Among PPI-461 recipients there have been only transient clinical adverse events with no dose-related or treatment-related patterns of specific adverse events or laboratory abnormalities

Lorcaserin's only adverse event in human clinical trials was a mild or moderate transient headache

Washington Editor WASHINGTON – Things should be a little quieter at the FDA this week as new safety reporting requirements go into effect to reduce the "noise" from the overreporting of individual serious adverse events in clinical trials...serious adverse events from bioavailability and bioequivalence studies that are exempt from IND requirements...The FTC challenged LabCorp's acquisition of the rival clinical laboratory testing company in December, alleging it would harm competition. (See BioWorld

And it suffered some tough breaks in 2008, including a temporary hold on then-lead clinical program mocetinostat (MGCD0103) and the termination of its partnership with Celgene Corp...MethylGene has run four Phase I studies in healthy volunteers, with data showing no clinically significant drug-related adverse events or dose-limiting toxicities...is the sole underwriter of the offering, which is expected to close by March 29.

The aim of the trial is to optimize the treatment by modifying a range of clinical parameters...Hunter Immunology Ltd., of Melbourne, Australia, is recruiting patients for a clinical trial of oral vaccine HI 164OV in chronic obstructive pulmonary disorder...The trial, with an overall response rate of 19 percent, provided early clinical proof of concept for the combination of NADH oxidase inhibitors with standard-of-care chemotherapy and laid the ground work for the study of the company's next

Amicus had halted clinical development of AT2220 in 2009 after two patients reported adverse events. (See BioWorld Today, March 2, 2009

Biomoda Inc., of Albuquerque, N.M., completed patient enrollment and sample collection for the pilot study to determine the clinical sensitivity and specificity of its CyPath diagnostic assay for the early detection of lung cancer...The 48-week interim results showed the candidate was safe and well tolerated with no clinically relevant differences in adverse events between treatment groups and standard of care

Endpoints include vitamin D status, adverse events, physical and clinical laboratory assessments and changes in serum calcium, phosphorus and intact parathyroid hormone

the placebo group, and crofelemer continues to be found safe, with no apparent differences in adverse events between the treatment and placebo arms...The single-arm study was designed to determine the clinical benefit rate of the combination treatment in patients with advanced or metastatic disease who have not receive any prior chemotherapy or biotherapy

No new safety findings were observed, and adverse events were consistent with those seen in previous Avastin studies...The primary endpoints are to assess the relative clinical responses to delafloxacin, linezolid and vancomycin and to assess the utility, variability and measurement techniques of several objective measures of clinical efficacy for use in future trials

The study also met secondary endpoints, and the drug was well tolerated, with no serious adverse events reported...Neurokine Pharmaceuticals Inc., of Vancouver, British Columbia, signed a contract with Clinical Investigations Group for Phase II trials of anti-inflammatory agent NK-001 in protecting patients against cognitive impairment side effects of coronary artery bypass graft surgery...Shionogi-ViiV Healthcare LLC, of London, started a clinical study, SINGLE, designed to support a fixed-dose

A primary objective is to evaluate biomarkers in blood and archived tissue samples and their correlation with tivozanib clinical activity and/or drug-related toxicity...No serious adverse events were reported and, in those vaccinated in the 18 to 49 age group at the 20 mcg dosage level, 82 percent developed an immune response against the H5N1 virus after the second immunization, while 65 percent of subjects had a fourfold increase in HI titers from baseline and 65 percent had seroprotective

Synergy Pharmaceuticals Inc., of New York, reported that the next clinical trial of plecanatide to treat chronic idiopathic constipation patients, planned to begin in the second quarter, has been designed as a Phase II/III trial...The company said that in this study XOMA 052 was well tolerated with no significant differences in adverse events, lab abnormalities and vital signs between XOMA 052 and placebo and no drug-related adverse events

A preliminary analysis of all data available at the end of 12 weeks of dosing revealed no serious adverse events and no discontinuations due to adverse events

The trial is designed to assess the safety of ALD-401 and its potential efficacy to improve clinical outcomes in patients with ischemic strokes when administered 13 and 19 days after the stroke...No treatment-related serious adverse events were observed

The IOM said the Clinical Trials Cooperative Group Program "faces many difficulties at present that undermine its ability to facilitate the multi-institutional collaborations necessary to conduct large, late-stage trials that answer important research questions single institutions and the private sector cannot or do not tackle...Clinical trials run by the program typically compare the prevailing standard of care to a drug or combination of drugs and other treatment modalities...The new studies also

Pfizer will continue funding all aspects of the deal, including all clinical studies and continuing research and preclinical development efforts at Icagen on sodium channel targets...The study tested single doses of the drug in two cohorts of healthy volunteers, with results showing that it was well tolerated, had good bioavailability and did not cause any serious adverse events

Additional data showed that onset of efficacy was seen at three days to five days of treatment, and the product was shown to be safe and well tolerated with no serious adverse events and no reported site irritation...Viron said it plans to continue further clinical testing in 2011 with a fully glycosylated version of the original drug that has shown significantly enhanced efficacy in animal models over the original drug with a similarly high margin of safety

Gentium SpA, of Villa Guardia, Italy, presented clinical results for Defibrotide in patients veno-occlusive disease (VOD) and multi-organ failure (MOF) from several studies...The drug was well tolerated with no significant drug-related adverse events in both trials, which enrolled 24 patients with sickle cell disease and 21 with beta thalassemia intermedia