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NIH Announces Final Guidelines For Federally Funded Embryonic Stem Cell Research
NIH on Monday announced final guidelines for assessing whether newly created embryonic stem cell lines can be used for federally funded research, as well as clarifying how old lines will be evaluated, CongressDaily reports (CongressDaily, 7/7). In March, President Obama overturned former President George W. Bush"s policy limiting federal funding of embryonic stem cell research to 21 lines. Obama asked NIH to develop new guidelines that would govern such research going forward. The agency received about 49,000 comments on a draft version of the guidelines announced in April (Vergano, USA Today, 7/7). The final guidelines, which take effect on Tuesday, state that stem cell lines used in federally funded research must come from embryos discarded after in vitro fertilization procedures. In addition, donors must have been informed that the embryo would be destroyed for stem cell research and made fully aware of other options, which include donating the embryo to other individuals for use in infertility treatments. Lastly, donors cannot be paid for an embryo, and no threats or other inducement can be part of the decision to donate (Vedantam, Washington Post, 7/7).Raynard Kington, acting director of NIH, said that lines developed before Tuesday likely would be approved if they were created in the spirit of the new rules, even if they do not follow them to the letter (Harris, New York Times, 7/7). NIH"s Advisory Committee to the Director will review such lines on a case-by-case basis. NIH also will create a registry of qualifying stem cell lines for use by researchers (Los Angeles Times, 7/7). Kington said, "Many of the lines already in existence may have met very rigorous standards of informed consent but may have been implemented in ways not consistent with the present guidelines." He added, "It"s unreasonable to retroactively apply procedures intended for future use" (New York Times, 7/7). Kington also said of the new guidelines, "We think this is a reasonable compromise to achieve the president"s goal of both advancing science while maintaining rigorous ethical standards. We believe that judgment is necessary" (Los Angeles Times, 7/7). Broadcast CoverageNPR"s "Morning Edition" on Tuesday reported on the stem cell guidelines (Shapiro, "Morning Edition," NPR, 7/7).
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The Evolution Of Migraine From Episodic Headache To Chronic Disorder
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Endocrinology

Data On PolyMedix Heptagonist Compounds Presented At The International Society On Thrombosis And Hemostasis (ISTH) Conference

PolyMedix, Inc., an emerging biotechnology company developing acute care products for infectious diseases and acute cardiovascular disorders based on biomimetics, announced that three posters relating to the Company"s heptagonist compounds were presented at the International Society on Thrombosis and Hemostasis Conference. The posters were presented at the conference on July 16, 2009, by PolyMedix"s collaborators at Loyola University. Titled "In Vitro Characterization of the Neutralization of Low Molecular Weight Heparin and Heparin-Like Drugs by Novel Salicylamide Derivatives", "In Vivo Neutralization of Unfractionated Heparin and Low Molecular Weight Heparin by a Novel Salicylamide Derivative", and "Ex Vivo Neutralization of Enoxaparin in Primates by a Novel Heparin Antagonist", the posters described a series of laboratory and animal studies with various PolyMedix heptagonist compounds, including PMX-60056, and described their abilities to reverse the activities of low molecular weight heparin, fondaparinux, and unfractionated heparin. The poster presentations will be made available on PolyMedix"s website at http://www.polymedix.com. PolyMedix"s lead heptagonist compound is PMX-60056, currently in Phase I clinical development. PMX-60056 is a novel small-molecule drug candidate designed to block the anticoagulant action of heparin and low molecular weight heparins (LMWH), clot prevention drugs which are commonly used in a number of applications. On March 11, 2009 PolyMedix announced the successful completion of a Phase I clinical study with PMX-60056. The data from that study demonstrated that single intravenous doses can be given at levels that will support the planned follow-on therapeutic proof-of-concept Phase IB clinical trial. Further clinical development is expected to continue for this drug as an agent for the rapid reversal of heparin after surgery, and for emergencies where heparin anticoagulation presents a clinical problem. Heparin and LMWH are widely used anticoagulants, drugs to prevent blood clotting. However, they have the risk of potentially serious bleeding side effects. Protamine is currently the only approved drug used to reverse the action of heparin, and there is no approved reversing agent for LMWH. However, there are serious potential side effects associated with protamine. Based on preclinical studies conducted by PolyMedix and its collaborators, potential advantages of PMX-60056 over protamine may include reduced bleeding complications, reduced risk of immune-mediated side effects, and the ability to neutralize LMWH. PMX-60056 was designed to bind to the pentasaccharide region found on heparin. PMX-60056 is believed to form a stable electrostatic bond to heparin, blocking its action. This molecular combination is believed to persist until removed from circulation by normal processes. In previous studies conducted by PolyMedix and other groups, PMX-60056 has been demonstrated to reverse the action of heparin and low molecular weight heparin in isolated human plasma, isolated human whole blood, and in animal studies in rats, dogs, and primates. PolyMedix, Inc.


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