AstraZeneca plc, of London, said results from two pivotal Phase III studies of naloxegol showed that the 25-mg dose met its primary and secondary endpoints for efficacy and showed a safety profile consistent with previous studies. Naloxegol is a peripherally acting mu-opioid receptor antagonist in development for opioid-induced constipation. Data were presented at the Digestive Disease Week conference in Orlando, Fla. Boehringer Ingelheim GmbH, of Ingelheim, Germany, reported that tiotropium

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

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

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

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

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

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

AMAG Pharmaceuticals Inc., of Lexington, Mass., said a new subgroup analysis from IDA-301, a Phase III, randomized, placebo-controlled trial, was presented at the first poster session of the American College of Obstetrics and Gynecology annual meeting in New Orleans. In the full IDA-301 study, 608 adult patients with iron deficiency anemia (IDA) who had failed or could not tolerate oral iron were treated with ferumoxytol and 200 received placebo, with the demographics and all baseline

Derma Sciences Inc., of Princeton, N.J., said patient screening started in the second of two Phase III trials testing topical drug candidate DSC127 for the treatment of diabetic foot ulcers. The study will have three arms of 211 patients each and will test a 0.03 percent formulation of the drug against a topical vehicle and against a standard-of-care hydrogel. The first Phase III trial, which started in February, is testing two arms of 211 patients each, evaluating DSC127 vs. topical vehicle

Inovio Pharmaceuticals Inc., of Blue Bell, Pa., said its SynCon universal H1N1 influenza vaccine generated protective antibody levels comparable to an FDA-approved seasonal influenza vaccine against a currently circulating flu strain. Data from the Phase I study in healthy volunteers were presented at the World Vaccine Congress in Washington. Northwest Biotherapeutics Inc., of Bethesda, Md., said that a patient treated with DCVax-L for glioblastoma multiforme in 2002 has celebrated his 10th

Advanced Cell Technology Inc., of Marlborough, Mass., treated the first patient in patient cohort 2a of its Phase I trials, consisting of patients with better vision, in its U.S. trial for Stargardt's Macular Dystrophy (SMD), a form of juvenile macular degeneration. The patient was injected with 100,000 human embryonic stem cell-derived retinal pigment epithelial cells. As the company announced on Jan. 22, patients with a visual acuity of 20/100 are eligible for enrollment in cohort 2a in the

Pacira Pharmaceuticals Inc., of Parsippany, N.J., reported Phase IV (EXCLAIM) results for Exparel (bupivacaine liposome injectable suspension) in postsurgical analgesia. Patients who received Exparel after abdominoplasty, breast augmentation, breast reduction or a combination procedure had low pain scores, high satisfaction with their pain control and minimal opioid use. Pacira presented the findings at The Aesthetic Meeting 2013.

Reviva Pharmaceuticals Inc., of San Jose, Calif., reported top-line results from its Phase II REFRESH study of RP5063 in schizophrenia and schizoaffective disorder, with the dopamine serotonin stabilizer showing overall broad efficacy across the Positive and Negative Syndrome Scale total scores, as well as subscales: Positive, Negative and General Psychopathology. RP5063 also showed efficacy in the Clinical Global Impression Severity Scale and was well tolerated. The study enrolled 234 patients

Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., said the FDA accepted its investigational new drug application and announced treatment of the first 15 patients in a trial using Ampion to treat osteoarthritis of the knee. The trial will proceed in two parts, with the first run-in portion to evaluate two doses of Ampion in 320 adults to determine the optimal dosage for the second portion of the pivotal study. The number of patients required in the second part will be determined based on