April Flowers for redOrbit.com Your Universe Online

Columbia University ophthalmologists and stem cell researchers have developed an experimental treatment for blindness using the patients skin cells, which has improved the vision of blind mice in testing.

The findings of this research, published online in the journal Molecular Medicine, suggest that induced pluripotent stem cells (iPS) could soon be used to improve vision in people with macular degeneration and other eye retina diseases. iPS cells are derived from adult human skin cells but have embryonic qualities.

With eye diseases, I think were getting close to a scenario where a patients own skin cells are used to replace retina cells destroyed by disease or degeneration, says Stephen Tsang, MD, PhD, associate professor of ophthalmology and pathology & cell biology. Its often said that iPS transplantation will be important in the practice of medicine in some distant future, but our paper suggests the future is almost here.

Scientists were very excited by the advent of human iPS cells when they were discovered in 2007, as they provide a way to avoid the ethical complications of embryonic stem cells. Another advantage is that the iPS cells are created from the patients own skin, eliminating the need for anti-rejection medications. Like the ethically challenged embryonic cells, iPS cells can develop into any type of cell. To-date, no iPS cells have been implanted into people, but many ophthalmologists say that the eye would prove to be ideal testing ground for iPS therapies.

The eye is a transparent and accessible part of the central nervous system, and thats a big advantage. We can put cells into the eye and monitor them every day with routine non-invasive clinical exams, Tsang said. And in the event of serious complications, removing the eye is not a life-threatening event.

Professor Tsang is running a new preclinical iPS study using human iPS cells derived from the skin cells of a 53-year-old donor. The cells were first transformed with a cocktail of growth factors into cells in the retina that lie underneath the eyes light-sensing cells.

Retina cells nourish the light-sensing cells and protect the fragile cells from excess light, heat and cellular debris. In macular degeneration and retinitis pigmentosa, retina cells die, which allows the photoreceptor cells to degenerate causing the patient to lose their vision. It is estimated that 30 percent of people will have some form of macular degeneration by the time they are 75 years old, as it is the leading cause of vision loss in the elderly. Currently, it affects 7 million Americans and that is expected to double by 2020.

The Columbia research team injected the iPS-derived retina cells into the right eyes of 34 mice that had a genetic mutation that caused their retina cells to degenerate. In many of the mice, the iPS cells assimilated into the retina without disruption and functioned as normal retina cells well into the animals old age. Mice in the control group, who received injections of saline or inactive cells, showed no improvement in retina tests.

Our findings provide the first evidence of life-long neuronal recovery in a preclinical model of retinal degeneration, using stem cell transplant, with vision improvement persisting through the lifespan, Tsang says. And importantly, we saw no tumors in any of the mice, which should allay one of the biggest fears people have about stem cell transplants: that they will generate tumors.

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Blind Mice Get Experimental Stem Cell Treatment For Blindness

Recommendation and review posted by Bethany Smith

WALTHAM, Mass.--(BUSINESS WIRE)--

Histogenics, a regenerative medicine company combining cell therapy and tissue engineering technologies to develop highly innovative products for tissue repair and regeneration, announced today that it has been named to the FierceMedicalDevices Fierce 15 list, designating it as one of the leading medical device and diagnostic companies of 2012. FierceMedicalDevicesEditors Mark Hollmer and Damian Garde, in conjunction with Editor-in-Chief John Carroll and Executive Editor Ryan McBride, chose this years winners based on their top management teams, notable financial backing, and promising technologies and market opportunities.

We have worked hard over the past year, securing $49 million in financing and adding key new staff, investors and board members, so that we are now in the position to focus our full attention on continued successful clinical and regulatory execution for NeoCart cartilage regeneration implant, which is currently enrolling patients into the Phase 3 IND clinical study, and the EU regulatory development of our VeriCart cartilage repair scaffold, said Patrick ODonnell, President and Chief Executive Officer of Histogenics. We believe our product candidates have the potential to transform the treatment of cartilage injury with the goal of returning some of the estimated 1.8 million patients each year in the U.S. and E.U. that undergo arthroscopy for knee cartilage defects to their pre-injury level of activity.

Nailing down $49 million in financing in July reinforces the notion that this regenerative medicine company stands out for doing things differently.One example how: The company is well underway enrolling patients in a Phase 3 trial for NeoCart, a cartilage implant that uses a patients own cells to build it before treating cartilage lesions in the knee, said Hollmer.

NeoCart is an autologous neocartilage tissue implant in an ongoing Phase 3 clinical program that utilizes the patients own cells to regenerate cartilage in patients suffering from cartilage lesions in the knee.VeriCart, is a single-step, cell-free collagen scaffold uniquely designed to be used in conjunction with the patients own stem cells to repair small cartilage defects frequently observed in meniscal and anterior cruciate ligament repair procedures. Histogenics is seeking regulatory clearance in the European Union for VeriCart.

An internationally recognized e-newsletter reaching more than 34,000 medical device and diagnostic industry professionals, FierceMedicalDevices provides subscribers with a quick authoritative briefing on the days top stories, with a special focus on clinical studies, FDA/EMEA regulations and post-marketing. Sign up is free at http://www.fiercemedicaldevices.com/signup.

About FierceMarkets

FierceMarkets, a wholly owned subsidiary of Questex Media Group, is a leader in B2B emedia, providing information and marketing services in the telecommunications, life sciences, healthcare, IT, energy, government and finance industries through its portfolio of email newsletters, websites, webinars and live events. Every business day, FierceMarkets wide array of publications reaches more than 1.3 million executives in more than 100 countries.

About Histogenics

Histogenics is a leading regenerative medicine company that combines cell therapy and tissue engineering technologies to develop highly innovative products for tissue repair and regeneration. In May of 2011, Histogenics acquired Israeli cell-therapy company ProChon BioTech. Histogenics flagship products focus on the treatment of active patients suffering from articular cartilage derived pain and immobility. The Company takes an interdisciplinary approach to engineering neocartilage that looks, acts and lasts like hyaline cartilage. It is developing new treatments for sports injuries and other orthopedic conditions, where demand is growing for long-term alternatives to joint replacement. Histogenics has successfully completed Phase 1 and Phase 2 clinical trials in which the NeoCart autologous tissue implants effectiveness is compared to that of standard microfracture surgery. Based in Waltham, Massachusetts, the company is privately held. For more information, visitwww.histogenics.com.

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Histogenics Honored as a 2012 “Fierce 15” Company by FierceMedicalDevices

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NEW YORK, Oct. 2, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), an emerging leader in the fast growing cell therapy market, today announced that Company management and management of its subsidiary, Progenitor Cell Therapy ("PCT"), have been invited to present at multiple conferences in October.

RetailInvestorConferences.com

The RedChip 15th Annual Fall Small-Cap Conference

Regenerative Medicine Foundation 2012 Conference

2012 Stem Cell Meeting on the Mesa, 2nd Annual Investor and Partnering Forum

About NeoStem, Inc.

NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company.

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.

For more information on NeoStem, please visit http://www.neostem.com.

Forward-Looking Statements for NeoStem, Inc.

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NeoStem to Present at Multiple Conferences in October

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Public release date: 2-Oct-2012 [ | E-mail | Share ]

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

BETHESDA, MD October 2, 2012 -- Cancerous tumors contain hundreds of mutations, and finding these mutations that result in uncontrollable cell growth is like finding the proverbial needle in a haystack. As difficult as this task is, it's exactly what a team of scientists from Cornell University, the University of North Carolina, and Memorial Sloan-Kettering Cancer Center in New York have done for one type of breast cancer. In a report appearing in the journal GENETICS, researchers show that mutations in a gene called NF1 are prevalent in more than one-fourth of all noninheritable or spontaneous breast cancers.

