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September 22, 2008, 10:22 PM CT

Half of trials supporting FDA applications go unpublished

Half of trials supporting FDA applications go unpublished
Over half of all supporting trials for FDA-approved drugs remained unpublished 5 years after approval, says new research published in this week's PLoS Medicine The most important trials determining efficacy, and those with statistically significant results and larger sample sizes, are more likely would be published.

Ida Sim and his colleagues from the University of California San Francisco searched the medical literature to determine the publication status of all 909 clinical trials that supported the 90 new drug approval applications approved by the US Food and Drug Administration (FDA) between 1998 and 2000. Eventhough 76% of the pivotal trials (typically large Phase II or III trials designed to provide evidence on the overall risks and benefits of a drug) had been published in medical journalscommonly within 3 years of FDA approvalonly 43% of all of the submitted trials had been published.

The scientists also found evidence of selective reporting of the results from these trials. For example, Sim and his colleagues report that a pivotal trial in which a new drug works better than an old drug is more likely would be published than a trial in which the new drug does no better. This is a form of publication bias that may lead to an inappropriately favorable record in the medical literature of a drug's true risk-benefit profile relative to other standard therapies, and can lead to preferential prescribing of newer and more-expensive therapys, say the authors.........

Posted by: Scott      Read more         Source


September 18, 2008, 10:39 PM CT

Breakthrough in spinal injury treatment

Breakthrough in spinal injury treatment
Manipulating embryo-derived stem cells before transplanting them may hold the key to optimizing stem cell technologies for repairing spinal cord injuries in humans. Research published in BioMed Central's open access Journal of Biology, may lead to cell based therapies for victims of paralysis to recover the use of their bodies without the risk of transplant induced pain syndromes.

Dr. Stephen Davies, Associate Professor of Neurosurgery at the University of Colorado Denver School of Medicine, reported that in collaboration with scientists at the University of Rochester, NY his research team has transplanted two types of the major support cells of the brain and spinal cord, cells called astrocytes. These two types of astrocytes, which are both made from the same embryo-derived stem cell-like precursor cell, have remarkably different effects on the spinal repair process.

Using signal molecules known to be involved in the generation of embryonic astrocytes during spinal cord development, the scientists were able to make pure cultures of two different types of astrocytes from the GRP cells.

When Dr. Davies and his team transplanted these two types of astrocytes into the injured spinal cord, they had dramatically different effects. One type of astrocyte called GDAsBMP was remarkably effective at promoting nerve regeneration and recovery of limb motion when transplanted into spinal cord injuries. However, the other type of astrocyte cell generated called GDAsCNTF, not only failed to promote nerve fiber regeneration or functional recovery but also caused neuropathic pain, a severe side effect that was not seen in rats treated with GDAsBMP.........

Posted by: Daniel      Read more         Source


September 16, 2008, 10:14 PM CT

Pazopanib shrinks lung cancers before surgery

Pazopanib shrinks lung cancers before surgery
Pazopanib, a new oral angiogenesis inhibitor, has demonstrated interesting activity in difficult to treat non-small-cell lung cancer, US scientists report.

In a phase II trial, 30 out of 35 patients treated with preoperative pazopanib for a minimum of two weeks saw their tumor size shrink by up to 85%.

"This is a positive result that will be explored further," said Prof. Nasser Altorki from Weil Medical College of Cornell University in New York.

"To my knowledge, no other results on the effect of angiogenesis inhibitors in early stage operable lung cancer have been published.

The results presented here with pazopanib indicate a highly active drug in this setting and further development in lung cancer is underway to fully understand the value of this drug in this disease".........

Posted by: Scott      Read more         Source


September 14, 2008, 10:39 PM CT

Extremely exact images from inside the body

Extremely exact images from inside the body
The magnet has reached his final position: it is surrounded by a cage of steel weighin 250 tons which will, in future, be used to protect the surrounding area from the magnetic field. The hole in the center of the magnet will be the "pipe" in which the patient will be pushed in order to be examined.
It will be the only magnetic resonance tomograph of the modern 7 tesla generation in the world, in which a metrology institute is also involved. Magnetic resonance tomographs, which use a magnetic field of 7 tesla, have still not been in operation in hospitals and clinics, but have solely served research. For the first time in the world, cardiovascular research carried out on such a device is now also to play an important role. The magnetic resonance tomograph costing approximately seven million Euros and weighing 35 tonnes was delivered to its new location, the Experimental and Clinical Research Center (ECRC) of the Max Delbrück Center (MDC) for Molecular Medicine in Berlin-Buch on 11th September.

