EnVivo Pharmaceuticals Inc., of Watertown, Mass., reported results from its Phase IIb trial of EVP-6124, an alpha-7 agonist for Alzheimer's disease, which met both of the primary endpoints at the 2-mg dose, with statistically significant positive effects on cognition (p = 0.0189), as measured by the Alzheimer's Disease Assessment Scale-Cognitive subscale-13, and clinical function (p = 0.0253), as measured by the Clinical Dementia Rating Scale Sum of Boxes
Anthera reported top-line data from the PEARL-SC study late last month, showing that the trial missed its primary endpoint, defined as clinical improvement at 24 weeks in the SLE responder index for the pooled blisibimod dose groups...The primary endpoint is safety, tolerability and feasibility of the treatment regimen
Initiated in July 2011, the Phase I/II trial is designed to determine the safety and tolerability of hESC-derived RPE cells following subretinal transplantation in patients with SMD at 12 months, the study's primary endpoint. (See BioWorld Today, Jan. 24, 2012
At the primary endpoint, weight loss was significantly greater in the albiglutide group compared to the sitagliptin group (-0.79 kg vs. -0.19 kg, p = 0.0281...Theravance Inc., of South San Francisco, reported top-line results from 0084, the key study in the Phase IIb program evaluating TD-1211 in chronic, noncancer pain patients with opioid-induced constipation, which met its primary endpoint of change from baseline in average complete spontaneous bowel movements (SBMs) per week over the last four
The study failed to meet its primary endpoint in the prevention of postsurgical adhesions, though results suggested the drug may improve the postoperative outcome regarding hand mobility after surgery
Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., reported that a further analysis of Phase II data showed six out of seven subjects with diabetic macular edema who received the optimal low dose of Optina (danazol) saw a clinically relevant change in retinal thickness after 12 weeks, the primary endpoint, compared with 29 percent of subjects in the placebo group...The 27-patient, single-arm, open-label multicenter study has a primary endpoint to assess local and distant response rate
The primary endpoint is progression-free survival (PFS) at nine months, while secondary endpoints include PFS at one year and overall survival at one year
Teva Pharmaceutical Industries Ltd., of Jerusalem, presented Phase III results showing that lipegfilgrastim and balugrastim, long-acting granulocyte colony-stimulating factors, achieved the primary endpoint in breast cancer studies, demonstrating reduction in the duration of severe neutropenia in cycle 1, comparable to Neulasta (pegfilgrastim, Amgen Inc.) in both efficacy and safety measures
The study, dubbed ADAPT (Autologous Dendritic Cell Immunothearpy [AGS-003] Plus Standard Treatment of Advanced Renal Cell Carcinoma), is expected to begin dosing patients in the second half of this year, with a primary endpoint of overall survival...The NSCLC trial enrolled 150 patients and will assess safety and efficacy of CRLX101 as a monotherapy with the primary endpoint of overall survival
The study, dubbed TOURMALINE-MMI, is a randomized trial comparing MLN9708 plus Revlimid (lenalidomide, Celgene Corp.) and dexamethasone to placebo plus lenalidomide and dexamethasone, with progression-free survival as the primary endpoint
The study is designed to enroll up to 25 patients with Stage III or Stage IV cutaneous and in-transit metastatic melanoma and will assess local and distant objective response following treatment with DNA IL-12 and electroporation, with a primary endpoint of 24 weeks
The study also met its primary endpoint of absolute change in total lean body mass compared to placebo after 16 weeks of treatment...The primary endpoint was defined as a 50 percent or greater reduction in calcium/vitamin D supplements and a total serum calcium concentration that was normalized or maintained compared to baseline after 24 weeks of treatment
Pfizer Inc., of New York, said its ALK inhibitor Xalkori (crizotinib) met its primary endpoint in the PROFILE 1007 study, demonstrating significantly improved progression-free survival (PFS) when compared with pemetrexed or docetaxel, in previously treated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC
Infinity Pharmaceuticals Inc., of Cambridge, Mass., said interim Phase II data of saridegib (IPI-926) in patients with metastatic or locally advanced, inoperable chondrosarcoma indicated the treatment was similar to placebo and the trial would not meet its primary endpoint of progression-free survival...The primary endpoint is based on the Unified Huntington's Disease Rating Scale
EnVivo Pharmaceuticals Inc., of Watertown, Mass., reported results from its Phase IIb trial of EVP-6124, an alpha-7 agonist for Alzheimer's disease, which met both of the primary endpoints at the 2-mg dose, with statistically significant positive effects on cognition (p = 0.0189), as measured by the Alzheimer's Disease Assessment Scale-Cognitive subscale-13, and clinical function (p = 0.0253), as measured by the Clinical Dementia Rating Scale Sum of Boxes