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REGENERATIVE MEDICINE: NOVOCELL REPORTS SUCCESSFUL USE OF STEM CELLS TO GENERATE INSULIN IN MICE
San Diego-based Novocell said it demonstrated for the first time that human embryonic stem cells can be turned into pancreatic cells capable of producing insulin in mice. The findings are reported in an article appearing online in the journal Nature Biotechnology. This research provides evidence supporting the potential future use of human embryonic stem cells to replace insulin-producing pancreatic cells that are destroyed in people with Type 1 diabetes, requiring them to receive regular insulin treatment. The study showed that implantation of human embryonic stem cell-derived pancreatic cells into mice results in the generation of glucose-responsive insulin producing cells. These cells exhibit properties characteristic of functional adult pancreatic insulin producing cells in the pancreas. Most importantly, these cells provide protection in an animal model of diabetes characterized by loss of pancreatic insulin producing cells.

DIADEXUS: GETS FDA OK FOR AUTOMATED BLOOD TEST THAT IDENTIFIES STROKE, HEART ATTACK RISK
The. U.S. Food and Drug Administration has given South San Francisco, California-based diaDexus the green light to market a new automated version of its proprietary PLAC Test used to aid in assessing risk of both coronary heart disease and ischemic stroke associated with atherosclerosis. The new PLAC Test format is an automated immunoassay designed to run on common existing laboratory equipment, including clinical chemistry analyzers from Hitachi, Roche/Hitachi, and Olympus. The FDA’S move significantly expands the number of clinical labs and physician offices that are able to offer the PLAC Test, the company said. The PLAC Test is a simple blood test that measures lipoprotein-associated phospholipase A2 (Lp-PLA2), an enzyme specific to vascular inflammation implicated in the formation of rupture-prone plaque. The latest format is manufactured for diaDexus by Denka Seiken, based in Tokyo, a leading global diagnostics manufacturer. The privately held company said that a substantial body of evidence published in peer-reviewed journals supports Lp-PLA2 as a cardiovascular risk marker that provides new information, over and above traditional risk factors, to help uncover hidden heart attack and stroke risk.

PERSONALIZED MEDICINE: PLEXXIKON DATA DEMONSTRATES POSSIBLE APPROACH TO VARIETY OF CANCERS
Berkeley, California-based Plexxikon said studies of its targeted cancer compound, published in The Proceedings of the National Academy of Sciences by a team of scientists from the company and the Wistar Institute, show it may provide a personalized medicine approach to a variety of cancers. Plexxikon’s anti-cancer compound selectively destroys tumor cells that contain the B-RafV600E cancer-causing mutation, a defect present in most melanomas and thyroid tumors and a large number of colorectal and other cancers. Patients with the BRAFV600E gene may have particularly aggressive tumors often resulting in much poorer survival outcomes. Plexxikon said it has identified a portfolio of anti-cancer compounds that selectively kill cells with the B-RafV600E mutation, leaving healthy cells unharmed since the mutation only occurs in tumor cells. Plexxikon is conducting a Phase I clinical trial utilizing PLX4032, one of Plexxikon’s selective B-RafV600E inhibitors, in collaboration with Roche. Separately, Plexxikon and Roche Molecular Diagnostics collaborated to develop a test to identify patients who carry the tumor mutations and for whom a selective B-RafV600E inhibitor may have the greatest therapeutic benefit.

HIV: RESERACHERS FIND THERAPY TO STIMULATE PRODUCTION OF T-CELLS COULD FIGHT VIRUS
Scientists at San Francisco’s Gladstone Institute of Virology and Immunology and the University of California at San Francisco have found that therapy can be used to stimulate the production of vital immune cells, so-called “T- cells,” in adults with HIV infection. HIV disease destroys T-cells, leading to collapse of the immune system and severe infection. The thymus gland, which produces T-cells, gradually loses function over time (a process called “involution”) and becomes mostly inactive during adulthood. Because the thymus gland does not function well in adults, it is difficult for HIV-infected adults to make new T-cells. Thus, therapies that stimulate the thymus to produce new T-cells could help HIV-infected patients to rebuild their embattled immune systems, the researchers said. Although it has been long assumed that the thymus cannot be reactivated in humans, research published in the March issue of the Journal of Clinical Investigation, shows that the thymus can be stimulated to produce more T-cells. This study is the first to show that pharmacologic therapies can be used to enhance human thymic function.

BRAIN CANCER: GENE THERAPY “TRAINS” IMMUNE SYSTEM TO DESTROY MALIGNANT CELLS
Researchers at Cedars-Sinai Medical Center’s Board of Governors Gene Therapeutics Research Institute in Los Angeles said a new gene therapy approach attracts and “trains” immune system cells to destroy deadly brain cancer cells. The therapy, tested in rats, also provides long-term immunity, produces no significant adverse effects and—in the process of destroying the tumor—promotes the return of normal brain function and behavioral skills. The study, published in the journal Molecular Therapy, was conducted in a recently developed laboratory rat model of glioblastoma multiforme. The model closely simulates outcomes in humans and supports the translation of this procedure to human clinical trials later this year, researchers said. Glioblastoma multiforme, the most common and deadly type of brain cancer, usually claims the lives of victims within six to 12 months of diagnosis and is extremely difficult to treat. The researchers used a virus stripped of its disease-causing genes as a vehicle to deliver two therapeutic proteins directly into the tumor cells. Researchers said the therapy significantly improved survival rate, induced long-lasting systemic anti-tumor immunity, and resolved the neuropathological abnormalities caused by the tumors, which has been a stumbling block to many promising treatments.

