Tekmira Pharmaceuticals Corp., of Vancouver, British Columbia, said that complete results from a Phase I trial of its RNAi therapeutic, ALN-VSP have been published. The company said that the results validate longer-term safety and tolerability of its LNP delivery platform. Alnylam Inc., of Cambridge, Mass., licensed the LNP technology from Tekmira, and is developing several products under that license. Tekmira is due a $5 million payment related to initiation of clinical trials for ALN-VSP in

ArQule Inc., of Woburn, Mass., and Daiichi Sankyo Co. Ltd., of Tokyo, enrolled their first patient in a pivotal Phase III trial (METIV-HCC) of tivantinib (ARQ197) in hepatocellular carcinoma (HCC). The randomized, double-blind, placebo-controlled trial will enroll about 300 previously treated patients with MET-high inoperable HCC to receive tivantinib or placebo, with a primary endpoint of overall survival and a secondary endpoint of progression-free survival. (See BioWorld Today, Oct. 3, 2012

Adventrx Pharmaceuticals Inc., of San Diego, said it started patient recruitment in its pivotal Phase III study of ANX-188 (purified poloxamer 188) in sickle cell disease. The EPIC study is designed to demonstrate that ANX-188 reduces the duration of vaso-occlusive crisis in patients with sickle cell disease. The duration of vaso-occlusive crisis will be measured from the time a subject is randomized to the time at which the subject receives the last dose of parenteral opioid analgesic for the

Acceleron Pharma Inc., of Cambridge, Mass., said it started a Phase II study testing ACE-536 to treat anemia in patients with myelodysplastic syndromes (MDS). The trial is designed to test the drug's safety and efficacy in patients with low-risk or intermediate-1 risk MDS, with efficacy measures including increases in hemoglobin levels, reduction in red blood cell transfusion burden and other hematologic parameters, as well as biomarkers of iron and bone metabolism. ACE-536, a modified Type II

Amgen Inc., of Thousand Oaks, Calif., reported results from the Pegfilgrastim and anti-VEGF evaluation study (PAVES), a Phase III trial, which evaluated Neulasta (pegfilgrastim) in 845 patients receiving FOLFOX or FOLFIRI and bevacizumab for first-line treatment of locally advanced or metastatic colorectal cancer. The study met its primary endpoint, with Neulasta significantly reducing the incidence of febrile neutropenia. The incidence of grade 3 or 4 febrile neutropenia in patients receiving

Seattle Genetics Inc., of Bothell, Wash., said interim results from a Phase I trial of ASG-5ME in metastatic pancreatic ductal adenocarcinoma identified the maximum-tolerated dose for weekly administration, demonstrated tolerability and provided preliminary evidence for antitumor activity. The best response for 18 patients treated at 1.2 mg/kg weekly included one patient (6 percent) who achieved a partial response, six patients (33 percent) with stable disease and four (22 percent) with

Pfizer Inc., of New York, reported data from a Phase IV study showed that Toviaz (fesoterodine fumarate) 8 mg once daily reduced urge urinary incontinence episodes in patients with overactive bladder per 24 hours from baseline to week 12, which was statistically significantly more than Toviaz 4 mg. The efficacy of both doses was statistically significant vs. placebo. In separate news, Pfizer reported data from a Phase IV study testing Pristiq (desvenlafaxine) extended-release tablets, showing

Affymax Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals USA Inc., part of Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said pivotal Phase III data on the safety and efficacy of Omontys (peginesatide) Injection were published in the Jan. 24, 2013, New England Journal of Medicine. The studies, known as Emerald 1 and 2, compared Omontys given once monthly to epoetin administered one-to-three times per week in the treatment of anemia in adult chronic kidney disease patients on

EntreMed Inc., of Rockville, Md., said it started a Phase II study, titled "A Phase II Study of Oral ENMD-2076 Administered to Patients with Advanced/Metastatic Soft Tissue Sarcoma." ENMD-2076 is designed to inhibit both Aurora kinase A and angiogenesis. Shares of EntreMed (NASDAQ:ENMD) gained 28 cents, or 15.4 percent, to close Wednesday at $2.10. Santarus Inc., of San Diego, and VeroScience LLC, of Tiverton, R.I., said data from a pivotal study testing Cycloset (bromocriptine mesylate