In mice, NF1 mutations are associated with hyper-activation of a known cancer-driving protein called Ras. While researchers have found earlier evidence that NF1 plays a role in other types of cancer, this latest finding implicates it in breast cancer. This suggests that the drugs that inhibit Ras activity might prove useful against breast cancers with NF1 mutations.

"As we enter the era of personalized medicine, genomic technologies will be able to determine the molecular causes of a woman's breast cancer," said John Schimenti, Ph.D., a researcher involved in the work from the Center for Vertebrate Genomics at Cornell University College of Veterinary Medicine in Ithaca, New York. "Our results indicate that attention should be paid to NF1 status in breast cancer patients, and that drug treatment be adjusted accordingly both to reduce the cancer and to avoid less effective treatments."

To make this discovery, scientists analyzed the genome of mammary tumors that arise in a mouse strain prone to genetic instability -- whose activity closely resembles the activity in human breast cancer cells -- looking for common mutations that drive tumors. The gene NF1 was missing in 59 out of 60 tumors, with most missing both copies. NF1 is a suppressor of the oncogene Ras, and Ras activity was extremely elevated in these tumors as a consequence of the missing NF1 gene. Researchers then examined The Cancer Genome Atlas (TCGA) data, finding that NF1 was missing in more than 25 percent of all human breast cancers, and this was associated with a decrease in NF1 gene product levels, which in turn is known to increase Ras activity.

"This research is compelling because it helps us understand why some breast cancers are more likely to respond to only certain types of treatment," said Mark Johnston, Editor-in-Chief of the journal GENETICS. "The findings reported in this article may guide clinicians to better treatments specific to the needs of each patient."

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FUNDING: This study was supported by NIH training grants IT32HDO57854 and 5T32GM007617 that supported M.D.W.; Empire State Stem Cell Fund contract numbers C026442 and C024174 to J.C.S.; and C.M.P. and A.D.P. were supported by NCI Breast SPORE program (P50-CA58223-09A1), by U24-CA143848, and by the Breast Cancer Research Foundation.

CITATION: Marsha D. Wallace, Adam D. Pfefferle, Lishuang Shen, Adrian J. McNairn, Ethan G. Cerami, Barbara L. Fallon, Vera D. Rinaldi, Teresa L. Southard, Charles M. Perou, and John C. Schimenti Comparative Oncogenomics Implicates the Neurofibromin 1 Gene (NF1) as a Breast Cancer Driver Genetics October 2012 192:385-396

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Gene responsible for many spontaneous breast cancers identified

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ScienceDaily (Oct. 2, 2012) A research team at Aarhus University reveals a surprising interplay between the ends of human genes: If a protein-coding gene is too short it becomes inactive! The findings also explain how some short genes have adapted to circumvent this handicap.

Gene ends communicate

Human genomes harbour thousands of genes, each of which gives rise to proteins when it is active. But which inherent features of a gene determine its activity? Postdoctoral Scholar Pia Kjlhede Andersen and Senior Researcher Sren Lykke-Andersen from the Danish National Research Foundation's Centre for mRNP Biogenesis and Metabolism have now found that the distance between the gene start, termed the 'promoter', and the gene end, the 'terminator', is crucial for the activity of a protein-coding gene. If the distance is too short, the gene is transcriptionally repressed and the output is therefore severely decreased. This finding outlines a completely new functional interplay between gene ends.

Small genes utilise specialised terminators

Fortunately, most human protein-coding genes are long and are therefore not repressed by this mechanism. However, some genes, e.g. 'replication-dependent histone genes', are very short. How do such genes express their information at all? Interestingly, many of these differ from the longer protein-coding genes by containing specialised terminators. And in fact, if such a specialised terminator replaces a normal terminator in a short gene context, the short gene is no longer transcriptionally repressed. It therefore appears that naturally occurring short genes have evolved 'their own' terminators to achieve high expression levels.

The new findings add to a complex molecular network of intragenic communication and help us to understand the basic function of genes.

The researchers behind the results that have just been published in the international journal Genes & Development are affiliated with the Danish National Research Foundation's Centre for mRNP Biogenesis and Metabolism at the Department of Molecular Biology and Genetics, Aarhus University.

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Length matters in gene expression

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Sequencing, splicing and expressing DNA may seem to be the quintessence of cutting-edge scienceindeed DNA manipulation has revolutionized fields such as biofuels, chemicals and medicine. But in fact, the actual process can still be tedious and labor-intensive, something Lawrence Berkeley National Laboratory (Berkeley Lab) scientist Nathan Hillson learned the hard way.

After struggling for two days to design a protocol to put together a genetic circuit with 10 pieces of DNAusing a spreadsheet as his primary toolhe was dismayed to discover that an outside company could have done the whole thing, including parts and labor, for lower cost than him ordering the oligonucleotides himself. "I learned two things: one, I never wanted to go through that process again, and two, it's extremely important to do the cost-effectiveness calculation," said Hillson, a biochemist who also directs the synthetic biology program at the Berkeley Lab-led Joint BioEnergy Institute (JBEI). "So that was the genesis of the j5 software. This is the perfect thing to teach a computer to do."

The j5 software package, which has attracted users from more than 250 institutions worldwide since it was made available last year, is now the basis for the latest startup to emerge from JBEI, a Department of Energy research center established in 2007 to pursue breakthroughs in the production of cellulosic biofuels. By building on j5 and adding modules for commercial users, TeselaGen Biotechnology, founded by Hillson and two partners, says it will significantly reduce the time and cost involved with DNA synthesis and cloning, a multibillion-dollar market.

"It's like AutoCAD for biology," said TeselaGen co-founder and CEO Mike Fero. "Modern cloning is a computational problem. We are the missing informatic piece to making modern scarless DNA assembly methods a reality for the majority of biologists. Otherwise it's a small cadre of people who can do it."

Recombinant DNA assemblies are critical tools in a number of scientific pursuits: for understanding how cells are altered in diseases such as cancer, for building better antibiotics, for converting plant biomass to biofuels and for basic scientific understanding of cellular pathways. Standard cloning techniques have been in use for 40 years and are still the industry standard.

"Our biggest competition is traditional cloning, or inertia," said Fero, who was a particle physicist for 10 years before pursuing a career in biotech. "We have to make it so easy people will happily switch to the newer methods."

TeselaGen licensed j5 from Berkeley Lab, the lead institutional partner of JBEI, and currently has more than 100 scientists and engineers from large industrial and pharmaceutical companies in private beta.

"We are so pleased with the startup of TeselaGen, based on a deceptively simple idea but clearly providing a solution to a very difficult problem," said Cheryl Fragiadakis, director of technology transfer at Berkeley Lab. "It is a great example as well of a company coming out of our JBEI activities.The Lab's Tech Transfer encourages and supports entrepreneurial ventures, providing education and networking for our scientists, as a great way to get technologies out for the benefit of society."

The cloud-based software not only designs DNA construction protocols, it will compare methods to determine the one that is most cost-effective, weighing, for example, if it is cheaper to outsource a portion of the DNA construction.The more complex the task, the more time and money the program can save. The greatest savings are with combinatorial libraries, collections of hundreds to millions of related DNA assemblies, each with a different combination of genes or parts that perform similar functions in different organisms.