In contrast to the 1.5 and 3 tesla devices which have largely been the norm to date, its higher magnetic field will provide sharper images and better insights into the smallest structures of the human body. The aim is to detect the risk or commencement of an illness at a very early stage in heart, brain and cancer research. Above all, heart research by magnetic resonance tomography is viewed as very difficult. As such, a demanding task will be waiting for PTB researchers from January 2009, when the device has been fully installed: as the partner dealing with physics and technical issues in the joint project, they are responsible for making the unique potential of this tomograph useful for applications in clinics. The PTB will, moreover, find the ideal conditions to advance its work on patient safety in high-field tomographs and on the development of new concepts in MRT imaging. The other partners in the project, besides the Max Delbrück Center and the PTB, are Siemens, the constructors of the 7 tesla device, and the Charite hospital. The new ultra-high-field MRT equipment of the ECRC has been completed with a 9.4 tesla small animal MRT of the Bruker company which was supplied three weeks ago.........

Posted by: Scott      Read more         Source


September 14, 2008, 10:13 PM CT

Tuberculosis drug shows promise against latent bacteria

Tuberculosis drug shows promise against latent bacteria
Tuberculosis bacilli
A new study has shown that an investigational drug (R207910, currently in clinical trials against multi-drug resistant tuberculosis strains) is quite effective at killing latent bacteria. This revelation suggests that R207910 may lead to improved and shortened therapys for this globally prevalent disease.

Despite numerous therapy advances, tuberculosis (TB) remains a serious disease fueled by co-infection of HIV patients, the rise of drug-resistant strains, and the ability of Mycobacterium tuberculosis to become dormant and linger in the lungs. In fact, one third of the world population is infected, asymptomatically, with latent TB and is at risk of developing active TB disease during their life time.

Anil Koul and his colleagues at Johnson & Johnson tested R207910 on dormant M. tuberculosis in three different laboratory models of latency. R207910 targets a protein (ATP synthase) essential for making cellular energy (ATP) in actively replicating TB. The scientists reasoned that even dormant bacteria, which are essentially physiologically "turned off", still need to produce small quantities of ATP to survive. As such, a block in ATP synthesis might be an Achilles heel for killing dormant bacteria.

This reasoning proved to be correct and R207190 was able to kill dormant bacteria by greater than 95% whereas current drugs like isoniazid had no effect. Surprisingly, they observed that R207910 is slightly more effective in killing dormant bacteria as in comparison to actively replicating ones, a unique spin as all known TB drugs are more effective on replicating bugs. Koul and his colleagues hope to validate these results clinically, and note that ATP synthase should be looked at as a drug target for other persistent bacterial infections.........

Posted by: Mark      Read more         Source


September 14, 2008, 10:07 PM CT

Faster, cheaper way of analyzing the human genome

Faster, cheaper way of analyzing the human genome
Investigators at the Translational Genomics Research Institute (TGen) today announced a faster and less expensive way for researchers to find which genes might affect human health.

Using bar-codes, not unlike what shoppers find in grocery stores, TGen scientists found a way to index portions of the nearly 3-billion-base human genetic code, making it easier for researchers to zero in on the regions most likely to show variations in genetic traits.

The findings were published recently in the online version of the journal Nature Methods The study will be published in print in the journal's October edition.

Dr. David Craig, associate director of TGen's Neurogenomics Division, said the new method should cost only one-tenth, or less, of the current cost of sequencing genes usually done to analyze Single Nucleotide Polymorphisms (SNPs), and in performing Genome-Wide Association (GWA) studies.

"Our goal is to find the genetic basis of disease,'' said Craig, the study's lead author. "It (the new method) provides us a way to immediately use next-generation sequencing technology for studying hundreds to thousands of individuals.''.

John Pearson, the head of TGen's Bioinformatics Research Unit, said the new method would allow researchers worldwide to more easily tune their sequencing experiments, and conduct their experiments with greater speed.........

Posted by: Scott      Read more         Source


September 11, 2008, 9:39 PM CT

Developing Drug to Stop Cancer Recurrence

Developing Drug to Stop Cancer Recurrence
After years of working toward this goal, researchers at the OU Cancer Institute have found a way to isolate cancer stem cells in tumors so they can target the cells and kill them, keeping cancer from returning.

A research team led by Courtney Houchen, M.D., and Shrikant Anant, Ph.D., discovered that a particular protein only appears in stem cells. Until now, scientists knew of proteins that appeared in both regular cancer cells and stem cells, but none that just identified a stem cell.

The group has already begun work to use the protein as a target for a new compound that once developed would kill the stem cells and kill the cancer. By targeting the stem cells, researchers and physicians also would be able to stop the cancer from returning.

Houchen and Anant are focusing on adult cancer stem cells because of the major role they play in the start of cancer, the growth of cancer, the spread of cancer and the return of cancer.

Current therapies generally do not target stem cells in tumors. This allows stem cells to wait until after chemotherapy or radiation therapys to begin dividing. Scientists believe these stem cells are often responsible for the return of cancer after therapy. The identification of the stem cell marker enables scientists to develop new therapeutics that can target these cells.........

