereas we just harvest a small biopsy from inside the mouth."

The findings have just been published online in Stem Cells and Development. The team has now been funded by the Medical Research Council to investigate the cloned cells further.

###

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Key to immune system disease could lie inside the cheek

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In Treatment of Child’s Heart Defect, Doctors Find a Stem-Cell Surprise

By Ron Winslow

Doctors at Yale University have successfully implanted a biodegradablescaffold seeded with a four-year-old girls own bone-marrowcells to help treat a serious heart defect, as WSJs Heartbeat column describes.

The tube about three inches long is made of polyester material similar to that used in the manufacture of dissolvable sutures. Six months after Angela Irizarrys surgery, it had disappeared, replaced by a bioengineered conduit that acts like a normal blood vessel.

The vanishing act for the scaffold was expected, but what happens to the cells, including stem cells, that spawned the new vessel?

Much to the researchers surprise, says Chris Breuer, the Yale pediatric surgeon leading the experimental tissue-engineering project, the cells go away too.

Stem cells and certain other bone-marrow cells have building-block properties that make them the foundation for more specialized cells that grow into the bodys various tissues and structures. Researchers have long believed that stem cells transplanted into heart tissue, for instance, would be a primary component of whatever new tissue that grew as a result.

A lot of people think that when you put cells in, they turn into whatever cells you want them to turn into, Breuer tells the Health Blog. Weve clearly shown that doesnt happen in our graft.

Indeed, in experiments performed to learn how the tubes morphed into blood vessels, Breuer and his colleagues transplanted their scaffold seeded with human cells into mice bred with deficient immune systems to prevent rejection of the cells. Within a few days, the human cellswere gone, replaced within the scaffold by mouse cells, including cells characteristic of those that line the inner wall of blood vessels.

Initially, I refused to believe it, Breuer says. I redid the experiment three different ways and saw the same thing every time.

The upshot: Transplanted cells that have a quality of stem cells dont buildnew parts themselves, he says.They cause the body to induce regeneration.

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In Treatment of Child’s Heart Defect, Doctors Find a Stem-Cell Surprise

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AMP applauds Supreme Court ruling: Sees win for patients and personalized medicine

Public release date: 21-Mar-2012 [ | E-mail | Share ]

Contact: Mary Steele Williams mwilliams@amp.org 301-634-7321 Association for Molecular Pathology

Bethesda, MD, March 21, 2012: "The Association for Molecular Pathology (AMP) applauds the U.S. Supreme Court's ruling today in the case of Mayo Collaborative Services v. Prometheus Laboratories as a victory for patients and for the advancement of personalized medicine," stated Iris Schrijver, MD, the Organization's President. AMP, an international professional society representing more than 2000 physicians, doctoral scientists, and medical technologists, joined 10 other medical and healthcare organizations in filing an amicus brief with the Court in support of Mayo Clinic. AMP is also the lead plaintiff in Association for Molecular Pathology v. U.S. Patent and Trademark Office that challenges the validity of patents on two human genes associated with hereditary breast and ovarian cancer and is currently under review by the High Court.

"Prometheus acknowledged that physicians can infringe the patent by merely thinking about the relationship between drug metabolite levels and patient response," asserted Dr. Schrijver. "It is encouraging that the Court recognized that the Prometheus patents neither promote the advancement of medical practice, nor benefit patient care".

"In Prometheus, the Court wisely recognized that overly broad patents can inhibit innovation," stated Jennifer Hunt, MD, MEd, the Organization's President-Elect. "Establishing a drug reference range is important, but standard work for laboratory physicians. Awarding monopolies over the medical use of natural, biological relationships stifles innovation in true diagnostic test methods and obstructs improvements for patient care."

AMP believes the Supreme Court's reasoning in Mayo v. Prometheus extends to patents that claim ownership over another type of natural phenomenon, the biological relationships between genetic variants and clinical disease. Such relationships are at the heart of personalized medicine. "Patients are increasingly being disadvantaged by gene correlation patents," stated Roger D. Klein, MD, JD, Chair of AMP's Professional Relations Committee. As an example, Dr. Klein cited a method patent relating to a variation in a gene known as FLT3 that is used to qualify some leukemia patients for bone marrow transplant.

