The primary endpoint for both studies is mean change in hemoglobin from baseline

The randomized, placebo-controlled trial achieved statistical significance for its primary endpoint of mean number of oral ulcers at week 12

LONDON – South Korean biotech Kael-Gemvax is planning further investment and new clinical trials of GV1001, despite the cancer vaccine failing to meet the primary endpoint in a 1,062-patient UK Phase III trial that reported earlier this month

The randomized, placebo-controlled trial achieved statistical significance for its primary endpoint of mean number of oral ulcers at week 12

Flocor helped patients achieve resolution, but missing the primary endpoint meant the study could not qualify as a pivotal trial...They really learned a lot," and almost succeeded with the primary endpoint, garnering p = 0.07

primary endpoints of forced expiratory volume at one hour post-dose 5/2/13 Astellas Pharma Europe BV (Meppel, the Netherlands) Vesomni Solifenacin + tamsulosin Benign prostatic hyperplasia The Dutch Medicines Evaluation Board granted marketing authorization 5/24/13 Astrazeneca plc (London) Naloxegol A peripherally acting mu-opioid receptor antagonist Opioid-induced constipation Results from two pivotal Phase III studies showed the 25-mg dose met its primary and secondary endpoints for efficacy

it missed the primary endpoint of overall survival 5/17/13 Peregrine Pharmaceuticals Inc. (Tustin, Calif.) Bavituximab Immunotherapy Non-small-cell lung cancer Reached agreement with the FDA on a Phase III registration trial 5/21/13 CARDIOVASCULAR Amag Pharmaceuticals Inc. (Lexington, Mass.) Feraheme Ferumoxytol Iron deficiency anemia Reported a new subgroup analysis for a Phase III trial of 231 patients with gastrointestinal disease, with 82.1% of patients in the ferumoxytol group having an

sites 5/23/13 Oncogenex Pharmaceuticals Inc. (Bothell, Wash.) OGX-427 A heat-shock protein 27 Advanced or metastatic bladder cancer Started the Phase II Borealis-2 trial 5/1/13 Oncogenex Pharmaceuticals Inc. (Bothell, Wash.) OGX-427 Heat-shock protein 27 Advanced squamous cell lung cancer Began a Phase II trial 5/24/13 Oncolytics Biotech Inc. (Calgary, Alberta) Reolysin Reovirus variant for Ras-mutant cancers Metastatic melanoma Met the primary endpoint in the first stage of a Phase II trial

The primary endpoint is tumor regression...Overall survival is the primary endpoint. (See BioWorld Today, Dec. 22, 2010

Janssen Research & Development LLC, of Spring House, Pa., a unit of Johnson & Johnson, said a Phase III study published in The Lancet showed patients with active psoriatic arthritis who received either Stelara (ustekinumab) 45 mg or 90 mg achieved significant improvement in joint symptoms at the study's primary endpoint, compared to patients receiving placebo

placebo plus paclitaxel in recurrent tumors, met its primary endpoint in PFS, dropouts because of adverse events (AEs) amounted to more than in Phase II trials, but the dose in the Phase III experiment was higher, too

It will enroll 636 subjects, randomized equally to all three treatment arms, with a primary endpoint of time to alleviation of influenza

primary endpoint of improving overall survival compared with bendamustine plus rituximab or gemcitabine plus rituximab (investigator's choice

The primary endpoint was viral cure 12 weeks after completion of treatment

The primary endpoints are immunogenicity evaluated 21 days after each administration, as well as safety and tolerability after each administration and 12 months after the last injection

The primary endpoint was viral cure 12 weeks after completion of treatment

The primary endpoint of the Phase II cohort is to assess the complete remission rate...The primary endpoint of the study is to demonstrate efficacy, tolerability and safety of TI-001, with the secondary goal of determining the best Phase III dosage and exploring interlukin-6 levels as a potential biomarker for predicting efficacy

Previous results from TIVO-1 showed a statistically significant improvement in progression-free survival for tivozanib compared to sorafenib, successfully meeting the primary endpoint of the study

Previous results from TIVO-1 showed a statistically significant improvement in progression-free survival for tivozanib compared to sorafenib, successfully meeting the primary endpoint of the study