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Promising Biomarker And Candidate Tumor Suppressor Gene Identified For Colorectal Cancer
Researchers have identified a new candidate tumor suppressor gene in colorectal cancer and examined its use as a potential biomarker in stool samples, according to a new study published online June 17 in the Journal of the National Cancer Institute.
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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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Swine Flu And The Influenza Virus In 1918
The influenza virus that wreaked worldwide havoc in 1918-1919 founded a viral dynasty that persists to this day, according to scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. In an article published online on June 29 by the New England Journal of Medicine, authors Anthony S. Fauci, M.D., Jeffery K. Taubenberger, M.D., Ph.D., and David M. Morens, M.D., argue that we have lived in an influenza pandemic era since 1918, and they describe how the novel 2009 H1N1 virus now circling the globe is yet another manifestation of this enduring viral family.
Cardiovascular

Sucampo Initiates Pivotal Phase 3 Efficacy Trial Of Lubiprostone For Chronic Idiopathic Constipation In Japan

Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP), an international biopharmaceutical company, announced that its subsidiary, Sucampo Pharma, Ltd., has initiated enrollment and completed the randomization of the first patient into the pivotal phase 3 efficacy trial of lubiprostone for chronic idiopathic constipation (CIC) in Japan. Under the terms of a license, commercialization and supply agreement Sucampo signed in February 2009 with Abbott Japan Co., Ltd., Sucampo will receive a milestone payment in the amount of $7.5 million in recognition of this achievement. Abbott has exclusive rights to market lubiprostone in Japan for the treatment of CIC. Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer of Sucampo Pharmaceuticals, Inc., said, "We remain committed to our goal of broad international expansion of lubiprostone and this efficacy trial will increase our experience with the drug in the Japanese population." This pivotal phase 3 double-blinded, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of lubiprostone in Japanese patients with CIC over a 28-day treatment period. Patients will receive one lubiprostone 24-mcg, or placebo, capsule twice a day. This trial seeks to enroll approximately 116 patients, each of whom have a history of fewer than three spontaneous bowel movements (SBMs) per week for at least six months, as confirmed during a 14-day screening period. The primary efficacy endpoint is the change in SBMs at the end of the first week of treatment. Sucampo also has initiated enrollment and initial dosing of Japanese CIC patients, for up to 48 weeks of treatment, in an open-label phase 3 safety trial of lubiprostone (trade name Amitiza®). This is an open-label, multi-center, confirmatory trial in which patients will receive one 24-mcg lubiprostone capsule twice a day. This trial seeks to enroll 200 patients, each of whom has a history of fewer than three SBMs per week for at least six months, as confirmed during a 14-day screening period. Efficacy parameters being measured in this long-term safety trial include the frequency of SBMs at every week and the changes in SBMs at every week. In September 2008, Sucampo announced that lubiprostone met the primary endpoint of a statistically significant increase in mean change from baseline in SBM frequency after one week on treatment (p-value less than 0.0001) in a phase 2b trial in Japanese patients taking 24-mcg of lubiprostone twice daily versus placebo. About Sucampo Pharmaceuticals Sucampo Pharmaceuticals, Inc., an international biopharmaceutical company based in Bethesda, Maryland, focuses on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which are bio-lipids that occur naturally in the human body, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals" Chairman and Chief Executive Officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding Chief Executive Officer and currently Advisor, International Business Development. Sucampo markets Amitiza® (lubiprostone) 24 mcg in the U.S. for chronic idiopathic constipation in adults and Amitiza 8 mcg in the U.S. to treat irritable bowel syndrome with constipation in adult women. Sucampo also is developing the drug for additional gastrointestinal disorders with large potential markets. In April 2009, Sucampo acquired U.S. and Canadian rights to Rescula®, an FDA-approved treatment for open-angle glaucoma and ocular hypertension. Sucampo plans to re-launch Rescula in 2010, and to develop it for additional ophthalmic indications. In addition, Sucampo has a robust pipeline of compounds with the potential to target underserved diseases affecting millions of patients worldwide. Sucampo Pharmaceuticals, Inc. has three wholly owned subsidiaries: Sucampo Pharma Europe, Ltd., located in the UK; Sucampo Pharma, Ltd., located in Japan; and, Sucampo Pharma Americas, Inc., located in Maryland. To learn more about Sucampo Pharmaceuticals and its products, visit http://www.sucampo.com. Amitiza is a registered trademark of Sucampo Pharmaceuticals, Inc. About AMITIZA (lubiprostone) for Chronic Idiopathic Constipation and Irritable Bowel Syndrome with Constipation in the U.S. In the U.S., AMITIZA (lubiprostone) is indicated for the treatment of Chronic Idiopathic Constipation (24 mcg twice daily) in adults and for Irritable Bowel Syndrome with Constipation (8 mcg twice daily) in women ò‰¥18 years of age and older. AMITIZA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider to confirm the absence of such an obstruction prior to initiating AMITIZA treatment. The safety of AMITIZA in pregnancy has not been evaluated in humans. AMITIZA should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures. Patients taking AMITIZA may experience nausea. If this occurs, concomitant administration of food with AMITIZA may reduce symptoms of nausea. Patients who experience severe nausea should inform their healthcare provider. AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their healthcare provider if the diarrhea becomes severe. Patients taking AMITIZA may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their healthcare provider. Some patients have discontinued therapy because of dyspnea. In clinical trials of AMITIZA (24 mcg twice daily vs. placebo: N=1113 vs. N=316) in patients with Chronic Idiopathic Constipation, the most common adverse reactions (incidence >4%) were nausea (29% vs. 3%), diarrhea (12% vs. 1%), headache (11% vs. 5%), abdominal pain (8% vs. 3%), abdominal distention (6% vs. 2%), and flatulence (6% vs. 2%). In clinical trials of AMITIZA (8 mcg twice daily vs. placebo: N=1011 vs. N=435) in patients with Irritable Bowel Syndrome with Constipation, the most common adverse reactions (incidence >4%) were nausea (8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%). AMITIZA


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