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
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.
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
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.
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
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
Grifols SA, of Barcelona, Spain, presented results from a study demonstrating that a higher dose of Prolastin-C (alpha1-proteinase inhibitor [human]) increased levels of the alpha1 protein in patients with alpha1antitrypsin (AAT) deficiency to levels that are considered within the normal range for healthy individuals. AAT deficiency is a life-threatening, genetic condition in which low levels of the alpha1 proteinase inhibitor (A1PI) protein can lead to emphysema. Results of the PROLASTIN-C
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
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