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

The company said safety endpoints were met, with no significant toxicities observed at a higher dose

Four of nine patients treated at the highest dose (7 mg/kg) became HCV RNA undetectable after five weekly doses of miravirsen monotherapy

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

At the 2-mg dose, the drug was comparable in efficacy across key lipid parameters to the 4-mg dose of other prescription Omega products, though when patients were allowed to be titrated to a higher dose, Epanova provided a 7 percent reduction in non-HDL-cholesterol and a 21 percent reduction in triglycerides, with a nonsignificant increase in LDL-cholesterol of 1 percent

The trials, CARE-MS-I and CARE-MS II, showed that Lemtrada was significantly more effective at reducing annualized relapsed rates than Rebif (high dose subcutaneous interferone beta-1a, Merck Serono) and more patients receiving Lemtrada were relapse-free at two years

Initiation of the study followed a successful, dose-escalation Phase I study in which clinical activity was observed in five of seven patients receiving the two highest dose levels

Among the group that received the higher doses of ApoCell, no cases of GvHD grades 2-4 were observed, while 50 percent of similar patients who did not receive ApoCell did develop GvHD grades 2-4