VistaGen Secures Key U.S. Patent Covering Stem Cell Technology Methods Used To Test Drug Candidates For Liver Toxicity

South San Francisco, CA (Marketwire) - VistaGen Therapeutics, Inc. (OTCBB: VSTA) (OTCQB: VSTA), a biotechnology company applying stem cell technology for drug rescue, has secured a new United States patent covering the company's proprietary methods used to measure and type the toxic effects produced by drug compounds in liver stem cells.

Test methods included in this new patent, (U.S. Patent 11/445,733), titled "Toxicity Typing Using Liver Stem Cells," cover all mammalian liver stem cells -- rat and mouse cells, for example, in addition to human cells. Liver stem cells used in drug testing can be derived from in vivo tissue or produced from embryonic stem cells (ES) or induced pluripotent stem cells (iPS).

H. Ralph Snodgrass, Ph.D., VistaGen's President and Chief Scientific Officer, said, "This patent covers the monitoring of changes in gene expression as an assay for predicting drug toxicities. It is well known that drugs activate and suppress specific genes, and that the changes in gene expression reflect the mechanism of drug toxicities. The specific sets of genes that are affected become a profile of that drug."

VistaGen's new patent also covers techniques used to develop a database of gene expression profiles of drugs that have the same type of liver toxicity. Using sophisticated "pattern matching" database tools, drug developers can analyze these related profiles to determine "gene expression signatures" that are common and predictive of drugs that produce specific types of toxicity.

"Without this database capability, a drug's single gene expression profile could not be interpreted," Dr. Snodgrass added. "The ability to use liver stem cells to differentiate drug-dependent gene expression profiles, and to compare those profiles of drugs known to induce toxic liver effects, provides a powerful tool for predicting liver toxicity of new drug candidates, including drug rescue variants."

Shawn K. Singh, VistaGen's Chief Executive Officer, stated, "Strong and enforceable intellectual property rights are critical components of our plan to optimize the commercial potential of our Human Clinical Trials in a Test Tube platform. This new liver toxicity typing patent further solidifies our growing IP portfolio, and supports the continuing development of LiverSafe 3D, our human liver cell-based bioassay system, which complements our CardioSafe 3D human heart cell-based bioassay system for heart toxicity."

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. Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen's Facebook page at http://www.facebook.com/VistaGen

Cautionary Statement Regarding Forward Looking Statements The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals, the issuance and protection of patents and other intellectual property, the success of VistaGen's ongoing clinical studies, including the safety and efficacy of its drug candidate, AV-101, the failure of future drug rescue and pilot preclinical cell therapy programs related to VistaGen's stem cell technology-based Human Clinical Trial in a Test Tube platform, its ability to enter into drug rescue collaborations, risks and uncertainties relating to the availability of substantial additional capital to support VistaGen's research, development and commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to AV-101 and any drug rescue variants identified and developed by VistaGen. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at http://www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.

SOURCE: VistaGen Therapeutics, Inc.

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VistaGen Secures Key U.S. Patent Covering Stem Cell Technology Methods Used To Test Drug Candidates For Liver Toxicity

Pharmaceutical Company Merck Serono Signs an Agreement to Use Kadimastem's Platform for Drug Screening

NES ZIONA, Israel--(BUSINESS WIRE)--

Kadimastem, an Israeli Biotechnology company that develops human pluripotent stem cell-related products, today announced the signing of a five year framework agreement with Merck Serono, a division of Merck KGaA, Darmstadt, Germany. The agreement concerns the use of Kadimastem's drug-screening platform to discover new oral drugs for the treatment of the neurological disease Multiple Sclerosis (MS).

The system developed by Kadimastem allows using human functional tissues produced industrially from pluripotent stem cells as a means to search for potential new drugs, a direct approach that has advantages over the use of animals. In Multiple Sclerosis, the insulating myelin sheaths which cover many nerves in the brain and spinal cord are destroyed due to loss of the myelin-forming cells resulting in the impairment of nerve function and severe neurological disabilities. It is estimated that 2.5 million patients suffer from this disease around the globe. While the existing treatments act by slowing down the loss of myelin-forming cells, there is great interest in finding new medications that could repair the myelin by stimulating the regeneration of myelin-forming cells. The drug-screening project, to be carried out through the Kadimastem-Merck Serono agreement, aims precisely at the discovery of potential oral drugs that act by stimulating myelin repair.

