Inotek Pharmaceuticals Corp., of Lexington, Mass., said its multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase II trial achieved its primary and secondary endpoints in evaluating the efficacy and safety of its eye drop trabodenoson (INO-8875) in primary open-angle glaucoma or ocular hypertension...Novartis also plans to pursue clinical development in combination with a Raf inhibitor in BRAF mutant melanoma, with regulatory submissions projected on or after 2016

Chelsea Therapeutics International Ltd., of Charlotte, N.C., reported results from a clinical study designed to determine the blood pressure effect of escalating doses (100 mg, 200 mg and 400 mg) of Northera (droxidopa) in hypotensive individuals with chronic spinal cord injuries ranging from cervical to low thoracic lesions...The randomized, double-blind, placebo-controlled study will evaluate a range of doses in approximately 150 patients over an eight

Ultragenyx Pharmaceutical Inc., of Novato, Calif., completed enrollment of a randomized, double-blind, placebo-controlled Phase II study of UX001 (extended-release sialic acid) in patients with hereditary inclusion body myopathy (HIBM...Muscle strength, clinical function and patient-reported outcomes also will be evaluated, though the study is not powered for those endpoints...two dose levels of active drug at four clinical sites in the U.S

The study is a randomized, double-blind, double-dummy trial comparing the efficacy of dalbavancin to a regimen of vancomycin...Patients will be monitored for development of clinical symptoms and viral shedding

AIM Therapeutics Inc., of Toronto, said it initiated dosing in a double-blind, placebo-controlled, crossover Phase II study evaluating the efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of oral AIM-102 in mild to moderate allergic asthma...Derma Sciences Inc., of Princeton, N.J., said it plans to begin its Phase III program in December for DSC127, a clinical formulation of NorLeu3-A(1,7), in diabetic foot ulcers, to support the filing of a new drug application

The randomized, double-blind trial of safety and feasibility will enroll 45 patients at six centers in the U.S...StemCells Inc., of Newark, Calif., said two papers reporting clinical and preclinical data demonstrating the therapeutic potential of the company's HuCNS-SC cells (purified human neural stem cells) for a range of myelination disorders were published in the Oct. 10, 2012, edition of Science Translational Medicine

The randomized, double-blind trial, known as AETHERA, is comparing Adcetris against placebo in patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant...Vertex Pharmaceuticals Inc., of Cambridge, Mass., and collaborator Alios BioPharma Inc., of South San Francisco, reported results from a viral kinetic study of adenosine nucleotide analogue prodrug ALS-2158 in hepatitis C, with data showing that seven days of dosing with up to 900 mg of the drug was well

The results were published online in the Journal of Clinical Oncology in September 2012...Ohr Pharmaceutical Inc., of New York, began a randomized, double-blind, placebo-controlled, Phase II trial of Squalamine Eye Drops for wet, age-related macular degeneration...Topotarget A/S, of Copenhagen, Denmark, reported preliminary clinical results for a trial of belinostat for relapsed and refractory peripheral T-cell lymphoma

The randomized, double-blind, placebo-controlled, escalating dose study trial enrolled 48 healthy adult volunteers...The second trial, a randomized, double-blind study, compared the immunogenicity of Flunisyn, alone or with an undisclosed adjuvant, in 48 healthy adult volunteers

The randomized study has a six-month, double-blind, placebo-controlled primary treatment period and a six-month, open-label, follow-up period in which all subjects receive treatment with migalastat HCl...Omeros Corp., of Seattle, said it filed an investigational new drug application to start clinical studies of OMS824, the lead compound from its phosphodiesterase 10 program for schizophrenia and other cognitive disorders

News of the most recent clinical hold sent Idenix shares (NASDAQ:IDIX) on a rollercoaster ride Monday morning...The randomized, double-blind, placebo-controlled study in 200 patients has progression-free survival as its primary endpoint

The randomized, double-blind, placebo controlled trial measured benefit in overall survival compared to placebo...The double-blind, randomized study in 40 patients will produce top-line data by the middle of 2013

In 2010, Relypsa completed a 104-patient multicenter, randomized, double-blind, placebo-controlled Phase IIb study, PEARL-HF, which showed that RLY5016 significantly reduced the incidence of hyperkalemia in patients with heart failure, compared with placebo...is acting as sole book-running manager.

The trial will be carried out at clinical centers in the U.S...The double-blind, randomized, placebo-controlled trial will enroll 100 patients between 12 and 25 with confirmed EoE and problems swallowing food

Intercept is currently conducting POISE, a Phase III clinical trial of OCA in PBC...The target enrollment for the study is 180 patients who will first enter a one-year double-blind placebo controlled pivotal trial phase, followed by an open-label long-term safety extension phase for another five years

It began a Phase IIa, randomized, double-blind, placebo-controlled trial of IPI-145 for asthma, and has plans for another Phase IIa trial of IPI-145 in rheumatoid arthritis...The funds will be used as working capital to support clinical development of the company's products, including therapies for men's health, female sexual health and respiratory disorders.

Agenus Inc., of Lexington, Mass., said clinical data from a Phase I trial of a Prophage Series vaccine (HSPPC-96, vitespen) to treat patients with recurrent glioblastoma multiforme (GBM) were published online by Clinical Cancer Research...The randomized, double-blind, placebo-controlled, single-center trial will investigate the safety and pharmacokinetics of single and multiple ascending doses of 3K3A-APC in healthy adult volunteers, with results expected in the first quarter of 2013

The randomized, double-blind, placebo-controlled study will involve approximately 25 sites with the goal of enrolling 140 patients...The randomized, double-blind, placebo-controlled, cross-over study is designed to enroll 18 patients with active UC either to TSO (2,500 ova) or placebo every other week for 12 weeks, then cross over to the other treatment for an additional 12 weeks

Repeated daily application of Viaskin will be made over a 12-month double-blind treatment period, each Viaskin being applied for a period of 24 hours, either on the upper arms for adults (18-55 years) and adolescents (12-17 years) or on the back for children (6-11 years...Spectrum Pharmaceuticals Inc., of Henderson, Nev., said data published in the Journal of Clinical Oncology showed first-line consolidation with Zevalin (ibritumomab tiuxetan) injection in patients with mantle-cell lymphoma