Abbvie Inc., of Chicago, initiated a Phase III study called SONAR (Study Of Diabetic Nephropathy with Atrasentan) to assess the effects of the investigational compound atrasentan, when added to standard of care, on progression of kidney disease in patients with stage 2 to 4 chronic kidney disease (CKD) and Type II diabetes. SONAR is a multinational, double-blind, placebo-controlled clinical study that is expected to enroll more than 4,000 patients with diabetic nephropathy. The study will

UCB SA, of Brussels, Belgium, said data from a double-blind, placebo-controlled study found that Neupro (rotigotine transdermal system) reduced total nocturnal systolic blood pressure (NSBP) elevations associated with periodic limb movements during sleep (PLMS) and total PLMS in patients with idiopathic moderate to severe restless legs syndrome (RLS)/Willis-Ekbom disease. The data were presented at the annual meeting of the American Society of Hypertension. Results showed that rotigotine

Cellular Biomedicine Group Inc., of Palo Alto, Calif., achieved 50 percent enrollment of the total projected enrollment required for its Phase I trial to evaluate the safety and preliminary efficacy of human adipose-derived mesenchymal progenitor cells therapy for knee osteoarthritis. No severe adverse effects have been reported so far. Cytos Biotechnology AG, of Zurich, Switzerland, and Singapore's Agency for Science, Technology and Research (A*STAR) said the first healthy volunteer has been

Amgen Inc., of Thousand Oaks, Calif., reported findings from analyses of Vectibix (panitumumab) in combination with Folfox, an oxaliplatin-based chemotherapy regimen, as first-line treatment in metastatic colorectal cancer (mCRC). The analyses included the description of new predictive biomarkers of clinical response to Vectibix, activating mutations in KRAS (beyond exon 2) and in NRAS, collectively referred to as RAS. The RAS biomarkers were identified in a predefined retrospective subset

Bayer HealthCare Pharmaceuticals Inc., of Berkeley, Calif., and Onyx Pharmaceuticals Inc., of South San Francisco, said the FDA approved Bayer's Stivarga (regorafenib) for metastatic gastrointestinal stromal tumor previously treated with imatinib mesylate and sunitinib malate. Stivarga was previously approved for metastatic colorectal cancer. Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., enrolled their first patients in Phase III COMPARE and ASCERTAIN trials of

Jennerex Biotherapeutics Inc., of San Francisco, said data demonstrating the ability of its lead product candidate, Pexa-Vec (JX-594, pexastimogene devacirepvec) to induce functional anticancer immunity, both in patients with diverse solid tumor types and in animal models has been published in the May 15 issue of Science Translational Medicine. The paper described findings from a Phase I study evaluating the safety and efficacy of Pexa-Vec after an intratumoral administration in patients with

PharmaMar SA, of Madrid, Spain, a subsidiary of Zeltia, said it completed a Phase Ib trial testing PM01183 in combination with doxorubicin, with the combination displaying antitumor activity in all types of cancer included in the study. Complete and partial radiological remissions were observed in patients with small-cell lung, bladder, breast, endometrial and ovarian cancers, neuroendocrine tumors and synovial sarcoma. The company is planning a potential pivotal trial in small-cell lung cancer

BioAlliance Pharma SA, of Paris, reported the International Independent Board of Experts' data and safety monitoring board (DSMB) again recommended continuing the ReLive Phase III trial without modification. On Nov. 19, 2012, the DSMB unanimously recommended continuing the trial without modification. ReLive is an international, randomized Phase III trial aiming at demonstrating the efficacy of Livatag (doxorubicin Transdrug) on survival in 400 patients with hepatocellular carcinoma after

Biotie Therapies Corp., of Turku, Finland, began a Phase II study evaluating nepicastat (SYN117) in cocaine dependence. The randomized, double-blind, placebo-controlled 11-week trial is expected to enroll about 180 treatment-seeking cocaine-dependent subjects at approximately 12 U.S. clinics and take approximately two years to complete. The National Institute on Drug Abuse at the National Institutes of Health is funding the study under a Collaborative Research and Development Agreement signed

