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., 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

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

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.

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.

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

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

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

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

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

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