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A Low Dose of Dietary Resveratrol Partially Mimics Caloric Restriction and Retards Aging Parameters in Mice   Resveratrol, a natural compound found in grapes and red wine has previously been shown to extend lifespan in S. cerevisiae, C. elegans and Drosophila through a SIRT1 dependent mechanism. A recent paper published in the journal PLoSOne suggests that a low dose of Resveratrol partially mimics Caloric Restriction at the gene expression level and leads to prevention of some age-related parameters. The authors suggest that clinical trials with resveratrol should be conducted to test the relevance of these findings to humans. Because cardiac disease is a major contributor to age-related mortality, positive findings could lead to a novel and important approach to improve the quality of human life.   Citation: Barger JL, Kayo T, Vann JM, Arias EB, Wang J, et al. (2008) A Low Dose of Dietary Resveratrol Partially Mimics Caloric Restriction and Retards Aging Parameters in Mice. PLoS ONE 3(6): e2264. doi:10.1371/journal.pone.0002264   Abstract Resveratrol in high doses has been shown to extend lifespan in some studies in invertebrates and to prevent early mortality in mice fed a high-fat diet. We fed mice from middle age (14-months) to old age (30-months) either a control diet, a low dose of resveratrol (4.9 mg kg−1 day−1), or a calorie restricted (CR) diet and examined genome-wide transcriptional profiles. We report a striking transcriptional overlap of CR and resveratrol in heart, skeletal muscle and brain. Both dietary interventions inhibit gene expression profiles associated with cardiac and skeletal muscle aging, and prevent age-related cardiac dysfunction. Dietary resveratrol also mimics the effects of CR in insulin mediated glucose uptake in muscle. Gene expression profiling suggests that both CR and resveratrol may retard some aspects of aging through alterations in chromatin structure and transcription. Resveratrol, at doses that can be readily achieved in humans, fulfills the definition of a dietary compound that mimics some aspects of CR.   Read the full-length article at: http://www.plosone.org/article/fetchArticle.action?articleURI=info:doi/10.1371/journal.pone.0002264   Published: June 4, 2008   Copyright: © 2008 Barger et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Bacteria "Feed" on Earth's Ocean-Bottom Crust     --Rocks on and under seafloor offer feast for microbes--    Image Credit: NSF. Scientists have found that rocks beneath the seafloor are teeming with microbial life.   Seafloor bacteria on ocean-bottom rocks are more abundant and diverse than previously thought, appearing to "feed" on the planet's oceanic crust, according to results of a study reported in this week's issue of the journal Nature. The findings pose intriguing questions about ocean chemistry and the co-evolution of Earth and life.   Once considered a barren plain dotted with hydrothermal vents, the seafloor's rocky regions appear to be teeming with microbial life, say scientists from the Woods Hole Oceanographic Institution (WHOI) in Woods Hole, Mass., University of Southern California (USC) in Los Angeles, and other institutions.   While seafloor microbes have been detected before, this is the first time they have been quantified. Using genetic analyses, Cara Santelli of WHOI, Katrina Edwards of USC, and colleagues found three to four times more bacteria living on exposed rock than in the waters above.  "Initial research predicted that life could in fact exist in such a cold, dark, rocky environment," said Santelli. "But we really didn't expect to find it thriving at the levels we observed."   Surprised by this diversity, the scientists tested more than one site and arrived at consistent results, making it likely, according to Santelli and Edwards, that rich microbial life extends across the ocean floor. "This may represent the largest surface area on Earth for microbes to colonize," said Edwards.   "These scientists used modern molecular methods to quantify the microbial biomass and estimate the diversity of microbes in deep-sea environments," said David Garrison, director of the National Science Foundation (NSF)'s Biological Oceanography Program. NSF's Ridge 2000 program funded the research. "We now know that this remote region is teeming with microbes, more so than anyone had guessed."   Santelli and Edwards also found that the higher microbial diversity on ocean-bottom rocks compared favorably with other life-rich places in the oceans, such as hydrothermal vents.   These findings raise the question of where these bacteria find their energy, Santelli said. "We scratched our heads about what was supporting this high level of growth," Edwards said.   With evidence that the oceanic crust supports more bacteria than overlying water, the scientists hypothesized that reactions with the rocks themselves might offer fuel for life. In the lab, they calculated how much biomass could be supported by chemical reactions with the rocky basalt. They then compared this figure to the actual biomass measured. "It was completely consistent," Edwards said.   This discovery lends support to the idea that bacteria survive on energy from Earth's crust, a process that could add to our knowledge about the deep-sea carbon cycle and the evolution of life.   Many scientists believe that shallow water, not deep water, is better suited for cradling the planet's first life forms. Up until now, dark, carbon-poor ocean depths appeared to offer little energy, and rich environments like hydrothermal vents were thought to be relatively sparse. But the newfound abundance of seafloor microbes makes it possible that early life thrived--and perhaps began--on the seafloor.   "If we can really nail down what's going on, there are significant implications," Edwards said. "I hope that people turn their heads and notice: there's life down there."   In addition to Santelli and Edwards, the paper's co-authors are: Beth Orcutt of USC; Erin Banning of WHOI; Wolfgang Bach of WHOI and Universität Bremen; Craig Moyer of Western Washington University; Mitchell Sogin of the Marine Biological Laboratory; and Hubert Staudigel of the Scripps Institution of Oceanography.   The research was also funded by the NASA Astrobiology Institute and Western Washington University.   Source: Credit NSF Press Release http://www.nsf.gov