Posted by: Janet      Read more         Source


September 11, 2008, 9:21 PM CT

Keeping nerve axons on target

Keeping nerve axons on target
When immature neurons are placed on a microscopic running track, where flanking lanes are carpeted with repellant factors, their growing axons remain in their lanes (top). Neurons from mice lacking p75 are unreceptive to repulsive cues: when placed on the track, their axons meander all over the field, crossing lanes and running down repellant-covered stripes (bottom).

Credit: Courtesy of Dr. Yoo-Shick Lim, Salk Institute for Biological Studies
Neurons constituting the optic nerve wire up to the brain in a highly dynamic way. Cell bodies in the developing retina sprout processes, called axons, which extend toward visual centers in the brain, lured by attractive cues and making U-turns when they take the wrong path. How they find targets so accurately is a central question of neuroscience today.

Using the mouse visual system, a team of Salk Institute for Biological Studies researchers led by Dennis O'Leary, Ph.D., identified an unanticipated factor that helps keep retinal axons from going astray. They report in the Sept. 11 issue of Neuron that p75, a protein previously known to regulate whether neurons live or die, leads a double life as an axon guidance protein.

"Historically, we thought that factors that mediate cell survival and those controlling axon guidance were part of two separate processes," says O'Leary, a professor in the Molecular Neurobiology Laboratory, "But in this study we show a direct interaction between these two systems".

Collaborating with Kuo-Fen Lee, Ph.D., professor in the Clayton Foundation Laboratories for Peptide Biology, the O'Leary team observed a defect in mice genetically engineered to lack p75. Through their synaptic connections, retinal axons develop a two-dimensional map of the retina in their targets in the brain. In the mice lacking p75, retinal axons stopped short of their final target and formed a map that was shifted forward to the superior colliculus, a major visual center in the brain.........

Posted by: Mike      Read more         Source


September 11, 2008, 8:29 PM CT

Mad cow disease also caused by genetic mutation

Mad cow disease also caused by genetic mutation
A. Richt, Regents Distinguished Professor of Diagnostic Medicine and Pathobiology at Kansas State University's College of Veterinary Medicine.

Credit: Juergen Richt

New findings about the causes of mad cow disease show that sometimes it may be genetic.

"We now know it's also in the genes of cattle," said Juergen A. Richt, Regents Distinguished Professor of Diagnostic Medicine and Pathobiology at Kansas State University's College of Veterinary Medicine.

Until several years ago, Richt said, it was thought that the cattle prion disease bovine spongiform encephalopathy -- also called BSE or mad cow disease -- was a foodborne disease. But his team's new findings suggest that mad cow disease also is caused by a genetic mutation within a gene called Prion Protein Gene. Prion proteins are proteins expressed abundantly in the brain and immune cells of mammals.

The research shows, for the first time, that a 10-year-old cow from Alabama with an atypical form of bovine spongiform encephalopathy had the same type of prion protein gene mutation as found in human patients with the genetic form of Creutzfeldt-Jakob disease, also called genetic CJD for short. Besides having a genetic origin, other human forms of prion diseases can be sporadic, as in sporadic CJD, as well as foodborne. That is, they are contracted when people eat products contaminated with mad cow disease. This form of Creutzfeldt-Jakob disease is called variant CJD.........

Posted by: Mark      Read more         Source


September 10, 2008, 10:11 PM CT

Immaturity of the brain may cause schizophrenia

Immaturity of the brain may cause schizophrenia
The underdevelopment of a specific region in the brain may lead to schizophrenia in individuals. As per research published recently in BioMed Central's open access journal Molecular Brain, dentate gyrus, which is located in the hippocampus in the brain and believed to be responsible for working memory and mood regulation, remained immature in an animal model of schizophrenia.

Professor Tsuyoshi Miyakawa of Fujita Health University, National Institute for Physiological Sciences (NIPS), and Kyoto University led a research team in Japan, with support from the CREST program of Japan Science and Technology Agency (JST). First, the team investigated behaviors by conducting a systematic and well-defined behavioral test battery with alpha-CaMKII mutant mice, an animal model of schizophrenia. These mice showed abnormal behaviors similar to those of schizophrenic patients. Next, the team found the dentate gyrus neurons in hippocampus of the brain of these mice were not matured morphologically and physiologically. By a gene expression analysis, changes of gene expression correlation to the maturation of dentate gyrus neurons were also found in the brains of schizophrenic patients. Taken together, the immaturity of the dentate gyrus may be an underlying cause for schizophrenia.........

Posted by: Daniel      Read more         Source



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Did you know?
Scientists at Yale have brought to light a mechanism that regulates the way an internal organelle, the Golgi apparatus, duplicates as cells prepare to divide, according to a report in Science Express.Graham Warren, professor of cell biology, and colleagues at Yale study Trypanosoma brucei, the parasite that causes Sleeping Sickness. Like a number of parasites, it is exceptionally streamlined and has only one of each internal organelle, making it ideal for studying processes of more complex organisms that have a number of copies in each cell.

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