Teva Pharmaceutical Industries Ltd., of Jerusalem, said top-line results of its Phase III program testing narcolepsy drug Nuvigil (armodafinil) as adjunct therapy in adults with major depression associated with bipolar I disorder showed that the drug produced a numerical improvement but did not reach statistical significance in meeting its primary endpoint – determining whether armodafinil treatment, at a dosage of 150 mg per day, is more effective than placebo as adjunct therapy to mood

Advanced Cell Technology Inc., of Marlborough, Mass., said it is amending the patient treatment protocol for the remainder of its Phase I trials testing human embryonic cell-derived retinal pigment epithelial cells in Stargardt's macular dystrophy and dry age-related macular degeneration to allow patients with better vision, defined as a visual acuity of 20/100 to enroll in the studies. The company said treating patients earlier in the course of the diseases should produce a more significant

CSL Behring, of King of Prussia, Pa., said it enrolled the first patient in the pivotal pediatric Phase III trial to test efficacy and pharmacokinetics of recombinant fusion protein linking coagulation Factor IX with recombinant albumin in previously treated children (up to age 11).

Actinium Pharmaceuticals Inc., of New York, said Johns Hopkins University School of Medicine in Baltimore joined an ongoing Phase I/II trial of Actimab-A in about 50 elderly patients newly diagnosed with acute myeloid leukemia. The goal of the trial is to establish the drug's safety and efficacy. Actinium is planning to complete the study by the end of 2013. Amgen Inc., of Thousand Oaks, Calif., reported top-line Phase III results for Aranesp (darbepoetin alfa) showing that the trial did not

Cancer Research UK's Drug Development Office in London and partner AstraZeneca plc, of London, opened a three-armed study testing AZD0424 in a Phase I trial expected to recruit up to 30 patients, initially across all solid tumor types. The design of the trial later will be adapted, enabling it to separate into three separate personalized arms to test AZD0424 in different combinations alongside standard or other experimental treatments in specific patient populations. AZD0424 is designed to work

Cytos Biotechnology Ltd., of Zurich, Switzerland, said a technical issue was identified with the rubber stoppers used to close the injection vials containing clinical trial material for its Phase IIb study testing lead candidate CYT003 in allergic asthma. Cytos will replace that material with new material available at clinical sites in the second quarter. The firm expects overall guidance for the study, which will recruit about 360 adults with moderate to severe disease who are not sufficiently

Argos Therapeutics Inc., of Durham, N.C., said the first patients were enrolled in the ADAPT Phase III study testing the ability of AGS-003, a personalized dendritic cell-based immunotherapy, in combination with standard targeted therapy to extend overall survival vs. standard therapy alone in newly diagnosed patients with unfavorable risk metastatic renal cell carcinoma. About 450 patients will be enrolled. Secondary endpoints include progression-free survival, safety, overall response and

Neuralstem Inc., of Rockville, Md., said it has received FDA approval to start a Phase I trial of lead cell therapy candidate NSI-566 in chronic spinal cord injury patients. The open-label study, based on an investigational new drug application filed in 2010, will enroll up to eight patients with thoracic spinal cord injuries (T2-T12), who have an American Spinal Injury (AIS) Association A level of impairment, between one and two years after injury. The primary objective is to determine the

KaloBios Pharmaceuticals Inc., of South San Francisco, said it started dosing in a Phase II study testing KB001-A, its anti-PcrV Humaneered pegylated monoclonal antibody fragment, in chronic Pseudomonas aeruginosa infection in cystic fibrosis patients. The 16-week study will enroll 180 patients to receive repeated doses of KB001-A, with the primary endpoint defined as the time to need for antibiotics to treat worsening of respiratory tract signs and symptoms. Secondary endpoints will include

Novartis AG, of Basel, Switzerland, said data published in The Lancet showed that patients on mTOR inhibitor Afinitor (everolimus) tablets with noncancerous kidney tumors known as renal angiomyolipomas associated with tuberous sclerosis complex experienced a significant reduction in tumor size and the absence of tumor progression. In the study, 42 percent of patients on everolimus experienced an angiomyolipoma response vs. 0 percent on placebo.