For example, simple construction of a metabolic pathway that takes two and a half weeks and costs $1,400 using traditional cloning can be cut down to two weeks and less than half the cost with j5. A more complex task of constructing a combinatorial protein library (with 243 constructs) would drop from $122,000 and 11 months with traditional cloning to under $30,000 and 1.5 months with j5. The same task using direct DNA synthesis would cost $538,000 and take 2.3 months.

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DNA construction technology makes genetic engineering cheaper, faster

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Allergen-free cows milk and pigs with hardened arteries illustrate how the accuracy of genetic engineering has improved.

Two unsuspecting farm animals have helped to demonstrate the increasing accuracy of genetic engineering techniques. The first is a cow that produced hypoallergenic milk after researchers used RNA interference to block the production of an allergy-inducing protein, as reported this week (October 2) in PNAS. The second, reported in another paper in the same issue, is a pig that could be a model for atherosclerosis after researchers used an enzyme called a TALEN to silence a gene that helps to remove cholesterol.

Researchers have long struggled to remove cow milks allergy-inducing protein, beta-lactoglobulin, which can cause diarrhoea and vomiting in children. They were previously unable to introduce foreign genes precisely enough, however, so they could never quite successfully replace the gene that codes for beta-lactoglobulin with a defective form.

But scientists at AgResearch in Hamilton, New Zealand, worked with molecules that interfere with messenger RNA (mRNA), which helps translate genes into proteins. They found microRNA (miRNA) in mice that targeted beta-lactoglobulin mRNA, so they inserted DNA encoding a version of this miRNA into the genomes of cow embryos. Out of 100 embryos, one calf produced beta-globulin-free milk. This isnt a quick process, Stefan Wagner, a molecular biologist at AgResearch, told Nature. One problem is that RNA interference cant eliminate the protein completely because some mRNA slips through.

Another technique could speed up the process. TALENs are enzymes that target and cut out a specific DNA sequence from the genome. As the break is repaired, mutations are introduced that scramble the targeted gene, leaving it unable to function.

The TALEN technology is staggeringly easy, quick, and leaves no mark in the genome, researcher Bruce Whitelaw, told Nature. Whitelaw, a molecular biologist at the Roslin Institute near Edinburgh, UK, used TALENs to disrupt genes encoding low-density lipoprotein (LDL) receptors in pigs. Without those receptors, which remove LDL from the blood, Whitelaws pigs develop atherosclerotic arteries. Such pigs could be reliable models for biomedical researchers studying human atherosclerosis.

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The GM Barnyard

Recommendation and review posted by Bethany Smith

PARIS--(BUSINESS WIRE)--

Regulatory News:

Cellectis (ALCLS.PA), the French genome engineering specialist, announces in the Journal of Biological Chemistry, one of the most respected scientific journals in the world, the publication of a new approach regarding the targeted modification of DNA2. The manuscript unmasks novel perspectives and broadens the scope of TALENsTM technology to new therapeutic approaches to fight against cancer and genetic diseases. Until now, TALENsTM, the molecular scissors created by Cellectis Group, were only able to target certain parts of the genome. A team of the Groups researchers, led by Julien Valton and Philippe Duchateau, was able to overcome this constraint, opening the way to a wider range of applications, especially in the therapeutic field.

This study, the first to be published on TALENsTM, was awarded by the selection committee of the JBC as Paper of the Week.

Since their identification in 2009, TALEs have quickly emerged as the new generation of DNA-binding domain with programmable specificity and have been successfully used to generate the molecular scissors known as TALENsTM. However, their sensitivity to methylation, a ubiquitous modification of DNA, represents a major bottleneck for their widespread utilization in the genome engineering and therapeutic fields. Using a combination of biochemical, structural and cellular approaches, the R&D department of Cellectis was able to identify the basis of such sensitivity and more importantly, to propose an efficient and universal method to overcome it.

These results are proof of the scientific creativity and quality of our research teams, as well as the power of our genome engineering tools. This new publication strengthens the relevance of our investment in TALEstechnology, and confirms our strategy within the therapeutic field, declared Andr Choulika, Chief Executive Officer of Cellectis Group.

2) Overcoming TALE DNA Binding Domain Sensitivity to Cytosine Methylation Julien Valton, Aurelie Dupuy, Fayza Daboussi, Severine Thomas, Alan Marechal, Rachel Macmaster, Kevin Melliand, Alexandre Juillerat and Philippe Duchateau J. Biol. Chem. jbc.C112.408864. First Published on September 26, 2012, doi:10.1074/jbc.C112.408864

About Cellectis

Founded in France in 1999, the Cellectis Group is based on a highly specific DNA engineering technology. Its application sectors are human health, agriculture and bio-energies. Co-created by Andr Choulika, its Chief Executive Officer, Cellectis is today one of the world leading companies in the field of genome engineering. The Group has a workforce of 230 employees working on 5 sites worldwide: Paris & Evry in France, Gothenburg in Sweden, St Paul (Minnesota) & Cambridge (Massachusetts) in the United States. Cellectis achieved in 2011 16M revenues and has signed more than 80 industrial agreements with pharmaceutical laboratories, agrochemical and biotechnology companies since its inception. AFM, Dupont, BASF, Bayer, Total, Limagrain, Novo Nordisk are some of the Groups clients and partners.

Since 2007, Cellectis has been listed on NYSE-Euronext Alternext market (ALCLS.PA) in Paris.

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Cellectis Publishes Results Paving the Way for New Therapeutic Approaches against Cancer and Genetic Diseases

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FIVE POINTS, Calif., Oct. 2, 2012 /PRNewswire/ --S&W Seed Company (Nasdaq:SANW) today announced that it has signed agreements with Monsantoand Forage Genetics International, LLC. (FGI) that enables the company to produce and sell seed of approved varieties containing Monsanto's Roundup Ready trait. FGI has also agreed to incorporate the Roundup Ready trait into specific S&W-developed varieties previously selected for high yield and salt tolerance.

Using classical plant breeding methods, S&W has worked hard for 30 years to become a leader in developing high yielding, non-dormant, salt tolerant varieties of alfalfa. Adoption of biotechnology has been slower to occur in Europe and other areas compared to the United States, and most of S&W's existing export customers require verification that alfalfa seed does not have biotech traits. Demand for S&W's proprietary non-biotech varieties continues to grow at a strong pace in warm climate zones where non-dormant alfalfa is the market standard. Accordingly, non-biotech varieties of alfalfa seed will continue to be a primary focus for S&W in international markets where biotech varieties have not been approved. S&W will also continue to ensure its classically bred varieties are grown under strict guidelines requiring isolation and quality control in processing.

In order to meet the needs of its many domestic customers that want Roundup Ready alfalfa, S&W has been working in collaboration with FGI to pursue the development of S&W varieties that incorporate Monsanto and FGI's advanced traits, such as the Roundup Ready trait, into S&W's own seed varieties. Any biotech varieties ultimately produced by S&W will be targeted for sale to the U.S. domestic customers, at least initially.

Mark Grewal, chief executive officer of S&W Seed Company commented, "We are pleased and honored that Monsanto and Forage Genetics chose S&W as a business partner in the alfalfa seed market. FGI and Monsanto are the undisputed world leaders in pioneering biotech research for alfalfa. We have always taken pride in our classically bred, high yielding, non-dormant, salt tolerant varieties. New S&W varieties that fill the demand for Roundup Ready technology can only expand our market within the United States. We look forward to completing the lab and field work necessary to have an S&W seed variety ready for the biotech market. In addition to the ability to sell the newly developed alfalfa seed varieties, S&W hopes to access future alfalfa seed technology developed by FGI and Monsanto under future licensing agreements."