Enforcement of the FLT3 patent by a private company has been forcing physicians and laboratories to split and geographically distribute irreplaceable bone marrow specimens. "Splitting samples creates an additional risk of specimen loss and delays the receipt of patient results" stated Dr. Klein. "In addition, it interferes with the ability of pathologists to provide synoptic interpretations involving multiple tests, and prevents them from implementing cost saving algorithms that limit unnecessary testing. The Supreme Court's ruling is clearly a win both for our patients and for personalized healthcare."

###

ABOUT AMP:

The Association for Molecular Pathology (AMP) is an international medical professional association dedicated to the advancement, practice, and science of clinical molecular laboratory medicine and translational research based on the applications of molecular biology, genetics, and genomics. For more information, please visit http://www.amp.org.

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BioTime CEO Michael D. West to Present at 2012 Maxim Group Growth Conference

ALAMEDA, Calif.--(BUSINESS WIRE)--

BioTime, Inc. (NYSE Amex:BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Chief Executive Officer, Michael D. West, Ph.D., will present a corporate overview of BioTime and its subsidiaries with an update on recent developments at the 2012 Maxim Group Growth Conference on Monday, March 26, 2012, 11:00 a.m. EDT, at the Grand Hyatt in New York City. The presentation will be webcast and available online at the Investors section of the BioTime website at http://www.biotimeinc.com.

The 5th annual Maxim Group Growth Conference is designed to provide institutional clients with the opportunity to gain an in-depth perspective on the issues affecting the growth of presenting companies. The one-day event will feature more than 80 company presentations across six designated industry tracks including the healthcare and biotechnology sectors.

About BioTime, Inc.

BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate cell lines, culture media, and differentiation kits. BioTime's wholly owned subsidiary ES Cell International Pte. Ltd. has produced clinical-grade human embryonic stem cell lines that were derived following principles of Good Manufacturing Practice and currently offers them for use in research. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences, Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. Cell Cure's minority shareholder Teva Pharmaceutical Industries has an option to clinically develop and commercialize Cell Cure's OpRegen retinal cell product for use in the treatment of age-related macular degeneration. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-DxTM currently being developed for the detection of cancer in blood samples, therapeutic strategies using vascular progenitor cells engineered to destroy malignant tumors. ReCyte Therapeutics, Inc. is developing applications of BioTime's proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime's newest subsidiary, LifeMap Sciences, Inc., is developing an online database of the complex cell lineages arising from stem cells to guide basic research and to market BioTime's research products. In addition to its stem cell products, BioTime develops blood plasma volume expanders, blood replacement solutions for hypothermic (low-temperature) surgery, and technology for use in surgery, emergency trauma treatment and other applications. BioTime's lead product, Hextend, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements. Additional information about BioTime, ReCyte Therapeutics, Cell Cure, OrthoCyte, OncoCyte, BioTime Asia, LifeMap Sciences, and ESI can be found on the web at http://www.biotimeinc.com.

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.

To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: http://phx.corporate-ir.net/phoenix.zhtml?c=83805&p=irol-alerts

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BioTime CEO Michael D. West to Present at 2012 Maxim Group Growth Conference

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VistaGen Therapeutics Enters Strategic Drug Screening Collaboration With Vala Sciences

SOUTH SAN FRANCISCO, CA--(Marketwire -03/21/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA.OB - News) (OTCQB: VSTA.OB - News), a biotechnology company applying stem cell technology for drug rescue and cell therapy, and Vala Sciences, Inc., a biotechnology company developing and selling next-generation cell image-based instruments, reagents and analysis software tools, have entered into a strategic collaboration. Their goal is to advance drug safety screening methodologies in the most clinically relevant human in vitro bioassay systems available to researchers today.

Cardiomyocytes are the muscle cells of the heart that provide the force necessary to pump blood throughout the body, and as such are the targets of most of the drug toxicities that directly affect the heart. Many of these drug toxicities result in either arrhythmia (irregular, often fatal, beating of the heart) or reduced ability of the heart to pump the blood necessary to maintain normal health and vigor.

"Our collaboration with Vala directly supports the core drug rescue applications of our Human Clinical Trials in a Test Tube platform," said Shawn K. Singh, JD, VistaGen's Chief Executive Officer. "Our high quality human cardiomyocytes combined with Vala's high throughput electrophysiological assessment capabilities is yet another example of how we are applying our stem cell technology platform within a strategic ecosystem of complementary leading-edge companies and technologies. We seek to drive our drug rescue programs forward and generate a pipeline of new, cardiosafe drug candidates."

