Ablynx NV, of Ghent, Belgium, initiated preclinical development of next-generation anti-IgE Nanobody ALX-0962 in severe allergic asthma. ALX-0962 consists of a potent anti-IgE Nanobody with a dual mode of action – the ability to bind with high affinity to IgE while also displacing receptor-bound IgE – together with a serum albumin binding Nanobody for in vivo plasma half-life extension. BioAlliance Pharma SA, of Paris, reported the International Independent Board of Experts' data and safety

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

Its Russian partner, OAO Pharmsynthez, subsequently treated the first patients in the Phase II dose escalation portion of the trial

The study is an open-label, multiple-dose, dose-escalation pilot study, which will include eight infants

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 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

Anterios has previously completed multicenter, double-blind, randomized, controlled, dose-escalation studies for each indication and demonstrated that ANT-1207 was well tolerated and demonstrated clinically and statistically significant efficacy vs

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 dose-escalation and safety study is expected to treat up to 15 patients in five different dosing cohorts

Three dose cohorts were completed in the open-label, single arm, dose-escalation study without reaching dose-limiting toxicity, and no drug-related adverse effects were detected among patients who failed other available therapies

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

The fourth and last cohorts in a Phase I dose-escalation trial have completed treatment, and the last patient treated has been discharged from the hospital

The dose-escalation trial is designed to evaluate the safety, tolerability and efficacy of APS001F, a living recombinant bifidobacterium designed to express the cytosine deaminase gene in tumors

A Phase I, single-agent, dose-escalation study to test intravenous formulation of the drug in patients with metastatic or unresectable advanced solid cancers is being finalized

The open-label, dose-escalation study in approximately 22 patients with NCL-2 will evaluate safety, tolerability and effectiveness. (See BioWorld Today, Nov. 6, 2012

The dose-escalation trial is designed to evaluate the safety, tolerability and efficacy of APS001F, a living recombinant bifidobacterium designed to express the cytosine deaminase gene in tumors

The fourth and last cohorts in a Phase I dose-escalation trial have completed treatment, and the last patient treated has been discharged from the hospital