"We are pleased S&W will introduce our Roundup Ready technology into some of their upcoming product offerings," Stephen Welker, Alfalfa Lead, Monsanto, commented. "Roundup Ready technology will provide the ability to produce higher quality and higher yielding crops that are largely free of weeds and other plants that compete for nutrients from the soil. S&W has a reputation for developing alfalfa seed varieties with a strong performance, including some of the most salt-tolerant varieties available."

About S&W Seed Company

Founded in1980 and headquartered in the Central Valley of California, S&W Seed Company is a leading producer of warm climate, high yield alfalfa seed varieties, including varieties that can thrive in poor, saline soils, as verified over decades of university-sponsoredtrials.S&WSeedalso offers seed cleaning and processing at its 40-acre facility in Five Points, Californiaand, in 2011,began the commercial launch of its California-basedsteviabusinessin response tothe growing global demand for the all-natural, zero calorie sweetenerfrom the food and beverage industry. For more information, please visitwww.swseedco.com.

Safe Harbor Statement

This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may," "future," "plan" or "planned," "will" or "should," "expected," "anticipates," "draft," "eventually" or "projected." You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors and other risks identified in the Company's 10-K for thefiscal year ended June 30, 2012, and other filings made by the Company with the Securities and Exchange Commission.

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S&W Seed Announces Agreement with Monsanto and Forage Genetics

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Public release date: 2-Oct-2012 [ | E-mail | Share ]

Contact: Hilary Glover hilary.glover@biomedcentral.com 44-020-319-22370 BioMed Central

Drug resistance is a major problem when treating infections. This problem is multiplied when the infection, like HIV-1, is chronic. New research published in BioMed Central's open access journal Retrovirology has examined the genetic footprint that drug resistance causes in HIV and found compensatory polymorphisms that help the resistant virus to survive.

Currently the strategy used to treat HIV-1 infection is to prevent viral replication, measured by the number of viral particles in the blood, and to repair the immune system, assessed using CD4 count. Over the past 20 years treatment and life expectancy have vastly improved. However, due to drug resistance, complete viral suppression requires an array of drugs.

For the virus drug resistance comes at a cost. In the absence of the drug the virus carrying drug resistance mutations is less 'fit' than the wild-type virus and so should not be able to replicate as efficiently. During interruptions to treatment wild-type viruses quickly predominate. However newly infected people can be drug resistant even before they have received any treatment.

Researchers from the SPREAD project have been monitoring HIV infections across Europe. This multinational team has looked at 1600 people, newly infected with HIV-1 subtype B. Almost 10% of these patients had HIV-1 harbouring transmitted drug resistance (TDR) and worryingly, when they measured virus production and CD4 count, there was no indication that these strains of HIV-1 were weaker.

In recent years there has been much talk about polymorphisms, naturally occurring differences in the genes that are responsible for the differences between animals of the same species, for example blood groups or the ability to digest lactose in milk. They may also increase propensity for certain diseases including cancer and type 2 diabetes. But animals are not the only organisms that harbour polymorphisms they are present in viruses as well.

By examining polymorphisms in these strains of HIV-1 the researchers discovered that certain polymorphisms in the gene coding for protease (essential for viral replication) known to act as compensatory mechanisms, improve the 'fitness' of resistant strains, even in the absence of the drug. Kristof Theys, one of the researchers involved in the project commented, "Our worry is that over time we will be seeing more people presenting with TDR HIV-1."

Prof Anne-Mieke Vandamme, who led this study, fears "Contrary to what was expected, transmission of TDR virus may also contribute to a 'fitter' and more virulent HIV, which has important clinical implications in how we best treat these people."

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The genetics of HIV-1 resistance

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ALISO VIEJO, Calif.--(BUSINESS WIRE)--

Ambry Genetics (Ambry), a global leader in genetic services with a focus on clinical diagnostics and genomics, announces that chairman and CEO Charles Dunlop was honored with a RARE Champion award at Global Genes Projects Champions of Hope Gala Event on the evening of Thursday, September 27 in Newport Beach, Calif. Mr. Dunlop and Ambry Genetics were honored for Ambrys ongoing support of the Mauli Ola Foundation (Mauli Ola), a non-profit organization dedicated to alleviating symptoms of cystic fibrosis (CF) in children afflicted with the disorder through surfing.

This was truly amazing. I was both honored and humbled to accept this award on behalf of the incredible team at Ambry and Mauli Ola, commented Charles Dunlop. This honor means so much to us, but the greatest reward is still seeing the joy its bringing to kids with cystic fibrosis and their families. The surfing community has really rallied around this cause. Nothing could be more remarkable.

The award was issued in the Biotech/Industry category at the gala event held at Newport Beachs Balboa Bay Club & Resort, as part of the first annual RARE Tribute To Champions of Hope from the Global Genes Project. Ambrys award was presented by Rob Montelone, a schoolteacher from Yorba Linda, Calif. Rob and his wife are the parents of five children, three of whom have CF.

I was over the moon when I was invited by the Global Genes Project to present this award to Charles and Ambry, because Mauli Ola has been such an amazingly positive force for my family, having truly changed our lives, said Mr. Montelone. Mauli Olas good work has not only brought joy to my three children with cystic fibrosis; their symptoms have actually been alleviated.

Corporate sponsors of the event included Pfizer, Shire, Genzyme, Bayer, Goldman Sachs, Genzyme, and Burrill & Company.

This gala event was such a gratifying experience for a lot of us at Ambry, said Kelly Gonzalez, M.S., CGG, senior manager of clinical genomics at Ambry, who attended. We were particularly touched by some of the speeches from parents of children with rare diseases. It is just these types of diseases that we are successfully diagnosing with the Clinical Diagnostic Exome and other proprietary diagnostic tests, and it is very gratifying to be able to make a difference in the lives of such children and their parents.

About Ambry Genetics

Ambry Genetics is a College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified commercial clinical laboratory with headquarters in Aliso Viejo, Orange County, Calif. Since its founding in 1999, it has become a leader in providing genetic services focused on clinical diagnostics and genomic services, particularly in sequencing and array services. Ambry has established a reputation for unparalleled service and has been at the forefront of applying new technologies to the clinical molecular diagnostics market and to the advancement of disease research. To learn more about testing and services available through Ambry Genetics, visit http://www.ambrygen.com.

About the Mauli Ola Foundation

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Ambry Genetics Chairman and CEO Charles Dunlop Honored with “RARE Champion” Award at Global Genes Project’s Champions ...

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SILVER SPRING, Md. and SINGAPORE, Oct. 2, 2012 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), an international biotechnology provider of cell and gene therapy solutions, announced today its wholly-owned subsidiary, Austrianova Singapore Pte Ltd (ASPL) will attend this year's AusBiotech event.

The annual AusBiotech event this year will be held from October 30 - November 2 at the Melbourne Convention and Exhibition Centre, Melbourne, Australia. It has earned a reputation as the industry's premier biotechnology conference for the Asia Pacific region and has successfully expanded its relevance to the Australian and International Biotechnology industries by attracting more than 1100 participants from over 20 countries.

Dr Brian Salmons, CEO of ASPL said, "AusBiotech has grown in stature over the past several years. In prior years, we entered agreements with companies and found it to be one of the most valuable events for networking with new contacts. We anticipate meeting with companies with proprietary therapeutic cells, such as stem cells, that can leverage their technology with our Cell-in-a-Box(R) delivery system. We believe the new contacts we make will expand our customer base and increase the use of cell and gene therapy for making therapeutic products and treating diseases. We will also be promoting our Bac-in-a-Box(R) technology for the first time at this meeting and anticipate generating interest around its potential."