We are pleased to announce this agreement with Merck-Serono, a company with robust experience in drug discovery, development and marketing in the Multiple Sclerosis area, said Mr. Yossi Ben-Yossef, CEO of Kadimastem. The undisclosed compensation for this agreement will provide financial support for Kadimastem's own in-house drug discovery initiatives, in the field of neurodegenerative diseases as well as in the field of Diabetes. Kadimastem also produces pancreatic islet cells from pluripotent stem cells, for screening of drugs enhancing insulin secretion and eventually for cellular therapy of Diabetes.

Prof. Michel Revel, Chief Scientist of Kadimastem, further commented: We are very proud that after a thorough evaluation, Merck Serono decided to sign an agreement with us. We see it as a proof of our excellence in developing human myelin-forming cells and our capabilities in drug screening. We believe that this agreement is a first step towards further collaboration with Merck Serono and other Pharmaceutical companies, in which our capabilities in drug screening on human functional cell systems will synergize with their capabilities in medicinal chemistry and clinical development, to make drugs available more rapidly and more efficiently.

Prof. Revel from the Weizmann Institute of Science was the Chief Scientist of InterPharm, an Israeli biotech company part of the Merck Serono group that developed Prof. Revel's groundbreaking research which lead to Rebif (mammalian cell-produced recombinant Interferon beta-1a), today a leading drug for the treatment of Multiple Sclerosis with annual sales by Merck Serono of over US$ 2.3 billion.

Mr. Amir Naiberg, CEO of Yeda, the commercial arm of the Weizmann Institiute of Science, said: We are excited that Kadimastem, that was established around one of our technologies, is collaborating with Merck Serono. Merck Serono has a long and successful tradition of developing products that emerged from the Weizmann Institute labs,and we hope that Kadimastem will be another link in this chain.

About Kadimastem

Kadimastem (www.kadimastem.com) is a biotechnology company focused on the industrial development and commercialization of human pluripotent stem cell-based products. At Kadimastem, the pluripotent stem cell technology is used to produce specialized human cells and tissues for two major types of medical applications: 1) Drug-screening platforms using human functional cells and tissues as in vitro assays for discovering novel therapeutic drugs for neurological diseases and diabetes, and 2) Cell therapy for regenerative medicine, to repair tissues and organs affected by diseases, such as implanting insulin-secreting pancreatic islet cells as a treatment for insulin-dependent diabetes. Kadimastem is developing these technologies in its state of the art 1,000 m2 facilities in the Weizmann Science Park (Ness Ziona, Israel), for industrial research and production, with a staff of PhD-level and MSc-level scientists. Kadimastem uses pluripotent human stem cells made available through licensing agreements with the Embryonic Stem Cell Center of the Hadassah Medical center in Jerusalem (Prof. Benjamin Reubinoff) and the Shaarei Zedek Medical Center, Jerusalem, Israel.

About Merck Serono

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Pharmaceutical Company Merck Serono Signs an Agreement to Use Kadimastem's Platform for Drug Screening

Dr. Aaron Schimmer Receives the Till and McCulloch Award – Award Lecture to be Presented Today on Drug Screening with …

MONTRAL, April 30, 2012 /CNW/ - Canada's most coveted stem cell prize will be awarded to a Stem Cell Network researcher who has used drug screening to find a potential new treatment for a deadly form of cancer.

Dr. Aaron Schimmer, associate professor in the University of Toronto's Department of Medical Biophysics and a clinician-scientist in the Princess Margaret Cancer Program/Ontario Cancer Institute at University Health Network, has received the 2012 Till & McCulloch Award, presented each year by the Stem Cell Network in recognition of the year's most influential peer-reviewed article by a researcher in Canada. Dr. Schimmer will accept the award and present a lecture entitled "Novel therapeutic strategies to target leukemia stem cells" as part of the Till and McCulloch Meetings in Montral at 2 p.m. this afternoon.

In an advance interview, Dr. Schimmer described his findings and their potential as a new drug therapy in the treatment of leukemia.

"When you treat patients with leukemia, you can kill off 99 per cent of their leukemic cells with just about anything, and yet, 80 per cent or more of patients relapse," Schimmer explained. "When we examined this in a really objective way, the question was not how to kill off those bulk cells - we already knew how to do that - but are we really missing a critical component of what we should be targeting?"

Dr. Schimmer and his team eventually found that cutting off the energy production capacity of bulk leukemia cells and leukemia stem cells was a way of treating the disease, and that the compound tigecyclinean FDA-approved antibiotic sometimes used to treat skin and abdominal infectionswas up to the task.

