Acadia Pharmaceuticals Inc., of San Diego, presented data at the International Congress of Parkinson's Disease and Movement Disorders in Sydney, Australia, from its Phase III program testing pimavanserin in Parkinson's disease psychosis (PDP), including data from the pivotal -020 study and related -015 open-label safety extension trial. Interim data from the -015 study suggested that long-term administration of 40 mg of pimavanserin, an inverse agonist of serotonin 5-HT2A, is generally safe and
Acetylon Pharmaceuticals Inc., of Boston, presented data on lead candidate ACY-1215 for the treatment of relapsed or refractory multiple myeloma at the 18th Congress of the European Hematology Association. ACY-1215 is an oral, selective HDAC6 inhibitor currently being evaluated in a Phase Ib trial in combination with Revlimid (lenalidomide, Celgene) and a Phase I/II trial in combination with the first-in-class drug Velcade (bortezomib, Millennium: The Takeda Oncology Co.) for the treatment of
Astex Pharmaceuticals Inc., of Dublin, Calif., updated Phase I trial results for SGI-110 in a poster session at the 18th Congress of the European Hematology Association, June 13-16 in Stockholm, Sweden. Of 15 heavily treated intermediate or high-risk patients with myelodysplastic syndrome, six achieved a clinical response with a median duration of 92 days. The company said the updated results showed promise for clinical activity of the drugs in heavily pretreated MDS patients and confirmed
Astex Pharmaceuticals Inc., of Dublin, Calif., presented updated clinical results of its hypomethylating agent, SGI-110, in a poster session at the 18th Congress of the European Hematology Association in Stockholm, Sweden. The update focused on details of the biological and clinical activity as well as safety in the group of intermediate or high-risk relapsed or refractory myelodysplastic syndromes patients treated in the dose-escalation, Phase I part of the SGI-110-01 study. The study enrolled
Apceth GmbH, of Munich, Germany, received approval to conduct a clinical cancer trial with its genetically modified adult mesenchymal stem cells. The multicenter, open-label trial will recruit patients suffering from advanced adenocarcinomas of the gastrointestinal tract. The therapy is based on mesenchymal stem cells harvested from the patient's own (autologous) bone marrow, which are processed, genetically modified and re-infused into the patient. Celgene Corp., of Summit, N.J., said oral
Abbvie Inc., of Chicago, reported results from the CONCERTO trial testing different predefined doses of methotrexate in combination with anti-TNF-alpha drug Humira (adalimumab) in moderate to severe rheumatoid arthritis. CONCERTO showed that, at week 26, a statistically significant increasing trend was observed in the proportion of patients achieving low disease activity with an increasing dose of methotrexate when used with open-label Humira. Results were presented at the European League
Ariad Pharmaceuticals Inc., of Cambridge, Mass., said it started a Phase II trial of Iclusig (ponatinib) in adults with metastatic and/or unresectable gastrointestinal stromal tumors (GIST). The open-label study is designed to enroll about 45 patients and will provide initial data on the drug's efficacy and safety in patients with GIST following failure of prior tyrosine kinase inhibitor therapy. Patients whose tumors have an activating mutation in exon 11 of the cellular KIT, the primary
Boehringer Ingelheim GmbH, of Ingelheim, Germany, reported new findings presented during the APASL Liver Week in Singapore, highlighting the efficacy and safety of faldaprevir(+) plus pegylated interferon and ribavirin (PegIFN/RBV) in treatment-naïve patients with genotype-1 hepatitis C virus (HCV) in Asia. The post-hoc sub-analysis of the Phase III STARTVerso 1 and 2 trials showed that both doses of faldaprevir were associated with high viral cure rates and a shorter treatment duration in that
Argos Therapeutics Inc., of Durham, N.C., has expanded its ADAPT Phase III study for AGS-003 to additional cancer centers in the U.S., Canada and will soon be expanding into Europe and Israel. To date, more than 50 sites have been activated and more than 30 subjects have been enrolled in North America. The study is expected to expand to more than 120 global sites by early fall. The study is evaluating AGS-003, an investigational, fully personalized immunotherapy designed to stimulate a tumor
Alexion Pharmaceuticals Inc., of Cheshire, Conn., published data in the June 6, 2013, issue of the New England Journal of Medicine showing that chronic therapy with Soliris (eculizumab) was effective for hemolytic uremic syndrome. Results of two studies demonstrated that Soliris inhibited systemic complement-mediated TMA, decreased the need for TMA-related intervention, improved platelet count significantly, improved renal function and was associated with substantial kidney recovery. Chronic
Debiopharm Group, of Lausanne, Switzerland, said it treated the first patients in a Phase I study of Debio 1143, a small-molecule neutralizing inhibitor of apoptosis protein, combined with carboplatin and paclitaxel in patients with squamous non-small-cell lung cancer, platinum-refractory ovarian cancer and basal-like/claudin low-triple-negative breast cancer. The study will evaluate the safety and tolerability of the drug, establish a maximum tolerated dose and establish dosing for a further
CSL Behring, of King of Prussia, Pa., dosed the first patient in Part 3 of its AFFINITY trial program. The open-label Phase I/III study is evaluating the efficacy, safety and pharmacokinetics of its recombinant coagulation single-chain Factor VIII compared with recombinant human antihemophilic Factor VIII (octocog alpha) for the treatment of hemophilia A.
