CSL Behring, of King of Prussia, Pa., reported data from a single-arm, open-label study showing that Privagen (immune globulin intravenous [human], 10 percent liquid), an intravenous immunoglobulin (IVIG), may lead to improvement in function in patients with chronic inflammatory demyelinating polyneuropathy. Results showed an overall response rate of 60.7 percent, and the 25-week treatment period also showed that a response to IVIG can occur late – after more than six weeks of therapy. Eisai

Amicus Therapeutics Inc., of Cranbury, N.J., reported preliminary data from an open-label Phase II drug-drug interaction study showing that pharmacological chaperone AT2220 (duvoglustat HCl) co-administered with enzyme replacement therapy in Pompe disease patients resulted in no drug-related adverse events reported to date, and the independent data safety monitoring board determined the study should continue into the third dose cohort, now fully enrolled. In Cohort 1, an increase in acid alpha

Aeterna Zentaris Inc., of Quebec City, said final Phase III results for its oral ghrelin agonist, AEZS-130, showed it was safe and effective for diagnosing adult growth hormone deficiency (AGHD). The study compared AEZS-130 with growth hormone-releasing hormone plus L-arginine in AGHD patients and in control patients without the disease. A second stage of the study then tested AEZS-130 alone in patients with and without AGHD. Mean peak growth hormone levels in AGHD patients following AEZS-130

Ablynx NV, of Ghent, Belgium, reported Phase II data showing that its anti-TNF-alpha Nanobody, ozoralizumab (ATN-103) showed excellent safety and efficacy results in a 48-week open-label extension study in patients with rheumatoid arthritis who have an insufficient response to methotrexate alone. A total of 266 patients (85 percent) from the previous Phase II studies rolled over into the open-label portion, which was fully funded by partner Pfizer Inc., of New York. Data showed that only 2.6

Novo Nordisk A/S, of Bagsvaerd, Denmark, said its ultra-long-lasting insulin degludec significantly reduced the rate of hypoglycemia at night in adults with Type II diabetes, while obtaining equivalent improvement in glucose control compared with insulin glargine over a 52-week period. Data from that Phase IIIa trial were presented at the American Diabetes Association meeting in Philadelphia.

Astex Pharmaceuticals Inc., of Dublin, Calif., said it started the Phase II dose-expansion segment of its trial testing SGI-110, a hypomethylating agent, in patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML), enrolling treatment-native MDS and elderly AML patients (65 or older). The trial segment includes expansion of the total number of patients to about 90, and they will be treated on the five-day subcutaneous dosing schedule to evaluate

Aeterna Zentaris Inc., of Quebec, reported Phase I trial results for its oral PI3K/Akt inhibitor, perifosine, in an open-label dose-escalating study to assess toxicity and efficacy of the compound given in monotherapy to patients with neuroblastoma, a type of childhood cancer which usually begins in nerve tissues. Anti-neuroblastoma activity was evident by a 50 percent progression-free survival rate at 12 months and included one complete remission based on a normalized MIBG scan and three

Bristol-Myers Squibb Co., of New York, formed a strategic partnership with Emory University in Atlanta to conduct clinical trials involving the pharma's investigational compounds. Under the agreement, investigators from Emory and affiliated institutions will conduct Phase II, Phase III and pediatric trials in metropolitan Atlanta of investigational compounds across the company's portfolio. In the first studies under the agreement, researchers from Emory's Winship Cancer Institute will work with

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said the American Heart Journal published the design of the RE-ALIGN study, a Phase II trial aimed at evaluating the safety and pharmacokinetics of oral Pradaxa (dabigitran etexilate) in patients after heart valve replacement. The study is intended to evaluate Pradaxa as an alternative to warfarin.