NEUBLASTIN VIRTUALLY RESTORES COMPLETE LONG-TERM SENSORY MOTOR FUNCTION IN PRECLINICAL STUDIES --Findings by Biogen Idec, University of Arizona and Tufts University Reported in Nature Neuroscience--   Cambridge, MA -- March 24, 2008 -- Biogen Idec, in collaboration with scientists at the University of Arizona and Tufts University reported in the April issue of the journal Nature Neuroscience that in preclinical studies, injections of the protein neublastin (also known as artemin) promoted the regeneration of damaged sensory nerve cells and produced virtually complete, long-term restoration of sensory and motor function. These studies suggest neublastin has potential for further development as a treatment for traumatic nerve injury.   Neublastin, also known as artemin, belongs to a family of proteins, called glial-derived neurotrophic factors (GDNF), which promote nerve cell survival. The protein is unique because it acts selectively on sensory neurons. In previous preclinical studies, neublastin reversed a number of features of chronic pain associated with peripheral nerve injury.   Specifically in the studies, six neublastin injections were administered over 11 days following injury to the dorsal root, a bundle of peripheral nerve fibers adjacent to the spinal cord that transmit sensory information to the central nervous system. The injections promoted nerve growth into the spinal cord and restored the ability to respond normally to a variety of sensory stimuli and perform complex motor activities such as grasping an object on contact. The functional recovery occurred even after a two-day delay in administering neublastin and lasted for more than six months.   "Sensory nerves entering the spinal cord have minimal capacity to regenerate and severe injury often results in permanent loss of sensory functions," said Frank Porreca, PhD, Professor of Pharmacology at the University of Arizona, the study's senior author. "The results of our preclinical studies, showing dramatic, long-term recovery of pain sensation and complex motor skills after neublastin injections, represent an important and novel advance in research efforts in the area of traumatic nerve injury."   In a series of biochemical, molecular and electrophysiology studies, the researchers also demonstrated that neublastin promoted the regeneration of multiple classes of nerve cells back into the spinal cord and the re-establishment of functional connections with their spinal targets.   "These exciting results support further research, as the data suggest that neublastin may have the potential to promote sensory neuronal regeneration and functional recovery following injury," said Ken Rhodes, PhD, Vice President, Discovery Neurobiology, Biogen Idec. "The neublastin program is part of Biogen Idec's commitment to innovative neurological science and discovery."   Biogen Idec is developing neublastin for use in treating peripheral nervous system diseases under an exclusive license from NsGene. Scientists at NsGene discovered neublastin in 1998.   About Biogen Idec Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.   Source: Biogen Idec Press Release   Share your Favorite Biotech/Pharma/Medicine/Clinical Trials articles on Your Helix!-Professional Networking Site Designed for Biotech/Pharma Community:

X-treme Microbes They’re called extremophiles and they live in hellish places once thought uninhabitable. Now, they’re revealing their secrets to science … Credit: National Science Foundation Report View Special Flash Report at: http://www.nsf.gov/news/special_reports/microbes/index.jsp RADIATION EATERS Two miles deep in solid rock, researchers discovered super-exotic bacteria that get their food from radioactivity. AMAZING SURVIVORS They evolved to thrive in hostile environments, including bone-dry deserts, boiling acid, horrendous heat and incredible cold.   Radiation Eaters   Overview Not so long ago, everyone believed that the primary source of energy for all life was sunlight. Even for carnivores: After all, they eat herbivores that eat vegetation produced by photosynthesis. Ditto for bacteria stuck in the perpetual dark of the human gut, or for lightless ocean-bottom ecosystems that utilize oxygen dissolved in seawater—oxygen created by sunshine in plants and algae above. Ultimately, it seemed, everything depended on the Sun. But in the 1960s, scientists began discovering exotic organisms that play by astonishingly different rules, such as microbes living in near-boiling water or high-acidity environments. Now, a team searching deep in a South African gold mine has found one that redefines the very limits of life: Bacteria that subsist in rock at huge pressure for thousands of years by ’eating‘ by-products of radioactivity, completely isolated from any organic matter or effects of photosynthesis. Tullis Onstott of Princeton University, Lisa Pratt of Indiana University and colleagues think the microbes may have first trickled down there between three and 25 million years ago. The microbes were forced to survive on the leftovers that result when radioactivity from uranium, thorium and potassium in the native rock breaks down molecules of water, prompting a sequence of chemical reactions that produce hydrogen peroxide, break down pyrite, and form sulfates. They developed a way of taking metabolic advantage of these reactions that is very different from the processes used by their conventional topside cousins. These rock-dwellers may be some of above-ground life’s oldest relatives. Pratt and Onstott suspect that they’re probably not much different now than when they were separated from the surface, because they grow very slowly to conserve scarce nutrients. In fact, ’very slowly‘ is an understatement: Whereas E. coli, like those found in the intestines of mammals, divide every day or so, the subsurface microbes reproduce once a year at most, and possibly only every 300 years … or more!    So far, researchers haven’t been able to grow them in the lab under the microbes’ natural conditions. But they are working on genomic sequencing to evaluate how closely related the newly discovered bacteria are to other extremophiles and surface organisms. In the future, those studies may change the way instruments look for life on Mars. And they may even begin to answer the question: Did life on Earth begin underground? ---- Amazing Survivors    Overview Extremophiles are organisms capable of living in conditions that would kill other life-forms, including intense cold, heat, pressure, dehydration, acidity/alkalinity and other chemical and physical extremes. A few animals, such as frogs that freeze solid in winter, can qualify. But in large part, the world’s endurance champs are microbes: bacteria and archaea.   They’re at home in some of the most forbidding pockets of the planet, where scientists are studying their survival mechanisms—and probing the outermost boundaries of life.   Life can’t exist without any water. But research is showing how shockingly little is necessary. Even in the planet’s driest places—such as the Atacama high desert in Chile or the Dry Valleys in Antarctica—scientists have found that microbes can set up shop a few inches below the surface. In such circumstances, certain extremophiles have evolved novel biochemistry with functions that compensate in some respects for lack of water. Investigators are studying the DNA of these survivors to determine which genes contribute to the cells’ abilities.   