The study is the first of two identical trials, and the endpoints of both will include vitamin D status, adverse events, physical and clinical laboratory assessments and changes in serum calcium, serum phosphorous and plasma intact parathyroid hormone...The open-label trial will enroll about 40 patients chronically infected with HCV genotype-1a, and the primary endpoint will be sustained virologic response 12 weeks after the end of treatment

The findings were published in the Journal of Clinical Oncology...Navidea Biopharmaceuticals Inc., of Dublin, Ohio, began enrolling patients in its open-label Phase II safety and efficacy PET imaging study of

The investment comes in the wake of positive clinical data from early stage trials of both CV9103 and NSCLC vaccine CV9201...In an open-label Phase I/IIa trial in 44 patients with castrate-resistant prostate cancer and rising levels of PSA, CV9103 elicited an immune response against at least one antigen in 79 percent of the patients, and against more than one antigen in 58 percent of the responding patients

No new safety signals emerged in the study, and the overall safety profile of tofacitinib remained consistent with that seen previously in the RA clinical development program...Pfizer also will report data from a pooled analysis of two long-term, open-label extension studies (NCT00413699, NCT00661661) demonstrating patients with moderate-to-severe RA who had participated in randomized Phase II or III studies of tofacitinib showed a consistent safety profile and sustained efficacy over 48 months

The open-label Phase II study is enrolling 130 patients with Type I diabetes, randomized to BIOD-123 or insulin lispro at mealtime over 18 weeks...The open-label study is dosing patients twice-weekly for six weeks, followed by an observation period

Inovio Pharmaceuticals Inc., of Blue Bell, Pa., said an interim analysis of its open-label Phase I study of SynCon H1N1 influenza vaccine resulted in protective HAI titers to some of the most prevalent strains...Omeros Corp., of Seattle, said it filed an investigational new drug application to start clinical studies of OMS824, the lead compound from its phosphodiesterase 10 program for schizophrenia and other cognitive disorders

Debiopharm Group, of Lausanne, Switzerland, treated its first patient in an open-label, Phase III trial of triptorelin pamoate 22.5 mg 6-month formulation in children with central precocious puberty...A few weeks ago, the FDA placed a partial clinical hold on an ongoing Phase IIb trial of IDX184, Idenix's lead nucleotide polymerase inhibitor for HCV, for the same reason...News of the most recent clinical hold sent Idenix shares (NASDAQ:IDIX) on a rollercoaster ride Monday morning

The open-label, dose-escalation study will assess the safety and antitumor activity of the antibody drug conjugate in CD70-positive metastatic RCC...The primary endpoint is safety, with secondary endpoints of best clinical response, progression-free survival and overall survival

Aeras, of Rockville, Md., and the Infectious Disease Research Institute (IDRI) said they started a clinical trial of IDRI's tuberculosis vaccine candidate, ID93 + GLA-SE...The open-label, nonrandomized, three-treatment, three-period, single-dose study is enrolling 12 healthy adult males

If approved, the product, indicated for the treatment of autoimmune and inflammatory diseases, will enter clinical trials...An open-label, dose-escalating study in the UK is testing the human reovirus in combination with cyclophosphamide in patients with advanced or metastatic solid tumors, including pancreatic, lung and ovarian cancers that are refractory to standard therapy or for which there is no standard therapy

Intercept is currently conducting POISE, a Phase III clinical trial of OCA in PBC...The target enrollment for the study is 180 patients who will first enter a one-year double-blind placebo controlled pivotal trial phase, followed by an open-label long-term safety extension phase for another five years

The open label, single-arm trial is expected to enroll about 20 patients...The open-label trial will compare custirsen plus second-line chemotherapy to second-line chemotherapy alone

BHR Pharma LLC, of Phoenix, said it reached its SyNAPSe clinical trial enrollment midpoint of 590 patients...The single-arm, open-label study of JX-594, administered weekly by intravenous infusions, will examine radiographic response rate based on modified RECIST and modified Choi criteria and will subsequently follow patients for progression-free survival and overall survival

Eisai Europe Ltd., of Hatfield, UK, part of Eisai Inc., presented the first clinical data for E2609, a beta-site amyloid precursor protein-cleaving enzyme (BACE) inhibitor, during oral sessions at the Alzheimer's Association International Conference 2012 in Vancouver, British Columbia...The open-label, nonrandomized study evaluated ecopipam over an eight-week period at 50 mg per day for two weeks, and 100 mg per day for the remaining six weeks

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 open-label Phase I trial will enroll up to 18 patients to receive the antibody in combination with capcitabine and radiation for eight weeks

The trials will evaluate the difference in clinical response rates at the end of therapy, as well as sustained clinical response after treatment...The open-label, dose-escalation study will assess safety, immunogenicity, pharmacokinetics, biomarkers and initial signals of efficacy

OncoGenex Pharmaceuticals Inc., of Bothell, Wash., updated its clinical development plans for custirsen with details for a Phase III trial in non-small-cell lung cancer (NSCLC) to begin enrollment later this year...The open-label, 1 , 100-patient study will evaluate the potential survival benefit of combining custirsen with docetaxel in patients who have progressed after first-line treatment

Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., said Phase IIa ocular safety results published in the American Journal of Ophthalmology showed that CPP-109 (vigabatrin), a GABA aminotransferase inactivator in clinical trials to treat cocaine addiction, did not cause a decrease in visual acuity or significant peripheral visual field changes with short-term use...The open-label trial will combine perifosine with Velcade (bortezomib, Millennium) and dexamethasone in previously treated

Amicus Therapeutics Inc., of Cranbury, N.J., reported preliminary data from an open-label Phase II drug-drug interaction study showing that pharmacological chaperone AT2220 (duvoglustat HCl) co-administered with enzyme replacement therapy in Pompe disease patients resulted in no drug-related adverse events reported to date, and the independent data safety monitoring board determined the study should continue into the third dose cohort, now fully enrolled...PTC Therapeutics Inc., of South Plainfield