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New Data: Efficacy And Responder Analyses Of Divigel(R) (estradiol Gel) 0.1 Percent For The Treatment Of Menopause
Upsher-Smith Laboratories, Inc. presented the results of a secondary analysis to determine the response rates to three doses of transdermal Divigel(R) (estradiol gel) 0.1 percent at the recent 57th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG) in Chicago. The objectives of this secondary analysis of a phase III efficacy trial were to determine the percent of postmenopausal women who achieved a greater than 50 percent reduction in the frequency of moderate to severe vasomotor symptoms (MSVMS), or hot flashes, and to assess the change from baseline in a quality of life (Kupperman) index score that evaluated various menopausal symptoms. Divigel(R) doses studied included 1.0 mg, 0.5 mg and 0.25 mg of estradiol/day - the lowest effective approved dose of estradiol available for the treatment of MSVMS. The analysis showed a significantly greater percentage of women in all treatment groups versus placebo experienced > / = 50 percent reduction in the frequency of MSVMS at week 12. In the Divigel(R) 1.0 mg estradiol/day dosing group, 90 percent of women reported at least a 50 percent reduction in the frequency of MSVMS. Additionally, at 12 weeks, each of the doses of Divigel(R) significantly reduced the severity of menopausal symptoms identified by a quality of life index score compared to placebo.
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Supreme Court Nominee Sotomayor Pledges 'Fidelity To The Law' As Confirmation Hearing Begins
In the first day of her confirmation hearings before the Senate Judiciary Committee, Supreme Court nominee Judge Sonia Sotomayor said on Monday that "fidelity to the law" is central to her judicial philosophy and that the role of a judge is "not to make law" but "to apply the law," the Washington Post reports. Sotomayor said her record as a district and federal appeals judge "reflects my rigorous commitment to interpreting the Constitution according to its terms, interpreting statutes according to their terms and Congress" intent, and hewing faithfully to precedents established by the Supreme Court and by my circuit court." She also said her "personal and professional experiences help me listen and understand, with the law always commanding the result in every case" (Barnes et al., Washington Post, 7/14). The first day of the hearings was dedicated to opening statements from Sotomayor and senators, with the questioning portion scheduled to begin on Tuesday. According to the Wall Street Journal, Sotomayor is expected to be confirmed, as Democrats outnumber Republicans on the committee 12-7 and hold a 60-member majority in the Senate (Bravin/Bendavid, Wall Street Journal, 7/14). The New York Times reports that senators from both parties are likely to use Sotomayor"s confirmation as a way to frame the debate for the next Supreme Court nominee, with Democrats hoping to "build a lopsided victory" to give President Obama more leeway to choose a more liberal nominee. Conservatives, on the other hand, "hoped to draw a line making the president think twice about picking someone" like Sotomayor in the future, the Times reports (Baker/Lewis, New York Times, 7/14).In Monday"s hearing, both parties gave indications of how they plan to proceed for the rest of the confirmation process, the Post reports. Democrats in their statements portrayed Sotomayor as a role model for the country and a judge with a modest approach who would bring balance to the conservative-leaning court (Washington Post, 7/14). Sen. Charles Schumer (D-N.Y.) said Sotomayor "puts rule of law above everything else." He added, "Given her extensive and evenhanded record, I am not sure how any member of this panel can sit here today and seriously suggest that she comes to the bench with a personal agenda" (Stern/Perine, CQ Today, 7/13). Republicans used their statements to cast Sotomayor as a partial judge, saying previous statements and rulings show she is an activist judge (Washington Post, 7/14). In particular, GOP senators on the committee referenced a comment from a 2001 speech in which Sotomayor said that a "wise Latina" would reach better decisions than a white man in some cases (Baker/Lewis, New York Times, 7/14). Sen. Jeff Sessions (Ala.), the ranking Republican on the committee, said, "No senator should vote for an individual ... who believes it is acceptable for a judge to allow their own personal background, gender, prejudices or sympathies to sway their decision." He continued, "Call it empathy, call it prejudice or call it sympathy, but whatever it is, it"s not law" (Wall Street Journal, 7/14). However, Sen. Lindsey Graham (R-S.C.) noted that Republicans lost in last year"s presidential election and told Sotomayor, "Unless you have a complete meltdown, you"re going to get confirmed" (Lewis, New York Times, 7/14).Antiabortion-Rights Protesters Arrested During HearingsFour antiabortion-rights protesters were arrested for shouting comments during the senators" remarks (CQ Today, 7/13). One of the arrested protesters was Norma McCorvey, the plaintiff "Jane Roe" in Roe v. Wade. According to the AP/Google.com, McCorvey began screaming that Sotomayor was "wrong" about abortion during the opening statement of Sen. Al Franken (D-Minn.). McCorvey and the other three arrested protesters were charged with unlawful conduct-disruption of Congress. The protesters also prompted a warning from Senate Judiciary Committee Chair Patrick Leahy (D-Vt.), who said, "We"ll show respect to everybody who is here, we will show respect to everyb
News of the day
Efficacy Of CT Scans For Chest Pain Diagnosis Validated By Long-Term Study Results
The first long-term study following a large number of chest pain patients who are screened with coronary computerized tomographic angiography (CTA) confirms that the test is a safe, effective way to rule out serious cardiovascular disease in patients who come to hospital emergency rooms with chest pain, according to new research from the University of Pennsylvania School of Medicine which was presented Friday, May 15, 2009 at the Society for Academic Emergency Medicine"s annual conference.
