Ferring Pharmaceuticals SA, of Saint Prex, Switzerland, reported data from the EXPEDITE study at the First European Congress on Intrapartum Care in Amsterdam, the Netherlands, which demonstrated that use of a controlled-release misoprostol vaginal insert significantly reduced time (21.5 hours vs. 32.8 hours) to vaginal delivery compared to a dinoprostone vaginal insert. Misoprostol is a synthetic prostaglandin E1 analogue used for labor induction. The EXPEDITE study compared the efficacy and

Adherex Technologies Inc., of Research Triangle Park, N.C, said it received feedback from the FDA at an end-of-Phase II meeting, during which the company proposed a small pivotal single-arm study to testing eniluracil/5-FU/leucovorin in metastatic breast cancer patients, based on data from patients who had rapid disease progression on Xeloda (capecitabine, Roche AG). The agency, however, strongly recommended that Adherex consider other larger clinical trial design alternatives. Adherex said, in

Novo Nordisk A/S, of Bagsvaerd, Denmark, reported top-line results from a 56-week Phase IIIa trial testing the potential of GLP-1 drug liraglutide to induce and maintain weight loss in people without diabetes who are obese or overweight with co-morbidities such as prediabetes, hypertension and dyslipidemia. From a mean baseline weight of 106 kg and a body mass index (BMI) of 38 kg/m2, the average weight loss for those treated with liraglutide 3 mg was 8 percent vs. 2.6 percent for the placebo

La Jolla Pharmaceutical Co., of San Diego, released data detailing the ability of lead product candidate GCS-100 to improve renal function. The retrospective analysis details the positive effect that GCS-100 treatment had on the estimated glomerular filtration rate in patients with poorly functioning kidneys. GCS-100 is being developed as a treatment for chronic kidney disease, with a Phase IIa trial expected to begin soon. Lpath Inc., of San Diego, began dosing in a Phase IIa trial of Asonep

Acelrx Pharmaceuticals Inc., of Redwood City, Calif., reported top-line data that showed its sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System met the primary and secondary efficacy endpoints in a placebo-controlled, Phase III study. In the 48 hours following major orthopedic surgery, patients treated with sufentanil NanoTabs realized a significantly greater score in the Summed Pain Intensity Difference (SPID) than placebo-treated patients. Secondary endpoint data showed

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

Elcelyx Therapeutics Inc., of San Diego, said it is enrolling patients with Type II diabetes in a Phase IIb trial of NewMet, a delayed-release formulation of generic metformin. Results of the trial's primary endpoint of change in fasting plasma glucose are expected in late summer, and the read-out for long-term glucose lowering and weight benefits is due in the fourth quarter. Intercept Pharmaceuticals Inc., of New York, reported initial results from OBADIAH, an ongoing Phase IIa trial of

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

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