Public release date: 4-Jun-2012 [ | E-mail | Share ]

Contact: David Eve celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Tampa, Fla. (June 4, 2012) After carrying out a study comparing the repopulation efficiency of immature hepatic stem/progenitor cells and mature hepatocytes transplanted into liver-injured rats, a research team from Sapporo, Japan concluded that mature hepatocytes offered better repopulation efficiency than stem/progenitor cells.

Until day 14 post-transplantation, the growth of the stem/progenitor cells was faster than the mature hepatocytes, but after two weeks most of the stem/progenitor cells had died. However, the mature hepatocytes continued to survive and proliferate one year after their implantation.

The study is published in Cell Transplantation (21:1), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/.

"Cell-based therapies as an alternative to liver transplantation to treat liver disease have shown promise," said study corresponding author Dr. Toshihiro Mitaka of the Cancer Research Institute of the Sapporo Medical University School of Medicine, Sapporo, Japan. "However, the repopulation efficiency of two candidate cell sources - hepatic progenitor/stem cells and mature hepatocytes - had not been comprehensively assessed and questions concerning the efficiency of each needed to be resolved."

The researchers noted that the shortage of cell sources and the difficulties of cryopreservation have limited the clinical application of cell based therapies. Stem or progenitor cells have been considered candidate cells because they can expand in vitro and can be cryopreserved for a long time.

However, after transplantation into liver injured rats, the researchers found that stem/progenitor cells did not survive well and most of the transplanted cells had disappeared within two months. In contrast, the mature hepatocytes gradually repopulated the rat livers and continued doing so past one year.

The researchers noted that the sizes of the hepatocytes were not uniform.

"Unexpectedly, the small hepatocytes repopulated significantly less well than the larger ones," explained Dr. Mitaka. "We also found that serial transplantation did not enhance nor diminish the repopulation capacity of the cells to any significant degree."

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Mature liver cells may be better than stem cells for liver cell transplantation therapy

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06/04/2012

Gene Zimmerman, W3ZZ, of Gaithersburg, Maryland, passed away on Sunday, June 3. He was 71. Zimmerman wrote the popular QST column The World Above 50 MHz from 2002-2011. He also served on the ARRL Contest Advisory Committee, edited the VHF contesting column for CQ Contest magazine during its five-year lifespan and was director of the CQ VHF Contest from 2000-2002. An ARRL Life Member, Zimmerman earned VUCC on six bands: 50, 144, 222, 432, 903 and 1296 MHz, as well as DXCC, Worked All States and Worked All Continents on 6 meters. He was an early proponent of -- and participant in -- aggressive contest log checking.

First licensed in 1956 -- and an Amateur Extra since 1963 -- Zimmerman has logged several national Top-10 finishes in the ARRL November Sweepstakes (both modes), as well as a second-place North American finish in the CQ World Wide CW Contest (from VP2MDD). He also placed in the Top 10 several times in the ARRL VHF QSO Parties and in the ARRL VHF Sweepstakes.

Zimmerman earned a PhD in Microbiology from the University of Maryland in 1968. He began his professional career at the National Institutes of Health (NIH), where he spent a year as a technician in an NIH laboratory, studying respiratory viruses. This experience sparked an interest in virology and conquering the common cold. After this, he conducted early research at NIH, studying the relationship between retroviruses and cancer, the use of the simian model for studying leukemia and the use of interferon as an immune system modulator. In 1976, he joined the NIH Grants Associate Program, which groomed promising scientists for careers in managing NIH research programs. Zimmerman was then recruited to be the Scientific Review Administrator of the Allergy and Immunology Study Section of the Immunological Sciences Integrated Review Group, where he evaluated research proposals to provide funds for research in immunology.

Gene brought the same intensity and depth of knowledge of his career at the NIH to understanding propagation, said Ward Silver, N0AX. His tenure as the conductor of QSTs The World Above 50 MHz usually resulted in a sharp recounting and analysis of the months unusual on-the-air events. I learned something from every single column. But what most will remember about Gene, though, will be his amazing capacity for storytelling and the twinkling of his eyes as he told of the undoing of scoundrels with obvious and undiluted glee. Ive had the pleasure of being his roommate at Dayton and WRTC and I dont believe Ive ever laughed harder or longer. Gene knew where all the bodies were buried and relished his role as sage and historian.

Zimmerman was a shortwave listener before becoming a ham. After he got his ticket when he was a freshman at Yale University, Zimmerman became interested in weak signal VHF, due to his friendship with Paul Doane, W1HAD, who at the time was a college student at Brown. I remained active on the VHF bands until I left Connecticut in 1964, but I also developed an interest in HF and VHF contesting, he told the ARRL in June 2011. When I moved to Washington, DC, I became involved in HF contesting in a serious way, particularly building multi-op contest stations with Tom Peruzzi, W4BVV (SK). I returned to weak signal VHF in 1981 and built a pretty decent VHF station, which I have expanded to 10 GHz.

Unlike HF where some band is open for long distance communications all the time, Zimmerman said that openings on VHF are few and far between -- and extremely exciting when they happen. I guess I dont like things that are easy, so I chose to do VHF+, he explained. Over the years, I have worked more than 140 DXCC entities on 6 meters, 38 states and 9 DXCC terrestrially on 2 meters, 36 states on 222 MHz and VUCC on 50-1296 MHz. In contests, I have also been in the Top 10 nationally several times from my home station, and have won the multi-unlimited category four times with K8GP, the Delmarva VHF and Microwave Society. I think once you have built an interest in the VHF+ bands, it never goes away.

Gene was a pleasure to work with, witty and insightful, said QST Editor Steve Ford, WB8IMY. I am sure he will be greatly missed by many.

Amateur Radio has had its share of characters but none were more colorful or more widely respected than Dr Gene Zimmerman, W3ZZ -- a man who in one breath could identify the source of the worlds greatest hot dogs, explain once-in-a-lifetime propagation and recount the history of contesting and contesters, Silver said. We will all miss Genes presence greatly and it is a sad day for us all to learn of his passing.

Zimmerman was a member of the Delmarva VHF and Microwave Society, K8GP, the Grid Pirates Contest Group, a Past President of the Potomac Valley Radio Club and an honorary member of the Connecticut Wireless Association. Funeral arrangements are pending.

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Former “The World Above 50 MHz” Conductor Gene Zimmerman, W3ZZ (SK)

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ScienceDaily (June 4, 2012) A University of Saskatchewan research team led by Tony Kusalik and Scott Napper have harnessed bioinformatics and molecular biology to create powerful software that promises to become a "must have" tool in drug development research labs the world over.

The software is used to analyze kinases -- a type of enzyme involved in virtually every cellular function, from energy use and reproduction to modifying gene expression. Licensing of the patented technology is currently underway, and a demonstration of its effectiveness recently appeared in the journal Science Signalling.

"This is a premiere example of what can be achieved through interdisciplinary and collaborative research," says Kusalik, a professor in the computer science department.

Kinases are often involved in cellular functions that go awry, such as when pathogens such viruses or bacteria "hijack" a cell's functions for their own purposes. Pathogens also have kinases of their own.

"Kinases have a central role in controlling cellular processes and are associated with many diseases. They're logical points for understanding biology and represent important treatment targets," says Napper, an associate professor of biochemistry with the U of S and senior scientist at the Vaccine and Infectious Disease Organization-International Vaccine Centre (VIDO-InterVac).

The standard lab tool in kinase research is the microarray, which allows researchers to analyze many different kinases within a sample simultaneously. A microarray looks like a standard microscope slide with rows of spots, each spot representing a different molecular test.

"With older methods, it was like having a little flashlight in a cave -- you can see, but it doesn't tell you all that is there," Napper says. "These arrays give you the whole picture -- but you end up with absolutely mountains of data."

The problem for Napper and fellow VIDO-InterVac senior scientist Philip Griebel was that the mountains of data were making no sense. Griebel is also a faculty member with the U of S School of Public Health.

"They knew there were problems with the methodology they were following, because the results 'weren't working out,' but they didn't have sufficient expertise in bioinformatics to come up with an alternate method. That's where we came in," Kusalik says.

Kusalik is an expert in bioinformatics, which is the application of computers and information technology to biology and medicine. One well-known application of bioinformatics is DNA sequencing, including the Human Genome Project.

