Array BioPharma Inc., of Boulder, Colo., reported clinical data at the International Myeloma Workshop in Kyoto, Japan, showing that ARRY-520, a selective KSP inhibitor, demonstrated single-agent activity in heavily pretreated patients with relapsed or refractory multiple myeloma, with 19 months median overall survival and a 16 percent overall response rate...Cerulean Pharma Inc., of Cambridge, Mass., will present Phase II data for investigational nanopharmaceutical product CRLX101 at the American

Erytech Pharma SA, of Lyon, France, said it received clearance of its investigational new drug application for a Phase I trial of Eryasp (L-asparagainase-loaded erythrocytes) in patients 40 years and older with newly diagnosed acute lymphoblastic leukemia...The dose-escalation trial will enroll about 56 healthy volunteers and will assess safety, tolerability and pharmacokinetics of both single and multiple doses

Polyphor Ltd., of Allschwil, Switzerland, completed a Phase I trial demonstrating the clinical safety and tolerability of its Pseudomonas-specific antibiotic POL7080...All primary study objectives were achieved in the randomized, double-blind, placebo-controlled dose-escalation trial assessing the safety, tolerability and pharmacokinetics of POL7080 in 52 healthy male volunteers

Targeted Medical Pharma Inc., of Los Angeles, said results from an open-label study of oral amino acid-based erythrocyte stimulating system (ESS) for the treatment of chronic anemia showed that hemoglobin increased an average of 11.39 percent from baseline measurement to 45 days...Vertex Pharmaceuticals Inc., of Cambridge, Mass., said VX-787 in a Phase II influenza challenge study resulted in statistically significant improvements in viral and clinical measurements of infection...Also, 93 percent of

BioAlliance Pharma SA, of Paris, said the FDA approved a U.S...The open-label, dose-escalation trial was conducted in 52 men with hormone-refractory prostate cancer that had progressed despite prior treatment with taxane-based chemotherapy regimens

Two posters feature clinical data of PROSTVAC evaluated as monotherapy or in combination with a radiopharmaceutical...The final poster reviews results from the Phase I dose-escalation trial of MVA-BN PRO...BHR Pharma LLC, of Herndon, Va., said the European Medicines Agency (EMA) granted an orphan medicinal product designation for treating moderate and severe traumatic brain injury (TBI) to its intravenous progesterone infusion agent, BHR-100

Acceleron Pharma Inc., of Cambridge, Mass., said it started a Phase II study testing dalantercept (ACE-041), an angiogenesis inhibitor designed to target the activin receptor-like kinase pathway, in combination with Inlyta (axitinib, Pfizer Inc.), a vascular endothelial growth factor receptor tyrosine kinase inhibitor, in patients with metastatic renal cell carcinoma...The dose-escalation study will evaluate safety, tolerability and efficacy as determined by RECIST criteria and the company's cancer

Alnylam expects to initiate the dose-escalation study early this year, enrolling up to 40 healthy volunteers to evaluate safety and tolerability with a secondary assessment of clinical activity measured by serum TTR levels...Cerulean Pharma Inc., of Cambridge, Mass., said it dosed the first patient in a Phase II study of lead candidate CRLX101 in advanced gastric cancer

Noxxon Pharma AG, of Berlin, said it treated the first patients in a Phase IIa trial of its anti-hepcidin Spiegelmer NOX-H94 to treat anemia associated with chronic disease...The dose-escalation study enrolled 60 HIV-uninfected adults and tested doses of the vaccine, which comprises an rVSV vector expressing the HIV-1 gag protein, administered by intramuscular injection

The dose-escalation trial will evaluate the tablet form of the drug, with primary objectives of determining the maximum-tolerated dose and recommended Phase II dose and to assess the bioavailability and pharmacokinetics...Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of Paris, reported data at the European Association for the Study of Diabetes meeting in Berlin supporting the use of once-daily glucagon-like peptide-1 receptor agonist lixisenatide in combination with basal

The first clinical study, to be conducted in the U.S...Protalex Inc., of Summit, N.J., said data from its Phase Ib dose-escalation trial showed that PRTX-100 was well tolerated at all dose levels in adult patients with rheumatoid arthritis (RA) and, at the higher doses, more patients showed improvement in their Clinical Disease Activity Index for RA than did patients in the lower-dose or placebo cohorts

Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, published Phase III results from the AFFIRM trial of enzalutamide (MDV3100) in metastatic castration-resistant prostate cancer patients previously treated with docetaxel-based chemotherapy in the New England Journal of Medicine...The second trial, a single-arm dose-escalation study being conducted in the U.S., will evaluate Reolysin in combination with FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy in 21

ImmunoCellular Therapeutics Ltd., of Woodland Hills, Calif., will present new data from its previously completed Phase I trial of ICT-107 in glioblastomoa multiforme at the American Society of Clinical Oncology meeting in Chicago...The dose-escalation trial will evaluate the safety and pharmacokinetics of mibefradil when sequentially administered with temozolomide in an approach Tau calls interlaced therapy

Acacia Pharma Ltd., of Cambridge, UK, reported Phase II data showing that APD421 significantly reduced the incidence of nausea and vomiting compared to placebo in adult surgical patients at moderate to high risk of suffering postoperative nausea and vomiting (PONV...The dose-escalation trial is expected to enroll up to 24 patients in up to five cohorts with final safety and pharmacokinetic data expected in the first half of 2013

Data from the dose-escalation study, GIHU004, indicated the induction of long-lasting memory T-cell responses after a single immunization of DermaVir, the company's lead vaccine candidate in HIV...Sigmoid Pharma Ltd., of Dublin, Ireland, said it completed a multicenter, placebo-controlled, randomized Phase II trial of CyCol, its lead candidate, in ulcerative colitis

Bionor Pharma ASA, of Oslo, Norway, Eurocine Vaccines AB, of Solna, Sweden, and Oslo University Hospital reported that a trial of Bionor Pharma's Vacc-4x and Eurocine Vaccines adjuvant Endocine produced vaccine-related immune responses in a nasal immunization study in human patients...Clinical activity observed included favorable bone marrow responses in high-risk patients who were refractory to hypomethylating agents, a reduction in need for red blood cell (RBC) transfusions in transfusion

The study includes a dose-escalation arm of up to 36 patients divided into six cohorts and a dose-confirmation arm with an additional nine to 12 patients to be enrolled at the selected therapeutic dose...Syndax Pharmaceuticals Inc., of Waltham, Mass., said Phase II data published in the Journal of Clinical Oncology confirmed preclinical findings and demonstrated an improved overall survival in a subset of non-small-cell lung cancer (NSCLC) patients with tumors expressing elevated levels of E

The Phase I/II study will involve a dose-escalation portion, followed by an expansion cohort testing the drug in NSCLC patients who have failed EGFR-directed therapies such as Tarceva (erlotinib, Astellas Pharma Inc. and Roche AG) and Iressa (gefitinib, AstraZeneca plc) and have developed the T790M mutation

Curis Inc., of Lexington, Mass., said partner Debiopharm Group, of Lausanne, Switzerland, initiated a Phase Ib expansion study of Debio 0932, a heat-shock protein 90 inhibitor that recently completed a Phase Ia dose-escalation study evaluating safety and maximum-tolerated dose...ViroPharma Inc., of Exton, Pa., said data from the pivotal study for its orphan drug Plenadren (hydrocortisone, modified-release tablet) were published in the Journal of Clinical Endocrinology and Metabolism...Plenadren was