Through the collaboration, Vala will use its Kinetic Image Cytometer platform to demonstrate both the suitability and utility of VistaGen's human pluripotent stem cell derived-cardiomyocytes for screening new drug candidates for potential cardiotoxicity over conventional in vitro screening systems and animal models. VistaGen's validated human cardiomyocyte-based bioassay system, CardioSafe 3D, will permit Vala to demonstrate the quality, resolution, applicability and ease of use of its new instrumentation and analysis software to make information-rich, high throughput measurements and generate fundamentally new insights into heart cell drug responses. Accurate, sensitive and reproducible measurement of electrophysiological responses of stem cell-derived cardiomyocytes to new drug candidates is a key element of VistaGen's CardioSafe 3D drug rescue programs. VistaGen's strategic collaboration with Vala is directed towards this goal.

About VistaGen Therapeutics

VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy. VistaGen's drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, with modern medicinal chemistry to generate new chemical variants (Drug Rescue Variants) of once-promising small-molecule drug candidates. These are drug candidates discontinued due to heart toxicity after substantial development by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans, bringing human biology to the front end of the drug development process.

Additionally, VistaGen's small molecule drug candidate, AV-101, is in Phase 1b development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S. alone. VistaGen is also exploring opportunities to leverage its current Phase 1 clinical program to enable additional Phase 2 clinical studies of AV-101 for epilepsy, Parkinson's disease and depression. To date, VistaGen has been awarded over $8.5 million from the NIH for development of AV-101.

About Vala Sciences

Vala Sciences is a San Diego-based biotechnology company that develops and sells cell-image-based instrumentation, reagents and analysis software tools to academic, pharmaceutical and biotechnology scientists. Vala's IC 200 class of instrumentation, and CyteSeer Automated Image Cytometry software convert labor-intensive qualitative observations of biological changes that can take from days to months, into accurate measurements delivered automatically in minutes.

Cautionary Statement Regarding Forward Looking Statements

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VistaGen Therapeutics Enters Strategic Drug Screening Collaboration With Vala Sciences

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Entest BioMedical Excited With Progress on 10 Dog Pilot Study of “Universal Donor” Stem Cell Treatment for Canine …

SAN DIEGO, CA--(Marketwire -03/21/12)- Entest BioMedical Inc. (OTCQB: ENTB.PK - News) (Pinksheets: ENTB.PK - News)

Entest BioMedical Inc. (OTCQB: ENTB.PK - News) (Pinksheets: ENTB.PK - News) and RenovoCyte LLC announced they have treated 8 canine patients of a 10 dog pilot study utilizing Canine Endometrial Regenerative Cells (CERC) licensed from Medistem Inc. (Pinksheets: MEDS.PK - News) in the treatment of canine osteoarthritis.

Previously, Entest announced the treatment of the first canine patient on November 18, 2011. Since that time Entest's McDonald Animal Hospital has treated 8 dogs in its 10 Dog Pilot Study with RenovoCyte. To date, all of the dogs participating in this study have shown dramatic improvement in their mobility and apparent reduction of pain.

Dr. Greg McDonald, Chief Veterinarian at McDonald Animal Hospital, said, "50 million CERC stem cells have been injected intravenously into eight dogs. Each dog selected for this study showed signs of arthritis. Follow-up blood tests, urinalysis and physical exams are now being scheduled for the patients that have already been treated. So far, all these canine patients have shown improvement."

Entest BioMedical Chairman David Koos stated, "Osteoarthritis is considered one of the most common causes of lameness in dogs, occurring in up to 30% of all dogs. It is caused by a deterioration of joint cartilage, followed by pain and loss of range of motion of the joint. We expect this treatment to relieve these animals from the pain associated with arthritis. This has extraordinary possibilities for dogs and may lead the way for human treatment of arthritic pain."

The CERC is a "universal donor" stem cell product that does not require matching with the recipient allowing for the generation of standardized products that can be delivered to the office of the veterinarian ready for injection. This is in stark contrast to current stem cell therapies utilized in veterinary applications which require the extraction, manipulation, and subsequent implantation of tissue from the animal being treated. CERC is the canine equivalent of Medistem's Endometrial Regenerative Cell (ERC). Medistem was recently granted approval from the FDA to initiate a clinical trial in human patients using its ERCs.

