Ferring Pharmaceuticals SA, of Saint Prex, Switzerland, reported preliminary results from a study showing treatment with melt-in-the-mouth desmopressin, an orally disintegrating tablet, reduced period limb movements (PLMS) in children with nocturnal enuresis (bedwetting). The anti-diuretic effect of desmopressin melt correlated strongly with reduced PLMS, with 90 percent of children in the study experiencing reduced PLMS. Data were presented at the Joint Congress of the International Children's

Arena Pharmaceuticals Inc., of San Diego, said it started dosing in a Phase I trial of APD811, an oral drug candidate designed to target the prostacyclin receptor for the treatment of pulmonary arterial hypertension. The dose-titration study is planned to enroll up to 30 healthy adult volunteers and will evaluate safety, tolerability and pharmacokinetics of multiple ascending doses. Biogen Idec Inc., of Weston, Mass., reported data from studies testing oral BG-12 (dimethyl fumarate) at the

Cytori Therapeutics Inc., of San Diego, began a Phase I/II trial (ATHENA) of its cell therapy for refractory heart failure resulting from myocardial ischemia. The randomized, double-blind trial of safety and feasibility will enroll 45 patients at six centers in the U.S. who will be randomized to cell therapy or inactive placebo injection. All patients will have adipose tissue removed. The tissue is used for processing into adipose-derived stem and regenerative cells. Euthymics Bioscience Inc

Pierre Fabre Dermatolgie Laboratories, of Castres, France, a subsidiary of Pierre Fabre Laboratories, reported Phase III data showing that propranolol oral solution in infantile hemangioma resulted in complete or nearly complete resolution of the hemangioma for a sizeable majority of the infants who were treated, compared to an almost complete lack of effect from placebo. The company said it expects to submit for the drug's use in children in both the U.S. and Europe. Teva Pharmaceutical

Argos Therapeutics Inc., of Durham, N.C., said its ongoing Phase III ADAPT study testing personalized immunotherapy candidate AGS-003 in Stage IV kidney cancer was reviewed during the International Kidney Cancer Symposium in Chicago. The ADAPT study, which is being conducted under a special protocol assessment, is testing AGS-003 in combination with well-established targeted drug therapies and is expected to enroll about 450 newly diagnosed patients with metastatic disease. Enrollment is

Eli Lilly and Co., of Indianapolis, reported detailed data from two Phase III trials of solanezumab in Alzheimer's disease, showing that a prespecified analysis of pooled data in patients with mild disease, a statistically significant slowing of cognitive decline was shown, representing a 34 percent reduction in decline. The company previously reported that the drug missed its endpoints in two Phase III trials in Alzheimer's. The company said next steps for the drug, a monoclonal antibody that

Grupo Ferrer Internacional SA, of Barcelona, Spain, said it successfully completed an absorption, tolerability and safety trial in adult and juvenile patients from 2 months of age with impetigo involving Ozenoxacin formulated as a topical treatment for infectious dermatological conditions. The study will form the basis for the first regulatory filing for nonfluorinated quinolone antibacterial agent in 2013.

MannKind Corp., of Valencia, Calif., said it finished recruiting patients for two Phase III studies of Afrezza (insulin human [rDNA origin]), an investigational ultra-rapid-acting mealtime insulin therapy, administered using the firm's to-be-marketed next-generation inhaler. Both studies are on track to be completed in the second quarter of 2013, with top-line results next summer and a planned new drug application resubmission in the third quarter of 2013. The Medicines Co., of Parsippany, N

Eisai Co. Ltd., of Tokyo, and Bial SA, of S. Mamede do Coronado, Portugal, reported at the European Congress on Epileptology in London that it expects data from recently launched studies designed to increase the understanding of Zebinix (eslicarbazepine acetate), a once-daily adjunctive therapy for adults with partial-onset seizures with or without secondary generalization. Started in March, the Eslicarbazepine acetate in Partial-Onset Seizures study is intended to enroll about 800 patients

Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, reported Phase III results and pooled Phase III analyses supporting the use of DPP-4 Trajenta (linagliptin) in Type II diabetes, including patients who are elderly and those at with diabetic nephropathy. Data were presented at the European Association for the Study of Diabetes meeting in Berlin. Bristol-Myers Squibb Co., of New York, and Pfizer Inc., also of New York, reported that the reductions in

Aduro BioTech Inc., of Berkeley, Calif., said it enrolled the first patient in a Phase Ib study of CRS-207, a therapeutic cancer vaccine, combined with chemotherapy in patients newly diagnosed with malignant pleural mesothelioma. Patients will receive two prime vaccinations with CRS-207, followed by standard-of-care chemotherapy. Astex Pharmaceuticals Inc., of Dublin, Calif., said it started a Phase II study evaluating SGI-110, a small-molecule DNA-hypomethylating agent, in combination with

Acacia Pharma Ltd., of Cambridge, UK, reported results from its Phase IIa study of APD403 for the prevention of acute nausea and vomiting in cancer patients receiving cisplatin, with initial exploratory cohorts showing that single-agent APD403 had encouraging benefit, especially in controlling nausea. When the drug was combined with a standard dose of 5-HT3 antagonist ondansetron, a complete response in 19 of 23 patients (83 percent) was achieved, higher than the 50 percent response rate that

Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, reported new patient-reported health-related outcomes for its investigational oncology compound afatinib, including lung cancer-related symptoms and quality of life. The data are secondary endpoints of LUX-Lung 3, a Phase III trial of afatinib (n = 230) compared to chemotherapy (pemetrexed/cisplatin) (n = 115) in patients with epidermal growth factor receptor mutation-positive advanced non-small

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said it completed enrollment in two Phase III trials testing nintedanib (BIBF 1120) in patients with idiopathic pulmonary fibrosis. The identical studies will enroll a total of 970 patients to receive treatment or placebo over a 52-week period. The primary endpoint is the annual rate of decline in forced vital capacity, while secondary endpoints include health-related quality of life, exacerbations, respiratory mortality, overall survival and on

Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., said it was advised by the Department of Veterans Affairs Cooperative Studies Program (VACSP) that the availability of top-line results from its CPP-109 (vigabatrin) Phase IIb trial for cocaine addiction will be delayed, with top-line results now expected during the first half of November. Previously VACSP said top-line data would be provided around the end of September. The 207-patient study is designed to demonstrate that the rate

Clarus Therapeutics Inc., of Northbrook, Ill., said top-line data from the 90-day treatment phase of its ongoing Phase III study of CLR-610, an oral testosterone replacement product, demonstrated that 87 percent of the 141 men treated with CLR-610 achieved average serum T levels in the normal range (between 300 ng/dL and 1,000 ng/dL), the study's primary endpoint. The average serum T level in the CLR-610 group was 624 ng/dL. That compared to 80 percent of the 146 men in the T-gel comparison arm

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said recruitment was completed for two randomized Phase III trials assessing the efficacy and safety of nintedanib (formerly BIBF 1120) 150 mg twice daily in idiopathic pulmonary fibrosis (IPF). Approximately 1,000 patients are enrolled in the pivotal INPULSIS Phase III trials at sites in 23 countries, with a primary endpoint of the annual rate of decline in forced vital capacity over 52 weeks. Secondary endpoints include change from baseline in

Amgen Inc., of Thousand Oaks, Calif., said treatment with RANK ligand inhibitor denosumab decreased the number of tumor giant cells in patients with giant-cell tumor of the bone, and increased new bone formation, according to results of a Phase II study published in Clinical Cancer Research. Data from the 20-patient study showed that all patients had a decrease in giant cells of 90 percent or greater, an indication of a reduction of tumor burden. About 65 percent of patients also had new bone

Advanced Accelerator Applications SA, of Saint Genis Pouilly, France, said it started a Phase III trial testing the effect of theranostic drug Lutathera in patients with inoperable progressive midgut carcinoid. The NETTER-1 study will compare Lutathera to Sandostatin LAR (octreotide, Novartis AG) in patients and will measure progression-free survival as the primary endpoint. Secondary endpoints include safety, objective response rate, time to tumor progression, overall survival and quality of