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Powerful new tool for research and drug development

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CARLSBAD, Calif., June 5, 2012 /PRNewswire/ -- Life Technologies Corporation (NASDAQ: LIFE) today announced an expanded Ion AmpliSeq product line with the launch of new breakthrough Comprehensive Cancer and Inherited Disease Panels. These first of kind panels, when coupled with Ion AmpliSeq Designer V1.2, Ion AmpliSeq Library Kit 2.0 and the new Ion Reporter Software, represent complete solutions for scientists researching the genetic basis of human diseases.

Sequencing the millions of cancer research samples stored in bio-repositories around the world is a primary unmet need of the cancer research community. Analyzing these samples using next generation sequencing (NGS) has been difficult, as typically only nanogram amounts of DNA can be isolated, far less than current commercial protocols require. In addition, NGS creates a flood of data, requiring expensive bioinformatics expertise to interpret. The latest set of Ion AmpliSeq and Ion Reporter products from Ion Torrent offer turn-key solutions to overcome these challenges.

Bringing Simplicity and Speed to Disease Research Workflows

Ion AmpliSeq Panels, whether predesigned and therefore ready-to-use, or custom built to probe specific genes of interest, deliver a simplified, single day workflow comprising target selection, amplification, sequencing and analysis. Further, when using Ion Reporter Software, the integrated workflow also includes annotated readout detailing the biological significance of observed gene mutations. The breakthrough Ion AmpliSeq technology requires only tens of nanograms of input DNA, compared to technologies offered by other companies that require hundreds of nanograms or even micrograms of starting material.Orthogonal confirmation of variants observed with Ion AmpliSeq Panels is readily accomplished by selecting from 4.5 million ready-to-use TaqMan SNP Genotyping assays or by designing a custom TaqMan assay. TaqMan assays deliver "gold standard" sensitivity and specificity for SNP genotyping, and they may be analyzed in standard or digital PCR mode if increased sensitivity is required to detect low frequency or somatic mutations.

Scalability Demonstrated With Latest Edition of Ion AmpliSeq Designer Software

Initially launched in March, Ion AmpliSeq Designer has been immediately adopted by researchers world-wide, with over 1,000 custom designs submitted since inception. Ion AmpliSeq Designer Version 1.2 provides an additional leap in performance by generating up to 3,072 amplicons in a single tube allowing capture of up to 1 Mb of genetic sequence. This high level of multiplexing streamlines the workflow by ensuring that only 1 or 2 primer pools are needed for custom designs and also reduces the amount of input DNA required for analysis. Ion AmpliSeq Designer delivers exceptional performance, with target design rates and coverage uniformity up to 98%.

Improved Performance of Ion AmpliSeq Cancer Panel

In October of 2011 Ion Torrent launched the Ion AmpliSeq Cancer Panel, which has quickly become the product of choice for scientists working to advance clinical cancer research. Now, by pairing this 46 gene cancer hot spot panel with the new Ion AmpliSeq Library Kit 2.0, scientists can detect rare somatic mutations and enjoy 98% coverage uniformity and further reductions in strand bias.

New Ion AmpliSeq Comprehensive Cancer Panel

With input from leading cancer research institutions, the Ion AmpliSeq Comprehensive Cancer Panel (CCP) reveals tumor mutation profiles and is optimized for use with formalin fixed paraffin embedded, (FFPE) tissues. This panel allows sensitive, high coverage detection of rare genetic variants by employing more than 16,000 primer pairs targeting over 400 genes involved in tumor formation. Compared to whole exome sequencing, Ion AmpliSeq CCP requires only 40 ng of input DNA, has a significantly lower price, and provides nearly 10-fold better coverage of individual genes, providing better sensitivity and specificity to detect somatic mutations.The Ion AmpliSeq Comprehensive Cancer Panel delivers exceptional quality, with coverage uniformity and on target bases both greater than 90%.

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New Breakthrough Ion AmpliSeq™ Technology Delivers the Most Rapid and Comprehensive Sequencing of Gene Mutations to ...

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ScienceDaily (June 4, 2012) New hope has arrived for migraine sufferers following a Griffith University study with the people of Norfolk Island.

Led by Professor Lyn Griffiths from the University's Griffith Health Institute, the team has identified a new region on the X chromosome as playing a role in migraine.

The research provides compelling evidence for a new migraine susceptibility gene involved in migraine. The study also indicated that there may be more than one X chromosomal gene involved and implicated a gene involved in iron regulation in the brain.

All females have two X chromosomes whilst males have an X and a Y chromosome.

"These results provide more support for the role of the X chromosome in migraine and may explain why so many more females suffer from the disorder," said Professor Griffiths.

Tracking down and identifying the various genes that cause migraine is very important as it provides insights to allow us to develop better means of diagnosis and more targeted treatments.

"Currently, 12 per cent of the population suffers from migraine. Even though we have some very good treatments for this very debilitating disease, they certainly don't work for everyone and can have some adverse side effects. Hence there is a real need to develop new migraine treatments."

This National Health and Medical Research Council funded work involved a unique population study of the remote Norfolk Island where 80 per cent of inhabitants are able to trace their ancestry back to the famous historical event, The Mutiny on the Bounty.

"This population was used due to its unusual pedigree structure in which genetic relationships can be traced through genealogical data to the island's original founders, and also the high incidence of migraine sufferers in this population. It's very useful for gene mapping purposes because of the reduced genetic and environmental diversity," said Professor Griffiths.

A comprehensive chromosome analysis of around 300 Norfolk participants from a large multigenerational Norfolk family, including many who are affected by migraine, was conducted using DNA samples obtained from the islanders.

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New hope for migraine sufferers: Female gene link identified

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

Percepta Associates is pleased to announce the launch of the 2012 Gene Expression Profiling, Series 4 Life Science Dashboard market research report, providing rapid access to actionable key market indicators for the gene expression profiling market. The 2012 Dashboard draws comparisons to market data reported in Percepta's 2008 and 2010 Gene Expression Profiling Dashboards, including market size, competitive shares, growth rates, customer satisfaction/propensity to switch, and end-user practices, in an 'at a glance' easy to understand format, allowing suppliers of products for gene expression profiling to easily track the effectiveness of marketing strategies and tactics over time. Market segments analyzed, including several new areas of focus, are as follows:

Life Technologies (LIFE) is the leading supplier in five of the nine segments analyzed, with one entrenched leadership position. Affymetrix (AFFX) and Illumina (ILMN) hold dominant positions in two of the segments not led by Life Technologies. Bio-Rad (BIO) was also cited among the leading suppliers in several segments. Furthermore, findings reveal that over half of respondents, in six of the nine segments expressed an interest in switching primary suppliers. Several gene expression profiling market segments continue to experience rapid growth, with annual rates exceeding 10% in two key segments. Even as next-generation sequencing methods rapidly enter the mainstream, our data shows that expression profiling methods will continue to be necessary tools in the advancement of life science research, said Alison Rowland, Principalat Percepta.

The 2012 Gene Expression Profiling, Series 4 Life Science Dashboard also analyzes current primary and secondary applications for each market segment, uncovering key downstream application changes observed over the past four years. Specific product and protocol improvement needs that may drive customer switching behavior are cited by respondents and revealed as verbatim comments in this report.

The 2012 Gene Expression Profiling Dashboard was developed from responses to a 23-question survey completed by 460 scientists predominantly located in North America and Europe. These respondents perform gene expression profiling methods on a regular basis.

To view Gene Expression Profiling Dashboard Series 4 sample data and the survey questionnaire visit:

http://www.perceptaassociates.com/publications/12_gene_expression_overview.shtml

About Percepta

Founded in 2005 in Carlsbad, California Percepta Associates is a specialized consultancy providing expert market research, strategic business planning, portfolio management, product and corporate branding and marketing communications services to life science research suppliers globally. For more information visit: http://www.perceptaassociates.com or call 760 431 6300.

For more information visit http://www.perceptaassociates.com.

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Affymetrix, Illumina and Life Technologies Hold Entrenched Leadership Positions in Key Gene Expression Profiling ...

Recommendation and review posted by Bethany Smith

Public release date: 4-Jun-2012 [ | E-mail | Share ]

Contact: Mary Jane Gore mary.gore@duke.edu 919-660-1309 JAMA and Archives Journals

CHICAGO A 38-year longitudinal study of New Zealanders suggests that individuals with higher genetic risk scores were more likely to be chronically obese in adulthood, according to a report published in the June issue of Archives of Pediatrics & Adolescent Medicine, a JAMA Network publication.