"We are extremely pleased with our research relationship with Entest BioMedical. This study of canine pets suffering from naturally occurring osteoarthritis is a better test model than laboratory induced disease because it will give us the opportunity for long term follow up of these patients. RenovoCyte sees this study as part of the supporting documentation that will be needed to obtain FDA approval for widespread usage of this therapy," said Shelly Zacharias, DVM, Director of Veterinary Operations, RenovoCyte, LLC.

A spokesperson for Entest noted the Company is also currently conducting a 10 dog safety study on its immune-therapeutic cancer vaccine for dogs, having treated 3 dogs so far.

About Entest BioMedical Inc.:Entest BioMedical Inc. (http://www.entestbio.com) is a veterinary biotechnology company focused on developing therapies that harness the animal's own reparative / immunological mechanisms. The Company's products include an immuno-therapeutic cancer vaccine for canines (ImenVax). ImenVax is less invasive and less traumatic in treating cancer. Additionally, the Company serves as the contract research organization conducting a pilot study on a stem cell based canine osteoarthritis treatment (developed by RenovoCyte LLC) utilizing a 'universal donor' stem cell. Entest is also building a network of veterinary hospitals (with its initial location in Santa Barbara, CA and anticipates acquiring other veterinary hospitals in California) -- which serve as distribution channels for its products.

DisclaimerThis news release may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.

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Entest BioMedical Excited With Progress on 10 Dog Pilot Study of "Universal Donor" Stem Cell Treatment for Canine ...

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Stem Cell Therapy Could Boost Kidney Transplant Success: Study

TUESDAY, March 20 (HealthDay News) -- A novel technique that uses a kidney transplant recipient's own stem cells may someday replace or reduce the initial use of anti-rejection medications, new research suggests.

Six months after receiving a kidney transplant, only about 8 percent of people given their own mesenchymal stem cells experienced rejection compared with almost 22 percent of people on the standard anti-rejection drugs, according to the study.

"Mesenchymal stem cells are stem cells that can be differentiated into a variety of cells," explained Dr. Camillo Ricordi, study senior author and director of the Cell Transplant Center and Diabetes Research Institute at the University of Miami Miller School of Medicine.

"If you infuse mesenchymal stem cells at the time of the transplant, you could replace the use of powerful anti-rejection drugs, and maybe replace immunosuppressants altogether," he said. This technique could be used in the transplantation of islet cells (in the pancreas) for people with type 1 diabetes, and for other organ transplants, such as the liver, he added.

The people given their own stem cells also had improved kidney function earlier after transplant, Ricordi said.

Results of the study appear in the March 21 issue of the Journal of the American Medical Association.

One of the biggest remaining hurdles in organ transplantation remains the need for powerful anti-rejection and immune-suppressing medications after the transplant.

"Basically, the way we prevent kidney rejections is by putting you on very powerful anti-rejection drugs and immunosuppressive agents to prevent your cells from attacking the foreign organ," said Dr. Robert Provenzano, chair of the department of nephrology, hypertension and transplantation at St. John Providence Health System in Detroit. "But, the current standard has some problems, like an increased risk of infections and the possibility of creating a cancer."

The body's immune system sends out surveillance cells to protect the body against foreign invaders, such as a bacteria, virus or, in this case, a new organ, Provenzano said. The current method of preventing these cells from attacking the new organ is essentially to destroy the surveillance cells. But mesenchymal cells can naturally suppress those surveillance cells so they don't attack, he said.

To see if this suppression would be enough to prevent rejection, Ricordi and his colleagues, including researchers from Xiamen University in China, recruited 159 people with serious kidney disease who were on dialysis. They ranged in age from 18 to 61.

