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
Abbvie Inc., of Chicago, reported preliminary results from a Phase I study of ABT-199/GDC-0199, an investigational BCL-2 (B-cell lymphoma 2) selective inhibitor, in patients with high-risk relapsed/refractory chronic lymphocytic leukemia (CLL), and in patients with relapsed/refractory non-Hodgkin's lymphoma (NHL). The open-label, multicenter, international trial was designed to assess the safety, determine the maximum tolerated dose and recommended Phase II dose, and evaluate the
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
Ablynx NV, of Ghent, Belgium, will make an oral and poster presentation for arthritis candidate, ALX-0061, at the Annual European Congress of Rheumatology in Madrid, Spain, showing a strong efficacy and safety profile for the drug in a Phase II study. Pooled data at 24 weeks of treatment demonstrated that ALX-0061 led to an improvement of 84 percent in ACR20 and 58 percent DAS28 remission. At all doses, the drug was well tolerated with no clinically relevant neutropenia, no clinically
Bristol-Myers Squibb Co., of New York, reported year two data from the AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naïve rheumatoid arthritis Subjects With Background Methotrexate) trial of 646 patients comparing the safety and efficacy of the subcutaneous formulation of abatacept (Orencia) vs. adalimumab (Humira, Abbvie Inc.), each on a background of methotrexate (MTX), in biologic naïve patients with moderate to severe rheumatoid arthritis (RA). Results from the second year of
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
Pfizer Inc., of New York, began a Phase I trial of PF-06410293 (adalimumab), its biosimilar version of Humira. The trial will enroll about 210 subjects. Its primary objective will be measuring pharmacokinetic values, with secondary objectives including incidence of anti-adalimumab antibodies and neutralizing antibodies, time to maximum serum concentration, systemic clearance and serum decay half-life.
Andromeda Biotech Ltd., of Yavne, Israel, reported findings from an extension study of its Phase III trial of DiaPep277 in Type I diabetes. The open-label, 24-month extension study was designed to evaluate long-term safety, tolerability and efficacy for two years following the completion of the Phase III study, DIA-AID 1 in November 2011 . Forty-three patients who completed two years in the DIA-AID 1 study and who had residual beta cell function (stimulated C-peptide over 0.2 nmol/L) were
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.
Aerial BioPharma LLC, of Morrisville, N.C., said data from a Phase IIa trial evaluating the efficacy and safety of ADX-N05 for the treatment of excessive daytime sleepiness in adult subjects with narcolepsy will be presented at the SLEEP 2013 meeting in Baltimore this week. A total of 33 patients were randomized and completed both N05 and placebo periods in the double-blind, placebo-controlled, multicenter, crossover study. The average sleep latency across the four trials on the Maintenance of
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.
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
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