Obesity is capable of being inherited and genome-wide association studies (GWASs) have started to uncover the molecular roots of heritability by identifying multiple single-nucleotide polymorphisms (SNPs) associated with higher adult body mass index (BMI), the authors write in their study background.

"In this study, we asked how SNPs with replicated GWAS evidence for association with adult BMI relate to growth across the first four decades of life and to adult obesity in a birth cohort followed up prospectively from birth through 38 years of age," Daniel W. Belsky, Ph.D., of Duke University, Durham, N.C., and colleagues write in the study background.

Study participants were members of the Dunedin Multidisciplinary Health and Development Study, an investigation of health and behavior in a complete birth cohort. The 1,037 study members (52 percent were male) were born between April 1972 and March 1973 in Dunedin, New Zealand. Assessments were performed every few years starting at birth until 38 years.

Children with higher genetic risk scores (GRSs) had higher BMIs at every age assessed from age 3 through 38 years. Children at high genetic risk were 1.61 to 2.41 times more likely to be obese in their second, third and fourth decades of life and were 1.90 times more likely to be chronically obese across more than three assessments compared with children at low genetic risk, according to study results.

Adiposity rebound, when children begin to gain body fat after losing it during early childhood, occurred earlier in development and at higher BMI for children at higher genetic risk, the results indicate.

Higher genetic risk also predicted faster growth and increased obesity risk in children with normal-weight and overweight parents, the study results note. The authors comment that the GRS contributed "independent and additive information" to the prediction of children's growth and their risk for obesity in adulthood beyond the family history information.

"Thus, the results present compelling evidence that SNPs identified in GWASs of adult BMI and other obesity-related phenotypes predispose to more rapid growth in childhood, leading to increased risk for obesity in adulthood, and provide information not forthcoming from a simple analysis of family history," the authors conclude.

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Genetics, rapid childhood growth and the development of obesity

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SAN DIEGO--(BUSINESS WIRE)--

Pathway Genomics Corporation, a clinical genetic testing laboratory and results interpretation service based in San Diego, has been selected by San Diego Venture Group as one of 30 cool companies to be featured at its 10th Annual Venture Summit on June 6. Selected from a field of over 150 applicants, Pathway Genomics and the other 29 companies will be a prominent part of the event, which draws more than 100 venture capitalists and 500 attendees.

The selection is a reminder that companies like Pathway are at the forefront of a major shift in the way medicine is practiced throughout the world, said Jim Plante, Pathways founder and CEO.

Pathway provides genetic tests for drug responses, nutrition and exercise response, inherited genetic conditions, and risk of many diseases. Pathway consists of more than 40 scientific and medical professionals, including medical doctors, molecular geneticists, and genetic counselors, as well as a world-leading scientific advisory board.

To learn more about Pathways genetic testing services, visit http://www.pathway.com. For more information about San Diego Venture Groups Cool Companies 2012 and its 10th Annual Venture Summit, visit http://www.sdvg.org/venturesummit.

About Pathway Genomics

Pathway Genomics owns and operates an on-site genetic testing laboratory that is accredited by the College of American Pathologists (CAP), accredited in accordance with the U.S. Health and Human Services Clinical Laboratory Improvement Amendments (CLIA) of 1988, and licensed by the state of California. Using only a saliva sample, the company incorporates customized and scientifically validated technologies to generate personalized reports, which address a variety of medical issues, including an individuals carrier status for recessive genetic conditions, food metabolism and exercise response, prescription drug response, and propensity to develop certain diseases such as heart disease, type 2 diabetes and cancer. For more information about Pathway Genomics, visit http://www.pathway.com.

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Pathway Genomics Selected as a “Cool Company” by San Diego Venture Group

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First Bedside Genetic Test Could Prevent Heart Complications

A genotyping test from a Canadian biotech company enables timely personalized drug treatment.

For some cardiac patients, recovery from a common heart procedure can be complicated by a single gene responsible for drug processing. The risk could be lowered with the first bedside genetic test of its kind. The test shows promise for quickly and easily identifying patients who need a different medication.

Quick test: This shoebox-sized device from Spartan Bioscience supports the first bedside genetic test. Spartan Bioscience

After a patient receives a heart stenta small scaffold that props open an arteryhis or her doctor will prescribe a blood thinner to prevent platelets from building up inside the device. However, for some 70 percent of patients with Asian ancestry and 30 percent of patients with African or European ancestry, a single genetic variant will prevent one of the most commonly prescribed blood thinners from working. Alternatives exist, but they are more expensive, so hospitals could use an easy way to identify who does and does not need the more expensive drug.

Canada's Spartan Biosciencehas developed a near "plug-and-play" genotyping device that allows nurses and others to quickly screen patients at the bedside, perhaps while they are undergoing the stent placement procedure. Users take a DNA sample from a patient's cheek with a specialized swab, add the sample to a disposable tube, and then place the tube and sample in a proprietary shoebox-sized machine and hit a button. Shortly thereafter, the user receives a printout of the patient's genetic status for the drug-processing variant. The whole procedure takes about an hour. Most clinicians currently have to wait several days for similar information to come from off-site genetics testing companies.

"For six years we've been plugging away at this, and we finally broke through about a year and a half ago," says Spartan Bioscience founder Paul Lem. He says the simple test came to life with innovations at every stepfrom the special swab that collects the right amount of DNA, to the chemicals in the disposable reaction tube, to the software that automates the DNA readingand a team with diverse backgrounds including his in medicine and molecular biology and others' in optical hardware.

Lem has kept an eye on other companies trying to create a bedside genetic test, some going after the same variant, and calculates that over $1 billion in capital has been spent over the last five years in this area.

The University of Ottawa Heart Institute researchers conducted a proof-of-principle trial for the device and found that the bedside test is effective at quickly identifying carriers of the drug-processing variant and can be performed by nurses with minimal training. The findings were published in The Lancet last week.

"The stakes are pretty high" for the risks associated with the variant in the test, says Euan Ashley, a cardiologist with Stanford's Center for Inherited Cardiovascular Disease. Patients who receive a stent implant after a heart attack or as a preventive measure are at risk for serious adverse events if their bodies cannot process a commonly prescribed anti-platelet drug into its active form. "There's a startling number of people who carry the variant, which leaves them at risk," says Ashley. "Being able to get an answer within an hour or twowhen you are thinking of a patient's heartis a pretty compelling case for [testing for it]."

Originally posted here:
First Bedside Genetic Test Could Prevent Heart Complications

Recommendation and review posted by Bethany Smith

AMES, Iowa, June 4, 2012 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (Nasdaq:NLNK - News) today announced that data from Phase 1 and Phase 1B studies evaluating NLG8189 (D-1MT, 1-methyl-D-tryptophan or d-1-Methyltryptophan) will be presented in an oral presentation at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting being held in Chicago, IL in the E Arie Crown Theater from 3:15 to 3:30PM. The data show that NLG8189 is safe and well tolerated, with a favorable pharmacokinetic profile demonstrating good oral bioavailability. In addition, NLG8189 reached targeted therapeutic levels in the absence of serious toxicity. Interestingly, symptoms of hypophysitis (inflammation of pituitary) were observed in some patients suggesting early signs of biological activity. Furthermore, NLG8189 demonstrated a favorable safety profile in combination with Taxotere, as well as in combination with adenoviral autologous dendritic cell (DC) vaccines, with promising early signs of activity. These studies were conducted in conjunction with the National Cancer Institute (NCI).

Dr. Hatem Soliman, author of the abstract entitled "A phase I study of 1-methyl-d-tryptophan in combination with docetaxel in metastatic solid tumors" and also presenter of an oral abstract, commented, "In light of this favorable safety profile of NLG8189 and signs of activity we are especially interested in expanding our understanding of the mechanism underlying this compound's effect on the key immunomodulatory IDO pathway. The high response rate to chemotherapy after treatment with vaccine and NLG8189 suggests chemosensitization is occurring. In particular, we observed that 75% (6 out of 8 patients) responded to a combination of carboplatin and gemcitabine follow-on regimen including one complete response in a fifth line therapy."