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Stem Cell Therapy Could Boost Kidney Transplant Success: Study

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This Week in JAMA [This Week in JAMA]

Dexmedetomidine for Maintaining Sedation

During prolonged mechanical ventilation, sedation with midazolam or propofol is associated with serious adverse effects. Jakob and colleagues assessed the efficacy of dexmedetomidinean 2-agonist sedativecompared with either midazolam or propofol in 2 multicenter randomized trials that involved 998 patients expected to require more than 24 hours' mechanical ventilation. Among the authors' findings was that dexmedetomidine was not inferior to midazolam or propofol in maintaining light to moderate sedation or in reducing total ventilation duration compared with midazolam. However, dexmedetomidine was associated with more adverse events. In an editorial, Wunsch discusses the costs and benefits of sedative options for critically ill patients undergoing mechanical ventilation.

(ARTICLE) (ARTICLE)

Epinephrine is widely used in resuscitation of patients with out-of-hospital cardiac arrest; however, its effectiveness is not established. Hagihara and colleagues analyzed registry data from 417188 patients with out-of-hospital cardiac arrest to assess the relationship between prehospital epinephrine use and mortality and functional status among survivors. The authors report that prehospital epinephrine use was associated with increased return of spontaneous circulation before hospital arrival but decreased the likelihood of survival at 1 month or survival with good functional status. In an editorial, Callaway discusses the evidence that epinephrine use during cardiopulmonary resuscitation may not improve patient-oriented outcomes.

(ARTICLE) (ARTICLE)AND AUTHOR AUDIO INTERVIEW

Immunosuppressive induction therapyroutine in organ transplantsreduces the risk of organ rejection but is associated with adverse effects. Infusion of bone marrowderived mesenchymal stem cells, which have immunoregulatory effects, may offer an alternative immunosuppressive approach. In a randomized trial of 159 patients undergoing living-related kidney transplants, Tan and colleagues found that compared with conventional antiinterleukin 2 receptor antibodybased therapy, a regimen that involved infusion of autologous mesenchymal stem cells was associated with a lower incidence of acute rejection and better renal function at 1 year.

(ARTICLE)

The use of anesthesiologists or nurse anesthetists to administer procedural sedation during outpatient endoscopies increases costs. In a retrospective analysis of claims data from 1.1 million Medicare beneficiaries and 5.5 million commercially insured patients, Liu and colleagues found that utilization of anesthesia services during upper endoscopies and colonoscopies increased from approximately 14% in 2003 to more than 30% in 2009. The majority of anesthesia services were provided to low-risk patients and varied across geographic regions. In an editorial, Fleisher discusses factors that may contribute to increased use of anesthesia services for patients undergoing endoscopy procedures.

(ARTICLE) (ARTICLE)AND AUTHOR VIDEO INTERVIEW

Mrs N, a 75-year-old woman, has a several-year history of hearing loss, which is more bothersome to her family than herself. Pacala and Yueh discuss the prevalence, etiology, and consequences of hearing loss in older patients; its evaluation and treatment, including the selection and fitting of hearing aids; and special challenges to effective hearing aid use among older adults with multiple comorbidities.

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This Week in JAMA [This Week in JAMA]

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Pluristem reports success in stem cell heart attack treatment

Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) today announced that its PLacental eXpanded (PLX) cells improve several parameters in acute myocardial infarction (heart attacks) in animals. The preclinical trial was conducted at the Center for Regenerative Therapies in Germany.

The trial included 20 mice, which were given induced heart attacks. Half the mice were then given either PLX cells, and the other half were given a cell-free medium as a control. Five other mice underwent a sham (placebo) operation. After four weeks, the mice underwent an ECG, and were then killed for a physical examination of their hearts. The mice which received PLX had improved cardiac muscle function compared with the control group.

Study leader Prof. Christof Stamm said, "As a cardiac surgeon, the unique ability demonstrated by Pluristem's PLX cells for the treatment of heart disease is very exciting." He added, "PLX cells showed promising results in the AMI studies."

Pluristem chairman and CEO Zami Aberman said, "These results demonstrate the potential benefits of our cells for use in the treatment of ischemic heart disease, a multi-billion dollar annual market, and one in which many pharmaceutical companies are constantly looking to provide patients with innovative and effective solutions. In addition to moving ahead with our AMI trial, we look forward to continuing to work on finding cell therapy solutions for numerous debilitating diseases."

An article in the New England Journal of Medicine states that 624,000 patients suffer an acute myocardial infarction annually in the US, a number that will most likely increase with the rising prevalence of obesity, diabetes and the aging of the population.

