Mirna Therapeutics Inc., of Austin, Texas, has initiated a Phase I study of MRX34, the first miRNA to advance to a clinical trial for cancer...The study will consist of an initial dose-escalation phase followed by an enrichment phase, and is expected to enroll up to 48 patients in total

The NH004-3 clinical trial is a double-blind, placebo-controlled, randomized, crossover, multicenter study comparing NH004 and placebo thin films in Parkinson's disease patient complaining of sialorrhea...The study is an open-label, multiple-dose, dose-escalation study to evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to approximately 15 relapsed or refractory multiple myeloma, mantle cell (MCL) or diffuse large B-cell lymphoma (DLBCL) patients

The primary endpoint is clinical benefit, which will be assessed at six months...The study, dubbed STOP-TBI, is a randomized, dose-escalation study designed to test a single intravenous administration of Oxycyte, a nonpyrogenic perfluoro(t-butycyclohexane) emulsion product, in conjunction with supplemental oxygen

Cel-Sci Corp., of Vienna, Va., entered a co-development agreement with Ergomed, a clinical research organization (CRO), to expand its Phase III study of Multikine (leukocyte interleukin) as an injectable treatment for head and neck cancer...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 primary objectives include the evaluation of adverse events and a six-month clinical response...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

Fifty percent (eight patients) met the primary endpoint, defined as a reduction in the Mayo score between baseline and completion of treatment, while the remaining eight patients demonstrated a stable clinical condition or minor improvement...The dose-escalation and safety study is expected to treat up to 15 patients in five different dosing cohorts

Array BioPharma Inc., of Boulder, Colo., reported clinical data at the International Myeloma Workshop in Kyoto, Japan, showing that ARRY-520, a selective KSP inhibitor, demonstrated single-agent activity in heavily pretreated patients with relapsed or refractory multiple myeloma, with 19 months median overall survival and a 16 percent overall response rate...Patients are enrolling in the next dosing cohort in the dose-escalation study

The dose-escalation trial will enroll about 56 healthy volunteers and will assess safety, tolerability and pharmacokinetics of both single and multiple doses...Novavax Inc., of Rockville, Md., said top-line data from its Phase II dose-ranging study testing its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age hit its protocol-specified objectives, supporting progression to the next stage of advanced clinical testing

Benitec Biopharma Ltd., of Sydney, Australia, selected the Duke Clinical Research Unit in Durham, N.C., as a site for its upcoming Phase I/II first-in-human trial of TT-034 in hepatitis C virus (HCV...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

The dose-escalation study enrolled young, healthy volunteers...Vertex Pharmaceuticals Inc., of Cambridge, Mass., said VX-787 in a Phase II influenza challenge study resulted in statistically significant improvements in viral and clinical measurements of infection...Also, 93 percent of people in that dose group showed no clinical symptoms of influenza after three days of treatment, compared to 41 percent of people in the placebo group

Polyphor Ltd., of Allschwil, Switzerland, completed a Phase I trial demonstrating the clinical safety and tolerability of its Pseudomonas-specific antibiotic POL7080...All primary study objectives were achieved in the randomized, double-blind, placebo-controlled dose-escalation trial assessing the safety, tolerability and pharmacokinetics of POL7080 in 52 healthy male volunteers

Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., said its Phase III trial of Ampion for the treatment of osteoarthritis of the knee will include a dose-escalation run-in study as recommended by the FDA...The study also has exploratory endpoints for clinical efficacy and inflammation biomarkers...Ltd., of Taipei, Taiwan, added two additional Taiwanese clinical centers in Cel-Sci's Phase III head and neck cancer trial for Multikine (Leukocyte Interleukin, Injection), including the China Medical

Amicus Therapeutics Inc., of Cranbury, N.J., reported positive results from clinical and preclinical studies of the pharmacological chaperone AT2220 (duvoglustat HCl) in combination with ERT for Pompe disease at the Lysosomal Disease Network World Symposium...The open-label, dose-escalation trial was conducted in 52 men with hormone-refractory prostate cancer that had progressed despite prior treatment with taxane-based chemotherapy regimens

Two posters feature clinical data of PROSTVAC evaluated as monotherapy or in combination with a radiopharmaceutical...The final poster reviews results from the Phase I dose-escalation trial of MVA-BN PRO

Dose escalation will continue as planned to the 1,200-mg dose cohort...Following successful completion of the dose-escalation component of the study, an additional expansion cohort may be added at the highest dose of 1,200 mg

The two-part study will feature a dose-escalation portion testing the drugs in combination as a second-line treatment, while the second part will be an open-label, randomized study to determine whether treatment with dalantercept plus axitinib can prolong progression-free survival (PFS) vs...The dose-escalation study will evaluate safety, tolerability and efficacy as determined by RECIST criteria and the company's cancer stem cell biomarkers

The trial will assess safety and clinical benefit of various dose levels of cells...The dose-escalation study is being conducted under an investigational new drug application at two U.S

Thirty-five patents with relapsed or refractory disease after at least two previous regimens with other drugs were included in the dose escalation study...Sirtex Medical Ltd., of New South Wales, Australia, reported results from an analysis of 548 patients in a clinical study testing Selective Internal Radiation Therapy (SIRT) with SIR-Spheres microspheres in patients with metastatic colorectal cancer...Those data were presented at the American Society of Clinical Oncology's 2013 Gastrointestinal

Durata said the secondary endpoint of clinical success at the end of treatment – the expected primary endpoint for regulatory review in Europe – also was met...The 30-patient dose escalation trial evaluated the detailed pharmacokinetics of mibefradil administered four times a day and confirmed its safe dose levels for use in a Phase Ib trial