Other organisms found in Atacama and elsewhere can enter a seemingly lifeless, freeze-dried state, reviving only if and when some water appears. In the ultra-arid Dry Valleys, for example, researchers recently discovered that a mat of cells that had been dormant for two decades began photosynthesis within a day of exposure to liquid water. And a few marvelous microbes, tested in experiments on the space shuttle, have even survived the vacuum and radiation bombardment of empty space. Lots of creatures can live in the cold. But it takes special talents for cells to survive at the South Pole, where temperatures often drop below -100 F. Yet that’s where scientists found a certain kind of bacteria that can get through the polar winter and have active metabolisms in surroundings as cold as 1.4 F. That’s just one of many creatures specially adapted to extremely frigid venues. Researchers uncovered microbes in an ice core extracted from just above Lake Vostok, an ancient body of water buried thousands of feet below the Antarctic ice surface. At the other end of the Earth, extreme-tolerant organisms have shown up in the permafrost of northern Alaska.   Laboratory studies have shown that many cold-surviving life-forms (collectively known as psychrophiles) have remarkable cellular ingredients that prevent the formation of ice crystals. Others have evolved a talent for huddling together into mats called biofilms. Many can’t live at all above 50 F. It’s just too hot. Miles below the ocean surface on the lightless seafloor, giant cracks in the Earth’s crust create sites where mineral-dense water—heated to 600 F—spews forth in roiling clouds. It’s as forbidding an environment as one could imagine. Yet scientists have found hosts of organisms that have learned to thrive there. In those circumstances, of course, photosynthesis simply isn’t possible. But certain kinds of single-celled archaea have developed a unique alternative called chemosynthesis: a means of converting inorganic hydrogen sulfide dissolved from rocks into food. Archaea living on or under the seafloor make up vast microbial mats and other configurations that provide the foundation for a bizarre and abundant community of towering tube worms, gigantic clams and mussels, and strange fish and crabs that can withstand the titanic pressure and utter dark.   When it comes to acidity versus alkalinity, most mammals are wimps. On the pH scale, 7 is neutral. The lower the number, the more acidic; the higher, the more alkaline. Human blood has to stay between 6.8 and 7.8 to support life. But nature is replete with creatures that thrive on the extreme ends of the pH scale.   In Yellowstone National Park, for example, researchers took water samples and found organisms fully adapted to extremely hot acidic conditions. In California, other scientists studying the contents of mine drainage revealed incredibly tiny microbes living comfortably at a pH level as low as 0.5—the equivalent of battery acid.   On the double-digit side of the scale, soda lakes in Africa with a pH around 10 (about the same as drain unclogger) support dozens of microbial species with specially evolved chemistry that keeps the pH inside the cells neutral.   Lab studies of both acidophiles and alkalophiles continue to show the remarkable—and often unexpected—range of conditions to which life can adapt. Share your Favorite articles on the following Social Networks: Share on Facebook

Results from Study of Brain Electrical Activity Using Cyberkinetics' NeuroPort(TM) System at the American Epilepsy Society Meeting   --Neural monitoring technology shown to identify micro-seizure activity that precedes significant epileptic seizures--   --Advanced brain activity monitoring could help to improve treatment of epilepsy and other neurological disorders-   FOXBOROUGH, Mass---Researchers from Cyberkinetics Inc. were successfully able to record and monitor brain electrical activity with improved precision and detect micro-seizure activity in advance of larger epileptic seizures among patients implanted with the NeuroPort(TM) Neural Monitoring System (NeuroPort(TM) System) developed by Cyberkinetics Neurotechnology Systems, Inc. Results from an ongoing study at Columbia University Medical Center were presented on Saturday, December 1, 2007, at the 61st Annual Meeting of the American Epilepsy Society in Philadelphia, Pennsylvania.   Led by Ronald G. Emerson, M.D., and Catherine Schevon, M.D., Ph.D., the research team reported results from patients who had the NeuroPort(TM) sensor implanted, along with standard intracranial electroencephalography sensors. Using the NeuroPort(TM) System, researchers were able to:       --  successfully record and monitor brain electrical activity with         higher fidelity than is possible with other recording         technologies;       --  detect micro-seizures and micro-discharges in patients with         epilepsy that may play a role in the genesis of their         seizures, but that are not detectible by scalp or standard         electrodes placed directly on the brain; and       --  correlate this micro-activity to the onset of significant         epileptic seizure activity.   "With this sensor, we were able for the first time to observe micro-seizure activity in the brain that appears to precede epileptic seizures in some patients," stated Ronald G. Emerson, M.D., a lead investigator on the study and professor of clinical neurology in the Columbia Comprehensive Epilepsy Center at Columbia University College of Physicians & Surgeons and a member of the hospital staff at the New York-Presbyterian Hospital. "The ability to monitor brain activity with this level of precision could help us to identify the onset and progression of seizures in the years ahead. It may also help us more accurately identify brain tissue to be removed during surgical treatment of epilepsy."   Up to three percent of people in the United States will develop epilepsy in their lifetime. Approximately 50,000 people are diagnosed each year with epilepsy, nearly one third of whom are medically intractable, that is, unable to control seizure activity with drug treatment. Of people with intractable epilepsy, nearly one third would qualify as candidates for epilepsy surgery, though as few as 1,000 annually are actually referred for this procedure. According to the Epilepsy Foundation, annual direct and indirect medical costs to treat epilepsy in the United States alone exceed $12 billion.   "From a small sample area of the brain, this new monitoring system provides us with high quality information about the genesis and evolution of seizure activity," added Catherine Schevon, M.D., Ph.D., co-lead investigator and assistant professor of clinical neurology in the Columbia Comprehensive Epilepsy Center at Columbia University College of Physicians & Surgeons and a member of the hospital staff at the NewYork-Presbyterian Hospital. "These results expand our understanding of brain seizure activity and we hope it will someday enable us to develop more effective ways to detect and treat seizure disorders."   Cyberkinetics' NeuroPort(TM) System is a medical device indicated for the temporary (less than 30 days) recording and monitoring of brain electrical activity. It consists of a 4 x 4 mm, 100-microelectrode array and a signal processor. The array is implanted on the surface of the brain where the electrodes sense electrical activity from individual and groups of neurons. Cleared to market in the United States, the NeuroPort System is designed to provide neurologists and neurosurgeons with detailed, cellular-level information regarding the electrical activity of the brain, which might lead to more accurate diagnoses and enhanced patient outcomes.   "The medical, productivity and personal costs associated with the treatment of epilepsy represent a significant burden to the healthcare system and to society," added Timothy R. Surgenor, President and Chief Executive Officer of Cyberkinetics. "We believe that our NeuroPort(TM) technology could one day enable physicians to better locate seizure activity and treat epilepsy to help more patients adequately control this condition."   In March 2006, Cyberkinetics and Columbia University Medical Center signed a collaborative agreement to evaluate the utility of brain electrical activity recordings obtained using Cyberkinetics' NeuroPort(TM) System. Columbia intends to use the NeuroPort(TM) System to improve the understanding of certain abnormal human brain processes, which may include those commonly associated with epileptic seizures, Parkinson's disease and other movement disorders, as well as many other neurological diseases. The investigative team led by Dr. Emerson includes neurosurgeons, neurologists and neurophysiologists who are co-investigators with the research collaboration. To date, seven patients have received the NeuroPort(TM) System in the study.   About Cyberkinetics Neurotechnology Systems, Inc. Cyberkinetics Neurotechnology Systems, Inc., a leader in the neurotechnology industry, is developing neural stimulation, sensing and processing technology to improve the lives of those with severe paralysis resulting from spinal cord injuries, neurological disorders and other conditions of the nervous system. Cyberkinetics' product development pipeline includes: the Andara(TM) Oscillating Field Stimulator (OFS(TM)) Device, an investigative device designed to stimulate regeneration of the neural tissue surrounding the spinal cord and to restore sensation and motor function; the BrainGate System, an investigative device designed to provide communication and control of a computer, assistive devices, and, ultimately, limb movement; and the NeuroPort(TM) System, which is cleared to market in the United States, a neural monitor designed for acute inpatient applications and labeled for temporary (less than 30 days) recording and monitoring of brain electrical activity. Additional Information is available at Cyberkinetics' website at www.cyberkinetics.com . Share your Favorite articles on the following Social Networks: Share on Facebook

MEDICINEANDBIOTECH.COM LISTS PIVOTAL BIOTECH AND MEDICAL TECHNOLOGIES OF THE FUTURE e-published on MedicineandBiotech.com Jan 1st, 2007   1. Biochips for Improved Drug, DNA and Chemical testing   -         A better, cheaper  alternative to animal testing in drug development-   Biochips or MetaChips or DataChips are glass slides with nanoliter droplets of proteins or human enzymes or cells. For example a biochip with human liver enzymes can determine the toxicity results of a drug when exposed to human liver enzymes. A DataChip is similar but contains cell culture droplets from various human organs like liver, kidney, etc. and can examine the toxic effect of a compound on these cells. MetaChip and DataChip are now a reality because scientists are able to isolate and generate p450 liver enzymes as well as make three-dimensional cell cultures in droplets.   These Biochips can enable much cheaper pharmacological and toxicity studies of drug compounds of interest without the use of animals, plus these studies can be initiated much earlier in the R&D phase. Demand for biochip technology will definitely increase soon in response to a European Union ban on testing on animals set to take effect in March 2009.     2. Neurotechnologies   Technologies aimed at improving damaged nervous systems and neural functions will be key in the future. Neurotechnologies for neural stimulation, sensing and processing technology to improve the lives of those with severe paralysis resulting from spinal cord injuries, neurological disorders and other conditions of the nervous system will be in demand. An example is Cyberkinetics' product development pipeline that includes: Andara(TM) OFS(TM) Therapy for acute spinal cord injury, an investigative device designed to stimulate nerve repair and restore sensation and motor function; the BrainGate System, an investigative device designed to provide communication and control of a computer, assistive devices, and, ultimately, limb movement; and a pilot program in the detection and prediction of seizures due to epilepsy.   The Andara(TM) OFS(TM) System is intended as a treatment option for people with acute spinal cord injuries. The device is designed to be implanted in patients within 18 days following a spinal cord injury to stimulate nerves to grow across the area of injury. Though the device is removed after 15 weeks of treatment, improvement in both sensory and motor function may continue for months, even years, as nerves form new connections to transmit information to and from the brain.   VIEW VIDEO of The Andara(TM) OFS(TM) System

3. i-Snake -The future of surgery is in smart devices like i-Snake.   Experts are developing a flexible surgical robot, known as the i-Snake, which they say could revolutionize keyhole surgery. It could enable surgeons to do complex procedures previously possible only through more invasive techniques.   A team at Imperial College London has been granted £2.1 million for the work. They envisage using the i-Snake - a long tube housing special motors, sensors and imaging tools - for heart bypass surgery.   But it could also be used to diagnose problems in the gut and bowel by acting as the surgeon's hands and eyes in hard to reach places inside the body. The Imperial College team, which includes health minister and surgeon Lord Ara Darzi, will test the device initially in the laboratory before it is used on patients.    KEYHOLE SURGERY MILESTONES 1900s - Mirrors, lights and lenses attached to endoscopic tubes are used to examine bodies' interiors 1930s - Fibre-optics offer an essential light source; endoscopes now thinner and more flexible 1970s - Cameras attached to endoscopes mean that surgeons can operate from images on a screen. Lasers developed which can perform surgery   Minimally invasive surgery has obvious advantages - it can mean smaller scars, reduced hospital stays and shorter recovery times. Surgeons are also looking at ways to avoid skin incisions altogether. One approach is Natural Orifice Translumenal Endoscopic Surgery or Notes. This means operating in the peritoneal space through natural orifices or cavities, such as the bowel. The unrivalled imaging and sensing capabilities coupled with the accessibility and sensitivity of i-Snake will enable more complex diagnostic and therapeutic procedures than are currently possible. The cost benefits that i-Snake will introduce include earlier, cheaper and less invasive treatment, faster recovery and procedure times and intangible benefits through an increase in patient care and quality of life.     4. Molecular Methods for Early Diagnosis of Cancer in Circulating Blood, Serum or Cells   Researchers have now discovered molecular signposts pointing to the presence of cancer, and those signs can provide physicians with early and, in some cases, more specific cancer detection opportunities. The goal of screening and early detection is to identify primary tumors at initial stages of development when they can be successfully controlled or cured with local therapy. Most cancer deaths are caused by metastatic disease, later stage tumors that spread to other sites in the patient. Clinical monitoring of molecular markers of primary tumors and metastasis allows for early response strategies in the treatment to control or cure the disease.   * An example is the LC Detectsm  Test by Panacea Laboratories. LCDetect is a serum test for lung cancer screening. It works by measuring the serum levels of Human Aspartyl (Asparaginyl) β-Hydroxylase (HAAH). LC Detectsm is recommended for men and women, 50 years of age or older, who have smoked cigarettes extensively in the past, regardless of whether they currently smoke. HAAH levels in the serum of individuals with lung cancer are three-fold higher when compared to individuals who are cancer-free. LC Detectsm provides useful information about the likelihood of lung cancer in those at highest risk for the disease, such as current or former smokers. * Another Example is FDA approved CellSearch™ - advanced test for monitoring metastatic colorectal cancer.   The CellSearch™ System by Veridex LLC, a Johnson & Johnson company,  identifies and counts circulating tumor cells (CTCs) in a blood sample to predict progression-free survival and overall survival in patients with metastatic colorectal or breast cancer, and can do so earlier than the current standard of care. The results of serial testing for CTCs with the CellSearch™ System, in conjunction with other clinical methods for monitoring, can help physicians assess disease progression, thereby guiding more informed care decisions earlier.     5. Stem Cell Technologies   The technology centers on human stem cells. These are the "master" cells which have the potential to become any of the body's many different types of tissue. Scientists believe that if they can grow these cells in the laboratory and then control the way they develop, they are able to grow any type of tissue needed for transplant. New ways of growing human embryonic stem cells in the laboratory without animal protein contaminations will reduce the risk that their use in therapy could go wrong. It is essential that stem cells are cultured in a safe way to avoid immune reactions in transplantation, and to prevent genetic changes during long-term culture. Stem cells have remarkable potential to treat a range of diseases, including cardiovascular conditions, spinal cord injuries, Parkinson's and diabetes. Transplantation experiments in animal models have shown remarkable therapeutic effects for various chronic diseases, including spinal cord injuries. Share your Favorite articles on the following Social Networks: Share on Facebook

Advancing Personalized Medicine- FDA’s Perspective and Role   Credit: FDA Consumer Health Information e-published on MedicineandBiotech.com October 1st, 2007     Each person has a unique set of chemical blueprints that determine how his or her body looks and functions. These blueprints are contained in their own DNA which is made up of two twisting sequences or single strands that are able to be paired with another.   Here we discuss the following important topics of interest:   * What is Personalized Medicine? * How Does Personalized Medicine Work? * What's Involved? * What are the Benefits of Personalized Medicine? * What are the Challenges? * FDA's Role   Medications have been prescribed over the years mostly by trial-and-error to reach the best dose for each patient. Typically, doctors diagnosed a condition and then selected what they believed was the most promising drug for treatment. If one didn't work, they'd try another.   Today, as science gives way to the understanding that people and diseases differ at the genetic or molecular level, doctors are learning to tailor treatments—or personalize them—to individuals more effectively.   By using "genomics," or the identification of genes and how they relate to drug treatment, doctors will be able to treat patients based on the actual biology of a disease and not just according to symptoms, and as an individual, not just a member of a population.   The Food and Drug Administration is especially interested in clearing the pathway for the development of safe and effective, leading-edge products that this burgeoning field of genomics is spawning—multiple tools, technologies, and sciences that will translate into the discovery and safety of drugs and medical products that the agency regulates.   By ensuring that new products and technologies are developed and made available to doctors and patients as effectively as possible, FDA believes this can only enhance the health of all Americans.   What is Personalized Medicine? Personalized medicine uses information about a person's genetic makeup to tailor products that will detect, treat, or prevent disease in that person. The goal is to get the best medical outcomes by choosing treatments that work well with a person's genetic profile, or with certain characteristics in the person's blood or cells.   Scientifically, personalized medicine is known as pharmacogenomics (drugs combined with genes), or how genetic differences in individuals affect the way people respond to drugs. The science of pharmacogenomics tries to answer questions like: Why do some people get cancer and others don't? Why is cancer more aggressive in this person and not in that one? Why does this drug work for him and not for her? Why do some people show toxicity to a drug while others don't? Why does someone need twice the standard dose to be effective? And why do others need only half of the standard dose?     How Does Personalized Medicine Work? Someone diagnosed with colon cancer today would receive a treatment based on standard medication and dosing guidelines for that disease. The doctor might factor in weight, age, medical history, and how any blood relatives might have reacted to a certain medication. But the doctor cannot know how that person will respond to the medication, which may help the cancer or have no affect at all. The person could experience terrible side effects or none at all. And, it may be necessary for several revisits to the doctor for adjusting the dosage or to switch medications. This is considered the trial-and-error approach to medicine.   With personalized medicine, people may be able to take a genetic test that can help determine which diseases they are likely to develop, and a blood test to help determine which genetic variations they may have—even before they've taken a single dose of medicine. Based on test results, the doctor could tailor a patient's treatment by avoiding using a certain drug, prescribing another, or altering a dose to match the body's genetics. A person's unique genetic profile can help a doctor personalize treatments.   