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Arete Therapeutics Presents Positive Clinical And Preclinical Data For AR9281

Arete Therapeutics Inc. announced the presentation of three posters that validate the mechanistic activity and therapeutic potential of the company"s lead drug candidate, AR9281, an orally-administered soluble epoxide hydrolase (sEH) inhibitor that is in a Phase II clinical program for the treatment of type 2 diabetes. sEH is an enzyme involved in the metabolism of arachidonic acid, a key signaling molecule implicated in diabetes, hypertension and inflammatory disorders. Presented at the 69th Scientific Sessions of the American Diabetes Association (ADA) the data demonstrate that AR9281 exerts sEH mechanism-based improvement in glucose tolerance in preclinical models of type 2 diabetes. In addition, clinical data demonstrate a linear relationship between AR9281 exposure and blood sEH activity. "Taken together, these data showing AR9281"s safety and attractive pharmaceutic properties in normal healthy volunteers and strong evidence of its efficacy in animal models of type 2 diabetes support the further development of this novel drug candidate for the treatment of type 2 diabetes," said James A. Sabry, MD, PhD, Arete"s President and Chief Executive Officer. "We anticipate that the results from our ongoing phase IIa clinical program in pre-diabetic patients will establish proof of concept that sEH inhibition modulates glucose metabolism or blood pressure in patients with impaired glucose tolerance and hypertension to further corroborate the clinical importance of this novel therapeutic approach." Three Posters Presented at ADA The data presented by Arete scientists and colleagues are described as follows. -- "AR9281, a Soluble Epoxide Hydrolase Inhibitor - Efficacy in a DIO Mouse Model plus Pharmacokinetics and Pharmacodynamics in Mice and Men" (Whitcomb, R, Chen, D, Wang, J, Anandan, S-K, Gless, R and Webb, H). This poster describes the direct correlation between the concentration of AR9281 in blood and the activity of its target, sEH, in both mice and humans. The data further demonstrate that AR9281 improves glucose metabolism in rodent models of type 2 diabetes. -- "A Novel Inhibitor of Soluble Epoxide Hydrolase, AR9281, Improves Glucose Homeostasis in Diet-Induced Obese Mice" (Wong, K, Zhang, L-N, Vincelette, J, Chen, D, Mehra, U, Cheng, Y, Gless, R, Anandan, S-K, Webb, H). Data presented in this poster show that in diet-induced obese mice, AR9281 inhibits sEH and improves glucose tolerance in a highly-dose dependent manner. Improvement of glucose tolerance by AR9281 is not observed in sEH knock-out mice indicating that the action of AR9281 is sEH mechanism-based. These positive effects are associated with reductions in plasma insulin, IL-6, an inflammatory molecule elevated in people with type 2 diabetes, and resistin, a hormone that plays a role in predisposing obese individuals to diabetes. -- "Improvement of Glucose Homeostasis by AR9281, a Novel Inhibitor of Soluble Epoxide Hydrolase, in Diet-Induced Obese Mice Does Not Depend on Active Nitric Oxide Synthase" (Vincelette, J, Chen, D, Mehra, U, Cheng, Y, Gless, R, Anandan, S-K, MacIntyre, E and Wang, J). Data presented in this poster show the correlation between treatment with AR9281 and the lowering of the glucose levels after an oral glucose tolerance test and demonstrate that these effects are not inhibited by concurrent treatment with the nitric oxide synthase inhibitor L-NAME (NG-nitro-L-arginine methyl ester), thus furthering the understanding of the mechanism of action of this novel drug candidate. AR9281 Phase II Program Underway Arete is conducting a Phase IIa multicenter, double-blind, placebo-controlled study of AR9281 in pre-diabetic patients with impaired glucose tolerance, mild obesity and mild to moderate hypertension. All 150 enrolled patients will be treatment-naive for type 2 diabetes medications. The trial is evaluating two schedules of AR9281 and placebo using a parallel design to determine the feasibility of twice-a-day dosing. Each patient receives 28 days of treatment. Endpoints for the trial include safety, tolerability, reduction of blood pressure and various measures of glucose and lipid metabolism, with results expected in the first quarter of 2010. The Phase I clinical program for AR9281, consisting of two double-blind, placebo-controlled studies, demonstrated that AR9281 was safe and well tolerated in healthy volunteers. The studies met all safety, tolerability, pharmacokinetic and pharmacodynamic endpoints. In addition, AR9281 has shown favorable results in various published and proprietary in vitro and in vivo assays for potency, selectivity, efficacy, ADME, toxicity and safety. About AR9281 AR9281, an orally-administered soluble epoxide hydrolase (sEH) inhibitor, operates within the third branch of the arachidonic acid pathway and represents a novel and potentially more effective approach to treating type 2 diabetes, hypertension and inflammatory disease. The first two branches of this critical regulatory pathway have been targeted by several commercially successful marketed anti-inflammatory drugs including Aspirin(R) (acetylsalicylic acid), Motrin(R) (ibuprofen), Singulair(R) (montelukast) and Celebrex(R) (celecoxib). AR9281 has demonstrated an excellent safety profile and activity in multiple animal models of type 2 diabetes, and has the advantage of inhibiting a novel drug target that differentiates it from currently marketed diabetes medications. With this promising drug profile, AR9281 has the potential to provide safe and effective therapy for patients with type 2 diabetes either as monotherapy or in combination with existing treatment regimens. About Arete Therapeutics Inc. Arete Therapeutics is a privately-held biotechnology company dedicated to the discovery and development of novel drugs to treat type 2 diabetes, hypertension and inflammatory disorders. It is the world"s leading company focused on sEH, an important enzyme for the metabolism of arachidonic acid that plays an essential role in metabolic, inflammatory and cardiovascular physiology. The Company has raised a total of over $51 million in Series A financing led by Frazier Healthcare Ventures, Alta Partners, Three Arch Partners, Burrill & Company and Altitude Life Science Ventures. Arete Therapeutics Inc


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