Phase 1 and Phase 1B Study Designs

NewLink/NCI have completed Phase 1 single-agent pharmacokinetic/safety studies of the drug. Currently, two Phase 1B/2 clinical trials are enrolling patients to evaluate NLG8189 in combination with other cancer therapies. The initial Phase 1 dose escalation study evaluated 48 patients in escalating doses from 200 mg to 2,000 mg BID. The first Phase 1B clinical trial has primary endpoints assessing safety and efficacy of NLG8189 in combination with an Ad-p53 autologous dendritic cell vaccine for solid malignancies with p53 mutations, such as lung, breast and colon cancers. The second Phase 1B clinical trial has primary endpoints assessing safety and efficacy of escalating doses of NLG8189 in combination with Taxotere for patients with advanced stage solid tumors for which Taxotere is the standard-of-care, such as metastatic breast, prostate, ovarian and lung cancers. Furthermore, in breast cancer patients who had already received multiple prior chemotherapy regimens before treatment with DC vaccine and NLG8189, a 50% objective response rate was found when patients were next administered further salvage chemotherapy. This response rate was unexpected in patients who were so heavily pretreated and suggests that a chemosensitization effect occurred.

Study Findings

Initial Phase 1 studies confirmed that the drug has early signs of activity, good oral bioavailability, a favorable half-life that allows drug accumulation to levels estimated to be within the therapeutic range and that it is tolerated very well by patients. The adverse events were generally mild and self-limited, including several cases of measurable but easily managed hypophysitis that developed in immunologically sensitized patients, an indication that NLG8189 can elevate immune activation above baseline to clinically detectable levels. In the Phase 1B study of Taxotere plus NLG8189, patients with advanced solid tumors were shown to tolerate the drug combination at the maximum dose and are now being treated with this new drug combination and followed for efficacy. Similarly, the study combining Ad-p53 vaccine/NLG8189 has reached its maximum dose without limiting toxicity and is now collecting efficacy data.

"We have been encouraged by the data from the Phase 1 studies as we see very favorable safety and pharmacokinetic profiles for this drug," said Dr. Nicholas Vahanian, President and Chief Medical Officer of NewLink Genetics. He added "The evidence of biologic activity is encouraging, especially given that the immune-related events observed in several patients are a side effect that has correlated with positive clinical outcomes in studies of other immune-modulatory agents such as ipilimumab. It has always been our strategy to develop NLG8189 as a component of combination treatment with other anti-cancer agents and to explore how the potential chemosensitization observed in these studies might be further exploited."

About NLG8189

NLG8189 is a small-molecule, orally bioavailable product candidate based on NewLink's proprietary IDO pathway inhibitor technology. Preclinical experiments have demonstrated a strong, synergistic anti-tumor effect without increased toxicity when NLG8189 was administered in combination with a number of currently available chemotherapeutic agents. IDO pathway inhibitors, including NLG8189, represent a potential breakthrough approach to cancer therapy using small-molecule, anti-toleragenic product candidates intended to combat the mechanisms by which tumors evade immune-mediated destruction. IDO is an enzyme that regulates immune response by suppressing T-cell function and creating local tumor immune escape. Recent studies have demonstrated that IDO is overexpressed in many cancers, within both tumor cells as a direct defense against T-cell attack, and also within antigen presenting cells in tumor draining lymph nodes whereby IDO promotes peripheral tolerance to tumor-associated antigens ("TAAs"). When hijacked by developing cancers in this manner, IDO may facilitate the survival, growth, invasion, and metastasis of malignant cells expressing TAAs that might otherwise be recognized and attacked by the immune system as foreign.

About NewLink Genetics Corporation

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Data From Phase 1 and Phase 1B Studies of NewLink Genetics' IDO Pathway Inhibitor (NLG8189) Presented at 2012 ASCO ...

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SANTA MONICA, Calif. & BOTHELL, Wash.--(BUSINESS WIRE)--

Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., and Seattle Genetics, Inc. (SGEN) today announced interim data from a phase I clinical trial evaluating ASG-5ME for the treatment of castration-resistant prostate cancer (CRPC). ASG-5ME is an antibody-drug conjugate (ADC) targeting the SLC44A4 antigen that is being co-developed by both companies for the treatment of solid tumors. The data are being presented at the American Society of Clinical Oncology (ASCO) annual meeting being held June 1-5, 2012 in Chicago, IL.

SLC44A4 is an attractive target in prostate cancer and is present in the majority of patients with both localized and metastatic disease, said Leonard Reyno, M.D., Senior Vice President and Chief Medical Officer of Agensys. The current Phase I data demonstrates the tolerability of this antibody drug conjugate and further evaluation of safety and antitumor activity in patients with castration resistant prostate cancer is ongoing.

It is encouraging to observe these preliminary data with ASG-5ME in prostate cancer, a disease for which late-stage patients need additional therapeutic options, said Jonathan Drachman, M.D., Senior Vice President, Research and Translational Medicine of Seattle Genetics. In addition to prostate cancer, our two companies are continuing to evaluate the potential use of ASG-5ME in other solid tumor indications. In parallel, we are collaborating with Agensys to co-develop ASG-22ME, an ADC targeting Nectin-4 for solid tumors.

Phase 1 trial of ASG-5ME in metastatic castration-resistant prostate cancer (CRPC) (Abstract #4568) ASG-5ME is being evaluated in a single-agent phase I clinical trial to determine the maximum tolerated dose (MTD) and to assess the safety, pharmacokinetic profile and antitumor activity of escalating doses of ASG-5ME. At the time of data analysis, 26 patients were enrolled. The median age of the patients was 69.5 years and the median baseline prostate-specific antigen (PSA) level was 82.25.

Key findings, presented by Dr. Michael Morris from Memorial Sloan Kettering Cancer Center in New York, NY, and clinical investigator on the study include:

The phase I trial is ongoing, with enrollment to two expansion cohorts in chemotherapy nave and chemotherapy exposed CRPC patients planned.

Seattle Genetics and Agensys recently completed enrollment in a phase I pancreatic cancer trial of ASG-5ME dosed weekly. The companies plan to evaluate ASG-5ME in patients with gastric cancer based on preclinical expression data.

About ASG-5ME ASG-5ME is an ADC composed of a fully human antibody directed to SLC44A4, a solute carrier antigen family member identified by Agensys to be overexpressed in epithelial cancers, including more than 80 percent of samples derived from patients with prostate, pancreatic and gastric cancers. The antibody is attached to monomethyl auristatin E (MMAE) via an enzyme-cleavable linker using Seattle Genetics proprietary technology. The ADC is designed to be stable in the bloodstream, but to release MMAE upon internalization into SLC44A4-expressing tumor cells, resulting in targeted cell-killing.

Seattle Genetics and Agensys are co-developing and will globally co-commercialize and share profits on a 50:50 basis for ASG-5ME and ASG-22ME. Seattle Genetics also has an option for 50:50 cost and profit-sharing of a third ADC program at the time of investigational new drug submission.

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Agensys and Seattle Genetics Announce Interim Phase I Data from ASG-5ME Clinical Trial for Prostate Cancer

Recommendation and review posted by Bethany Smith

AMES, Iowa, June 4, 2012 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (Nasdaq:NLNK - News) announces that its HyperAcute(R) Pancreas (algenpantucel-L) Immunotherapy will be featured today in a poster presentation (abstract number 4049) at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting being held in Chicago, IL. The abstract entitled "Addition of algenpantucel-L immunotherapy to standard of care (SOC) adjuvant therapy for pancreatic cancer" will be shown in S Hall A2 from 8:00AM to 12:00PM . The study results show 37%, 59% and 121% improvement in 1-, 2- and 3-year survival, respectively, as compared to standard-of-care.

Dr. Jeffrey M. Hardacre, the study's Principal Investigator, from the University Hospitals Seidman Cancer Center and Case Western Reserve University, Cleveland, OH stated, "As a surgeon who regularly treats patients suffering from pancreatic cancer, and being accustomed to the dismal prognosis for these patients, I am highly encouraged with the exceptional overall survival data from this study."

"Given that the primary endpoint in our pivotal Phase 3 study targeting similar patients is overall survival, this data supports our cautious optimism," said Dr. Nicholas Vahanian, President and Chief Medical Officer of NewLink Genetics.