What's Involved? New technologies and tools have been developed as a direct result of the nation's effort to understand DNA—deoxyribonucleic acid—the blueprint that determines how each person’s body looks and functions. Those technologies and what they intend to accomplish within personalized medicine include:   Functional genomics—measures gene expression under normal and troubled conditions and attempts to predict the gene expression profiles for these conditions. Structural genomics—addresses questions concerning individual genetic differences and the impact that these genetic differences have on the development of disease. Proteomics—seeks to discover all proteins in a living organism, and determine their function and how they affect each other. Metabolomics—studies all the molecules involved in metabolism (metabolites) in a living organism by evaluating tissues and body fluids, such as urine, blood, plasma, and saliva for changes. Genomics and Medical Devices—understands how certain diseases, or increased risks pass from generation to generation. Nanotechnology—uses materials or devices at the level of molecules and atoms too small to be seen with a conventional laboratory microscope.   What are the Benefits of Personalized Medicine? * Diagnosing disease or predicting risk of disease. * Determining whether a treatment is working or not. * Monitoring healthy people to detect early signs of disease. * Producing safer drugs by predicting the potential for adverse effects earlier. * Targeting specific groups of people most likely to benefit from a drug, while keeping its use from those who may be harmed by it. * Providing researchers the opportunity to get a global view of the events that are always changing within a cell. * Producing new classes of structural materials that are expected to bring about lighter, stronger, smarter, cheaper, cleaner, and more precise medical products.     What are the Challenges of Personalized Medicine? Personalized medicine is new and still in the early stages. Using a pharmacogenomic test to determine who will respond to a treatment or who should not get a treatment may narrow the market for certain drugs—manufacturers may be reluctant to invest time and money. Identifying all of the genetic variations (perhaps millions) that may exist could take years. How a person responds to a medication may not be determined by just one gene, but rather, several genes and their products interacting with each other. This new way of doing things likely will be expensive and time-consuming.   FDA's Role Tests that scientists are beginning to use on body fluids and cells to determine the variations of disease were not available in the past. Such tests, coupled with the understanding of the expression of each individual’s genes, will allow scientists to detect differences between patients and diseases much more precisely. FDA's Critical Path Initiative—the scientific process through which a medical product is transformed from discovery to development—is organizing work across 76 science and regulatory areas to improve medical product development, especially for gene-oriented drugs and diagnostic tests.   FDA encourages applications for approval of new tools and technologies for a number of reasons:   * The ability to bridge data gaps that exist in preclinical studies (animals) and clinical studies (humans) used to assess the safety and effectiveness of products it regulates. * Technologies can be used not only in the discovery phase of potential products, but also in the safety and effectiveness evaluation phase of development and submission to the agency. * Adverse events likely can be predicted prior to the approval and marketing of a product.   FDA's role in personalized medicine will be to bring balance to an evolving science in a way that does not inhibit its growth. Thousands of cancer patients are already benefiting from several targeted drugs, such as Tarceva and Gleevec, both known to work better in people with certain genetic profiles. Hope for the future is that personalized medicine will improve the safety, quality and effectiveness of health care for every American.   Share your Favorite articles on the following Social Networks: Share on Facebook

Digitizing Biotechnology and Neurotechnology: Leading the Next Wave into Medicine of the Future   By Neerja Sethi, PhD, Managing Editor        e- published August 1, 2007   The first iMEME conference, organized by FORTUNE magazine in San Francisco on July 12th and 13th, featured the next wave of technologies that will impact human life, health and culture in a significant way. Prominent scientists and policymakers discussed the technological advancements taking place at the intersection of Biology and Information Technology. Panelists including J. Craig Venter, Founder and President of the J. Craig Venter Institute, John Donoghue, Director, Brain Science Program, Brown University and co-founder of Cyberkinetics, and Tomaso Poggio, Professor, Brain Research at MIT, discussed the progress and the impact of digitizing genomics and neurotechnology for the next generation of high-tech therapies. Craig Venter is one of the leading scientists and visionaries in the field of genomic research. He is the founder and president of the J. Craig Venter Institute and the J. Craig Venter Science Foundation.  The Venter Institute conducts basic research in the field of genomics, metagenomics, sequencing technologies and plays a key role in developing the ethical and policy implications of genomic discoveries. According to Craig Venter, DNA sequence is like a software that creates the hardware or the cell of an organism. And changing species is similar to changing the operating systems. Using combinatorial computational genomics, scientists can mix and match DNA sequences to create synthetic genomes of interest, as recently demonstrated by the results published by Craig Venter Institute in synthetic genomics demonstrating feasibility of  genome transplantation. Currently, according to Venter, the limiting factor in analysis and applications of genomics is-slow computers. However, there is hope that the next wave of faster, quantum computers can overcome this limitation. Professor John Donoghue, from the brain Science Program at Brown University, and cofounder of Cyberkinetics discussed the important role merging IT with Neurotechnology is playing, as seen in new generation of cochlear implants, electrodes for sight, remotely controlled pacemakers for the heart. The technology is also playing an important role in the preventative market where chips installed in the brain can be predictive of brain functions. For example, the microchip implants in the brains of Parkinson’s patients. About 30,000 Parkinson’s patients have these implants to help reduce tremors caused by the disease. The main focus of Donoghue’s work is to study if a brain-machine interface will open the door to mind control.  