Pexa-Vec is currently being evaluated in an international, randomized Phase IIb trial (TRAVERSE) in patients with advanced primary liver cancer who have failed sorafenib therapy...HIV-infected subjects enrolled in an ongoing SB-728-902 clinical trial (Cohorts 1-3) received a single infusion of SB-728-T, which resulted in a durable increase in total CD4 T-cells driven by increased ZFN-modified CD4 central memory T-cells

Assuming all goes according to plan, the Phase II study is expected to be a Phase IIb, designed to provide clear efficacy data...MediciNova has said it will proceed with Phase IIb trials in progressive multiple sclerosis upon receipt of necessary funding

CytRx Corp., of Los Angeles, said the independent data safety monitoring committee overseeing the company's international Phase IIb trial with aldoxorubicin as a first-line treatment for patients with late-stage metastatic soft tissue sarcoma has recommended conducting the clinical trial through completion...The Phase IIb study allows for a head-to-head comparison of the commonly used chemotherapeutic agent doxorubicin with aldoxorubicin, CytRx's tumor-targeting doxorubicin conjugate

In addition, the money is an insurance policy against the failure of GLP0634 in the Phase IIb study in rheumatoid arthritis and the eventuality that AbbeVie does not take up its options...The first clinical trials of the drug, GLPG1790, are expected to start within the next year

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

The trial, which will enroll 300 patients, is based on results from a Phase IIb study in newly diagnosed AML patients, 60-75, presented at the American Society of Clinical Oncology conference in 2011

The primary endpoint is clinical benefit, which will be assessed at six months...Oxygen Biotherapeutics Inc., of Morrisville, N.C., said it initiated the second cohort of its Phase IIb trial of Oxycyte in patients with severe, nonpenetrating traumatic brain injury (TBI...RepliCel Life Sciences Inc., of Vancouver, British Columbia, said it started clinical development of an autologous cell therapy for the treatment of a variety of chronic tendon injuries, including Achilles, patellar and elbow

It will use the same dosing scheme, patient population and duration of follow-up as the 650-patient Phase IIb study called RADAR that tested REG1 against heparin...Scioderm is advancing SD-101, a topical cream with a unique mechanism of action, into clinical development in epidermolysis bullosa (EB), a rare genetic condition that results in extremely fragile skin that blisters and tears easily

Chimerix Inc., of Durham, N.C., presented the first clinical outcomes data on lead candidate CMX001 in life-threatening infection with adenovirus (AdV), a disease with no approved therapy...Targacept Inc., of Winston-Salem, N.C., said it completed patient recruitment in the Phase IIb study of TC-1734, an alpha4beta2 neuronal nicotinic receptor, in mild-to-moderate Alzheimer's disease

Ceregene Inc., of San Diego, reported top-line data from its double-blind, randomized, controlled Phase IIb study of CERE-120 (AAV-neurturin), a gene therapy designed to deliver the neurotrophic factor neurturin, for Parkinson's disease...Navidea Biopharmaceuticals Inc., of Dublin, Ohio, said the Journal of Nuclear Medicine published the results from a clinical trial of NAV4694 in healthy subjects and those with diagnosed forms of dementia

AG014 comprises oral delivery of an anti-TNF antibody with proven clinical efficacy in IBD, resulting in local efficacy and an improved safety profile over systemic drugs...In its earnings release, MediciNova said proceeding with a Phase IIb trial in progressive multiple sclerosis would be dependent on receipt of funding

In tinnitus, what we are aiming for – and what we could show in the Phase IIb trial – is patients experiencing a reduction in the subjective loudness of the tinnitus...In a Phase IIb trial, AM-111 did demonstrate a clinically meaningful benefit – a 10 decibel recovery – in patients with severe to profound hearing loss but not in those with less severe problems

clinical trials, for SMD and dry age-related macular degeneration (dry AMD...BHR Pharma LLC, of Herndon, Va., said the 1,000th patient has been enrolled in its SyNAPSe clinical trial, a global Phase III study evaluating the effectiveness of its intravenous progesterone infusion agent, BHR-100, to treat severe traumatic brain injury (TBI...NeuroDerm Ltd., of Ness Ziona, Israel, said enrollment of patients is ongoing in its Phase IIa clinical trial of ND0612, a treatment for Parkinson's disease

Ltd., of Seoul, South Korea, said they completed the Phase IIb trial of Tarafenacin, in development for treating overactive bladder syndrome...Photocure ASA, of Oslo, Norway, reported final results from its Phase IIb study of Cevira in patients with human papillomavirus (HPV)-related disease of the cervix, showing that the drug-delivery device demonstrated significant and sustained efficacy in the eradication of oncogenic HPV infections and precancerous lesions in CIN2 patients

The company plans to move that compound into a 200-patient Phase IIb trial around mid-2014...The company's "exceptional team" and its potential to obtain rapid clinical efficacy data were two attractive attributes, Rafaèle Tordjman, managing partner at Sofinnova Partners, told BioWorld Today

The primary endpoint of the study is the induction of clinical remission at week 12...NovaBay Pharmaceuticals Inc., of Emeryville, Calif., enrolled first patients in Brazil into its global Phase IIb trial, BAYnovation...The study is being conducted by more than 60 clinical investigators worldwide, including about 11 sites in Brazil and 24 sites in India

Aastrom Biosciences Inc., of Ann Arbor, Mich., enrolled its first patients in a Phase IIb trial of ixCELL-DCM to assess safety and efficacy of ixmyelocel-T in advanced heart failure that is caused by ischemic dilated cardiomyopathy...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

Eyeing Better Mousetrap with Topical Product In 2009, Revance granted worldwide aesthetic and dermatological rights to RT002, then in preclinical studies, to Medicis Pharmaceutical Corp., of Scottsdale, Ariz., in exchange for $10 million at signing and another potential $94 million, based on clinical, regulatory and commercial milestones...The latest round is expected to support ongoing clinical development of lead candidate, LiRIS (lidocaine releasing intravesical system), in development for

Biotie Therapies Corp., of Turku, Finland, presented data from a Phase IIb study evaluating tozadenant (SYN115) in Parkinson`s disease patients experiencing levodopa-related end-of-dose wearing off...The Phase I/II trial showed a significantly slower decline in overall clinical and respiratory function, as measured by the ALS functional rating score (ALSFRS-R) and forced vital capacity (FVC) score, respectively, in the six patients who received an intrathecal injection of the cells in the six