The multicenter MM-003 study assessed the efficacy and safety of pomalidomide (POM) in combination with low-dose dexamethasone (POM+LoDex) and in comparison to high-dose Dex in MM patients with late-stage disease who previously failed lenalidomide (Revlimid) and bortezomib (Velcade, Millennium: The Takeda Oncology Co...Both progression-free survival (PFS) and overall survival (OS) improved with POM+LoDex compared to high-dose Dex (PFS: four months vs. 1.9 months, respectively; OS: 12.7 months vs. 8
Prometheus Laboratories Inc., of San Diego, said PROCLIVITY02, a study comparing the sequence of Proleukin (high dose interleukin-2), followed by Yervoy (ipilimumab, Bristol-Myers Squibb Co.) to the converse order, as therapy in patients with metastatic melanoma, has investigational review board approval and anticipates enrolling patients this summer
The company is exploring the best options for a new clinical study with higher doses of amitifadine in that population...A statistically significant post-dose reduction of serum galectin-3 was also observed at the higher doses of GCS-100, which was sustained until day seven when a rebound to levels above baseline was observed
Grifols SA, of Barcelona, Spain, presented results from a study demonstrating that a higher dose of Prolastin-C (alpha1-proteinase inhibitor [human]) increased levels of the alpha1 protein in patients with alpha1antitrypsin (AAT) deficiency to levels that are considered within the normal range for healthy individuals
Prometheus Laboratories Inc., of San Diego, said PROCLIVITY 01, a multicenter study of Proleukin (High Dose Interleukin-2 [HD IL-2])1 plus vemurafenib therapy in patients with BRAF V600 mutation-positive metastatic melanoma (mM) is enrolling patients
At the end of the treatment period, TT-401-treated patients in the three highest dose groups experienced statistically significant reductions in mean fasting plasma glucose relative to placebo...Statistically significant mean body weight reduction relative to baseline occurred in the three highest dose groups, and a similar reduction in body weight also was observed in the obese nondiabetic cohort
The effect was demonstrated with intravenous GAL-021 under conditions including high doses of opioids and elevated carbon-dioxide levels in a group of 12 patients
Omeros Corp., of Seattle, reported data from the multiple-ascending-dose portion of its Phase I trial, showing that OMS824, its lead phosphodiesterase 10 (PDE10) candidate, was well tolerated by all subjects, and the only apparent drug-related adverse event was mild somnolence at the highest dose evaluated
Upsher-Smith Laboratories Inc., of Maple Grove, Minn., presented data at the American Academy of Neurology meeting in San Diego, supporting favorable tolerability and a predictable, consistent pharmacokinetic profile of USL255 at high doses following single-dose administration to healthy subjects
Acorda Therapeutics Inc., of Ardsley, N.Y., reported data from a Phase I dose-escalation study showing that a single dose of glial growth factor 2 (GGF2), a neuregulin peptide, in patients with heart failure was generally well tolerated up to 0.75 mg/kg, while higher doses might be associated with reversible hepatotoxic events
The trial will enroll patients who have relapsed on platinum-based therapy and high-dose chemotherapy, or patients who are not eligible for high-dose chemotherapy
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
Diamyd Medical AB, of Stockholm, Sweden, said it's planning to start a new 60-patient study in February with diabetes vaccine Diamyd, testing it in combination with other drugs – relatively high doses of vitamin D and anti-inflammatory drug ibuprofen – to potentiate the effect of the vaccine's ability to help the body control blood sugar levels in newly diagnosed Type I diabetics
Ligand Pharmaceuticals Inc., of San Diego, started a pivotal trial with Captisol-enabled, propylene glycol-free (PG-free) high-dose melphalan as a conditioning treatment prior to autologous transplant for patients with multiple myeloma
Omeros Corp., of Seattle, reported that in a Phase I trial, its compound OMS824 was well tolerated with linear pharmacokinetics and expected pharmacological effects at its highest dose in healthy subjects
Cotara, a targeted loco-regional therapy designed to deliver a high dose of radiation directly into the brain tumor while sparing radiation exposure to healthy brain tissue, has orphan and fast track status in the U.S
Cohorts two and three will enroll 18 subjects each, and an additional 50 patients with severe traumatic brain injury will be treated at the highest dose approved
At week 12, AMG 145 reduced LDL-C by up to 66 percent when dosed every two weeks and up to 50 percent when dosed every four weeks, compared to placebo (p < 0.001 for the highest dose vs. placebo
The multicenter MM-003 study assessed the efficacy and safety of pomalidomide (POM) in combination with low-dose dexamethasone (POM+LoDex) and in comparison to high-dose Dex in MM patients with late-stage disease who previously failed lenalidomide (Revlimid) and bortezomib (Velcade, Millennium: The Takeda Oncology Co...Both progression-free survival (PFS) and overall survival (OS) improved with POM+LoDex compared to high-dose Dex (PFS: four months vs. 1.9 months, respectively; OS: 12.7 months vs. 8