Eli Lilly and Co., of Indianapolis, said the Phase III PRELUDE study of enzastaurin, which explored the molecule as monotherapy in preventing relapse in patients with diffuse large B-cell lymphoma, failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy. Lilly said it will stop development of enzastaurin, a serine/threonine kinase inhibitor of the PKC beta and AKT pathways, and

Acucela Inc., of Bothell, Wash., and Otsuka Pharmaceutical Co. Ltd., of Tokyo, reported results of a Phase IIa trial of emixustat hydrochloride for geographic atrophy (GA) of dry age-related macular degeneration at the Association for Research in Vision and Ophthalmology meeting in Seattle. The objective of the 72-patient study was safety and tolerability of emixustat hydrochloride doses in subjects with GA compared to placebo. Biological activity of emixustat hydrochloride in the retina also

Eisai Inc., of Woodcliff Lake, N.J., said antiepileptic drug Fycompa (perampanel) showed a clear therapeutic benefit in difficult-to-treat patients with partial epilepsy, according to two new analyses of early clinical experience. Data were presented at the joint meeting of the German and Austrian Societies for Epileptology and the Swiss League Against Epilepsy in Interlaken, Switzerland.

Cell Medica Ltd., of London, treated its first patient in the ASPIRE Phase I/II trial of Cytovir ADV for adenovirus infection in immunosuppressed pediatric patients following bone marrow transplantation. The project is a collaboration between Cell Medica, UCL Institute of Child Health, and Great Ormond Street Hospital for Children, funded in part by a grant from the Technology Strategy Board, the UK's innovation agency. The trial will enroll up to 15 patients and is scheduled for completion in

Aileron Therapeutics Inc., of Cambridge, Mass., completed the first-in-human study of its lead stapled peptide drug, ALRN-5281. The long-acting growth hormone-releasing hormone agonist is in development for orphan endocrine disorders such as adult growth hormone deficiency and HIV lipodystrophy and broader indications in metabolic and endocrine disease. The initial Phase I evaluated the safety and tolerability of single ascending doses of ALRN-5281 administered by subcutaneous injection in

Baxter International Inc., of Deerfield, Ill., said a Phase III study testing immunoglobulin did not meet the co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer's disease. Results, however, showed a positive, numerical difference in the change from baseline vs. placebo in cognition in a subgroup analysis, though the study was not powered to show statistical significance among subgroups. Based on those data, Baxter

Janssen Research & Development LLC, of Raritan, N.J., part of Johnson & Johnson, said patients are now enrolling in a multicenter, open-label expanded access program (EAP) in the U.S. for the investigational oral Bruton's Tyrosine Kinase inhibitor ibrutinib, which is being jointly developed by Janssen and Pharmacyclics Inc., of Sunnyvale, Calif. The mantle cell lymphoma (MCL) EAP is available to eligible patients with relapsed or refractory MCL, who could benefit from treatment with ibrutinib

Esperion Therapeutics Inc., of Ann Arbor, Mich., disclosed full results of a Phase II trial of ETC-1002 in patients with Type II diabetes and hypercholesterolemia. The trial met its primary endpoint, demonstrating that ETC-1002 lowered LDL-C by up to 43 percent, and was associated with improvements in control of other cardiometabolic risk factors. ETC-1002 was well tolerated. The data were presented in an oral session at the Arteriosclerosis, Thrombosis, and Vascular Biology 2013 Scientific

AcelRx Pharmaceuticals Inc., of Redwood City, Calif., reported additional findings for sufentanil NanoTab PCA system, its lead product in moderate to severe acute pain in the hospital setting. New analyses from the Phase III comparison trial demonstrated that sufentanil delivered through the AcelRx system produced greater reduction in pain intensity in the first four hours after initiating treatment than intravenous patient-controlled analgesia (IV PCA) with morphine (p < 0.01). In addition

Agenus Inc., of Lexington, Mass., said preliminary data from a Phase II trial showed that newly diagnosed glioblastoma multiforme (GBM) patients treated with Prophage G-100 (heat shock protein-peptide complex-96, HSPPC-96) vaccine plus the standard of care showed a 146 percent increase in progression-free survival (PFS) and a 60 percent increase in overall survival (OS) as compared to the standard of care alone. Results were presented at the 81st American Association of Neurological Surgeons