Finally, the company is working to complete its double-blind Phase II trial of TO-2061 in OCD...Assuming that we succeed, of course, at that point we plan to sit down with the FDA to determine what they're going to want in the balance of the clinical program," Oclassen said

The double-blind, placebo-controlled study explored a single ascending dosing of up to 1,800 mg, and 15-day multiple-dose regimens of twice-daily 600 mg and 800 mg...The next clinical trial of the defensin-mimetic antibiotic as a single dose is planned for later this year

Three smashing clinical successes by Gilead Sciences Inc.'s nuc drug GS-7977 for hepatitis C virus (HCV) have lit up the 2012 International Liver Congress of the European Association for the Study of the Liver, sending the company's stock up 12 percent Thursday...Gilead also reported interim results from QUANTUM, a Phase II, randomized, double-blind, placebo-controlled study of GS-7977 for chronic HCV infection...Novartis AG put its antiviral DEB025 on clinical hold following reports of pancreatitis

Fibrocell Science Inc., of Exton, Pa., said pivotal clinical trial data demonstrated that Laviv (azficel-T) for nasolabial fold wrinkles is effective...The results came from two identical Phase III randomized, double-blind, placebo-controlled studies of 421 patients

The randomized, double-blind, placebo-controlled trial will evaluate safety and efficacy of single-agent MORAb-004 with supportive care for progression-free survival in patients with chemo-refractory metastatic colorectal cancer...It will enroll up to 160 patients at clinical centers in the U.S

The company completed the 12-week, randomized, double-blind, placebo-controlled, Phase II trial at the end of 2011...Threshold Pharmaceuticals Inc., of South San Francisco, received a $20 million milestone payment from Darmstadt, Germany-based Merck KGaA, which was triggered by results from a clinical trial of its drug TH-302 in pancreatic cancer

The program includes an international, randomized, double-blind, placebo-controlled, parallel-group, two-year study in more than 5,000 postmenopausal women with osteoporosis...The FDA is expected to decide whether to lift the clinical hold within 30 days, provided the response is sufficient

SymBio Pharmaceuticals Ltd., of Tokyo, said the clinical trial notification for its Phase I trial of rigosertib in refractory and relapsed myelodysplastic syndrome had been accepted...The study will be randomized and double-blind, comparing once-daily LCP-Tacro to twice-daily Prograf with a composite primary endpoint including biopsy-proven acute rejection, graft failure, loss to follow-up or death

The randomized, double-blind trial will compare farletuzumab at two doses in combination with second-line standard of care against standard of care and placebo with a primary endpoint of progression-free survival...Data were determined following the removal of one clinical site due to inconsistent and incorrect application of the efficacy assessment protocol

Esperion Therapeutics Inc., of Plymouth, Mich., presented data from a randomized, double-blind Phase II trial in 177 dyslipidemic patients showing that ETC-1002 was well tolerated and decreased LDL-C levels up to 27 percent after two weeks of treatment...Theravalues Corp., of Tokyo, presented clinical data showing that Theracurmin improved symptoms of left ventricular diastolic failure

The trial is randomized, double-blind and placebo-controlled, and it will assess safety, tolerability, pharmacokinetics and pharmacodynamics of the drug in up to 120 healthy volunteers...Nuvilex Inc., of Silver Spring, Md., said data from an early clinical trial in pancreatic cancer indicated that its Cell-in-a-Box technology, acquired from SG Austria, of Singapore, might have an effect on downstream micro metastatic disease

The double-blind, placebo-controlled trial will have safety, tolerability and pharmacokinetics and pharmacodynamic profiling of single ascending doses as a primary objective...The double-blind, placebo-controlled trial will enroll 800 RA patients who have not been previously treated with disease-modifying antirheumatic drugs with the goal of inducing and sustaining a clinical response

Oncolytics Biotech Inc., of Calgary, Alberta, said it entered an agreement for the NCIC Clinical Trials Group at Queen's University in Kingston, Ontario, to sponsor and conduct a Phase II study of Reolysin in patients with recurrent or metastatic castration-resistant prostate cancer...The study will enroll about 800 subjects with IBS-D who will be treated with rifaximin, with those who respond to the initial course of treatment followed until symptoms recur, at which time they will undergo double

The vaccine was safe and well tolerated and induced robust cellular and humoral immune responses in patients 65 and older, meeting the primary safety and secondary immunogenicity endpoints of the randomized, double-blind, placebo-controlled study in 120 volunteers...ViroPharma Inc., of Exton, Pa., said data from the pivotal study for its orphan drug Plenadren (hydrocortisone, modified-release tablet) were published in the Journal of Clinical Endocrinology and Metabolism

It will enroll up to 15 patients and assess clinical and biological effects of increased local expression of IL-12 protein in the tumor microenvironment following treatment with OMS ElectroImmunotherapy...Santarus Inc., of San Diego, began patient enrollment in a randomized, double-blind, placebo-controlled Phase IIIb trial of Uceris (budesonide) tablets 9 mg to look for incremental benefit when added to oral aminosaliculate therapy in ulcerative colitis...Assuming its clinical trial application is

Bone metastases-free survival is a valid and robust endpoint for clinical studies and is a clinically useful objective to aim for in our management of patients with prostate cancer," Fred Saad, a professor and chairman of the urology division at the University of Montreal Hospital Center, said in a statement submitted for the meeting...Amgen used BMFS as the primary endpoint in its randomized, double-blind, placebo-controlled trial in 1,432 men with CRPC considered at high risk for bone metastases

When administered as a single agent in a randomized, double-blind, placebo-controlled, dose-escalation Phase IIb study, the compound was well tolerated and produced significant reductions in uric acid in the blood...This is a very different compound we're developing, with a very different clinical and commercial profile," he pointed out

The randomized, double-blind, placebo-controlled study will enroll 850 patients with a primary endpoint of slowing the accumulation of disability not related to relapses...Great North Children's Hospital, of Newcastle upon Tyne, UK, is leading the trial, with participation by four other clinical centers

A pivotal global, randomized, double-blind, placebo-controlled Phase III study of TASQ in metastatic CRPC continues, with the goal of confirming the compound's effect on the disease, with radiological PFS as the primary endpoint and OS as secondary endpoint...The existing clinical program includes a Phase III study in diffuse large B-cell lymphoma and a trial to evaluate Zevalin in previously untreated follicular non-Hodgkin's lymphoma. (See BioWorld Today, Jan. 6, 2011