The Chief Executive of Nuvilex, Dr. Robert Ryan, stated "Attendance at this important biotech event in Australia and within easy reach of Southeast Asia will enable us to have increased exposure for our Cell-in-a-Box(R) and Bac-in-a-Box(R) live cell encapsulation technology and to showcase its immense versatility, thus providing our companies greater visibility at a time that such capabilities are becoming more important in the marketplace. It is our goal to bring more projects to fruition from this meeting as more companies today are looking to bring cellular-based therapy and product creation from the drawing board to reality and into regular use."

About Nuvilex

Nuvilex, Inc. (NVLX) is an international biotechnology provider of live therapeutically valuable, encapsulated cells and services for research and medicine. A great deal of work is ongoing to move Nuvilex and its Austrianova Singapore subsidiary forward. This was clearly apparent during Dr. Ryan's trip to Singapore and the advent of new developments in the company as a whole. Our company's own offerings will include cancer, diabetes, other treatments and capabilities using the company's cell and gene therapy expertise and live-cell encapsulation technology.

The Nuvilex, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13494

Safe Harbor Statement

This press release contains forward-looking statements described within the 1995 Private Securities Litigation Reform Act involving risks and uncertainties including product demand, market competition, and meeting current or future plans which may cause actual results, events, and performances, expressed or implied, to vary and/or differ from those contemplated or predicted. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, reflect events or circumstances afterward, or disclose unanticipated occurrences, except as required under applicable laws.

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Nuvilex Subsidiary Austrianova Singapore to Participate in AusBiotech 2012

Recommendation and review posted by Bethany Smith

April Flowers for redOrbit.com Your Universe Online

Columbia University ophthalmologists and stem cell researchers have developed an experimental treatment for blindness using the patients skin cells, which has improved the vision of blind mice in testing.

The findings of this research, published online in the journal Molecular Medicine, suggest that induced pluripotent stem cells (iPS) could soon be used to improve vision in people with macular degeneration and other eye retina diseases. iPS cells are derived from adult human skin cells but have embryonic qualities.

With eye diseases, I think were getting close to a scenario where a patients own skin cells are used to replace retina cells destroyed by disease or degeneration, says Stephen Tsang, MD, PhD, associate professor of ophthalmology and pathology & cell biology. Its often said that iPS transplantation will be important in the practice of medicine in some distant future, but our paper suggests the future is almost here.

Scientists were very excited by the advent of human iPS cells when they were discovered in 2007, as they provide a way to avoid the ethical complications of embryonic stem cells. Another advantage is that the iPS cells are created from the patients own skin, eliminating the need for anti-rejection medications. Like the ethically challenged embryonic cells, iPS cells can develop into any type of cell. To-date, no iPS cells have been implanted into people, but many ophthalmologists say that the eye would prove to be ideal testing ground for iPS therapies.

The eye is a transparent and accessible part of the central nervous system, and thats a big advantage. We can put cells into the eye and monitor them every day with routine non-invasive clinical exams, Tsang said. And in the event of serious complications, removing the eye is not a life-threatening event.

Professor Tsang is running a new preclinical iPS study using human iPS cells derived from the skin cells of a 53-year-old donor. The cells were first transformed with a cocktail of growth factors into cells in the retina that lie underneath the eyes light-sensing cells.

Retina cells nourish the light-sensing cells and protect the fragile cells from excess light, heat and cellular debris. In macular degeneration and retinitis pigmentosa, retina cells die, which allows the photoreceptor cells to degenerate causing the patient to lose their vision. It is estimated that 30 percent of people will have some form of macular degeneration by the time they are 75 years old, as it is the leading cause of vision loss in the elderly. Currently, it affects 7 million Americans and that is expected to double by 2020.

The Columbia research team injected the iPS-derived retina cells into the right eyes of 34 mice that had a genetic mutation that caused their retina cells to degenerate. In many of the mice, the iPS cells assimilated into the retina without disruption and functioned as normal retina cells well into the animals old age. Mice in the control group, who received injections of saline or inactive cells, showed no improvement in retina tests.

Our findings provide the first evidence of life-long neuronal recovery in a preclinical model of retinal degeneration, using stem cell transplant, with vision improvement persisting through the lifespan, Tsang says. And importantly, we saw no tumors in any of the mice, which should allay one of the biggest fears people have about stem cell transplants: that they will generate tumors.

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Blind Mice Get Experimental Stem Cell Treatment For Blindness

Recommendation and review posted by simmons

NEW YORK, Oct. 2, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), an emerging leader in the fast growing cell therapy market, today announced that Company management and management of its subsidiary, Progenitor Cell Therapy ("PCT"), have been invited to present at multiple conferences in October.

RetailInvestorConferences.com

The RedChip 15th Annual Fall Small-Cap Conference

Regenerative Medicine Foundation 2012 Conference

2012 Stem Cell Meeting on the Mesa, 2nd Annual Investor and Partnering Forum

About NeoStem, Inc.

NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company.

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.

For more information on NeoStem, please visit http://www.neostem.com.

Forward-Looking Statements for NeoStem, Inc.

Continued here:
NeoStem to Present at Multiple Conferences in October

Recommendation and review posted by simmons

Washington, October 2 (ANI): A new study has suggested that induced pluripotent stem (iPS) cells - which are derived from adult human skin cells but have embryonic properties - could soon be used to restore vision in people with macular degeneration and other diseases that affect the eye's retina.

In the study conducted by Columbia ophthalmologists and stem cell researchers, adult stem cells developed from a patient's skin cells improved the vision of blind mice.

"With eye diseases, I think we're getting close to a scenario where a patient's own skin cells are used to replace retina cells destroyed by disease or degeneration," said the study's principal investigator, Stephen Tsang, MD, PhD, associate professor of ophthalmology and pathology and cell biology.

"It's often said that iPS transplantation will be important in the practice of medicine in some distant future, but our paper suggests the future is almost here," he stated.

The advent of human iPS cells in 2007 was greeted with excitement from scientists who hailed the development as a way to avoid the ethical complications of embryonic stem cells and create patient-specific stem cells.

Like embryonic stem cells, iPS cells can develop into any type of cell. Thousands of different iPS cell lines from patients and healthy donors have been created in the last few years, but they are almost always used in research or drug screening.

In Tsang's new preclinical iPS study, human iPS cells - derived from the skin cells of a 53-year-old donor - were first transformed with a cocktail of growth factors into cells in the retina that lie underneath the eye's light-sensing cells.

The primary job of the retina cells is to nourish the light-sensing cells and protect the fragile cells from excess light, heat, and cellular debris. If the retina cells die - which happens in macular degeneration and retinitis pigmentosa - the photoreceptor cells degenerate and the patient loses vision.

Macular degeneration is a leading cause of vision loss in the elderly, and it is estimated that 30 percent of people will have some form of macular degeneration by age 75.

In their study, the researchers injected the iPS-derived retina cells into the right eyes of 34 mice that had a genetic mutation that caused their retina cells to degenerate.

See the original post here:
Patients' own skin cells could restore vision in elderly with macular degeneration

Recommendation and review posted by sam

Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that the U.S. Food and Drug Administration (FDA) approved its application for an Investigational New Drug (IND) to assess the clinical effects of Stemedyne-MSC (Stemedicas human bone marrow-derived ischemia tolerant mesenchymal cells) in subjects with a myocardial infarct.

San Diego, CA (PRWEB) October 02, 2012

The clinical trial will address the prevalence of cardiovascular disease estimated to carry a global disease burden in excess of $400 billion each year. More than one million patients undergo PTCA and stenting in the Untied States annually; another 800,000 have the procedures each year in Europe.

