SONAR is a multinational, double-blind, placebo-controlled clinical study that is expected to enroll more than 4,000 patients with diabetic nephropathy...Destiny Pharma Ltd., of Brighton, UK, reported progress in the Phase I U.S

In addition to Zytiga and Xtandi, the FDA approved Wednesday Xofigo (radium Ra 223 dichloride), an alpha particle-emitting radioactive therapeutic agent from Algeta ASA and partner Bayer AG that demonstrated in clinical studies an overall survival benefit with antitumor effects on bone metastases...Kite Pharma Inc., of Los Angeles, said it closed a $20 million private placement of shares of its Series A preferred stock

Acasti Pharma Inc., of Laval, Quebec, a subsidiary of Neptune Technologies & Bioressources Inc., reported preliminary data from a randomized, open-label, dose-ranging, multicenter trial assessing the safety and efficacy of NKPL66, or CaPre, in mild-to-high hypertriglyceridemia...The NX03-0040 prostate cancer clinical study of 150 men is testing low (2.5 mg) and high (15 mg) single doses of NX-1207 for the effect to eradicate or shrink low-grade localized prostate cancer tumors

The company is planning to begin clinical studies in the first half of 2014

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

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...BioAlliance Pharma SA, of Paris, said the FDA approved a U.S

CrystalGenomics Inc., of Seoul, South Korea, said it received a draft of the clinical study report from the recently completed Phase IIa study of CG400549, an antibiotic candidate for methicillin-resistant Staphylococcus aureus (MRSA...The complete clinical study report for the interim analysis would be supplied to the FDA during the review within 60 days of the resubmission

Acasti Pharma Inc., of Laval, Quebec, said it achieved significant progress in two ongoing clinical studies with CaPre for lipid management

Clavis Pharma ASA, of Oslo, Norway, said it reached the enrollment target for its Phase III CLAVELA study investigating elacytarabine in patients with relapsed or refractory acute myeloid leukemia (AML...A further nine patients are expected to be enrolled at three oncological centers in the U.S. Based on the results, the company will implement a clinical study aimed at evaluating the effects of Reparixin, an inhibitor of the CXCR1 receptor activated by chemokine interleukin 8, in oral monotherapy

Bayer Inc., of Deerfield, Ill., and the Population Health Research Institute said they started the COMPASS trial, the largest clinical study to date of oral anticoagulant rivaroxaban

The net proceeds will be used for working capital and general corporate purposes, including the continued conduct of the Abili-T clinical study, Opexa's recently initiated Phase IIb trial of personalized T-cell therapy Tcelna in patients with secondary progressive multiple sclerosis.

Cellceutix Corp., of Beverly, Mass., said it has recruited the first patients with advanced solid tumors for clinical studies of cancer candidate Kevetrin...TransTech Pharma Inc., of High Point, N.C., said data from a 399-patient study testing TTP488, a small-molecule drug targeting the receptor for advanced glycation endproducts, demonstrated evidence of slowing cognitive decline over 18 months in patients with mild to moderate Alzheimer's disease

Thus, Calderon said she "would recommend requiring clinical studies to fully evaluate the abuse potential" of products submitted for review that exceed that level

The PCAST report is timely, given that industry concern about the cost and inefficiency of clinical trials prompted formation of the nonprofit TransCelerate BioPharma Inc., the pharma industry's initiative to accelerate drug commercialization that was officially launched last week. (See BioWorld Today, Sept. 26, 2012.) Many of TransCelerate's goals are aligned with those of HHS, which recently retained consulting firm Eastern Research Group Inc...to analyze trial cost data and identify factors

The company said the financing will enable them to complete a clinical study to confirm the positive treatment effects of Oxabact previously seen in patients with primary hyperoxaluria, a rare inborn autosomal genetic disorder leading to markedly elevated levels of endogenous oxalate in plasma and urine...Tranzyme Pharma Inc., of Research Triangle Park, N.C., said it closed a registered direct offering of approximately 3 million shares of its common stock at $3.85 per share for gross proceeds

Proceeds will be used to support clinical studies, R&D activities and for general corporate purposes, including working capital and administrative expenses

The first clinical study, to be conducted in the U.S

The pivotal clinical study results were presented during the American Academy of Neurology annual meeting in April 2012. (See BioWorld Today, April 30, 2012

Noxxon Pharma AG, of Berlin, has treated the first patient in a Phase IIa trial of its anti-CCL2/MCP-1 Spiegelmer NOX-E36 in patients with diabetic nephropathy...Zalicus Inc., of Cambridge, Mass., has completed a Phase I single ascending dose clinical study with Z944, its oral, T-type calcium channel blocker