Pluristem's share price rose 5.1% by mid-afternoon on the TASE today to NIS 8.50, after closing at $2.15 on Nasdaq yesterday, giving a market cap of $95 million. The share is up 6.5% in premarket trading on Nasdaq today.

Published by Globes [online], Israel business news - http://www.globes-online.com - on March 20, 2012

Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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Pluristem reports success in stem cell heart attack treatment

Recommendation and review posted by Bethany Smith

Collaborative Study from the Diabetes Research Institute Federation and The Cure Alliance Shows that Stem Cells Can …

To: HEALTH, MEDICAL AND NATIONAL EDITORS

MIAMI, March 20, 2012 /PRNewswire-USNewswire/ -- New findings from a transplant study led by scientists from the Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine and a DRI Federation center at Xiamen University in China showed that mesenchymal stem cells may replace a powerful anti-rejection drug in transplant recipients. The results of this pioneering study involving kidney transplant patients is published in the March 21 issue of the Journal of the American Medical Association (JAMA) and may fundamentally transform the future of clinical transplantation.

(Logo: http://photos.prnewswire.com/prnh/20120126/DC42842LOGO)

Patients undergoing a transplant routinely receive a regimen of immunosuppressive therapy to block the body's immune system from rejecting the donor organ or cells. While these drugs have been shown to improve graft function and minimize rejection episodes, they increase the risk of dangerous side effects, including infections and organ toxicity. To eliminate these adverse effects, scientists at the Diabetes Research Institute and collaborating centers worldwide have been investigating safer methods for preventing transplant rejection and have turned their attention to naturally-occurring cells in the body that have immuno-modulatory properties, like mesenchymal stem cells.

A mesenchymal stem cell (MSC) is a type of cell that can differentiate into bone, cartilage, fat and other body tissues. But MSCs have also been found to have a number of other beneficial therapeutic properties, including their ability to modulate the immune system by inhibiting T-cell proliferation, eliminating graft-vs.-host disease, limiting cytotoxic inflammation and stimulating vascularization, among other benefits.

"This study represents a first, important step towards the definition of cell-based strategies that will one day allow for transplantation without the need for life-long, anti-rejection drugs," said Camillo Ricordi, M.D., director of the University of Miami Diabetes Research Institute and Cell Transplant Center. "The worldwide collaborative strategy of the Diabetes Research Institute Federation and The Cure Alliance has resulted in yet another small step forward in our worldwide cure-focused efforts, indicating safety and efficacy of a stem cell-based strategy towards reducing and eventually eliminating anti-rejection drugs. This is particularly important to the DRI mission, as transplantation without immunosuppression is a major goal in any strategy for transplantation of insulin producing cells and a requirement for becoming a reality for all patients with Type 1 or Type 2 insulin dependent diabetes."

In this recent study, "Induction Therapy with Autologous Mesenchymal Stem Cells in Living-Related Kidney Transplants," patients with end-stage renal disease received infusions of bone-marrow derived autologous mesenchymal stem cells together with either standard-dose or low-dose calcineurin inhibitors (CNI). The control group received an immunosuppression regimen consisting of anti-IL-2 receptor antibody plus standard-dose CNI.

After one year post-transplant, the results of the study indicate that among the patients undergoing a kidney transplant, the use of autologous MSCs compared with the standard immunosuppressive therapy resulted in lower incidence of acute organ rejection, decreased risk of infection and better kidney function.

"We reported on the first 12 months follow-up, which showed no adverse events associated with MSC therapy. We will continue monitoring the patients in the study to assess the long-term effects on kidney transplant function and survival, as well as the safety of MSCs transplantation in this setting. Should long-term safety of MSCs be confirmed, it may be valuable for improving transplantation outcomes while reducing the risks associated with anti-rejection drugs," said Antonello Pileggi, M.D., Ph.D., director of Preclinical Cell Processing and Translational Models Program at the Cell Transplant Center of the DRI.

"This collaboration was part of the ongoing global efforts of The Diabetes Research Institute Federation and of The Cure Focus Research Alliance. The opportunity to contribute these results obtained through the combined team efforts of Affiliated Fuzhou General Hospital of Xiamen University and DRI to a journal as high impact as JAMA represents an important achievement for the China-USA Collaborative Human Cell Transplant Program at the Cell Transplant Center of DRI," said Xiumin Xu, M.S., director of the China-US Collaborative Human Cell Transplant Program at the Diabetes Research Institute.