"Tigecycline appeared to work by essentially shutting down the energy supply of the leukemia cells and stem cells," said Dr. Schimmer. "Essentially it is like producing a selective power outage in leukemia cells but not normal cells."

By focusing on FDA-approved drugs, Dr. Schimmer was able to produce results that were quickly translated into clinical trials. Less than two years passed between his initial findings and the commencement of a phase-one clinical triala process that can otherwise take three or four times that long.

"It is incredibly impressive how much progress Dr. Schimmer has made in such a short period of time by using these stem cell screening techniques," said Stem Cell Network Scientific Director Michael Rudnicki. "By identifying drugs which are already approved for human therapies and testing their efficacy in treating diseases such as leukemia, Dr. Schimmer has shaved years off of the clinical trial process. It is likely that his discovery will improve the outcomes for many patients in the near future."

In 2005, the Stem Cell Network established the Till & McCulloch Award in honour of Canadians Drs. James Till and Ernest McCulloch, whose pioneering work established the field of stem cell research. The Award had been granted at the Stem Cell Network's Annual Scientific Meeting, but became part of the Till & McCulloch Meetings this year.

The previous winner was Timothy Caulfield, who was recognized for his global leadership in the field of stem cell ethics.

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Dr. Aaron Schimmer Receives the Till and McCulloch Award - Award Lecture to be Presented Today on Drug Screening with ...

Bellevue doctor tests stem-cell cream as anti-aging therapy

by JEAN ENERSEN / KING 5 News

KING5.com

Posted on April 27, 2012 at 11:01 PM

A Bellevue doctor is one of only two researchers in the country testing stem cells as an anti-aging treatment.

Working with volunteer patients, Dr. Fredric Stern extracts stem cells with a liposuction-like procedure. The cells are then mixed with a special medium.

"Half is saved cyrogenically for future use and the other half is shipped to the laboratory in Arizona where on that end the stem cells are grown further," Stern said.

The end product goes into a cream called tropoelastin. The hope is that high concentrations of a patient's own stem cells in the cream will boost the skink's ability to repair itself.

If the eye cream proves successful in the eight-week study, the company will also offer a facial cream. Both could be available within a few months.

Stern said he expects the price to be comparable to high-end cosmetic products that typically cost hundreds of dollars.

Stern said the skin treatment is just the beginning. He said wound care is another possible use.

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Bellevue doctor tests stem-cell cream as anti-aging therapy

Division of Labor in Neural Stem Cell Maintenance

Newswise NEWARK, N.J. -- Sibling growth factors cooperate to maintain a pool of neuron-generating stem cells in the brain, according to a study published in the journal Stem Cells by researchers at the University of Medicine and Dentistry of New Jersey (UMDNJ).

Numerous soluble proteins and receptors help to maintain neural stem cells (NSCs) supportive environment in central nervous system (CNS). NSCs access some of these nurturing factors by sending cellular extensions into the cerebral spinal fluid (CSF), which is rich in stem cell-promoting proteins.

Insulin-like growth factors (IGF-I and IGF-II) are essential for the growth and development of the CNS. But although they are abundant in the brain and CSF, it was not clear whether they are required by NSCs. Steven Levison, PhD, and Teresa Wood, PhD, of UMDNJ-New Jersey Medical School and colleagues now show that IGF-I and II cooperate to maintain NSC numbers and the NSCs ability to self-renew. IGF-I maintains NSC numbers by promoting cell division (via the IGF-I receptor), whereas IGF-II drives the expression of proteins essential for NSC self-renewal and stemness (via the insulin receptor).

The role of IGF-I and -II in maintaining NSC numbers and function might help to explain the cognitive impairments associated with aging, as the abundance of both proteins declines with age.

Disclosure: This study was funded by a Deans grant from UMDNJ-New Jersey Medical School, NIH grants (R21HL094905, F31NS065607 and T32-HL069752) and a grant from the LeDucq Foundation.

The University of Medicine and Dentistry of New Jersey (UMDNJ) is New Jerseys only health sciences university with more than 6,000 students on five campuses attending the state's three medical schools, its only dental school, a graduate school of biomedical sciences, a school of health related professions, a school of nursing and New Jerseys only school of public health. UMDNJ operates University Hospital, a Level I Trauma Center in Newark, and University Behavioral HealthCare, which provides a continuum of healthcare services with multiple locations throughout the state.