John Donoghue has built a brain decoder that could transform the lives of people paralyzed by injury or disease. John Donoghue demonstrated his results from a clinical trial with four patients who had paralyzed limbs in a video clip. Donoghue implanted a chip in these patients that can monitor their brain activity and convert their intentions into computer commands. The chip’s electrodes  detects neurons signaling in an area of the brain that controls arm movement and translates neuronal activity into electronic signals. A computer program decodes the brain signals into commands that allow the patient to direct a cursor on a computer screen or the movement of an artificial limb. The results were well demonstrated in the video clip shown at the meeting. According to Donoghue, with such technologies, people with paralyzed limbs and normal brain functions, are capable of leading full and productive lives. In conclusion, the consensus is that digitizing Medicine, whether it is in a hospital setting or developing new therapeutic technologies, is the essential step forward. What’s next in future for the IT-Biotech-Neurotech interface? Can we increase human memory capacity, increase IQ, cure mental diseases through a computer chip or through combinatorial genomics and molecular biology?  The race is on between the technologies to achieve these goals!     Share your Favorite articles on the following Social Networks: Share on Facebook

FDA Clears CellSearch™ - Advanced Test For Monitoring Metastatic Colorectal Cancer   --Capable of detecting minute numbers of circulating cancer cells in 40 billion blood cells, the CellSearch™ test can help guide patient care decisions--   Veridex LLC, a Johnson & Johnson company announced that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for the CellSearch™ System to be used as an aid in the monitoring of metastatic colorectal cancer. CellSearch™ is currently approved for monitoring metastatic breast cancer.   The CellSearch™ System identifies and counts circulating tumor cells (CTCs) in a blood sample to predict progression-free survival and overall survival in patients with metastatic colorectal or breast cancer, and can do so earlier than the current standard of care. The results of serial testing for CTCs with the CellSearch™ System, in conjunction with other clinical methods for monitoring, can help physicians assess disease progression, thereby guiding more informed care decisions earlier.   "We are very excited that we can now offer the CellSearch™ test to patients who have metastatic colorectal cancer," said Dr. Ravi Patel of the Comprehensive Blood and Cancer Center in Bakersfield, California, which will become the first clinical site in the U.S. to offer the test under the new indication. "CellSearch™ will have a very positive impact on the care of these patients, in the same way it has positively impacted the care of our patients with metastatic breast cancer over the last year."   The CellSearch™ System is the first diagnostic test to automate the detection and enumeration of CTCs, cancer cells that detach from solid tumors and enter the blood stream, and is the standard in a new class of diagnostic tools. The system's specificity, sensitivity and reproducibility allow for serial assessment of CTCs as early as the first cycle of treatment to help evaluate disease progression sooner.   According to the American Cancer Society, colorectal cancer claims approximately 55,000 lives each year, the vast majority of which are a result of recurrent metastatic disease. Metastatic colorectal cancer occurs when tumor cells spread to other locations in the body and grow. Although there are several options for the treatment of metastatic colorectal cancer, oncologists often have to wait several months before they can determine if a specific treatment is beneficial to the patient. The CellSearch™ System helps physicians to predict disease progression and patient survival any time during therapy through its ability to locate minute numbers of circulating tumor cells in the approximately 40 billion cells contained in a 7.5 ml sample of blood – an achievement never before documented in any diagnostic tool.   The CellSearch™ System was originally cleared by the FDA in January 2004 as a diagnostic tool for identifying and counting CTCs in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast cancer.   A prospective, multi-center clinical trial was conducted to validate the expanded clearance for CellSearch™. The study, which took place in 55 clinical centers in the United States and Europe, involved 430 metastatic colorectal patients about to enter first- or second-line therapy. Data showed that patients with less than three CTCs at baseline had significantly better survival rates versus patients with more than three CTCs – an overall finding consistent with metastatic breast cancer patients. Data also showed that CTCs are a strong independent predictor of progression-free survival and overall survival, and that the combination of CTC analysis and radiological assessment may provide the most accurate assessment of prognosis.   "Clinical research validates the significance of circulating, cancer tumor cells," said Robert McCormack, Ph.D., Vice President of Medical and Scientific Affairs, Veridex. "Elevated CTCs in the blood stream are associated with lower survival rates. We believe, based on the clinical research, that identifying CTCs as soon as possible can lead to improved patient outcomes."   The CellSearch™ test works by using antibodies that are joined to microscopic iron particles, called ferrofluid. These antibody/ferrofluid combinations attach very specifically to CTCs. Powerful magnets then "pull" the CTCs out of the blood sample. They are then stained with additional bio-molecules and chemicals so that they can be positively identified as CTCs. The CellSearch™ test differs from the current standard of care because it can be used much earlier than traditional imaging (e.g., CT scans), and is not subject to the variation observed with other blood tests, called serum tumor markers.   In August 2004, a clinical study using the CellSearch™ test in metastatic breast cancer patients was published in The New England Journal of Medicine. The authors of this study concluded "the very short median progression-free survival in patients with elevated circulating tumor cells at the first follow-up visit suggests that these patients are receiving ineffective therapy." In addition, as recently as November 2006, a metastatic breast cancer study was published in Clinical Cancer Research where the authors concluded: "The results reported here indicate that the evaluation of CTCs is an accurate measure of treatment efficacy." Additionally, the authors said: "The ability to serially quantitate and interrogate CTCs in patients with breast cancer makes possible new ways of managing and investigating the disease."   About Veridex Veridex, LLC, a Johnson & Johnson company, develops cancer diagnostic products that will enable earlier disease detection as well as more accurate staging, monitoring and therapeutic selection. The company is initially developing two complementary product lines: CellSearch™ assays that identify, enumerate and characterize circulating tumor cells directly from whole blood; and GeneSearch™ assays that use molecular technology to diagnose, stage and more accurately characterize tumors. www.veridex.com.