Nabil Dib, M.D., MSc., F.A.C.C., Director of Cardiovascular Research at Mercy Gilbert and Chandler Regional Medical Centers, and an Associate Professor of Medicine and Director of Clinical Cardiovascular Cell Therapy at the University of California, San Diego, will serve as the principal investigator of the FDA-approved study. Dr. Nib commented, We've learned from bench top research that not all stem cells are created equally. We believe that the ischemic tolerance of Stemedica's MSCs and the robustness of their protein array will translate into significant patient benefits post myocardial infarction.

Stemedicas interest in this indication was triggered by a successful randomized study in acute myocardial infarction conducted by the National Scientific Medical Center (NSMC) in Astana, Kazakhstan using Stemedyne-MSCs. The study was conducted under clinical protocol and in compliance with the ICH-E6 (Good Clinical Practice) guidelines and local laws. All patients signed an informed consent. Nineteen (19) patients in this study received Stemedyne-MSCs after PTCA and stenting. Administration of Stemedyne-MSC resulted in a statistically-significant decrease in inflammation as judged by the level of C-reactive protein, significant decrease in end-systolic and end-diastolic volume of left ventricle, as well as significant increase in the left ventricular ejection fraction (LVEF) from 38.4% to 54.7% at 6 months post administration, bringing this parameter to a normal range for healthy individuals (50-65%).

Professor Daniyar Jumaniyazov, M.D. Ph.D., principal investigator of the NSMC study commented, The stem cell transplantation was safe and the procedure was well tolerated. No product-related adverse events were reported. Treatment of patients in this study resulted in improvement of overall and local contractive myocardium functions and also normalization of systolic and diastolic filling of the left ventricle as compared to the control group. Based upon the safety and efficacy results, we will soon conduct a Phase III myocardial infarct clinical trial at the NSMC with Stemedicas ischemia tolerant mesenchymal stem cells.

Lev Verkh, Ph.D., Stemedica Chief Regulatory and Clinical Development Officer commented, Stemedicas FDA submission included data from the NSMC clinical trial, the results of which were also reported at the annual American College of Cardiology meeting in April, 2012. These results contrasted with reports, at the same conference, of minimal improvement in studies with autologous stem cells. In addition to the United States sites, the study will be duplicated at leading hospitals in Europe, Asia and the Middle East. With regard to the spectrum of stem cell treatment for cardiovascular disease, Dr. Verkh noted that, Stemedyne-MSC has been approved for the treatment of chronic heart failure at Hospital Angeles, Tijuana, Mexico by COFEPRIS (the Mexican equivalent of the FDA).

Jackie See, M.D., F.A.C.C., founder of interventional cardiology at the University of California, Irvine, noted, "In the days and weeks following a myocardial infarction we may have the ability to intervene with stem cells to minimize scarring, enhance the amount of functional heart tissue, and restore the microcirculation. Stemedica's ischemia tolerant mesenchymal stem cells are ideal for this purpose. I can foresee the day when all coronary stenting is accompanied by stem cell injection. It is not unreasonable to postulate that the anti-inflammatory and anti-fibrotic effects of the mesenchymal stem cells may have an impact on the incidence of restenosis, a common condition caused by blockage of the stents.

The Stemedyne-MSC product is uniquely manufactured to contain increased amounts of the important growth factors that combat ischemic damage. According to Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica, Our ischemia tolerant MSCs secrete increased amounts of vascular endothelial growth factor (VEGF), which is necessary for new blood vessel development and stromal cell-derived factor (SDF), which is responsible for rescuing dying cells. Stemedyne-MSCs also demonstrate significantly higher migratory abilities. As a company we are unique in our unparalleled scalability, with our master bank at two passages and the cells that go into patients having only been expanded four times. We have the ability to treat more than 500,000 patients with cells created from a single organ donation.

Stemedyne-MSC is one of the three adult allogeneic stem cell products developed by the Company. Other products include Stemedyne-NSC neural human stem cells and Stemedyne-RPE, retinal progenitor epithelial cells available in early 2013. All Stemedica products are unique in their ability to tolerate ischemic conditions.

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FDA Approves Stemedica Phase II Clinical Trial For Acute Myocardial Infarction With Ischemia Tolerant Mesenchymal Stem ...

Recommendation and review posted by Bethany Smith

DENVER - Can you imagine having a family member who's diagnosed with a disease and no one in your family, including yourself, is a match to donate.

That's the reality for 70 percent of patients needing bone marrow or stem cells. They have no other choice but to go through the bone marrow registry.

Those families rely on complete strangers who are willing to donate whatever they can in hope of saving someone's life.

One of those donors is Aurora resident Denise Camacho. She joined the bone marrow registry never thinking that anything would ever come of it.

"I have a family friend that works with Bonfils," Camacho said. "She emailed me and my family and said there's a huge need for minorities to join the registry. So we went down not knowing anyone of us would ever be called."

But just two years later, she was called to make a donation.

"I got a phone call that I'm a match, but I need to go in for further testing. All they told me was that there was a 13-year-old boy in Cleveland who has leukemia." Camacho said. "How do you say 'no' when there's a family out there that you can help and possibly save a life. I was going to do what I could."

That 13-year-old boy was Enrique Linares. He was diagnosed with acute lymphoblastic leukemia.

His entire family, 38 people in all, were tested to be a donor but none of them were a match.

After nearly two years, spent mostly in the hospital, there was a match. It was a match no one expected. Camacho is unrelated and has a different blood type.

Continued here:
Bone marrow donor meets recipient

Recommendation and review posted by Bethany Smith

Washington, October 2 (ANI): A new study has suggested that induced pluripotent stem (iPS) cells - which are derived from adult human skin cells but have embryonic properties - could soon be used to restore vision in people with macular degeneration and other diseases that affect the eye's retina.

In the study conducted by Columbia ophthalmologists and stem cell researchers, adult stem cells developed from a patient's skin cells improved the vision of blind mice.

"With eye diseases, I think we're getting close to a scenario where a patient's own skin cells are used to replace retina cells destroyed by disease or degeneration," said the study's principal investigator, Stephen Tsang, MD, PhD, associate professor of ophthalmology and pathology and cell biology.

"It's often said that iPS transplantation will be important in the practice of medicine in some distant future, but our paper suggests the future is almost here," he stated.

The advent of human iPS cells in 2007 was greeted with excitement from scientists who hailed the development as a way to avoid the ethical complications of embryonic stem cells and create patient-specific stem cells.

Like embryonic stem cells, iPS cells can develop into any type of cell. Thousands of different iPS cell lines from patients and healthy donors have been created in the last few years, but they are almost always used in research or drug screening.

In Tsang's new preclinical iPS study, human iPS cells - derived from the skin cells of a 53-year-old donor - were first transformed with a cocktail of growth factors into cells in the retina that lie underneath the eye's light-sensing cells.

The primary job of the retina cells is to nourish the light-sensing cells and protect the fragile cells from excess light, heat, and cellular debris. If the retina cells die - which happens in macular degeneration and retinitis pigmentosa - the photoreceptor cells degenerate and the patient loses vision.

Macular degeneration is a leading cause of vision loss in the elderly, and it is estimated that 30 percent of people will have some form of macular degeneration by age 75.

In their study, the researchers injected the iPS-derived retina cells into the right eyes of 34 mice that had a genetic mutation that caused their retina cells to degenerate.

