Alkermes Inc., of Waltham, Mass., reported preliminary results of a Phase II study showing that once-daily administration of ALKS 33, which is under investigation as a treatment of reward disorders and other central nervous system disorders, was generally well tolerated at all three dose levels
Neuraltus Pharmaceuticals Inc., of Palo Alto, Calif., reported top-line data from a Phase I trial of NP001, a small-molecule regulator of macrophage activation in development, in 32 patients with amyotrophic lateral sclerosis, showing that the drug was safe and well tolerated when given at four different dose levels as a single dose
The trial will be carried out at the Wilmer Eye Institute at Johns Hopkins in Baltimore and will enroll 18 patients with wet AMD to evaluate three dose levels of the drug
The 77-patient study, which randomized patients into six cohorts, showed a dose-dependent effect on blood pressure, with minimal or mild blood pressure reduction at the 1 .25 ng/kg/min and 2.5 ng/kg/min dose levels, and moderate blood pressure reduction at 3.75 ng/kg/min
Intellect Neurosciences Inc., of New York, obtained an initial draft report of its Phase Ib trial for lead Alzheimer's candidate Oxigon (OX1), with data showing that the drug was safe and well tolerated at all dose levels tested in healthy elderly volunteers, ages 60 and older, during 14 days of repeated dosing
Idera Pharmaceuticals Inc., of Cambridge, Mass., reported that IMO-3100 was well tolerated at all dose levels evaluated in the 30 healthy subjects that received IMO-3100 in a single-dose, dose-escalation Phase I clinical trial, and that target engagement of TLR7 and TLR9 was observed through inhibition of TLR7- and TLR9-mediated immune responses
The primary efficacy endpoint, defined as change from baseline in spontaneous bowel movements (SBMs), showed a dose-dependent increase and significant results were obtained for the two highest dose levels
Neovacs SA, of Paris, said its data safety monitoring board authorized the firm to proceed to the next higher dose of INFalpha-Kinoid in its ongoing Phase I/II trial in lupus after reviewing the data for patients administered the second dose level
MultiStem was well tolerated at all dose levels and improved mean wall motion score, potentially indicating heart function improvement, post-heart attack
The results demonstrate that AP214 is well tolerated and safe at all three dose levels...At the highest dose level, AP214 markedly reduced the development of AKI by 70 percent and reduced the IL-6 response by 40 percent, compared to placebo
That trial examined the safety and activity of different dose levels of a tablet formulation of oral methylnaltrexone in subjects with chronic, noncancer pain with a history of OIC receiving various opioid treatment regimens
Preliminary data showed that the drug was well tolerated at all dose levels, with no drug-related serious adverse events or dose-related trends in frequency or type of adverse events
Hemodynamic parameters will be evaluated during intravenous infusion of CXL-1020 at several dose levels, and investigators will assess hemodynamics using invasive and noninvasive techniques, including both echocardiography and direct Swan-Ganz catheter-based measures of heart pressures and function
Athersys Inc., of Cleveland, and partner Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, reported four months of post-treatment data from a Phase I trial of MultiStem, an allogeneic cell therapy product designed for administration after myocardial infarction, showing that it was well tolerated at all dose levels and suggested improvement in heart function in treated patients
The randomized, double-blind trial in 160 patients worldwide will have two dose levels plus placebo