Alkermes plc, of Dublin, disclosed positive Phase II data with ALKS 5461, an opioid modulator, in patients with major depressive disorder and inadequate response to standard therapies. ALKS 5461 met its primary endpoint, met key secondary endpoints and demonstrated significant reduction in depressive symptoms versus placebo. The study was presented in an oral session at the 53rd Annual New Clinical Drug Evaluation Unit meeting in Hollywood, Fla. Bioheart Inc., of Sunrise, Fla., enrolled and
Alios BioPharma Inc., of South San Francisco, began oral dosing of ALS-8176 in a Phase I trial. ALS-8176 is an anti-respiratory syncytial virus (RSV) nucleoside analogue that is being developed for the treatment of acute RSV infection. ALS-8176 demonstrated potent antiviral activity across multiple strains of RSV in preclinical studies, the firm said. Alios signed a potential $1.5 billion deal with Vertex Pharmaceuticals Inc., of Cambridge, Mass., in 2011. (See BioWorld Today, June 14, 2011
AstraZeneca plc, of London, developed AZD3965, which Cancer Research UK's development office said will enter a 63-patient trial to determine its potential benefit. The first-in-man trial will be undertaken by the National Institute of Health Research Experimental Cancer Medicine Centre, based at the Northern Institute of Cancer Research at Newcastle University, as well as at least one other clinical center. AZD3965 targets monocarboxylate transporter 1.
Euthymics Bioscience Inc., of Cambridge, Mass., reported top-line results from TRIADE (Triple Reuptake Inhibitor Anti-Depressant Effects), a Phase IIb/IIIa study designed to assess the safety and efficacy of amitifadine, a serotonin-preferring triple reuptake inhibitor antidepressant, in patients with major depressive disorder (MDD) failing to respond to one course of first-line antidepressants. Amitifadine efficacy at 50-mg or 100-mg doses did not show a statistically significant difference
Eli Lilly and Co., of Indianapolis, reported new data showing that Forteo significantly increased lumbar spine volumetric bone mineral density (vBMD) compared to risedronate in men with glucocorticoid-induced osteoporosis. Glucocorticoid-induced osteoporosis is caused by excess intake of glucocorticoids, a class of steroid hormones used to treat inflammatory, autoimmune and allergic disorders. Study results are published in the June 2013 issue of the Journal of Bone and Mineral Research
Alkermes plc, of Dublin, Ireland, reported Phase I data showing that ALKS 3831, a drug candidate for treating schizophrenia, produced significantly less weight gain in subjects compared to olanzapine. ALKS 3831 combines olanzapine with the company's opioid modulator, ALKS 33, to treat schizophrenia without the associated weight gain usually seen with olanzapine treatment. Data showed the drug also was found to be safe and well tolerated. Those results were presented at the New Clinical Drug
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
Acadia Pharmaceuticals Inc., of San Diego, presented data at the International Congress of Parkinson's Disease and Movement Disorders in Sydney, Australia, from its Phase III program testing pimavanserin in Parkinson's disease psychosis (PDP), including data from the pivotal -020 study and related -015 open-label safety extension trial. Interim data from the -015 study suggested that long-term administration of 40 mg of pimavanserin, an inverse agonist of serotonin 5-HT2A, is generally safe and