FDA Approves Neupro Patch for Treatment of Early Parkinson’s Disease

May 9, 2007. The U.S. Food and Drug Administration (FDA) today announced the approval of Neupro (rotigotine transdermal system), a skin patch designed to treat symptoms of early Parkinson's disease.   Rotigotine is a drug not previously approved in the United States. Neupro is the first transdermal patch approved for the treatment of symptoms of Parkinson's disease.   Parkinson's disease, which belongs to a group of conditions called motor system disorders, results from the loss of dopamine-producing brain cells. Rotigotine, a member of the dopamine agonist class of drugs, is delivered continuously through the skin (transdermal) using a silicone-based patch that is replaced every 24 hours. A dopamine agonist works by activating dopamine receptors in the body, mimicking the effect of the neurotransmitter dopamine.   The effectiveness of Neupro was demonstrated in one fixed-dose response study and two flexible-dose studies. The parallel group studies were randomized, double-blinded, and placebo-controlled, and involved 1,154 patients with early Parkinson's disease who were not taking other Parkinson's medications.   The most common side effects for Neupro included skin reactions at the patch site, dizziness, nausea, vomiting, drowsiness and insomnia, most of which are typical of this class of drugs. Other potential safety concerns include sudden onset of sleep while engaged in routine activities such as driving or operating machinery (sleep attacks), hallucinations, and decreased blood pressure on standing up (postural hypotension).   Neupro Patch is manufactured by Schwarz Bioscience of Research Triangle Park, N.C.   According to the Parkinson's Action Network, more than 1 million Americans live with Parkinson's disease and 60,000 new cases are diagnosed each year. The four primary symptoms of Parkinson's are trembling in hands, arms, legs, jaw, and face (tremor); stiffness of the limbs and trunk (rigidity); slowness of movement (bradykinesia,); and impaired balance and coordination (postural instability). As these symptoms become more pronounced, patients may have difficulty walking, talking, or completing other simple tasks.   For more information National Institute of Neurological Disorders and Stroke http://www.ninds.nih.gov/disorders/parkinsons_disease/parkinsons_disease.htm

Technique for Converting Blood Types Developed

April 2007. The work, led by the University of Copenhagen, is reported in the journal Nature Biotechnology. Scientists have developed a way of converting one blood group type into another type. The technique potentially enables blood from groups A, B and AB to be converted into group O, which can be safely transplanted into any patient.   The method, which makes use of newly discovered enzymes, may help relieve shortages of blood for transfusions. Using incompatible blood during a transfusion can put a patient's life in danger.   The blood cells of people with group A and B blood contain one of two different sugar molecules - known as antigens - which can trigger an immune system response.   People with AB blood have both types of molecule, while those with group O blood have neither.   People produce antibodies against the antigens they lack.   This means groups A, B and AB can only be given to patients with compatible blood, while O - as long as it is rhesus negative - can be given to anyone.   The new technique works by using bacterial enzymes to cut sugar molecules from the surface of red blood cells.   After a search of 2,500 fungi and bacteria the researchers discovered two bacteria - Elizabethkingia meningosepticum and Bacterioides fragilis - which contained potentially useful enzymes.   They found that enzymes from both bacteria were able to remove both A and B antigens from red blood cells.   Trials needed   However, they say that patient trials will be needed before the conversion method can be used in hospitals.   Writing in the same journal, blood experts Geoff Daniels, of the Bristol Institute for Transfusion Sciences, and Stephen Withers, of the University of British Columbia, Canada, welcome the research.   They said the use of enzymes to convert blood group has long been proposed, but has proved to be impractical due to the inefficiency and incompatibility of available enzymes.   However, they say the enzymes discovered in the latest study may finally overcome these problems.   They write: "Their method may enable manufacture of universal red cells, which would substantially reduce pressure on the blood supply."   The new process cannot do anything about another antigen that can trigger an immune response. Blood which carries this antigen is known as rhesus positive.   This means that only rhesus negative blood can be used to create the new type of group O supplies

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