Key data from the 69 patient Phase 2 algenpantucel-L trial demonstrated:

The primary endpoint of the study, 12-month disease free survival (DFS), was 62%. The median DFS was 14.1 months. Subgroup analysis showed that patients receiving 300 million cells/dose had a 12-month DFS of 81%, while those receiving 100 million cells/dose had a 12-month DFS of 51% (p=0.02, Fisher's Exact). Prognostic criteria did not significantly differ between the two groups.

Overall 12-month survival was 86%. The predicted 12 month overall survival in our study was 63%. Subgroup analysis showed that patients receiving 300 million cells/dose had an overall 12-month survival of 96%, while those receiving 100 million cells/dose had an overall 12-month survival of 79% (p=0.053, Fisher's Exact). Two-year overall survival in our study was 51% with a predicted survival of 32% and 3-year overall survival was 42% with a predicted survival of 19%. Predicted survivals were computed using prognostic factors gathered for each patient and calculated using a nomogram published by Brennan et al from Memorial Sloan Kettering Cancer Center. Over the 33 month median follow up period of the study, the percentage improvement in overall survival rate compared to nomogram analysis increased over time. These data are consistent with recent studies of active immunotherapies (Sipuleucel-T and Ipilimumab) in that immune benefits appear greater in some patients over time.

Prominent eosinophil responses have been observed with the majority of patients demonstrating measurable increases in peripheral blood eosinophilia. In addition to eosinophilic infiltrates at the injection site in all tested patients, 70% developed eosinophilia, with 30% showing persistent eosinophilia for up to 2 years.

The HyperAcute(R) Pancreas immunotherapy product candidate, also referred to as algenpantucel-L, demonstrated good tolerability and a favorable safety profile with no grade four adverse events considered attributable to the immunotherapy. The predominant adverse events related to the immunotherapy were grade one or two injection site reactions, all treated with conservative local therapies.

Anecdotally, three patients with cancer recurrence after receiving algenpantucel-L obtained complete radiographic responses with the use of subsequent chemotherapy. As of May 16, 2012, all three patients remain in remission with no evidence of disease for periods ranging from six to 36 months. "We are presenting data from three different HyperAcute products at ASCO this year and each of these has generated intriguing data that provide insights into the activity and mechanisms associated with the treatment of patients with HyperAcute immunotherapies," stated Dr. Charles Link, CEO and Chief Scientific Officer of NewLink Genetics. "These observations include survival advantages that improve over time, objective responses, novel immunological findings and chemosensitization."

About the Phase 2 Study

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NewLink Genetics Reports Two- and Three-Year Overall Survival Data From Its Phase-2 HyperAcute(R) Pancreas ...

Recommendation and review posted by Bethany Smith

AMES, Iowa, June 4, 2012 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (Nasdaq:NLNK - News) announced its HyperAcute(R) Lung (tergenpantucel-L) immunotherapy will be featured today in a poster presentation (abstract number 2571) at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting being held in Chicago, IL. The abstract entitled "Correlation of interferon-g (IFN) response with survival in a phase II hyperacute (HAL) immunotherapy trial for non-small cell lung cancer (NSCLC)" will be shown in S Hall A2 from 8:00AM to 12:00 PM. The study presented by Dr. John C. Morris, Professor and Director of Thoracic Cancer Division at the University of Cincinnati, demonstrated a direct correlation between immune response and survival in non-small cell lung cancer patients. In addition, patient survival compared favorably to that seen in patients receiving other second-line chemotherapy agents, suggesting encouraging clinical benefit.

"The overall survival data is particularly remarkable when compared to current standard-of-care, which primarily utilizes cytotoxic chemotherapy agents with their associated debilitating side effects," commented Dr. Nick Vahanian, President, Chief Medical Officer, NewLink Genetics.

"These data suggest an intriguing relationship between a patient's immunological response to tergenpumatucel-L and overall survival," said Dr. John C. Morris. He added, "Survival of the late stage patients in this study compares favorably with that seen in approved agents and there is emerging data to suggest that patient response to some of these agents may be enhanced by prior treatment with tergenpumatucel-L."

Phase 1B/2 Study Design

Seventeen patients were treated in the Phase 1 portion of the study and 37 patients were treated in the phase 2 portion. Patients had metastatic or recurrent NSCLC and had failed first-line chemotherapy. Twenty-eight of the 37 phase 2 patients were evaluable for clinical response. All phase 2 patients received 300 million cells per injection every two weeks for up to eight scheduled doses. Serum samples were collected before and after immunization and then at two-month follow-up visits. Peripheral blood mononuclear cells (PBMC) were collected prior to immunization and after the fourth and eighth vaccinations. Response was determined using RECIST criteria.

Results

There were 28 patients in the phase 2 portion of the study evaluable for response. Among these patients median overall survival was 11.3 months. Eight patients (28.5 percent) demonstrated stable disease after 16 weeks of treatment, including one patient that initially progressed and later regressed, surviving over 40 months. Eighteen patients with pre-immunization and post-immunization serum samples were tested for elevations in interferon-gamma response to drug. Eleven of these 18 responded with increased interferon-gamma, and the overall survival of these patients was 21.9 months. The increase in overall survival of patients with increased interferon gamma compared to non-responders was statistically significant with a p-value of 0.044. Six of the 11 responders showed reactivity to CL4-H522, a cellular target not present in HyperAcute Lung, suggesting cross priming to shared antigens.

Safety and Tolerability

No serious adverse events were reported as definitely or probably attributable to HyperAcute Lung. The most frequently observed adverse events attributable to the therapy were skin reactions at the site of injection. These were generally either acute inflammatory reactions or delayed-type hypersensitivity reactions that resolved without intervention in the vast majority of cases.

Dr. Charles Link, CEO and Chairman of NewLink, stated that, "We are gratified that in addition to seeing positive clinical data with our HyperAcute-Lung product candidate, this study provides us with meaningful insight into the fundamental mechanisms by which this class of immunotherapies work."

Visit link:
NewLink Genetics HyperAcute(R) Lung (tergenpumatucel-L) Immunotherapy Demonstrates a Correlation Between Immune ...

Recommendation and review posted by Bethany Smith

SEATTLE, WA--(Marketwire -06/04/12)- Atossa Genetics, Inc., a privately-held health care company focused on the prevention of breast cancer through the commercialization of diagnostic tests that can detect precursors to breast cancer, and through the research, development, and ultimate commercialization of treatments for pre-cancerous breast lesions, today announced that Steven C. Quay, M.D., Ph.D., FCAP, Chairman, President & CEO of Atossa Genetics and Director of the National Reference Laboratory for Breast Health, will conduct a workshop at Active Communications International's 5th National Breast Centers of Excellence conference, June 6-8, 2012, in Dallas, Texas.

The workshop, titled "Using Unique Molecular Tests to Grow Your Breast Center of Excellence Patient Base," will take place on Friday, June 8, from 2:15-3:15 pm Central Time. Workshop attendees will learn how to:

"I am pleased to have the opportunity to conduct a workshop on molecular tests at this prestigious event," stated Steven C. Quay, M.D., Ph.D., FCAP, Chairman, President and CEO of Atossa Genetics and Director of the National Reference Laboratory for Breast Health. "Our suite of new molecular tests can provide Breast Centers of Excellence with a unique offering to help set them apart in their local markets. By partnering with a national reference laboratory for breast health, Breast Centers of Excellence can show their commitment to best practice and can set the stage for their participation with the next generation of breast cancer prevention, intraductal pharmaceutical treatment of DCIS and related pre-cancerous lesions."

About Atossa Genetics, Inc.

Atossa Genetics, Inc. is a privately held health care company based in Seattle, Washington, that provides a comprehensive set of innovative breast health evaluation products and services that provide accurate and actionable results for personalized cancer prevention and breast health. Atossa has established the National Reference Laboratory for Breast Health, a specially equipped, CLIA-certified laboratory located in Seattle that provides comprehensive test results to guide personalized breast cancer prevention and treatment solutions.

About the National Reference Laboratory for Breast Health

The National Reference Laboratory for Breast Health, a division of Atossa Genetics, Inc., is focused on developing novel, clinically relevant tests for evaluating Breast Health in all women. The National Reference Laboratory for Breast Health, located in Seattle, Washington, is the only CLIA-registered laboratory focused exclusively on breast health. The National Reference Laboratory for Breast Health provides comprehensive test results to guide personalized breast cancer prevention and treatment solutions. For additional information on the ForeCYTE Breast Health Test and the ArgusCYTE Breast Health Test, please visit http://www.NRLBH.com.