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Collaborative Study from the Diabetes Research Institute Federation and The Cure Alliance Shows that Stem Cells Can ...

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Drug Makes Leukemia More Vulnerable to Chemo

Newswise Doctors at Washington University School of Medicine in St. Louis have shown that a new drug makes chemotherapy more effective in treating acute myeloid leukemia, a cancer of the white blood cells. Instead of attacking these cells directly, the drug helps drive them out of the bone marrow and into the bloodstream, where they are more vulnerable to chemotherapy.

Were usually very good at clearing these leukemia cells from the blood, says Geoffrey L. Uy, MD, assistant professor of medicine and co-first author on the study published in the journal Blood. But its much harder to clear these cancerous cells from the bone marrow.

This combined phase 1 and 2 clinical trial included 52 patients with acute myeloid leukemia (AML) who had relapsed or whose AML was resistant to the standard chemotherapy regimen. In the phase 2 portion with 46 patients, all received the investigational drug, and 46 percent achieved complete remission, meaning no evidence of cancer could be found in the blood or bone marrow after treatment.

In general, we see complete remission rates between 20 and 30 percent, says Uy, who treats patients at the Alivn J. Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital. But a lot depends on individual patient characteristics.

Indeed, recent genetic studies have shown that mutations leading to AML may differ greatly among patients. But regardless of individual mutations, all of these leukemia cells rely in some way on the protective effects of the bone marrow, according to senior author John F. DiPersio, MD, PhD, the Virginia E. and Sam J. Golman Professor of Medicine.

With DNA sequencing identifying so many mutations that are unique to one patient, it may be very hard to find therapies that work directly on the cancer, says DiPersio, who also treats patients at the Siteman Cancer Center. Instead, we are targeting a common pathway that all leukemic cells are addicted to in this case, the relatively normal environment of the bone marrow.

DiPersio calls the results of this study encouraging and worthy of additional exploration.

If these results are repeated in a larger study, it would be transformative, he says. It would change the standard way we treat these patients we would use this approach with everybody. In addition, the approach of targeting the tumor microenvironment could also be exploited for the treatment of other hematologic and solid tumor malignancies.

Bone marrow protects leukemia cells by inhibiting the cell-suicide response that might otherwise lead AML cells to self-destruct. Although leukemia cells in the bone marrow do not rapidly divide, their stability makes them very resistant to treatment. And while chemotherapy can clear the bloodstream of leukemia for a period of time, these protected cells in the bone marrow may cause the cancer to return.

The drug used in this study, called plerixafor, blocks the leukemia cells from attaching to the bone marrow. Released from their protective environment into the bloodstream, the cells lose the bone marrows survival signals and begin to divide. Rapidly dividing cells are more sensitive to chemotherapy.

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Drug Makes Leukemia More Vulnerable to Chemo

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Use of stem cells for adults receiving related donor kidney transplants appears to improve outcomes

Public release date: 20-Mar-2012 [ | E-mail | Share ]

Contact: Omar Montejo omontejo@miami.edu 305-243-5654 JAMA and Archives Journals

CHICAGO Among patients with end-stage renal disease undergoing living-related kidney transplants, the use of bone-marrow derived mesenchymal (cells that can differentiate into a variety of cell types) stem cells instead of antibody induction therapy resulted in a lower incidence of acute rejection, decreased risk of opportunistic infection, and better estimated kidney function at 1 year, according to a study in the March 21 issue of JAMA.

Induction therapy, routinely implemented in organ transplant procedures, consists of use of biologic agents to block early immune activation. New induction immunosuppressive protocols with increased efficacy and minimal adverse effects are desirable. "Antibody-based induction therapy plus calcineurin inhibitors (CNIs) reduce acute rejection rates in kidney recipients; however, opportunistic infections and toxic CNI effects remain challenging. Reportedly, mesenchymal stem cells (MSCs) have successfully treated graft-vs.-host disease," according to background information in the article.

