The Phase III study met its primary endpoint and demonstrated statistically significant protection against clinical and severe malaria in infants...The primary endpoint, the results for which were previously released, showed significantly greater (p < 0.001) improvement in nasal symptoms compared with placebo for both QNASL 160 mcg and 80 mcg over the two-week treatment period

The primary endpoint for the study is change in percent "off" time during waking hours, as measured by patient self-assessment during the treatment period relative to the baseline period...The study, dubbed STOP-ALF, is expected to enroll a total of 24 patients with severe acute liver injury or acute liver failure and will measure safety and tolerability as the primary endpoint

As one of two co-primary endpoints was met, Novartis said the study achieved its primary objective based on pre-specified protocol criteria...Data showed that each study achieved its individual primary endpoint, as patients on PA32540 experienced fewer gastric ulcers compared to those taking enteric-coated aspirin alone

The primary endpoint data are event-driven, with results expected by the end of 2013...Approximately 500 adenocarcinoma patients with advanced non-small-cell lung cancer who received one prior chemotherapy regimen will be randomized 1-to-1 to docetaxel plus ganetespib or docetaxel alone, with overall survival as the primary endpoint

The primary endpoint is the incidence of CDAD from the first dose of study drug through the 30-day follow-up period after the last day of drug

The study will enroll about 24 patients and will measure overall response rate as the primary endpoint...EnVivo Pharmaceuticals Inc., of Watertown, Mass., said data from its Phase IIb study of EVP-6124, an alpha-7 agonist, in Alzheimer's disease met both of the trial's primary endpoints, with statistically significant positive effects on cognition (p = 0.0189), as measured by ADAS-COG-13, and clinical function (p = 0.0253), as measured by the Clinical Dementia Rating Scale Sum of Boxes

placebo as the primary endpoint...The studies, POWER 1 and POWER 2, are evaluating as co-primary endpoints at three months of treatment the response rates of enobosarm vs

The primary endpoint of the analysis will be the six-week effect of the drug on cognitive function...The primary endpoint of the 33-patient study is to determine the clinical benefit rate, while secondary objectives include progression-free survival and safety and tolerability

Celgene Corp., of Summit, N.J., said its Celgene International Sarl subsidiary reported the data safety monitoring board (DSMB) determined that the Phase III study MM-003 testing pomalidomide plus low-dose dexamethasone compared to high-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma met the primary endpoint of improvement in progression-free survival (PFS) at the PFS final analysis...The primary endpoints are safety and the improvement in function of the hands, as

The study will enroll about 210 patients, with a primary endpoint of overall survival

primary endpoint, compared with placebo

The co-primary endpoints are overall hematologic response rate, including complete response (CR), very good partial response, partial response and rate of two-year vital organ deterioration and mortality rate...Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said detailed one-year results from the VIEW 1 and VIEW 2 Phase III trials published in Ophthalmology showed that Eylea (aflibercept), dosed every eight weeks following three initial monthly injections, was clinically equivalent to Lucentis

Janssen Research & Development LLC, of Spring House, Pa., a unit of Johnson & Johnson, said a Phase IIb study testing Stelara (ustekinumab) in moderate to severe Crohn's disease showed that, among patients who had previously failed or were intolerant to at least one tumor necrosis factor antagonist, a significantly greater proportion receiving intravenous Stelara achieved the primary endpoint of clinical response at week six, defined as a 100-point reduction in Crohn's Disease Activity Index

Nabi Biopharmaceuticals Inc., of Rockville, Md., reported Phase II data showing that smoking cessation candidate NicVAX (nicotine conjugate immunotherapeutic) in combination with Chantix (varenicline, Pfizer Inc.) did not meet the study's primary endpoint...The single-arm, open-label study will enroll up to 20 patients, with a primary endpoint of objective response rate and secondary endpoints of safety and tolerability, duration of response, complete remission rate and progression-free survival

Pfizer Inc., of New York, said a Phase III study of Inlyta (axitinib) did not meet its primary endpoint of demonstrating statistically significantly longer progression-free survival (PFS) vs. Nexavar (sorafenib, Onyx Pharmaceuticals Inc. and Bayer AG) in treatment-naïve patients with advanced renal cell carcinoma

The study will test the drug, a selective MET inhibitor, as a single agent in previously treated patients with MET diagnostic-high inoperable HCC, with a primary endpoint of overall survival in the intent-to-treat population

Eli Lilly and Co., of Indianapolis, said the Phase III REGARD trial testing ramucirumab in patients with metastatic gastric cancer met its primary endpoint of improved overall survival and also showed prolonged progression-free survival

The study enrolled 93 patients and evaluated an increase in bone mineral density at the lumbar spine at 24 weeks as the primary endpoint

The primary endpoint is overall survival, while secondary endpoints include progression-free survival and immunological response...Summit plc, of Oxford, UK, reported top-line results from a Phase I trial of SMT C1100 in Duchenne's muscular dystrophy (DMD), showing that the study met its primary endpoints, demonstrating the formulation of the oral small molecule to be safe and well tolerated at all doses