Acasti Pharma Inc., of Laval, Quebec, a subsidiary of Neptune Technologies & Bioressources Inc., reported preliminary data from a randomized, open-label, dose-ranging, multicenter trial assessing the safety and efficacy of NKPL66, or CaPre, in mild-to-high hypertriglyceridemia...The company examined the triglycerides data from its open-label study in the course of planning its Phase III development of CaPre...The NX03-0040 prostate cancer clinical study of 150 men is testing low (2.5 mg) and high (15

Targeted Medical Pharma Inc., of Los Angeles, said results from an open-label study of oral amino acid-based erythrocyte stimulating system (ESS) for the treatment of chronic anemia showed that hemoglobin increased an average of 11.39 percent from baseline measurement to 45 days

The open-label study followed 21 patients with unfavorable risk mRCC, with an expected survival of approximately 15 months...BioAlliance Pharma SA, of Paris, said the FDA approved a U.S

Two posters feature clinical data of PROSTVAC evaluated as monotherapy or in combination with a radiopharmaceutical...BHR Pharma LLC, of Herndon, Va., said the European Medicines Agency (EMA) granted an orphan medicinal product designation for treating moderate and severe traumatic brain injury (TBI) to its intravenous progesterone infusion agent, BHR-100...A randomized Phase II, open-label study of Provenge with concurrent or sequential abiraterone acetate (AA) plus prednisone (P) in metastatic

Acasti Pharma Inc., of Laval, Quebec, said it achieved significant progress in two ongoing clinical studies with CaPre for lipid management...The second Phase II open-label study should be completed by the end of the first quarter of 2013

Tiltan Pharma Ltd., of Jerusalem, said it enrolled the first U.S...ViroPharma Inc., of Exton, Pa., said data from an open-label study testing escalating doses of C1 INH-nf in patients with hereditary angioedema (HAE) who are not adequately controlled with 1,000 U every three or four days provide evidence of the safety profile of Cinryze (C1 esterase inhibitor [human]) at doses of up to 2,500 units in HAE patients

The open-label study is dosing patients twice-weekly for six weeks, followed by an observation period...Zealand Pharma A/S, of Copenhagen, Denmark, said it dosed the first patient in a Phase I study of ZP2929, a dual-acting glucagon/GLP-1 peptide agonist, in development for treating patients with Type II diabetes and/or patients with obesity

BHR Pharma LLC, of Phoenix, said it reached its SyNAPSe clinical trial enrollment midpoint of 590 patients...The single-arm, open-label study of JX-594, administered weekly by intravenous infusions, will examine radiographic response rate based on modified RECIST and modified Choi criteria and will subsequently follow patients for progression-free survival and overall survival

Antisense Pharma GmbH, of Regensburg, Germany presented complete data from its Phase I/II study of trabedersen, an antisense compound that specifically inhibits expression of transforming growth factor beta 2 (TGF-β2) – a protein which is overexpressed in advanced tumors – in patients with advanced pancreatic cancer, malignant melanoma or colorectal cancer...CytRx Corp., of Los Angeles, reported Phase Ib/II data showing that tumor-targeting doxorubicin conjugate INNO-206 produced a clinical benefit

Sunovion Pharmaceuticals Inc., of Marlborough, Mass., reported results from an open-label study that switched clinically stable, but symptomatic adult outpatients with schizophrenia from other antipsychotic agents to Latuda (lurasidone HCl...The six-week open-label study included 244 patients who were clinically stable for at least eight weeks prior to the start of the study and had been on stable doses of other antipsychotic agents for at least four weeks

The open-label study is designed to test safety, tolerability and clinical response activity of the drug in patients, 60 and older, who have relapsed or primary refractory disease...Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of Paris, presented new results from a four-week Phase II study showing that GLP-1 agonist Lyxumia (lixisenatide) produced significantly greater postprandial glucose lowering than Victoza (liraglutide, Novo Nordisk A/S) in patients with Type II diabetes

The open-label study will assess the efficacy of MORAb-004 at one of two doses as determined by progression-free survival in patients with metastatic melanoma in Australia, Europe and the U.S. Secondary objectives include assessment of an overall survival benefit and identification of biomarkers to predict efficacy...NovaDel Pharma Inc., of Bridgewater, N.J., opened an investigational new drug application with the FDA for Duromist, an oral spray formulation of New York-based Pfizer Inc.'s Viagra

Innate Pharma SA, of Marseilles, France, said the National Cancer Institute enrolled the first patient in a Phase II trial of anti-KIR monoclonal antibody IPH 2101 in smoldering myeloma...The open-label study will involve about 20 patients and is expected to be completed in March

7TM Pharma A/S completed a Phase I trial of its first-in-class CB1 receptor antagonist, TM38837, for obesity...Astex Therapeutics, of Cambridge, UK, will report clinical data on three anticancer candidates at the 22nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics Nov. 16-19 in Berlin...It was statistically noninferior to Zyvox (linezolid, Pfizer Inc.) for all clinical test-of-cure and short-term follow-up endpoints

The randomized, open-label study of TCAD therapy (amantadine and ribavirin administered with oseltamivir) was tested against oseltamivir monotherapy in immunocompromised patients with influenza A. Seven patients with confirmed influenza A were enrolled, and data showed that up to 10 days of TCAD therapy was observed to be well tolerated, with five of six TCAD-treated subjects who completed the study achieving a clinical response by day 10...PLx Pharma Inc., of Houston, reported positive results

Acorda Therapeutics Inc., of Hawthorne, N.Y., presented four new analyses of clinical trial data on Ampyra (dalfampridine) Extended Release Tablets 10 mg as a treatment to improve walking in patients with multiple sclerosis...Responders showed improvement in average walking speed compared to their average baseline for up to 2.5 years in open-label studies...UCB Pharma Inc., of Atlanta, said data showed that patients with moderate to severe restless legs syndrome using rotigotine achieved sustained

AM-Pharma BV, of Bunnik, the Netherlands, disclosed positive results from its Phase II acute kidney injury trial with alkaline phosphatase at the International Symposium on Intensive Care and Emergency Medicine...The open-label study enrolled 15 patients who were administered a course of NTx-265, sequential administration of human chorionic gonadotropin followed by erythropoietin, with the first dose at 24 hours to 48 hours after stroke onset

AM-Pharma BV, of Bunnik, the Netherlands, reported positive results from its Phase II acute kidney injury trial with alkaline phosphatase, which showed statistically significant improvement on the primary clinical endpoint and on several secondary endpoints after interim analysis of the treatment effect on 26 patients...The open-label study in up to 56 patients is designed to evaluate the efficacy of AR-67 dosed intravenously for five days on a 21-day cycle until the onset of toxicity requiring

BioAlliance Pharma SA, of Paris, gained approval from the French drug agency to start a Phase II trial of clonidine Lauriad in radiotherapy- and chemotherapy-induced oral mucositis...The open-label study will assess safety, tolerability and pharmacokinetics in severe, previously treated hemophilia A patients