MULTIPLE SCLEROSIS: STANFORD RESEARCHERS FIND PROTEIN TARGETS FOR POTENTIAL TREATMENT
Stanford University School of Medicine researchers have identified therapy targets that could lead to personalized treatments for patients at each phase of multiple sclerosis, which leads to a variety of neurological disorders. The team essentially cataloged all of the brain-tissue proteins that they found were distinct to three discrete stages of multiple sclerosis. When they tested drugs that block two of these proteins in a mouse model of multiple sclerosis, the mice improved dramatically, researchers said. Multiple sclerosis, which affects more than 2.5 million people worldwide, develops when the immune system launches an attack against the myelin sheath surrounding nerve cells, causing them to misfire. The research, published in Nature, found that when drugs blocked two of the proteins found in the chronic-active phase (long-term myelin damage and areas of recent inflammation) of multiple sclerosis, mice with the symptoms of MS showed improvement in the severity of their disease. The two proteins were tissue factor, which is involved in the coagulation of blood, and protein C inhibitor, which blocks the anticoagulant protein C.

APPLIED BIO: NEW FORENSIC TESTING KIT WILL IMPROVE DNA ANALYSIS IN ASSAULT CASES
Applied Biosystems, based in Foster City, California, said its new forensic testing kit will enable forensic labs to obtain more predictive and comprehensive information from complicated DNA evidence earlier in the testing process, helping to improve results from sexual assault cases and other challenging samples that previously yielded limited or no results. The company said samples from sexual assault cases can be difficult to analyze because of the mixtures of male and female DNA, making it hard to recover key information in up to 20 percent of the cases. The new kit, the company said, simultaneously provides a quantitative and qualitative assessment of total human female and human male DNA and more accurately estimates the quantity of DNA in degraded samples. This efficiently provides the male-to-female DNA mixture ratio, guides selection of the optimal DNA profiling chemistry kit, and is expected to increase analysis success rates, the company said. In particular, labs will be able to detect low amounts of male DNA mixed with high quantities of female DNA and compare that to the total amount of DNA in each sample, Applied Bio said.

HOLOGENIX: SPECIAL TEXTILE APPEARS TO REDUCE PAIN AS WELL AS INCREASE OXYGEN LEVELS
Newport Beach California-based Hologenix, which makes a fabric designed to increase oxygen levels in the body, said early data analysis from a clinical study suggests the product called Celliant also reduces pain. The magnitude of pain relief reported by participants using products enhanced with Celliant was much greater than that reported by participants using placebo products, according to the recent research conducted by scientists affiliated with Long Beach VA Healthcare System and UCI Medical Center. Hologenix sponsored the trials in the double-blind study, which used measurement techniques employed in FDA-supervised clinical trials of pain relief medications. Celliant is a specially formulated material that is knit, woven, or added to fabrics to enhance oxygen levels in the body. The company said increased oxygen levels have been clinically proven to relieve pain, promote quicker healing, improve sleep quality, heighten athletic performance, and improve overall wellness. The company said study subjects who suffered from diabetic neuropathic pain as well as a second group of non-diabetic subjects experienced significant pain relief using Celliant. Hologenix added that the research team is planning to submit the results to a peer-reviewed medical journal and are not disclosing any further details to avoid compromising evaluation by the scientific community.

BREAST CANCER: BIONOVO REPORTS POSITIVE DEVELOPMENTS IN ONGOING PHASE I/II TRIAL
Emeryville, California-based Bionovo said that the higher doses of its breast cancer drug candidate, BZL101 were well tolerated. As a result, the company will be extending the dose escalation portion of the study longer than previously stated. The company had expected to reach the maximum tolerated dose earlier, and then transition to the full Phase 2 component of the trial with that dose. Instead, it said it has seen “very favorable” tolerability data at the higher doses, and will continue to escalate the dose. The company plans to continue the dose escalation as long as it continues to see favorable tolerability and safety, after which it will transition to the full phase II study. BZL101 is an oral drug designed for the treatment of advanced breast cancer and pancreatic cancer with a novel mechanism of action. BZL101 targets cancer cells while leaving normal cells healthy and intact. Normal cells depend primarily on the citric acid cycle and very little on glycolysis for energy production. In contrast, cancer cells depend largely on glycolysis for energy production. BZL101 leads to energy collapse in cancer cells by inhibiting glycolysis. This leads to DNA damage and cell death in cancer cells while normal cells remain unharmed.

COLLABORATION: GEISINGER AND CELERA TO WORK TOGETHER ON LIVER DISEASE TEST
Health services company Geisinger Health System and diagnostics firm Celera have formed a research pact to develop a diagnostic test for the increased risk of non-alcoholic steatohepatitis, or NASH, which is an advanced stage of a condition where there is accumulation of excess fat in the liver. The accumulated fat results in significant inflammation and scarring. The collaboration will evaluate Alameda, California-based Celera’s numerous genetic findings in liver diseases, including a risk score for cirrhosis, in the Danville, Pennsylvania-based Geisinger’s bank of more than 600 liver tissue and blood case-control samples donated from patients who have undergone bariatric weight loss surgery. The companies said that better knowledge of those individuals most likely to suffer from NASH, which can lead to cirrhosis, could enable closer monitoring of these individuals, resulting in better overall disease management. Researchers involved with the project said the development of a blood test to detect risk for non-alcoholic fatty liver disease, the earlier stage of the disease, would be a tremendous benefit to patients as currently a needle liver biopsy is the only way to definitively diagnose the disease. Financial terms of the deal were not disclosed.