Jianming Tan, M.D., Ph.D., of Xiamen University, Fuzhou, China and colleagues examined the effect of autologous (derived from the same individual) MSC infusion as an alternative to anti-IL-2 receptor antibody for induction therapy in adults undergoing living-related donor kidney transplants. The randomized study included 159 patients. Patients were inoculated with marrow-derived autologous MSC at kidney reperfusion and two weeks later. Fifty-three patients received standard-dose and 52 patients received low-dose CNIs (80 percent of standard); 51 patients in the control group received anti-IL-2 receptor antibody plus standard-dose CNIs.

Patient and graft survival at 13 to 30 months was similar in all groups. The researchers found that after 6 months, 4 of 53 patients (7.5 percent) in the autologous MSC plus standard-dose CNI group and 4 of 52 patients (7.7 percent) in the low-dose group compared with 11 of 51 controls (21.6 percent) had biopsy-confirmed acute rejection. Renal function recovered faster among both MSC groups showing increased estimated glomerular filtration rate (eGFR; a measure of kidney function) levels during the first month after surgery than the control group.

The authors also found that during the 1-year follow-up, combined analysis of MSC-treated groups revealed significantly decreased risk of opportunistic infections than the control group.

"In our prospective randomized trial on a large patient population, autologous MSCs could replace anti-IL-2 receptor-induction therapy in living-related donor kidney transplants. Recipients of autologous MSCs showed lower frequency of biopsy-confirmed acute rejection in the first 6 months than the control group," the researchers write.

"Extended monitoring of study participants will allow assessment of the long-term effects of autologous MSCs on renal allograft function, survival, and safety."

###

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International Stem Cell Corporation Announces 2011 Financial Results

CARLSBAD, Calif.--(BUSINESS WIRE)--

International Stem Cell Corporation (OTCBB: ISCO.OB - News) (www.internationalstemcell.com) today announced year-end financial results for the year ended December 31, 2011. ISCO is a California-based development-stage biotechnology company that is focused on therapeutic, biomedical and cosmeceutical product development and commercialization with multiple long-term therapeutic opportunities and two revenue-generating businesses offering potential for increased future revenue.

ISCO reported revenue of $1.1 million for the fourth quarter ended December 31, 2011, reflecting a 110% increase from the same period of the prior year. For the twelve months ended December 31, 2011, the Company reported revenue of $4.5 million, reflecting a year-over-year increase of 189%. The increases in revenues in both periods were primarily driven by strong sales at ISCOs wholly-owned subsidiary Lifeline Skin Care (LSC). In addition, steady growth in sales from ISCOs other wholly-owned subsidiary, Lifeline Cell Technology (LCT), contributed to the increases in revenues for both periods.

While the Company continued to invest in therapeutic projects, development of new technologies, and expansion of products and channels of distribution, to date we have generated limited revenue to support our core therapeutic research and development efforts. For the three months ended December 31, 2011, development expenses, excluding cost of sales, increased $507,000 or 17% compared with the same period of 2010, a reflection of increased G&A expenses resulting from higher stock-based compensation expenses.

For the twelve months ended December 31, 2011, development expenses, excluding costs of sales, increased approximately $3.0 million or 26% when compared with the prior year period.The majority of the increase was primarily due to increases in general and administrative and research and development activities. General and administrative expenses increased largely due to increased non-cash stock-based compensation, higher headcount, and increased expenses related business development activity and general corporate expenses. Research & Development expenses increased mainly due to increased number and complexity of experiments associated with our scientific projects. The increase in development expenses was also related to increased research activities on therapeutic products and product research activities for LSC and LCT coupled with increased sales and marketing expenses related to our skin care products.

Some of the 2011 Highlights:

-- A number of donors willing to provide oocytes for research purposed were enrolled in ISCO's program to establish a bank of clinical grade hpSC capable of being immune-matched to millions of patients.

-- The Research and Development team successfully completed the first series of preclinical studies that supports the therapeutic use of hepatocytes (liver cells) and neuronal cells derived from human parthenogenetic stem cells (hpSC). These in vivo experiments demonstrated that the derived cells are able to survive in targeted locations in mice without causing tumors.

-- We became Sarbanes-Oxley compliant and maintained, in all material respects, effective internal controls over financial reporting as of December 31, 2011.

-- We strengthened our Management Team through the appointments of well-known industry executives: Kurt May as President & Chief Operating Officer, Linh Nguyen as Chief Financial Officer, Donna Queen as Vice President of Marketing and Business Development for LSC.

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International Stem Cell Corporation Announces 2011 Financial Results

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