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.

BioTime Inc., of Alameda, Calif., said it submitted a clinical investigation protocol to European regulatory authorities for approval to initiate studies for its Renevia stem cell delivery platform. Renevia, a member of the firm's HyStem family of hydrogels, is a formulation designed to mimic human extracellular matrix. Studies are expected to start in the second quarter. GeoVax Labs Inc., of Atlanta, said it completed enrollment in a nine-patient Phase I/II trial testing its DNA/MVA vaccine

Advanced Cell Technology Inc., of Marlborough, Mass., reported evidence of engraftment of transplanted human embryonic stem cell-derived retinal pigment epithelial cells and visual acuity gain in a Phase I/II trial in Stargardt's macular dystrophy (SMD) and dry age-related macular degeneration (AMD). Patients were treated over 18 months, and no safety issues were raised. The company also observed persisting engraftment in more recent SMD and AMD patients, as well. Intercept Pharmaceuticals Inc

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

Synergy Pharmaceuticals Inc., of New York, said dosing has commenced in a Phase IIb trial of plecanatide to treat patients with constipation-predominant irritable bowel syndrome (IBS-C). The 350-patient trial is being conducted at 70 sites in the U.S. Participants with IBS-C will be treated with one of four doses of plecanatide (0.3, 1, 3 or 9 mg) or placebo, taken once daily over a period of 12 weeks. The trial will measure the mean change in complete spontaneous bowel movements (CSBM) over

Celator Pharmaceuticals Inc., of Princeton, N.J., treated its first patient in a Phase III, randomized, open-label trial of CPX-351 (cytarabine/daunorubicin) liposome injection compared to conventional cytarabine and daunorubicin for first-line therapy of acute myeloid leukemia. The trial is being carried out at about 50 centers in the U.S. and Canada in partnership with the Leukemia and Lymphoma Society, which has previously supported the development of CPX-351. The primary endpoint of the

Ironwood Pharmaceuticals Inc., of Cambridge, Mass., told licensor Bionomics Ltd., of Adelaide, Australia, that the planned Phase I trial of the investigational anti-anxiety drug candidate IW-2143 (BNC210) has begun in the U.S. The trial is designed to assess the safety and pharmacokinetics of IW-2143 in healthy volunteers, using single and multi-dose administration. (See BioWorld Today, Jan. 6, 2012.) Coronado Biosciences Inc., of Burlington, Mass., entered an agreement with the National

Acura Pharmaceuticals Inc., of Palatine, Ill., said it filed an investigational new drug application with the FDA for clinical testing of its hydrocodone bitartrate with acetaminophen formulated using its Aversion Technology. Acura intends to complete clinical testing for a new drug submission via the 505(b)(2) pathway in the first half of 2014. BioAlliance Pharma SA, of Paris, said the European Independent Board of Experts held its first meeting on the ReLive Phase III trial evaluating the

Adventrx Pharmaceuticals Inc., of San Diego, said ANX-188 (purified poloxamer 188) passed quality control release specifications and is in the quality assurance release process for a Phase III study in sickle cell disease. Initiation of the trial is expected in about six weeks. Idera Pharmaceuticals Inc., of Cambridge, Mass., said 48 percent of patients with moderate to severe plaque psoriasis (12 of 15) treated with IMO-3100, a selective antagonist of Toll-like receptors 7 and 9, demonstrated

EyeGate Pharma Inc., of Waltham, Mass., said it enrolled the last patient in a 200-subject pivotal Phase III study of EGP-437 (dexamethasone phosphate ophthalmic solution) in patients with anterior uveitis. The study's objective is to test ocular iontophoresis with EGP-437 vs. treatment with topically applied prednisolone acetate ophthalmic suspension eyedrops. The primary endpoint will measure the proportion of patients with anterior chamber cell count of zero at day 14. Top-line data are

Acasti Pharma Inc., of Laval, Quebec, said it achieved significant progress in two ongoing clinical studies with CaPre for lipid management. The registrational Phase II double-blind, placebo-controlled clinical study has completed the first of two interim analyses. The second Phase II open-label study should be completed by the end of the first quarter of 2013. It has been delayed due to the need for further patient recruitment after the approved clinical trial amendment to add an additional 4

AcelRx Pharmaceuticals Inc., of Redwood City, Calif., reported top-line data from a Phase III trial demonstrating that the Sufentanil NanoTab PCA System was noninferior (p < 0.001) to intravenous patient-controlled analgesia with morphine for the primary endpoint of Patient Global Assessment (PGA) of method of pain control over the 48-hour study period as determined by the combined percentage of patients with PGA ratings of "good" or "excellent" (78.5 percent vs. 66.1 percent, respectively