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Division of Labor in Neural Stem Cell Maintenance

Hadassah centenary honored May 6 by Chicago chapter

By Natasha Wasinski Contributor April 23, 2012 11:10AM

Miriam Schencker Goldberger (right) sits with two of her four grandchildren, Ari Schencker, 7, and his sister Sadie, 9, as 4-year-old Noah Schencker approaches to have his photo taken. Miriam, a member to Hadassah for past 50 years, purchased life members

storyidforme: 29352286 tmspicid: 10613889 fileheaderid: 4867083

Updated: April 23, 2012 8:47PM

With this year marking its centennial anniversary, the largest Jewish membership and womens organization in the U.S. has much to celebrate.

The Chicago chapter of Hadassah, the Womens Zionist Organization of America, hosts a benefit dinner May 6 at the Bryn Mawr Country Club in Lincolnwood to support trailblazing stem cell research efforts of a Jerusalem medical center.

Special guest Ehud Kokia, director general of Hadassah University Medical Center, is visiting from Israel to give a keynote address.

He oversees the Hadassah organizations flagship cause, which includes two hospitals with 1,000 beds, 31 operating theaters, nine intensive care units and five medical-profession schools, owned and operated in collaboration with the Hebrew University.

Supporting health work is a core component of Hadassahs service-oriented mission.

The national volunteer-led organization provides funding for programs and projects in Israel related to the Hadassah Medical Organization, education and youth institutions, and reforestation and parks.

Here is the original post:
Hadassah centenary honored May 6 by Chicago chapter

Hadassah centennial to be honored by Chicago chapter

By Natasha Wasinski Contributor April 23, 2012 11:10AM

Miriam Schencker Goldberger (right) sits with two of her four grandchildren, Ari Schencker, 7, and his sister Sadie, 9, as 4-year-old Noah Schencker approaches to have his photo taken. Miriam, a member to Hadassah for past 50 years, purchased life members

storyidforme: 29352286 tmspicid: 10613889 fileheaderid: 4867083

Updated: April 23, 2012 8:47PM

With this year marking its centennial anniversary, the largest Jewish membership and womens organization in the U.S. has much to celebrate.

The Chicago chapter of Hadassah, the Womens Zionist Organization of America, hosts a benefit dinner May 6 at the Bryn Mawr Country Club in Lincolnwood to support trailblazing stem cell research efforts of a Jerusalem medical center.

Special guest Ehud Kokia, director general of Hadassah University Medical Center, is visiting from Israel to give a keynote address.

He oversees the Hadassah organizations flagship cause, which includes two hospitals with 1,000 beds, 31 operating theaters, nine intensive care units and five medical-profession schools, owned and operated in collaboration with the Hebrew University.

Supporting health work is a core component of Hadassahs service-oriented mission.

The national volunteer-led organization provides funding for programs and projects in Israel related to the Hadassah Medical Organization, education and youth institutions, and reforestation and parks.

Read more from the original source:
Hadassah centennial to be honored by Chicago chapter

Hadassah centennial to be honored

By Natasha Wasinski Contributor April 23, 2012 8:14PM

Miriam Schencker Goldberger (right) sits with two of her four grandchildren, Ari Schencker, 7, and his sister Sadie, 9, as 4-year-old Noah Schencker approaches to have his photo taken. Miriam, a member to Hadassah for past 50 years, purchased life members

storyidforme: 29385357 tmspicid: 10613889 fileheaderid: 4867083

Updated: April 24, 2012 11:03AM

With this year marking its centennial anniversary, the largest Jewish membership and womens organization in the United States has much to celebrate.

The Chicago chapter of Hadassah, the Womens Zionist Organization of America, will conduct a benefit dinner May 6 at the Bryn Mawr Country Club in Lincolnwood to support stem-cell research efforts of a Jerusalem medical center.

Special guest Ehud Kokia, director general of Hadassah University Medical Center, is visiting from Israel to give a keynote address.

He oversees the Hadassah organizations flagship cause, which includes two hospitals with 1,000 beds, 31 operating theaters, nine intensive care units and five medical profession schools, owned and operated in collaboration with the Hebrew University.

Supporting health work is a core component of Hadassahs service-oriented mission.

The national volunteer-led organization provides funding for programs and projects in Israel related to the Hadassah Medical Organization, education and youth institutions, and reforestation and parks.

Originally posted here:
Hadassah centennial to be honored

Medical Center Researchers Discover "Housekeeping" Mechanism for Brain Stem Cells

Published: April 22, 2012

Findings offer new insights into neurologic development and regenerative therapies for neurologic disease

(New York, NY, April 22, 2012) Researchers at Columbia University Medical Center (CUMC) have identified a molecular pathway that controls the retention and release of the brains stem cells. The discovery offers new insights into normal and abnormal neurologic development and could eventually lead to regenerative therapies for neurologic disease and injury. The findings, from a collaborative effort of the laboratories of Drs. Anna Lasorella and Antonio Iavarone, were published today in the online edition of Nature Cell Biology.

