The study design calls for the collection of 5,250 clinical endpoints, and Merck remains blinded to the actual results of the analysis and to other safety and efficacy data

Inc., of Whitehouse Station, N.J., said researchers from the Clinical Trial Service Unit at Oxford University presented results from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of Tredaptive (extended-release niacin/laropiprant) during the late-breaking clinical trial session at the American College of Cardiology 62nd Annual Scientific Session in San Francisco...Findings were presented during the late-breaking clinical trial session

Janssen and partner Bayer AG, of Leverkusen, Germany, will enroll patients into five global clinical trials, which will involve a total of 28,850 patients

Zealand Pharma A/S, of Copenhagen, Denmark, disclosed in a pipeline update that it plans to advance danegaptide into a single site clinical efficacy study to further profile the peptide drug in cardio protection

The ATX-101 global clinical development program has enrolled more than 2,500 total patients, of which more than 1,500 have been treated with ATX-101, the company said

Vertex Pharmaceuticals Inc., of Cambridge, Mass., said VX-787 in a Phase II influenza challenge study resulted in statistically significant improvements in viral and clinical measurements of infection...Also, 93 percent of people in that dose group showed no clinical symptoms of influenza after three days of treatment, compared to 41 percent of people in the placebo group

Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, reported the first interim results in HCV/HIV co-infected patients from the company's ongoing hepatitis C (HCV) clinical trial program, HCVerso...Polyphor Ltd., of Allschwil, Switzerland, completed a Phase I trial demonstrating the clinical safety and tolerability of its Pseudomonas-specific antibiotic POL7080...The study compared the efficacy and safety of once-weekly Milprosa to daily 8 percent

The volasertib clinical development program is the company's most advanced in cell cycle inhibition

Proceeds will be used to support continuing clinical development of Ravicti (glycerol phenylbutyrate) in HE, a brain disorder caused by chronic liver failure

In conjunction with the changes in its clinical program, the company said it reduced its work force by 50 percent and outsourced noncritical research and development functions

The company is planning to begin clinical studies in the first half of 2014...The product, a therapeutic antibody, has shown potential in preclinical studies to to reduce damage, allowing pumping efficiency to return to normal levels.

The study also has exploratory endpoints for clinical efficacy and inflammation biomarkers...Ltd., of Taipei, Taiwan, added two additional Taiwanese clinical centers in Cel-Sci's Phase III head and neck cancer trial for Multikine (Leukocyte Interleukin, Injection), including the China Medical University Hospital, of Taichung, Taiwan, and the Buddhist Tzu Chi General Hospital, of Hualian, Taiwan

The agency also finalized its draft guidance on financial disclosures by clinical investigators...and explains the FDA's review of clinical investigator financial disclosure information.

Sihuan Pharmaceutical Holdings Group Ltd., of Hong Kong, said pinoxacin hydrochloride received approval for clinical studies from the State Food and Drug Administration

UCB also picked up clinical development and commercialization costs. (See BioWorld Today, May 11, 2006.) In 2009, the companies reported results from a Phase IIb dosing study of the drug showing a 24.9 percent treatment advantage over placebo in systemic lupus erythematosus (SLE) patients...The funding will support the advancement of Blaze's Tumor Paint product candidate, BLZ-100, into clinical development for use in surgery in multiple solid tumor types. (See BioWorld Today, June 11, 2012...Oxygen

The clinical trial is a randomized, double-blind, placebo-controlled parallel group study to evaluate the safety, clinical efficacy and pharmacokinetic profile of bertilimumab in subjects with active moderate-to-severe ulcerative colitis...Repros Therapeutics Inc., of The Woodlands, Texas, provided a clinical update of its Androxal Phase III program following receipt of written guidance from the FDA

NCIC Clinical Trials Group at Queen's University in Kingston, Ontario, is conducting four studies in various tumor types, which will "go a long way to helping us figure out" where to put the most resources, Look said...The multitude of clinical trials adds up to a program that "sounds like a heck of a burn requirement...The initial fundings position Cytomedix to execute on its 2013 operational business plan, the company said.

The primary objectives include the evaluation of adverse events and the evaluation of six-month clinical response...Edison Pharmaceuticals Inc., of Mountain View, Calif., said it started a Phase II study, titled "Double-Blind, Placebo-Controlled Clinical Trial of EPI-743 in Patients with Cobalamin C Defect

Amicus Therapeutics Inc., of Cranbury, N.J., reported positive results from clinical and preclinical studies of the pharmacological chaperone AT2220 (duvoglustat HCl) in combination with ERT for Pompe disease at the Lysosomal Disease Network World Symposium...Based on those results, the company plans to initiate a repeat-dose clinical study in the third quarter of 2013 to evaluate an intravenous formulation of AT2220 co-administered with Myozyme/Lumizyme...The company is currently enrolling patients