Continued here:
Patients' own skin cells could restore vision in elderly with macular degeneration

Recommendation and review posted by Bethany Smith

SEATTLE, Oct. 2, 2012 /PRNewswire/ --Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced that OPAXIO (paclitaxel poliglumex) has been granted orphan-drug designation by the U.S Food and Drug Administration ("FDA") for the treatment of glioblastoma multiforme ("GBM"), a malignant brain cancer.

Orphan designation was granted based on preliminary activity seen from phase 2 results of OPAXIO when added to standard therapy (temozolamide ("TMZ") plus radiation). In this study, progression-free and overall survival was encouraging among patients with GBM, including patients whose tumors expressed unmethylated MGMT. Current standard therapy is less effective in patients with tumors that have unmethylated MGMT, an important DNA repair enzyme. A randomized trial is now underway for patients with GBM with unmethylated MGMT comparing standard TMZ and radiation to OPAXIO and radiation.

According to theNational Cancer Institute, GBM is the most common and deadliest type of primary brain tumor in adults. It is estimated that there will be 10,000-12,000 new cases of GBM diagnosed in the US this year alone. The standard of care for patients with GBM is a surgical resection, if possible, followed by radiation given with concurrent TMZ. The prognosis for the majority of patients with GBM is poor with less than 25% of patients surviving two years with current therapies. Survival is shorter for patients whose tumors have active (unmethylated) MGMT.

Orphan-drug designation is granted by the FDA to novel drugs that seek to treat a rare disease or condition. Orphan-drug designation provides substantial potential benefits to the drug developer, including seven years of market exclusivity for the product upon regulatory approval, fee waivers and tax incentives.

Under the leadership of Dr. Howard Safran at Brown University Medical Center, a multicenter Phase 2 study (BrUOG 244) has been initiated comparing the efficacy of OPAXIO plus radiation with that of TMZ plus radiation in newly-diagnosed patients with GBM and unmethylated MGMT. In approximately 55% of patients with GBM, MGMT is unmethylated, thereby decreasing the efficacy of standard therapy with TMZ plus radiation therapy ("RT"). The randomized study seeks to determine whether OPAXIO plus radiation will improve progression free survival and overall survival when compared to TMZ plus radiation, the current treatment standard in this disease.

"The current randomized trial is based on the encouraging results previously demonstrated with OPAXIO and radiation in patients with newly diagnosed malignant brain cancer and specifically targets GBM patients with a genomic marker, unmethylated MGMT, who are less likely to benefit from the current standard of care TMZ and radiation," stated Howard Safran, M.D., Medical Director of the Brown University Oncology Group. "We are pleased OPAXIO has been granted orphan-drug designation as patients with this disease have a serious unmet medical need for improved long-term survival particularly when MGMT is unmethylated."

About the Study

The study is expected to enroll up to 120 patients. Patients in the OPAXIO arm will receive OPAXIO once every week plus RT for six weeks. Patients in the TMZ arm will receive daily oral TMZ plus RT for six weeks. After completion of initial therapy, both arms will receive maintenance TMZ on day 1-5 and then every 28 days for up to 12 cycles for a total of 48 weeks. Participating institutions include Rhode Island Hospital of Brown University, Memorial Hospital of University of Massachusetts, Maine Medical Center, Upstate Medical Center of the State University of New York (Syracuse), the University of Washington, the University of California at San Diego and Penn State Hershey Medical Center.

About OPAXIO

OPAXIO (paclitaxel poliglumex, CT-2103), is an investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in Taxol, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, paclitaxel is inactive, potentially sparing normal tissue's exposure to high levels of paclitaxel and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to macromolecules such as OPAXIO. Based on preclinical studies, it appears that OPAXIO is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed, allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing active paclitaxel.Unlike standard radiosensitizing agents, OPAXIO appears tumor selective and does not appear to enhance radiation toxicity to normal tissues.

Link:
Cell Therapeutics OPAXIOTM Receives Orphan Drug Designation for Malignant Brain Cancer from FDA

Recommendation and review posted by Bethany Smith

ScienceDaily (Oct. 1, 2012) A novel therapy in the early stages of development at Virginia Commonwealth University Massey Cancer Center shows promise in providing lasting protection against the progression of multiple myeloma following a stem cell transplant by making the cancer cells easier targets for the immune system.

Outlined in the British Journal of Hematology, the Phase II clinical trial was led by Amir Toor, M.D., hematologist-oncologist in the Bone Marrow Transplant Program and research member of the Developmental Therapeutics program at VCU Massey Cancer Center. The multi-phased therapy first treats patients with a combination of the drugs azacitidine and lenalidomide. Azacitidine forces the cancer cells to express proteins called cancer testis antigens (CTA) that immune system cells called T-cell lymphocytes recognize as foreign. The lenalidomide then boosts the production of T-cell lymphocytes. Using a process called autologous lymphocyte infusion (ALI), the T-cell lymphocytes are then extracted from the patient and given back to them after they undergo a stem cell transplant to restore the stem cells' normal function. Now able to recognize the cancer cells as foreign, the T-cell lymphocytes can potentially protect against a recurrence of multiple myeloma following the stem cell transplant.

"Every cell in the body expresses proteins on their surface that immune system cells scan like a barcode in order to determine whether the cells are normal or if they are foreign. Because multiple myeloma cells are spawned from bone marrow, immune system cells cannot distinguish them from normal healthy cells," says Toor. "Azacitidine essentially changes the barcode on the multiple myeloma cells, causing the immune system cells to attack them," says Toor.

The goal of the trial was to determine whether it was safe, and even possible, to administer the two drugs in combination with an ALI. In total, 14 patients successfully completed the investigational drug therapy. Thirteen of the participants successfully completed the investigational therapy and underwent a stem cell transplant. Four patients had a complete response, meaning no trace of multiple myeloma was detected, and five patients had a very good partial response in which the level of abnormal proteins in their blood decreased by 90 percent.

In order to determine whether the azacitidine caused an increased expression of CTA in the multiple myeloma cells, Toor collaborated with Masoud Manjili, D.V.M., Ph.D., assistant professor of microbiology and immunology at VCU Massey, to conduct laboratory analyses on bone marrow biopsies taken from trial participants before and after treatments. Each patient tested showed an over-expression of multiple CTA, indicating the treatment was successful at forcing the cancer cells to produce these "targets" for the immune system.

"We designed this therapy in a way that could be replicated, fairly inexpensively, at any facility equipped to perform a stem cell transplant," says Toor. "We plan to continue to explore the possibilities of immunotherapies in multiple myeloma patients in search for more effective therapies for this very hard-to-treat disease."

In addition to Manjili, Toor collaborated with John McCarty, M.D., director of the Bone Marrow Transplant Program at VCU Massey, and Harold Chung, M.D., William Clark, M.D., Catherine Roberts, Ph.D., and Allison Hazlett, also all from Massey's Bone Marrow Transplant Program; Kyle Payne, Maciej Kmieciak, Ph.D., from Massey and the Department of Microbiology and Immunology at VCU School of Medicine; Roy Sabo, Ph.D., from VCU Department of Biostatistics and the Developmental Therapeutics program at Massey; and David Williams, M.D., Ph.D., from the Department of Pathology at VCU School of Medicine, co-director of the Tissue and Data Acquisition and Analysis Core and research member of the Developmental Therapeutics program at Massey.

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Immune system harnessed to improve stem cell transplant outcomes

Recommendation and review posted by Bethany Smith

A new cancer research centre has been opened in Adelaide.

The $5 million centre has been funded by the Australian Cancer Research Foundation and the South Australian Government.

Its focus will be gene research and development of individually-tailored treatments.

SA Health Minister John Hill said the centre, in Frome Road in the city, would benefit many people for years to come.