About the Breast Center of Excellence Designation

The Breast Imaging Center of Excellence (BICOE) designation is awarded to breast imaging centers that achieve excellence by seeking and earning accreditation in all of the American College of Radiology's voluntary breast-imaging accreditation programs and modules, in addition to the mandatory Mammography Accreditation Program.

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Atossa Genetics to Participate in 5th National Breast Centers of Excellence Conference in Dallas, Texas

Recommendation and review posted by Bethany Smith

OMAHA, Neb.--(BUSINESS WIRE)--

Transgenomic, Inc. (TBIO) today announced the commercial launch of its ICE COLD-PCR mutation detection technology, a breakthrough technology enabling unmatched sensitivity and complete DNA mutation detection using the standard sequencing equipment already installed in laboratories around the world. The launch coincides with the 2012 annual meeting of the American Society of Clinical Oncology.

ICE COLD-PCR is capable of identifying mutation frequencies as low or lower than 0.01% which surpasses the limits of currently available mutation detection tests. This extremely high sensitivity enables detection of mutations from virtually any sample type including tissue biopsies, blood, and circulating tumor cells (CTCs). Mutation profiling from blood and CTCs may benefit cancer patients because it avoids the risks of additional surgical procedures while providing an up-to-date picture of any additional mutations the cancer may have acquired throughout treatment.

An ICE COLD-PCR kit for enrichment of KRAS mutations is now available worldwide to molecular diagnostic laboratories for use with standard DNA sequencing equipment. Transgenomic plans to expand the ICE COLD-PCR testing platform to include other therapeutically relevant mutations including BRAF, EGFR, and PIK3CA.

The broad use of ICE COLD-PCR has the potential to revolutionize cancer screening, diagnosis, monitoring, and therapy selection said Craig Tuttle, Chief Executive Officer of Transgenomic. It offers us the ability to accurately perform safer, less invasive, and more frequent assessments of a cancer and its mutations, all through a simple blood draw. Ultimately, the goal is to provide real-time monitoring of cancer progression, resistance mutations and response to therapy. With the proliferation of targeted anti-cancer drugs now available or in clinical trials, ICE COLD-PCR will help determine the right path for each patient at every step of his or her treatment, making precision medicine even more precise.

Mr. Tuttle added: ICE COLD-PCR provides extreme sensitivity and coverage to ensure that mutations are not missed, both are needed for reliable mutation profiling from blood, CTCs, and small sample sizes. Because it is used with the sequencing equipment already installed in labs around the world, we expect broad and sustained adoption of this technology, with kit sales beginning this year. Each of the markets addressed by ICE COLD-PCR diagnosis, monitoring, and disease recurrence is substantial, providing a significant value-creation opportunity for Transgenomic.

ICE COLD-PCR technology was developed in collaboration with the Dana-Farber Cancer Institute and is supported by multiple validation studies confirming reproducible mutation detection at very high sensitivity up to 1,000 times more sensitive than traditional PCR techniques. The technology is also being evaluated in an ongoing study with The University of Texas MD Anderson Cancer Center to analyze DNA isolated from CTCs.

About Transgenomic, Inc.

Transgenomic, Inc. (www.transgenomic.com) is a global biotechnology company advancing personalized medicine in cancer and inherited diseases through its proprietary molecular technologies and world-class clinical and research services. The Company has three complementary business divisions: Transgenomic Pharmacogenomic Services is a contract research laboratory that specializes in supporting all phases of pre-clinical and clinical trials for oncology drugs in development, Transgenomic Clinical Laboratories, which specializes in molecular diagnostics for cardiology, neurology, mitochondrial disorders, and oncology, and Transgenomic Diagnostic Tools which produces equipment, reagents, and other consumables that empower clinical and research applications in molecular testing and cytogenetics. Transgenomic believes there is significant opportunity for continued growth across all three businesses by leveraging their synergistic capabilities, technologies, and expertise. The Company actively develops and acquires new technology and other intellectual property that strengthen its leadership in personalized medicine.

Forward-Looking Statements

Original post:
Transgenomic Launches Breakthrough Blood-Based Cancer Gene Testing Technology at 2012 ASCO Annual Meeting

Recommendation and review posted by Bethany Smith

DEERFIELD, Ill.--(BUSINESS WIRE)--

Baxter International Inc. (BAX) today announced that it has entered into an exclusive global agreement with Chatham Therapeutics, LLC, an affiliate of Asklepios BioPharmaceutical, Inc. (AskBio), for the development and commercialization of potential treatments for hemophilia B utilizing Chathams gene therapy technology.

The collaboration will allow Baxter to investigate Chathams Biological Nano ParticlesTM (BNP), an advanced recombinant adeno-associated virus-(rAAV) based gene therapy technology that has shown potential therapeutic benefit in early clinical studies. A small independent study involving six patients using Chatham technology components was the topic of a 2011 article in The New England Journal of Medicine.i This agreement will involve the next generation of this gene therapy technology, which Baxter and Chatham will investigate through U.S.-based hemophilia B clinical trials. Baxter has obtained global rights for the marketing and commercialization of the new treatment.

''This collaboration demonstrates Baxters ongoing commitment to scientific innovation in advancing treatment options for patients living with hemophilia. This initiative complements Baxters extensive hemophilia portfolio and helps to address unmet needs of hemophilia patients,'' said Ludwig Hantson, Ph.D., president of Baxters BioScience business.

Baxter made a $25 million upfront cash payment for the development and advancement of the program through early clinical trials, and will record this amount as a special pre-tax in-process research and development charge in the second quarter of 2012. Baxter may make additional payments over the next several years based on certain development and commercial milestones.

''This agreement initiates a clinical development collaboration dedicated to advancing a potential long-term treatment paradigm for hemophilia patients. We look forward to working with Baxter and view this transaction as the optimal path toward providing a sustainable therapeutic to a worldwide patient population,'' said Jade Samulski, Vice President at AskBio and Co-Founder of Chatham Therapeutics.

Hemophilia B is the second most common typeof hemophilia (also known as Christmas disease) and is the result of insufficient amounts of clotting factor IX, a naturally occurring protein in blood that controls bleeding.ii Hemophilia B occurs in about one in 25,000 males, with approximately 4,000 people in the United States currently diagnosed with the disease.iii Hemophilia B is often a debilitating, chronic disease with complications that include bleeding episodes, hemophilic arthropathy (bleeding into a joint) and hospitalization.iv

Baxter is pursuing a number of research opportunities in hemophilia. The company is conducting a Phase I/III clinical trial of BAX326, a recombinant Factor IX being evaluated for the treatment of patients with hemophilia B, and expects to file for U.S. approval by the end of 2012.

About Baxter International Inc.

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

Continued here:
Baxter Announces Collaboration with Chatham Therapeutics for Factor IX Hemophilia B Gene Therapy Treatment

Recommendation and review posted by Bethany Smith

BALTIMORE, June 4, 2012 /PRNewswire/ --Sapio Sciences (http://www.SapioSciences.com) is pleased to announce the immediate availability of Exemplar Biomarker Discovery LIMS. This release is the result of Sapio's extensive experience in implementing LIMS with Biomarker Discovery at leading pharmaceutical and biotech companies. Exemplar Biomarker Discovery addresses these clients' needs for a single, integrated solution to a breadth of requirements.

Personalized Medicine: The Future of Medicine

It has been known that the idea that a "one size fits all" application of a drug to a disease is not practical. Each person has a unique response to a medication that will determine whether that particular drug will work for them or not. Ideally, certain biological markers, a.k.a. biomarkers, would be known that could be measured and used to predict the efficacy of any particular drug for a particular patient. This is the promise of personalized medicine.

With advances in genetics, genomics, proteomics, and metabolomics over the last two decades, it is now possible to perform detailed profiling of study subjects' response to treatments. The proper tracking and interpretation of this data can lead to the aforementioned desired patient profiling for a particular drug to have the best chance of success.

Proper interpretation of this data can also lead to the success or failure of a drug in clinical trials. Certain drugs may appear ineffective, but in fact are working for a small subset of the patient population with some combination of biomarkers. If these markers could be discovered, then the patient population can be preselected for suitable candidates, and the drug trial has a greater chance of success, whereas it may fail without such a predictor in place.

