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...The drug was well tolerated, with similar rates of adverse events between the groups...Cerulean Pharma Inc., of Cambridge, Mass., will present

No serious adverse events were reported, and the reported adverse events were mild to moderate and transient in nature...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

Acasti Pharma Inc., of Laval, Quebec, a subsidiary of Neptune Technologies & Bioressources Inc., reported preliminary data from a randomized, open-label, dose-ranging, multicenter trial assessing the safety and efficacy of NKPL66, or CaPre, in mild-to-high hypertriglyceridemia...No serious adverse events were reported...The NX03-0040 prostate cancer clinical study of 150 men is testing low (2.5 mg) and high (15 mg) single doses of NX-1207 for the effect to eradicate or shrink low-grade localized

Adverse events were consistent with those already known for eplerenone, primarily hyperkalemia...Findings were presented during the late-breaking clinical trial session at the American College of Cardiology 62nd Annual Scientific Session in San Francisco

Polyphor Ltd., of Allschwil, Switzerland, completed a Phase I trial demonstrating the clinical safety and tolerability of its Pseudomonas-specific antibiotic POL7080...Adverse event (AE) profiles were similar between the two treatment groups and consistent with known AEs associated with progesterone

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...VX-787 was generally well tolerated, with no adverse events leading to discontinuation

Antisense Pharma GmbH, of Regensburg, Germany, revised its business objectives related to the advancement of its next-generation TGF-beta inhibitor oligonucleotide program...The trial reported no imbalance in serious adverse events, and there were a low number of major adverse cardiovascular events...Kiadis Pharma BV, of Amsterdam, the Netherlands, said it received a No Objection Letter from Canadian regulators to proceed with a Phase II study testing ATIR, a cell-based product designed to enable stem

BioAlliance Pharma SA, of Paris, said the FDA approved a U.S...The most commonly reported adverse events were anorexia and fatigue

No serious adverse events were reported, and the drug demonstrated a dose-dependent lowering effect on growth hormone (hGH), as shown by an analysis of the pharmacodynamics effect on hGH, when stimulated by growth hormone-releasing hormone...Cerulean Pharma Inc., of Cambridge, Mass., said CRLX101 achieved the predefined gating criterion for advancement into the second stage of a Phase II trial in advanced ovarian cancer...The complete clinical study report for the interim analysis would be supplied to

Alnylam Pharmaceuticals Inc., of Cambridge, Mass., filed a clinical trial application with the U.K. Medicines and Healthcare Products Regulatory Agency to initiate a Phase I study of ALN-TTRsc, an RNAi therapeutic targeting transthyretin (TTR), in TTR-mediated amyloidosis...ALN-TTRsc is the first GalNAc-siRNA to enter clinical development...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

BioAlliance Pharma SA, of Paris, said the European Independent Board of Experts held its first meeting on the ReLive Phase III trial of Livatag (doxorubicin transdrug) in primary liver cancer and recommended continuing the study without modification...Clavis Pharma ASA, of Oslo, Norway, said it reached the enrollment target for its Phase III CLAVELA study investigating elacytarabine in patients with relapsed or refractory acute myeloid leukemia (AML...with experience and expertise in stem cell

Because of the nature of the registry and vision testing variability, the company said, a clear comparison could not be drawn between registry data and clinical trial results...Single doses up to 7.5 mg were generally well tolerated, with no significant adverse events

The most common adverse events included fatigue, rash, diarrhea, nausea, cough, joint pain, fever and itching, with seven MK-3475-related Grade 3/4 adverse events potentially immune related

The Phase III study met its primary endpoint and demonstrated statistically significant protection against clinical and severe malaria in infants...The overall incidence of adverse events (AEs) was generally similar across all treatment arms

Investigators will report clinical response, clinical remission and mucosal healing results through one year at the American College of Gastroenterology meeting in Las Vegas...Doses of 0.5 mg and 1 mg laquinimod also were well tolerated, with adverse events similar to placebo

The clinical relevance of neratinib as a 'pan-HER' family inhibitor and it being irreversible is yet to be proven," the paper said...Funds will be used to support the clinical development of cancer drugs aldoxorubicin and tamibarotene and for general corporate purposes, which could include working capital, capital expenditures, R&D and commercial activities.

The most frequently reported adverse events were dizziness, insomnia, balance disorder, headache, nausea, urinary tract infection, back pain and asthenia...AlphaCore Pharma Inc., of Ann Arbor, Mich., said its Phase I trial met the primary endpoint by demonstrating the safety and tolerability of ACP-501 (recombinant human LCAT...The positive clinical effects of the twice-daily dose of the drug relative to placebo were observed in a variety of standard psoriasis assessment parameters, with the responses

Started in March, the Eslicarbazepine acetate in Partial-Onset Seizures study is intended to enroll about 800 patients, with a primary endpoint of six-month retention rate and other assessments, including seizure frequency, adverse events and quality of life...Additional results from the PHOENIX-2 study showed that high levels of clinical responses were achieved and maintained with up to five years of ustekinumab treatment

No serious adverse events were reported in the primary analysis period, and no clinically meaningful differences in related adverse events were reported between the two treatment groups...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 insulin in Type II diabetes