"The end result of this research will contribute to the eventual development of personalised cancer treatment with fewer long-term side effects and better patient outcomes," he said.

A new unit also has been opened at a cancer research facility in Adelaide's southern suburbs, with a focus on cancer prevention.

The unit at the Flinders Centre for Innovation in Cancer cost about $4 million to establish.

Researcher Professor Graeme Young said behavioural, dietary and environmental factors would be studied, and there would be a focus on early detection and screening programs.

"We need better solutions for cancer prevention because we're still battling to control this problem, especially as people age," he said.

Read the original:
Cancer research facilities boosted

Recommendation and review posted by Bethany Smith

By Elizabeth Lopatto - 2012-10-01T19:53:38Z

Scientists have altered the genes of a dairy cow to produce milk thats rich in a protein used in numerous food products and lacking in a component that causes allergies in humans.

Using a process called RNA-interference that turns certain genes on or off, scientists from New Zealand produced a cow whose milk had increased casein, a protein used to make cheese and other foods, and almost no beta-lactoglobulin, a component in milk whey protein that causes allergies. The female calf was also born without a tail, according to the report today in the journal Proceedings of the National Academy of Sciences.

The study can be seen as a proof-of-concept that tinkering with nutritional content genetically is possible, said William Hallman, director of the food policy institute at Rutgers University. More testing will be needed to determine the milks full dietary content, and scientists must consider the effects of breeding gene-altered animals, he said. The field has been controversial because of safety and environmental concerns.

Could you clone a breeding stock that would allow for a herd with milk of this type? Hallman, who wasnt involved in the study, said in a telephone interview. There are lots of issues about what might happen in the next generation.

Todays research represents a road map for other groups that may wish to knock out proteins, and not just in milk, he said.

Farmers in the U.S. earned about $35 billion in 2011 from dairy sales, said Christopher Galen, a spokesman for the National Milk Producers Federation.

Aside from the hypoallergenic qualities, the genetically modified cows milk may also be valuable for its higher content of casein. The milk protein is used in a range of food products, including cheese, thickening agents in soups, salad dressings and whipped toppings. Its also used in adhesives, cosmetics and some pharmaceuticals, Hallman said.

In terms of dairy economics, casein is the most profitable part of the milk, he said.

Ordinarily, the proportion of whey to casein in the milk from dairy cows is 21-to-79, according to the paper. The milk from the genetically altered cow had a ratio of 4-to-96, according to a paper. Thats probably due to a 96 percent reduction in beta-lactoglobulin, or BGL, the paper said.

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Gene-Modified Cow Makes Milk Rich in Protein, Study Finds

Recommendation and review posted by Bethany Smith

The U.S. National Institutes of Health (NIH) today announced that researchers investigating a gene known to increase the risk of Alzheimers have discovered the gene is also associated with lower levels of beta amyloid in healthy older people. This finding throws into question the current hypothesis in Alzheimers research that holds increasing beta amyloid levels are a large part of the disease. Beta amyloid is a brain protein that is a main component of deposits found in the brains of Alzheimers patients.

The prevailing hypothesis has implicated factors increasing beta amyloid in the brain as an integral element of Alzheimers disease pathology, said Dr. Richard Hodes, National Institute on Aging (NIA) director. This study indicates the importance of exploring and understanding other distinct mechanisms that may be at work in this disease.

Researchers used brain scans to measure brain amyloid in 57 cognitively normal older people from the Baltimore Longitudinal Study of Aging (BLSA) and 22 cognitively normal people from the Alzheimers Disease Neuroimaging Initiative (ADNI). The participants were age 78.5 on average. They found that 17 of the BLSA participants and four of the ADNI participants carried the Alzheimers risk variant of the complement receptor-1 (CR1) gene.

We found that brain amyloid burden in the group with the CR1 risk variant was lower than in the group without it, said Dr. Madhav Thambisetty, lead author of the study and chief of the Clinical and Translational Neuroscience Unit in the Laboratory of Behavioral Neuroscience of the NIAs Intramural Research Program. This difference in brain amyloid between the two groups is statistically significant in several brain regions. That suggests to us that the CR1 risk factor gene, if it contributes to Alzheimers disease, does it in a way unrelated to increasing amyloid burden.

The findings suggest that the increased risk of Alzheimers associated with CR1 is not driven by an increase in amyloid in the brain and that we may also need to consider multiple genetic risk factors in combination. It may be possible that CR1 acts through other mechanisms, distinct from those that increase amyloid deposition in the brain. These may include influencing inflammation in the brain, but further research is needed to identify what these other mechanisms might be.

The study was a joint effort by the NIH and NIA. It was recently published in the journal Biological Psychiatry.

More:
Alzheimer’s Gene Linked to Lower Brain Amyloid

Recommendation and review posted by Bethany Smith

FRIDAY, Sept. 28 (HealthDay News) -- Lower back pain that occurs when discs in the spine deteriorate over time may be linked to a specific gene, according to a new study.

Researchers at King's College London said their findings could lead to the development of new treatments for this common type of back pain, known as lumbar disc degeneration.

Vertebrates develop bony growths called osteophytes when the discs next to them become dehydrated and lose height. These growths can lead to lower back pain. More than one-third of middle-aged women have at least one degenerate disc, the researchers said, and between 65 and 80 percent of the people with this condition inherited it.

By comparing the spines of 4,600 people using MRI images and mapping their genes, the study found the PARK2 gene, in particular, was linked to those with degenerating discs. This gene, they explained, may be turned off in people with lumbar disc degeneration. The researchers also said this gene could affect how quickly discs in the spine deteriorate.

It's still unclear how the PARK2 gene may get turned off in people with lumbar disc degeneration. The researchers suggested environmental factors, such as lifestyle or diet, could play a role.

"Further work by disc researchers to define the role of this gene will, we hope, shed light on one of the most important causes of lower back pain," said Dr. Frances Williams, senior lecturer from the department of twin research and genetic epidemiology at King's College London, in a college news release.

The study authors added that more research is needed to fully explain how this condition is triggered. Their research uncovered an association between the gene and disc problems, not a cause and effect.

"It is feasible that if we can build on this finding and improve our knowledge of the condition, we may one day be able to develop new, more effective treatments for back pain caused by this common condition," Williams added.

The study was published online Sept. 19 in the Annals of Rheumatic Diseases.

-- Mary Elizabeth Dallas

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Study Ties Common Back Ailment to Faulty Gene

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The announcement about scientists producing GE milk will damage New Zealands brand on which our more than $10 billion a year dairy exports rely, the Green Party said today.

Today AgResearch scientists announced they have used genetic engineering (GE) technology to breed the first cow in the world that produces high protein milk that may be hypo-allergenic.

"This is just another GE mirage; another announcement from GE proponents about a potential product which we do not need and has no market," Green Party GE Steffan Browning said today.

"Its not right for these scientists to be touting their finding as a solution to milk allergies in babies as some sort of justification for the huge amount of resources that have been invested into GE research.

"We see this over and over again with GE scientists; this new product or that new product that will have apparent amazing results but it never actually meets our real needs for a safe, healthy food supply.

"The Royal Commission into GE recommended that wherever possible animals that are a common source of food should not be used for GE but that recommendation has been ignored.

"Field trials in New Zealand need to be closed down and GE research needs to be kept in the lab.

"Our export markets want safe food grown in a natural environment but the production of GE milk puts those markets at risk.

"Putting at $10 billion a year industry at risk for half a glass of milk is not something to be celebrating," said Mr Browning.

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Just another GE mirage

Recommendation and review posted by Bethany Smith