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

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

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.

TapImmune Inc., of Seattle, said an interim safety analysis of the first five breast cancer patients treated with HER2/neu Class II antigens did not show any serious adverse events, so treatment of the remaining 17 patients in the Phase I study at the Mayo Clinic will progress

Baxter International Inc., of Deerfield, Ill., reported pivotal Phase III results showing that routine prophylaxis vs. on-demand treatment of FEIBA NF (anti-inhibitor coagulant complex [nanofiltered and vapor-heated]) in patients with hemophilia A or B reduced median annual bleed rate. Results showed the annual bleed rate dropped from 28.7 percent during FEIBA NF on-demand treatment to 7.9 percent during FEIBA NF prophylactic treatment, marking a 72.5 percent reduction. Baxter intends to file a

Baxter International Inc., of Deerfield, Ill., said it submitted an investigational new drug application for hemophilia A candidate BAX 855, a full-length longer-acting recombinant Factor VIII developed to increase the half-life of ADVATE (Antihemophilic Factor [Recombinant] Plasma/Albumin-Free Method). Baxter expects to start enrolling adults in a Phase II/III study later this quarter. Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, said top-line

Amicus Therapeutics Inc., of Cranbury, N.J., reported positive preliminary results from all four dose cohorts in its Phase II study (Study 010) evaluating the safety and pharmacokinetics of chaperone AT2220 (duvoglustat HCl) co-administered with enzyme replacement therapy (ERT) in Pompe disease (Myozyme and Lumizyme [alglucosidase alfa, or recombinant human GAA enzyme (rhGAA), Sanofi SA/Genzyme Corp.]). Myozyme and Lumizyme are the only approved treatments for Pompe disease, in which deficient

Alkermes plc, of Dublin, Ireland, reported positive top-line results from a Phase I study of antipsychotic candidate ALKS 3831, which combines a drug molecule ALKS 33 with Zyprexa (olanzapine, Eli Lilly and Co.). ALKS 3831, in development for schizophrenia, is designed to attenuate the antipsychotic-related metabolic side effect of weight gain. The study compared the mean change from baseline in body weight in 106 healthy volunteers following three weeks of once-daily, oral administration of