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Protecting The Heart With Glucocorticoid Drugs
Glucocorticoids are steroid hormones that have numerous functions; for example, they regulate the response to stress and suppress inflammation. Synthetic glucocorticoids are used clinically in many situations, most famously to treat asthma, allergies, and autoimmunity. They have also been shown in animals and humans to help protect the heart from the damaging effects of heart attack, and this has been attributed to their anti-inflammatory effects. However, Motoaki Sano and colleagues, at Keio University School of Medicine, Japan, have now determined another mechanism by which glucocorticoids protect rodent hearts from the damaging effects of heart attack. Specifically, glucocorticoids, acting via the glucocorticoid receptor (GR), induced mouse and rat heart muscle cells to produce PGD2, and this was responsible for the ability of glucocorticoids to reduce damage to mouse hearts in both an ex vivo and an in vivo model of heart attack. The authors therefore suggest that GR-selective glucocorticoids might be more beneficial to humans following heart attack than glucocorticoids that activate both GR and the MR protein, activation of which occurs in response to stress and might have unwanted consequences.

Media Devotes Little Attention To Sotomayor's Catholicism Compared With Conservative Nominees, WSJ Columnist Writes
Supreme Court nominee Sonia Sotomayor would be the sixth Roman Catholic currently on the court if she is confirmed, but there have been no more than "a few scattered references to this fact," Wall Street Journal columnist William McGurn writes. He continues that "for the most part the judge"s religion has been greeted, as a USA Today headline put it, with a "yawn."" McGurn adds, "How different from just a few years ago," when Catholics Justice Samuel Alito and Chief Justice John Roberts were nominated by former President George W. Bush.According to McGurn, when Alito was a Supreme Court nominee, "talk was about the "fifth Catholic" on the bench." He adds that Feminist Majority Foundation President Eleanor Smeal "complained that "with Alito, the majority of the court would be Roman Catholics."" McGurn writes that prior to the confirmation hearings for Chief Justice John Roberts, the Los Angeles Times "ran a piece headlined, "Wife of Nominee Holds Strong Antiabortion Views."" According to the Times, Roberts" wife worked for Feminists for Life, and the paper "characterized [her] as an "extremely, extremely devout Catholic,"" McGurn writes."It"s possible, of course, that Democrats and their allies in the media and activist community no longer regard Catholics with the suspicion they did back when ... Bush"s nominees were up for consideration," according to McGurn. "More likely, the relatively soft reaction to Ms. Sotomayor"s Catholicism is because of a calculation that when it comes to hot-button issues such as abortion or gay marriage, she doesn"t really believe what her church teaches," he writes.McGurn continues that if the "indifference" to "Sotomayor"s Catholicism were truly a sign of a new respect for the "no religious test" provisions of the Constitution, that would be something to celebrate." He concludes, "But in the unlikely case that this "wise Latina" ever comes to see the legal wisdom of overturning [Roe v. Wade] and returning abortion to the democratic process, we"ll be reading a very different story" (McGurn, Wall Street Journal, 7/14).
News of the day
Breast Cancer Help, Inc. Attends National Breast Cancer Coalition Annual Advocacy Conference In Washington, D.C.
As part of its community outreach, Breast Cancer Help, Inc. attended the annual National Breast Cancer Coalition (NBCC) conference, which was held May 2-5 at Washington, D.C. Representatives of Breast Cancer Help, along with hundreds of other activists, met at the nation"s capital to meet with elected officials who are responsible for the majority of the funding for breast cancer research. The conference was held to challenge the newly elected leaders in Washington to create the changes necessary to ensure the much-needed funding for research and access to quality care.
Cardiovascular

A.P. Pharma Submits New Drug Application For APF530 In Chemotherapy-Induced Nausea And Vomiting

A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company, announced that it has submitted a New Drug Application (NDA) for its lead product, APF530, to the U.S. Food and Drug Administration (FDA). APF530 is being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV) and is a long-acting formulation of granisetron that utilizes the Company"s proprietary Biochronomer™ drug delivery system. "The submission of this NDA marks a significant milestone for the APF530 program, our Biochronomer™ drug delivery technology and A.P. Pharma as a company," said Ronald J. Prentki, A.P. Pharma"s president and chief executive officer. "Our number-one priority has been to assemble and submit a complete and high-quality NDA. We thank our regulatory, CMC, clinical and e-filing experts for their tireless efforts and look forward to a timely review by the FDA." "The favorable efficacy and safety demonstrated in the APF530 Phase 3 clinical program provides a strong foundation for our submission," stated Mr. Prentki. "We believe APF530, which maintains therapeutic drug levels for five days, will be a "long acting" agent offering important advantages over anti-emetics currently used in the prevention of CINV, and would provide a particular benefit to those many patients suffering with delayed onset nausea and vomiting." The NDA was submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, whereby the Company can rely upon the FDA"s prior safety and efficacy findings for APF530"s active ingredient, granisetron. The FDA is expected to determine whether to accept the NDA for filing within 60 days, and to notify the Company of its determination within fourteen days thereafter. If the NDA is accepted for filing, under the Prescription Drug User Fee Act guidelines, it is expected that the FDA will complete its review and provide an action letter with respect to the NDA within 10 months following NDA submission. About APF530 A.P. Pharma"s lead product candidate, APF530, is being developed for the prevention of both acute and delayed onset chemotherapy-induced nausea and vomiting (CINV). APF530 contains the 5-HT3 antagonist, granisetron, formulated in our proprietary Biochronomer™ drug delivery system, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection. Injections and oral tablets containing granisetron are approved for the prevention of acute onset CINV, but not for delayed onset CINV. Granisetron was selected because it is widely prescribed by physicians based on a well-established record of safety and efficacy. In September 2008, A.P. Pharma reported positive top-line results from its pivotal Phase 3 study. In this multi-center, randomized trial that enrolled 1,395 cancer patients, APF530 was shown to be equally as effective as (statistically non-inferior to) palonosetron (Aloxi®) in the prevention of both acute onset and delayed onset CINV. Palonosetron is the only injectable 5-HT3 antagonist FDA-approved for the prevention of delayed onset CINV. APF530 was also generally well-tolerated in this study. About CINV Prevention and control of nausea and vomiting, or emesis, are very important in the treatment of cancer patients. The majority of patients receiving chemotherapy will experience some degree of emesis if not prevented with an anti-emetic, typically administered just prior to chemotherapy. Chemotherapy treatments can be classified as moderately emetogenic, meaning that 30% to 90% of patients experience CINV, or highly emetogenic, meaning that more than 90% of patients experience CINV, if they do not receive an anti-emetic. Acute onset CINV occurs within the first 24 hours following chemotherapy treatment. Delayed onset CINV occurs more than 24 hours after treatment and may persist for several days. Prevention of CINV is important because the distress caused by CINV can severely disrupt patient quality of life and can lead some patients to delay or discontinue chemotherapy. A.P. Pharma


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