The open-label trial will randomize 20 postmenopausal women with estrogen receptor-positive disease who have responded previously to hormone therapy to receive 9 mg of enobosarm once daily until they show clinical progression or have completed 336 days of treatment
The open-label trial will evaluate efficacy, safety and tolerability at two sites in France, enrolling up to 32 HCV-infected patients of any genotype who previously failed or relapsed following standard-of-care treatment...The open-label study, which randomized 153 patients, evaluated two schedules of TG4040 in combination with PegIFNα2a (P) and ribavirin (R) vs. P/R alone (arm A
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...Data from the open-label, dose-escalation pilot study will be used to define the optimal dose for a larger Phase II/III study in infants
The study is an open-label, multiple-dose, dose-escalation study that will evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to approximately 15 relapsed or refractory multiple myeloma, mantle cell or diffuse large B-cell lymphoma patients
The open-label study under an investigational new drug application is designed to evaluate the safety and efficacy profile of repeated escalating doses of BL-8040 in adults with relapsed/refractory AML...The open-label Phase I/II study is designed to assess the safety and potential efficacy of gevokizumab, a monoclonal antibody designed to bind to interleukin-1 beta
Kythera Biopharmaceuticals Inc., of Calabasas, Calif., disclosed positive interim results from a Phase IIIb, multicenter, open-label study (ATX-101-11-26) of ATX-101 during the "Innovations and Renewals" session of the 11th Anti-Aging Medicine World Congress in Monte Carlo, Monaco
Emergent BioSolutions Inc., of Rockville, Md., expanded the protocol for its ongoing Phase Ib, single-arm, open-label study (Protocol 16009) that is evaluating the safety and efficacy of TRU-016 in combination with rituximab in previously untreated patients with chronic lymphocytic leukemia (CLL...Sarepta Therapeutics Inc., of Cambridge, Mass., reported updated data from Study 202, a Phase IIb open-label extension study of eteplirsen in Duchenne's muscular dystrophy (DMD
Vital Therapies Inc., of San Diego, enrolled the first patient in a Phase III trial designated VTI-208, a randomized, open-label, multicenter, controlled trial comparing the company's investigational bio-artificial liver support system, ELAD plus standard of care, vs
The open-label study will test the safety and efficacy of intra-articular injections of the autologous treatment in order to reduce inflammation and regenerate damaged joint tissue
The open-label study, which will assess safety and pharmacokinetics in 12 Gaucher subjects, is expected to be completed in the third quarter...The trial is designed to test the safety and efficacy of the product in up to 124 patients with IC, and those who successfully complete the study will be eligible to participate in a subsequent open-label extension arm
Convergence Pharmaceuticals Ltd., of Cambridge, UK, reported interim data from the ongoing Phase II trial testing sodium channel blocker CNV1014802 in patients with trigeminal neuralgia, a severe form of facial pain, showing that, in the open-label portion, a total of 70 percent had a successful response and were subsequently randomized into the double-blind treatment period...Navidea Biopharmaceuticals Inc., of Dublin, Ohio, said it started enrolling patients in its Phase IIb, open-label positron
The open-label study assessed the safety and efficacy of CCH in Stage II unilateral idiopathic FSS in comparison to an exercise-only control group...OncoSec expects to complete enrollment in the single-arm, open-label, multicenter trial, with approximately 25 patients, in the second quarter
The open-label, dose escalation study will evaluate the safety and activity of single doses of TT-034 in patients with chronic HCV genotype 1 infection who failed previous treatments
Acasti Pharma Inc., of Laval, Quebec, a subsidiary of Neptune Technologies & Bioressources Inc., reported preliminary data from a randomized, open-label, dose-ranging, multicenter trial assessing the safety and efficacy of NKPL66, or CaPre, in mild-to-high hypertriglyceridemia...The company examined the triglycerides data from its open-label study in the course of planning its Phase III development of CaPre
Merrimack Pharmaceuticals Inc., of Cambridge, Mass., enrolled its last patient in a Phase II, open-label, randomized trial of MM-121, a human monoclonal antibody, in combination with paclitaxel, compared to paclitaxel alone in advanced ovarian cancers
The single-arm, open-label extension trial was designed to evaluate repeat dosing with the iron replacement therapy in patients with persistent or recurring iron deficiency anemia (IDA) regardless of the underlying cause and history of unsatisfactory oral iron therapy or in whom oral iron could not be used
The open-label trial will evaluate the efficacy, safety and tolerability of the drug in patients infected with HCV, of any genotype, who have previously failed or relapsed following standard-of-care treatment...The open-label trial consists of weekly doses of the Imprime PGG immunotherapeutic candidate, with Avastin administered once per cycle and the chemotherapies carboplatin and paclitaxel administered during week one of the first four to six cycles
Ziopharm Oncology Inc., of New York, initiated a randomized, open-label Phase II study of Ad-RTS IL-12 (previously ZIN ATI-001) in combination with palifosfamide in nonresectable recurrent or metastatic breast cancer
The open-label trial will randomize 20 postmenopausal women with estrogen receptor-positive disease who have responded previously to hormone therapy to receive 9 mg of enobosarm once daily until they show clinical progression or have completed 336 days of treatment