The results of a 12-week, head-to-head, Phase III study, published online in Hypertension, found systolic blood pressure reductions of a fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg were statistically superior to those of the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide 40/25 mg. The fixed-dose combination (azilsartan medoxomil and chlorthalidone) is currently marketed as Edarbyclor in the U.S. by Takeda Pharmaceuticals U.S.A. Inc., part of

A new retrospective subanalysis of the RE-LY trial suggested similar rates of periprocedural bleeding and thromboembolic complications in nonvalvular atrial fibrillation patients undergoing a surgical or invasive procedure treated with Pradaxa (dabigatran etexilate mesylate), from Boehringer Ingelheim GmbH, of Ingelheim, Germany, compared to warfarin. RE-LY was a global, Phase III, randomized trial of 18,113 patients enrolled in 951 centers in 44 countries, investigating whether dabigatran

Bristol-Myers Squibb Co., of New York, reported six-year follow-up results from a Phase III trial of Sprycel (dasatinib) in Philadelphia chromosome-positive chronic-phase chronic myeloid leukemia adult patients resistant or intolerant to Glivec (imatinib, Novartis AG), demonstrating a progression-free survival rate of 49.3 percent and an overall survival rate of 71 percent for patients receiving dasatinib, with 6 percent of patients progressing to accelerated or blast phase of the study at six

4SC AG, of Frankfurt, Germany, presented data, at the 17th Congress of the European Hematology Association (EHA) in Amsterdam, the Netherlands, on biomarkers that show they could help stratify patient populations in the Phase II SAPHIRE trial with its anticancer compound resminostat. The study is in patients with relapsed/refractory Hodgkin's lymphoma. Civitas Therapeutics Inc., of Chelsea, Mass., said it started a Phase IIa trial testing CVT-301, an inhaled formulation of levodopa (L-dopa

Sanofi SA, of Paris, presented results from the ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial at the American Diabetes Association 72nd Scientific sessions, reporting that Lantus (insulin glargine [rDNA] injection) showed no statistically significant positive or negative impact on cardiovascular (CV) outcomes compared to standard of care during the six-year study period and no association with increased risk of any cancer. The findings, also published online in The New

Biomay AG, of Vienna, Austria, said its vaccine for grass pollen allergy showed significant improvements for patients in a Phase IIa trial. The vaccine, BM32, is based on a recombinant peptide carrier technology designed to allow for fewer injections and fewer side effects compared with other immunotherapy treatments. It significantly reduced allergy-related nasal symptoms in a study group of 70 patients. Data also showed that BM32 significantly reduced skin reactivity to grass pollen as

Merck & Co. Inc., of Whitehouse Station, N.J., reported data from two pivotal Phase III trials of suvorexant in insomnia at SLEEP 2012, the annual Meeting of the Associated Professional Sleep Societies. The orexin receptor antagonist reduced the time it took patients to fall asleep and increased the time that patients stayed asleep as early as the first night and at three months, compared to placebo. Endpoints from the trials included mean change from baseline for suvorexant compared to placebo

AB Science SA, of Paris, said Phase II results published in BMC Neurology showed that masitinib, an oral tyrosine kinase inhibitor, has potential therapeutic benefits in patients with progressive forms of multiple sclerosis. Results showed that for the primary endpoint of Multiple Sclerosis Functional Composite score, 32 percent of patients treated with masitinib were responders compared to 0 percent in the placebo group. Responses were seen in the third month and were more or less sustained

Eli Lilly and Co., of Indianapolis, and Boehringer Ingelheim GmbH, of Ingelheim, Germany, presented results from two Phase II studies of their investigational basal insulin analogue LY2605541 at the American Diabetes Association meeting in Philadelphia. In a Type I diabetes trial, patients treated with LY2605541 showed better glycemic control after eight weeks than those who received insulin glargine. The LY2605541 patients also had a 17 percent reduction in their mealtime insulin dose while

Acorda Therapeutics Inc., of Hawthorne, N.Y., said the first patient was enrolled in a proof-of-concept study exploring the use of Ampyra (dalfampridine) extended-release tablets in treating patients who have post-stroke deficits, which refer to chronic neurological deficits that persist in people who have suffered strokes. The trial is designed to assess the safety and tolerability of Ampyra in subjects with stable post-stroke deficits after an ischemic stroke, and exploratory outcome measures