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Efficacy Of Tecarfarin Mirrors Earlier Studies While Primary Endpoint Missed
ARYx Therapeutics, Inc. (NASDAQ:ARYX), a biopharmaceutical company, announced results from its Phase 2/3 clinical trial, EmbraceAC, comparing its novel anticoagulant agent tecarfarin (previously ATI-5923) with the leading oral anticoagulant warfarin. In this trial, tecarfarin demonstrated efficacy essentially the same as in earlier Phase 2 studies but did not achieve the primary endpoint of superiority over warfarin, as measured by time in therapeutic range (TTR). This was due to the virtually unprecedented performance of warfarin in this trial. Using the International Normalized Ratio (INR), which is the standard measure of anticoagulation to evaluate TTR, the patients in the trial who were administered tecarfarin stayed within the target therapeutic range 74.0% of the time treated as compared to those patients receiving warfarin who stayed within the target therapeutic range 73.2% of the time (p=0.506). The result for the warfarin group was unexpected based upon the extensive history of prior studies and published literature for the drug. Tecarfarin appeared to be well tolerated by the patients in this Phase 2/3 clinical trial.
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Delivering Vaccine Through The Skin Could Be The Future For The Prevention Of Ear Infections
An experimental vaccine applied to the surface of the skin appears to protect against certain types of ear infections. Scientists from the Research Institute at Nationwide Children"s Hospital in Columbus, Ohio, reported their findings at the 109th General Meeting of the American Society for Microbiology in Philadelphia.
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What Is Alzheimer's Disease? What Causes Alzheimer's Disease?
Alzheimer"s disease is a progressive neurologic disease of the brain leading to the irreversible loss of neurons and the loss of intellectual abilities, including memory and reasoning, which become severe enough to impede social or occupational functioning. Alzheimer"s disease is also known as simply Alzheimer"s, and Senile Dementia of the Alzheimer Type (SDAT) .
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Delivering Vaccine Through The Skin Could Be The Future For The Prevention Of Ear Infections

An experimental vaccine applied to the surface of the skin appears to protect against certain types of ear infections. Scientists from the Research Institute at Nationwide Children"s Hospital in Columbus, Ohio, reported their findings at the 109th General Meeting of the American Society for Microbiology in Philadelphia. "Our data are the first to show that transcutaneous immunization is an effective way to prevent experimental ear infections and lays the foundation for an effective, yet simple, inexpensive - and potentially transformative - way to deliver vaccines," says Laura Novotny, one of the study researchers. Nontypeable Haemophilus influenzae (NTHi) is one of the three main bacterial causes of otitis media (OM), an infection or inflammation of the middle ear. OM is one of the most significant health problems for children in the United States, costing approximately $5 billion annually. It is estimated that 83% of all children will experience at least one ear infection prior to 3 years of age. Currently infections are managed with antibiotics; however, the emergence of antibiotic-resistant microorganisms is of concern. Surgery to insert tubes through the tympanic membrane relieves painful symptoms, but the procedure is invasive and requires the child to be under general anesthesia. Thus, it is necessary to develop different ways to treat or preferably prevent this disease. "We have designed several vaccine candidates which target proteins on the outer surface of this bacterium. Previous work in our lab showed that after immunization by injection, each of the three vaccine candidates prevented experimental ear infections caused by NTHi. In this study, we now wanted to test an alternative but potentially equally effective method to deliver a vaccine," says Novotny. The method, known as transcutaneous immunization, involved placing a droplet of each vaccine onto the ear and rubbing it into the skin. In this study, four groups of chinchillas were immunized with one of the three vaccine candidates. A fourth group received a placebo. Each vaccine was placed on the ears of chinchillas once a week for three weeks. All animals were then inoculated with NTHi through the nose and directly into the middle ears. Animals that received the vaccines were able to very rapidly reduce, or completely eliminate NTHi from the nose and ears, but animals that received a placebo did not. This study was performed by Laura A. Novotny of Dr. Lauren O. Bakaletz"s laboratory in the Center for Microbial Pathogenesis at The Research Institute at Nationwide Children"s Hospital in Columbus, OH and in collaboration with Dr. John D. Clements, Department of Microbiology and Immunology, Tulane University, New Orleans, LA. Research was made possible by funding from the NIDCD/NIH R01 03915 & 007464. Data were presented at the 109th General Meeting of the American Society for Microbiology in Philadelphia, PA on May 21, 2009. Jim Sliwa American Society for Microbiology


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