A Comprehensive Biomarker Discovery LIMS Solution

While the promise of personalized medicine is great, little actual progress has been made. One of the major reasons for this is the lack of tools to help manage the diverse and voluminous study data, and to interpret that data. At most companies this important data is spread across the organization in various applications, data stores, and spreadsheets. This means that making discoveries becomes extremely costly, time consuming, and sometimes impossible because of the lack of a single integrated view of the data.

Companies developing pharmaceuticals need to be able to track samples in the sense of traditional LIMS applications, but also want to be able to track treatment regimens, subjects and their phenotypic attributes, and assay data. Within the same application there is also the need to take this aggregated data and perform data mining queries and statistical analysis on it. A comprehensive Biomarker Discovery application should include all of the following:

Exemplar Biomarker Discovery LIMS addresses each of these needs while allowing for configurationcustomization meeting each company's specific requirements.

"The Exemplar Biomarker Discovery product release is the culmination of our extensive experience working with leading drug development firms who are aware of the importance of personalized medicine to their future success. Now, for the first time, these firms can get a single solution that addresses everything from sample management through study data management, assay data management, data mining and statistical analysis," says Kevin Cramer, VP of Sales and Marketing at Sapio.

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Sapio Sciences Announces Exemplar Biomarker Discovery LIMS for Personalized Medicine

Recommendation and review posted by sam

CARLSBAD Before heading in to his 2 p.m. therapy session for a spinal cord injury, Sadru Dada enjoyed a couple of slices of freshly made margherita pizza and anchovies from a food truck parked in front of the building.

Project Walk, a spinal cord injury recovery center that opened in Carlsbad in 1999, started Food Truck Wednesdays in February. Each Wednesday a different truck sets up from 11 a.m. to 2 p.m. and offers a tasty lunch, including burgers and seafood. This week it hosted Red Oven Pizza, wood-fired pizza made using an Italian made Mugnaini mobile oven.

Lunch costs about $10 and part of the proceeds benefit the center.

Whatever helps Project Walk we want to do, Dada said from his wheelchair. They know what theyre doing, and its a unique place. Theyre trying to make me walk.

Project Walk does not offer traditional rehabilitation, instead it concentrates on exercise to get the client out of a wheelchair to work their entire bodies.

Were looking at trying to do any type of reconnection, getting the body to remember the walking patterns and breaking down each of the movements, said Gigi Betancourt, client services manager at the center. Whether it be on the table, in our track system, or any of our elliptical machines.

Dada, who lives in Dubai, suffered his injury seven years ago when he was struck by a car as he was walking down a street. Four weeks ago he made the more than 30-hour trip to Carlsbad with his wife, Firoza. Hes hoping to take his first steps before his sessions wrap up at the end of July and he heads to New Jersey to visit his two sons and two grandchildren.

Food Truck Wednesdays are part of a recent effort made to draw more attention to the center, which upgraded to a new location seven months ago. Project Walk occupies part of the business center at 5850 El Camino Real that used to be The Boxing Club and Raphaels Party Rentals. The 24,000 square-feet of space is 9,000 square feet bigger than its previous location on Loker Avenue.

The program currently has 80 clients, with one to five new ones starting every week. Programs are tailored to a clients needs and what the person can afford. Insurance doesnt cover the cost. The typical program is four days a week, two to three hours a day. Programs average four weeks to six months.

Clients are paired one on one with certified specialists, who have a background in kinesiology or sports science. Currently 27 certified specialists work at the center.

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Food trucks serve lunches for a cause

Recommendation and review posted by sam

Public release date: 4-Jun-2012 [ | E-mail | Share ]

Contact: David Eve Celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Tampa, Fla. (June 4, 2012) When autologous (self-donated) lung-derived mensenchymal stem cells (LMSCs) were transplanted endoscopically into 13 adult female sheep modeled with emphysema, post-transplant evaluation showed evidence of tissue regeneration with increased blood perfusion and extra cellular matrix content. Researchers concluded that their approach could represent a practical alternative to conventional stem cell-based therapy for treating emphysema.

The study is published in Cell Transplantation (21:1), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/.

"Mensenchymal stem cells are considered for transplantation because they are readily available, highly proliferative and display multi-lineage potential," said study corresponding author Dr. Edward P. Ingenito of the Brigham and Women's Hospital Division of Pulmonary and Critical Care Medicine. "Although MSCs have been isolated from various adult tissues - including fat, liver and lung tissues - cells derived from bone marrow (BM) have therapeutic utility and may be useful in treating advanced lung diseases, such as emphysema."

However, according to the authors, previous transplantation studies, many of which used an intravenous delivery method, have shown that BM-MSCs have been only marginally successful in treating lung diseases. Further, therapeutic responses in those studies have been limited to animal models of inflammatory lung diseases, such as asthma and acute lung injury.

To try and answer the questions surrounding the utility of BM-MSCs for treating advanced emphysema, a disease characterized by tissue destruction and loss of lung structural integrity, for this study the researchers isolated highly proliferative, mensenchymal cells from adult lung parenchyma (functional tissue) (LMSCs) and used an endoscopic delivery system coupled with a scaffold comprised of natural extracellular matrix components.

"LMSCs display efficient retention in the lung when delivered endobronchially and have regenerative capacity through expression of basement membrane proteins and growth factors," explained Dr. Ingenito.

However, despite the use of autologous cells, only a fraction of the LMSCs delivered to the lungs alveolar compartment appeared to engraft. Cell death likely occurred because of the failure of LMSCs to home to and bind within their niche, perhaps because the niche was modified by inflammation or fibrosis. These cells are attachment-dependent and failure to attach results in cell death."

Their findings did suggest, however, that LMSCs were capable of contributing to lung remodeling leading to documented functional improvement rather than scarring 28 days post transplantation.

Read more from the original source:
Cell transplantation of lung stem cells has beneficial impact for emphysema

Recommendation and review posted by simmons

SAN DIEGO, CA--(Marketwire -06/04/12)- Medistem Inc. (MEDS) announced today positive safety data from the first 5 patients enrolled in the Non-Revascularizable IschEmic Cardiomyopathy treated with Retrograde COronary Sinus Venous DElivery of Cell TheRapy (RECOVER-ERC) trial. The clinical trial uses the company's "Universal Donor" Endometrial Regenerative Cells (ERC) to treat Congestive Heart Failure (CHF).

According to the study design, after 5 patients enter the trial, they must be observed for a two month time period before additional patients are allowed to enter the study. Patient data was analyzed by the study's independent Data Safety Monitoring Board (DSMB), which concluded that based on lack of adverse effects, the study be allowed to continue recruitment.

"Medistem is developing a treatment for CHF that uses a 30-minute catheter-based procedure to administer the ERC stem cell into the patients' hearts. The achievement of 2 month patient follow-up with no adverse events is a strong signal for us that our new approach to this terrible condition is feasible," said Thomas Ichim, CEO of Medistem.

The RECOVER-ERC trial will treat a total of 60 patients with end-stage heart failure with three concentrations of ERC stem cells or placebo. The clinical trial is being conducted by Dr. Leo Bockeria, Chairman of the Backulev Centre for Cardiovascular Surgery, in collaboration with Dr. Amit Patel, Director of Clinical Regenerative Medicine at University of Utah.

"As a professional drug developer, I am very optimistic of a stem cell product that can be used as a drug. The ERC stem cell can be stored frozen indefinitely, does not need matching with donors, and can be injected in a simple 30-minute procedure into the heart," said Dr. Sergey Sablin, Vice President of Medistem and co-founder of the multi-billion dollar NASDAQ company Medivation.

Currently patients with end-stage heart failure, such as the ones enrolled in the RECOVER-ERC study, have no option except for heart transplantation, which is limited by side effects and lack of donors. In contrast to other stem cells, ERC can be manufactured inexpensively, do not require tissue matching, and can be administered in a minimally-invasive manner. Animal experiments suggest ERC are more potent than other stem cell sources at restoring heart function. The FDA has approved a clinical trial of ERC in treatment of critical limb ischemia in the USA.

About Medistem Inc. Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia and heart failure. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf.