The research builds on recent studies, which showed that stem cells reside in specialized niches, or microenvironments, that support and maintain them.

From this research, we knew that when stem cells detach from their niche, they lose their identity as stem cells and begin to differentiate into specific cell types, said co-senior author Antonio Iavarone, MD, professor of Pathology and Neurology at CUMC.

However, the pathways that regulate the interaction of stem cells with their niche were obscure, said co-senior author Anna Lasorella, MD, associate professor of Pathology and Pediatrics at CUMC and a member of the Columbia Stem Cell Initiative.

In the brain, the stem cell niche is located in an area adjacent to the ventricles, the fluid-filled spaces within the brain. Neural stem cells (NSCs) within the niche are carefully regulated, so that enough cells are released to populate specific brain areas, while a sufficient supply is kept in reserve.

Neural stem cells detaching from the vascular niche. Image credit: Anna Lasorella, CUMC /Nature Cell Biology

In previous studies, Drs. Iavarone and Lasorella focused on molecules called Id (inhibitor of differentiation) proteins, which regulate various stem cell properties. They undertook the present study to determine how Id proteins maintain stem cell identity.

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Medical Center Researchers Discover "Housekeeping" Mechanism for Brain Stem Cells

Silicon Biosystems to Present Single-Circulating Tumor Cell Molecular Characterization at the Fourth World CTC Summit

BOLOGNA, Italy--(BUSINESS WIRE)--

Silicon Biosystems, S.p.A., a provider of specialized molecular and cellular biology technologies, will present at the Fourth World Circulating Tumour Cells Summit, April 25, 2012 at 3:30 p.m. at the Maritim Hotel in Berlin. Dr. Nicol Manaresi, founder and chief technology officer of Silicon Biosystems, will provide an overview of the DEPArray system, which uses image-based single-cell sorting to deliver pure populations of rare tumor cells.

As part of the presentation, Dr. Manaresi will also offer recent data demonstrating single-CTC molecular characterization based on Whole Genome Amplification using the companys proprietary Ampli1 WGA kit followed by sequencing with Ion Torrent.

Silicon Biosystems is a device manufacturer leading the field in the detection and isolation of single cells for cancer research and prenatal genetic testing. The companys DEPArray technology exploits microelectronics and the principles of dielectrophoresis to find, sort, isolate, and collect 100 percent pure populations of rare cells, such as CTCs, for single-cell based genomic and transcriptional profiling.

The collection of pure individual CTCs from biological samples is a game changer in the quest to obtain clinical utility of these cells as it enables individual cell-based molecular profiling for personalized therapy, going beyond existing cell counting approaches for prognostic purposes, said Manaresi. We show that 100 percent pure single-CTC sorting by DEPArray and DNA amplification with our Ampli1 WGA seamlessly integrates with Ion Torrent AmpliSeq Cancer Panel sequencing to deliver a comprehensive overview of the mutational status, cell-by-cell, in a streamlined and automated manner. To the best of our knowledge, it is the first time this has been achieved.

There are multiple large and expanding market opportunities for technology that find and isolate rare cells for molecular analysis. Silicon Biosystems DEPArray is used for translational medicine applications in metastatic cancer, cardiovascular disease, prenatal genetics, and stem cells research.

The World CTC Summit attracts important members across the CTC study community including diagnosticians, drug developers, technology providers and clinicians, said Manaresi. Silicon Biosystems is eager to join our peers and share the excitement of this achievement, and the impact of our unique method for CTC collection and analysis for the advancement of patient diagnosis and decision making.

About Silicon Biosystems

Silicon Biosystems, Inc. was formed in October 2010 as a wholly owned subsidiary of Silicon Biosystems, S.p.A. based in Bologna, Italy. The company manufactures and sells the DEPArray platform which is based on the principle of dielectrophoresis to isolate and manipulate cells in suspension with a microelectronic array. The approach, patented by Silicon Biosystems, offers the unique ability to control individual cells and micro-particles inside a disposable cartridge. The DEPArray platform makes it possible to find, sort, select and separate individual cells for further analysis or culturing. For more information on Silicon Biosystems visit http://www.siliconbiosystems.com.

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Silicon Biosystems to Present Single-Circulating Tumor Cell Molecular Characterization at the Fourth World CTC Summit