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Insmed Announces Results Of IPLEX(TM) Phase II Trial In Myotonic Muscular Dystrophy
Insmed Inc. (Nasdaq: INSM), a biopharmaceutical company, announced results from its exploratory U.S. Phase II clinical trial evaluating IPLEX(TM) (mecasermin rinfabate) in patients with myotonic muscular dystrophy ("MMD"). The randomized, double-blind, placebo-controlled Phase II trial conducted in 13 centers across the U.S. enrolled 69 patients with MMD, for a six-month period. As this was an exploratory trial, a primary endpoint was not pre-defined. The trial explored measures of endurance, using the six-minute walk test, muscle function and strength, cognitive function, gastrointestinal function, pain, quality of life, insulin sensitivity, lipid metabolism, and safety and tolerability of IPLEX(TM).
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Recent Releases: HIV Prevention; Clinical Trials Debate; Definition Of Global Health; Drug Resistant TB

Future Studies Needed To Determine If "Test And Treat" Approach Could "End HIV Pandemic Within 50 Years," Researchers Say In a Journal of the American Medical Association commentary piece, Anthony Fauci and Carl Dieffenbach of the National Institute of Allergy and Infectious Diseases explore results from a WHO mathematical model study that found universal, voluntary, annual HIV testing followed up with immediate treatment for those testing positive -- the "test and treat model" -- could "reduce HIV incidence" and "end the [HIV] pandemic within 50 years." Fauci said in a written statement, "Given these conclusions, test and treat potentially could represent an important public health strategy for fighting HIV/AIDS. However, the WHO model is based on numerous assumptions that need to be tested and also raises concerns about individual rights, cost effectiveness and other critical issues that require broad public debate" (NIAID release, 6/9). In their commentary, the authors highlight the various areas of research that are necessary to verify or refute the test and treat approach (Fauci/Dieffenbach, JAMA, 6/10). PLoS Debate Addresses Global Health Research In Light of Failed Microbicide Trials This month"s PLoS Medicine Debate addresses global health research in light of three large vaginal microbicide clinical trials that have recently failed. According to PLoS, "James Lavery and colleagues propose a new mechanism, based on stopping trials early for "opportunity costs." They argue that microbicide trial sites could have been saturated with trials of scientifically less advanced products, while newer, and potentially more promising, products were being developed. They propose a mechanism to reallocate res invested in existing trials of older products that might be better invested in more scientifically advanced products that are awaiting clinical testing. But David Buchanan argues that the early stopping of trials for such opportunity costs would face insurmountable practical barriers, and would risk causing harm to the participants in the trial that was stopped" (Lavery/Buchanan et al., PLoS Medicine, 6/9). A Recognized Definition Of Global Health "Global health is derived from public health and international health, which, in turn, evolved from hygiene and tropical medicine. However, although frequently referenced, global health is rarely defined," write the authors in a Lancet opinion piece. The authors examine several ways that global health is defined, and suggest their own definition, while calling for a common definition to be adopted. They write that global health "is an area for study, research, and practice that places a priority on improving health and achieving equity in health for all people worldwide" (Koplan et al., Lancet, 6/6). Risk Factors For Drug-Resistant TB Identified The Annals of Internal Medicine published a study conducted in Estonia, which identifies the risk factors for extensively drug-resistant tuberculosis and multi-drug resistant TB because previously predictors have been "unclear." The study found that "factors associated with increased risk for extensively drug-resistant disease included previous antituberculosis treatment, HIV infection, homelessness, and alcohol abuse" (Kliiman/Altraja, Annals of Internal Medicine, 6/2). This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org. © Henry J. Kaiser Family Foundation. All rights reserved.


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