Cautionary Statement This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain 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. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

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Medistem Achieves Important ERC Stem Cell Clinical Trial Milestone

Recommendation and review posted by simmons

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Stem cells tested for heart attack repair

Recommendation and review posted by Bethany Smith

SOUTHAMPTON, England, June 3 (UPI) -- British physicians say some patients with osteonecrosis who need hip replacements could be treated with stem cells from their own bone marrow.

The procedure, developed by Doug Dunlop of Southampton General Hospital in England, involves mixing the stem cells with cleaned, crushed bone from another patient who has had his own hip replaced and using it to fill the hole made after damaged tissue removed from the joint, The Daily Telegraph reported.

The new stem cell therapy could prevent the need for hip replacements due to osteonecrosis, a condition where poor blood supply causes significant bone damage leading to severe arthritis, Dunlop said.

The stem cells send chemical signals to blood vessels and it's hoped the new vessels in the hip would supply nutrients to improve bone strength, Dunlop explained.

Oesteoarthrits, caused by wear and tear of the bone, results from the temporary or permanent loss of blood flow to bones.

This causes osteonecrosis -- or the bones to "die" -- and ultimately severe arthritis, but if osteonecrosis occurs at the bone joint, it can cause it to collapse and the only option is a hip replacement, Dunlop said.

View post:
Stem cells may preclude hip replacements

Recommendation and review posted by Bethany Smith

SAN DIEGO, CA--(Marketwire -06/04/12)- Medistem Inc. (MEDS) announced today positive safety data from the first 5 patients enrolled in the Non-Revascularizable IschEmic Cardiomyopathy treated with Retrograde COronary Sinus Venous DElivery of Cell TheRapy (RECOVER-ERC) trial. The clinical trial uses the company's "Universal Donor" Endometrial Regenerative Cells (ERC) to treat Congestive Heart Failure (CHF).

According to the study design, after 5 patients enter the trial, they must be observed for a two month time period before additional patients are allowed to enter the study. Patient data was analyzed by the study's independent Data Safety Monitoring Board (DSMB), which concluded that based on lack of adverse effects, the study be allowed to continue recruitment.

"Medistem is developing a treatment for CHF that uses a 30-minute catheter-based procedure to administer the ERC stem cell into the patients' hearts. The achievement of 2 month patient follow-up with no adverse events is a strong signal for us that our new approach to this terrible condition is feasible," said Thomas Ichim, CEO of Medistem.

The RECOVER-ERC trial will treat a total of 60 patients with end-stage heart failure with three concentrations of ERC stem cells or placebo. The clinical trial is being conducted by Dr. Leo Bockeria, Chairman of the Backulev Centre for Cardiovascular Surgery, in collaboration with Dr. Amit Patel, Director of Clinical Regenerative Medicine at University of Utah.

"As a professional drug developer, I am very optimistic of a stem cell product that can be used as a drug. The ERC stem cell can be stored frozen indefinitely, does not need matching with donors, and can be injected in a simple 30-minute procedure into the heart," said Dr. Sergey Sablin, Vice President of Medistem and co-founder of the multi-billion dollar NASDAQ company Medivation.

Currently patients with end-stage heart failure, such as the ones enrolled in the RECOVER-ERC study, have no option except for heart transplantation, which is limited by side effects and lack of donors. In contrast to other stem cells, ERC can be manufactured inexpensively, do not require tissue matching, and can be administered in a minimally-invasive manner. Animal experiments suggest ERC are more potent than other stem cell sources at restoring heart function. The FDA has approved a clinical trial of ERC in treatment of critical limb ischemia in the USA.

About Medistem Inc. Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia and heart failure. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf.

Cautionary Statement This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain 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. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

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Medistem Achieves Important ERC Stem Cell Clinical Trial Milestone

Recommendation and review posted by Bethany Smith

Researchers successfully used this nanoparticle, made from several strands of DNA and RNA, to turn off a gene in tumor cells. Image: Hyukjin Lee and Ung Hee Lee

Using a technique known as nucleic acid origami, chemical engineers have built tiny particles made out of DNA and RNA that can deliver snippets of RNA directly to tumors, turning off genes expressed in cancer cells.

To achieve this type of gene shutdown, known as RNA interference, many researchers have tried with some success to deliver RNA with particles made from polymers or lipids. However, those materials can pose safety risks and are difficult to target, says Daniel Anderson, an associate professor of health sciences and technology and chemical engineering, and a member of the David H. Koch Institute for Integrative Cancer Research at MIT.

The new particles, developed by researchers at MIT, Alnylam Pharmaceuticals and Harvard Medical School, appear to overcome those challenges, Anderson says. Because the particles are made of DNA and RNA, they are biodegradable and pose no threat to the body. They can also be tagged with molecules of folate (vitamin B9) to target the abundance of folate receptors found on some tumors, including those associated with ovarian cancer one of the deadliest, hardest-to-treat cancers.

Anderson is senior author of a paper on the particles appearing in the June 3 issue of Nature Nanotechnology. Lead author of the paper is former MIT postdoc Hyukjin Lee, now an assistant professor at Ewha Womans University in Seoul, South Korea.

Genetic disruption

RNA interference (RNAi), a natural phenomenon that cells use to control their gene expression, has intrigued researchers since its discovery in 1998. Genetic information is normally carried from DNA in the nucleus to ribosomes, cellular structures where proteins are made. Short interfering RNA (siRNA) disrupts this process by binding to the messenger RNA molecules that carry DNAs instructions, destroying them before they reach the ribosome.

siRNA-delivering nanoparticles made of lipids, which Andersons lab and Alnylam are also developing, have shown some success in turning off cancer genes in animal studies, and clinical trials are now underway in patients with liver cancer. Nanoparticles tend to accumulate in the liver, spleen and lungs, so liver cancer is a natural target but it has been difficult to target such particles to tumors in other organs.

When you think of metastatic cancer, you dont want to just stop in the liver, Anderson says. You also want to get to more diverse sites.

Another obstacle to fulfilling the promise of RNAi has been finding ways to deliver the short strands of RNA without harming healthy tissues in the body. To avoid those possible side effects, Anderson and his colleagues decided to try delivering RNA in a simple package made of DNA. Using nucleic acid origami which allows researchers to construct 3-D shapes from short segments of DNA they fused six strands of DNA to create a tetrahedron (a six-edged, four-faced pyramid). A single RNA strand was then affixed to each edge of the tetrahedron.

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Researchers achieve RNA interference, in a lighter package

Recommendation and review posted by Bethany Smith

A recent study finds that Germans are incapable of enjoying life.

APPARENTLY, the Germans joy gene is kaput. As I scrolled down Der Spiegel online news about a week back, the headline, Study Finds Germans Incapable Of Enjoying Life, stood out.

It even trumped my original reason for trawling the website, which was to read commentaries on Bayern Munichs dismal defeat at the hands of Chelsea in the Champions League final, which I should add was (and remains) no laughing matter.

Anyway, Rheingold (a Cologne-based market research and consultancy institute) had found that 46% of Germans claim to be increasingly unable to enjoy anything due to the stress of daily life and the feeling of being constantly reachable. Fifty-five per cent of the studys younger participants even claimed to have lost their ability to feel good. The researchers concluded that, Our joy gene is increasingly defective weve forgotten how to enjoy ourselves.

While this is no scientific study, it remains an eyebrow raiser. Yet how reflective is it of reality?

I know Ive repeated myself oftentimes about the lack of spontaneity when it comes to fun pursuits like going for massages or catching up with the extended family for a mini-reunion.

The precision planning that goes into preparing for such activities, for example, often overwhelms me.

This is in stark contrast to the spur-of-the-moment adventures Ive had back home. One minute we are breakfasting on karipap sardin and kuih bom and the next minute my niece says, Shall we go to Malacca, ah? Three hours later, my sister, my niece and I were counting change at the Malacca toll plaza. We were there for only three days but returned rejuvenated and high on laughter and onde onde.

I bet if I were to float such an idea here to say, my mum-in-law, wed still be discussing logistics and the fact that it might not be such a good idea after all.

Our family reunion dates are fixed a year in advance and an activity programme is sent out to all members closer to the date via email for voting and approval. In other words, organised fun. Last minute tweaks to a finalised programme have on occasion caused consternation.

The rest is here:
Joy gene alert

Recommendation and review posted by Bethany Smith