The exploratory analysis identified a more robust response to CERE-120 in Parkinson's patients diagnosed within five years prior to treatment relative to those diagnosed 10 years or older (p < 0.005), as measured by change from baseline on the Unified Parkinson's Disease Rating Scale, the primary endpoint...Previously, Ceregene reported the primary endpoint was not met for the overall study population, although a key secondary endpoint of diary-hours off demonstrated statistical significance and no
Results of the trial's primary endpoint of change in fasting plasma glucose are expected in late summer, and the read-out for long-term glucose lowering and weight benefits is due in the fourth quarter...Overall survival will be the primary endpoint
Patients treated with afatinib lived for almost a year before their tumor started to grow again (progression-free survival [PFS], the primary endpoint) as compared with just under six months for patients treated with gemcitabine/cisplatin...In the study, at Day 28 (primary endpoint, p = 0.26), 24 percent of treated patients achieved resolution compared to 12 percent in the sham injection arm
Amgen Inc., of Thousand Oaks, Calif., said the Phase III head-to-head ASPECCT ('763) trial evaluating its Vectibix (panitumumab) vs. Erbitux (cetuximab, Eli Lilly and Co.) as a single agent for the treatment of chemorefractory metastatic colorectal cancer in patients with wild-type KRAS tumors (n = 1 ,010) met its primary endpoint of noninferiority for overall survival
Baxter International Inc., of Deerfield, Ill., said a Phase III study testing immunoglobulin did not meet the co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer's disease
The trial met its primary endpoint, demonstrating that ETC-1002 lowered LDL-C by up to 43 percent, and was associated with improvements in control of other cardiometabolic risk factors
Seaside Therapeutics Inc., of Cambridge, Mass., said its Phase IIb trial evaluating arbaclofen (STX209) in core impairments of autism spectrum disorder (ASD) failed to show improvement on the primary endpoint of social withdrawal but demonstrated improvement on the clinical global impression of severity scale
Median OS, which is the primary endpoint for the trial, in patients treated with HSPPC-96 is currently 23.3 months...The study will randomize about 130 patients to receive either OGX-427 or placebo in combination with Abraxane and gemcitabine, and the primary endpoint will measure overall survival
The 400/12 mcg combination of aclidinium/formoterol demonstrated statistically significant improvements in change from baseline for the co-primary endpoints of forced expiratory volume (FEV1) at one hour post-dose vs
The primary endpoint is clinical benefit, which will be assessed at six months...The primary endpoint is overall survival, with secondary endpoints evaluating safety, tolerability, tumor response rates and the effect of therapy on Hsp27 levels and circulating tumor cells
The primary endpoint is to evaluate the effect of the 16-week combination therapy, comprised of ribavirin and hydroxychloroquine...The primary endpoint was met in arm C with a complete early viral response of 64 percent, compared to 30 percent in the control arm
Pfizer Inc., of New York, said that top-line data for a Phase IV trial of Celebrex (celecoxib) capsules or naproxen in juvenile idiopathic arthritis patients demonstrated no difference in changes to systolic blood pressure, the primary endpoint, and diastolic blood pressure, the secondary endpoint
AcelRx Pharmaceuticals Inc., of Redwood City, Calif., reported that its Phase II study of sublingual sufentanil NanoTab for acute pain, ARX-04, met its primary endpoint of significantly greater pain reduction than placebo (p = 0.003
The primary endpoint of the randomized, double-blind, placebo-controlled trial is the effect of repeat oral dosing of the Cav2.2 selective blocker on the pain experienced in PHN after three weeks, compared with baseline...The open-label, pivotal trial will enroll 400 subjects at about 80 sites in Australia, Canada, China, Europe, Latin America and the U.S. The primary endpoint is progression-free survival, and secondary endpoints include overall survival and safety
The primary endpoint of the trial is safety and tolerability of the drug...The primary endpoint of the trial, which compares ibrutinib monotherapy to ofatumumab, will be improvement in progression-free survival
The exploratory analysis identified a more robust response to CERE-120 in Parkinson's patients diagnosed within five years prior to treatment relative to those diagnosed 10 years or older (p < 0.005), as measured by change from baseline on the Unified Parkinson's Disease Rating Scale, the primary endpoint...Previously, Ceregene reported the primary endpoint was not met for the overall study population, although a key secondary endpoint of diary-hours off demonstrated statistical significance and no