• Advanced Magnetics Inc., of Cambridge, Mass., reported positive results from two additional Phase III trials of ferumoxytol as an intravenous iron replacement therapeutic. Data from one trial in 303 non-dialysis-dependent chronic kidney disease patients randomized to receive either two doses of ferumoxytol within one week or 200 mg of oral iron daily for three weeks showed that the drug met all primary and secondary endpoints with statistical significance. The second study, which enrolled 750 CKD patients, both on dialysis and non-dialysis-dependent, was designed to evaluate safety as its primary endpoint, with the analysis based on descriptive comparison of adverse events experienced during ferumoxytol and placebo administration. Results showed that treatment-related AEs occurred in 37 patients (5.2 percent) receiving ferumoxytol and in 30 patients (4.2 percent) receiving placebo. Treatment-related serious adverse events occurred in one patient in both the ferumoxytol and placebo arms. Data were presented at the National Kidney Foundation meeting in Orlando, Fla. Data were consistent with a previous Phase III trial, reported in November, and the company anticipates results from one more pivotal study before filing a new drug application in the fourth quarter. (See BioWorld Today, Nov. 20, 2006.)

• Affymax Inc., of Palo Alto, Calif., said results from its Phase II trial of Hematide, dosed monthly in dialysis patients previously treated with three-times-weekly epoetin alfa, demonstrated that mean hemoglobin levels can be maintained at clinically acceptable levels following a switch to Hematide. The 165-patient study was designed to test Hematide's safety, pharmacodynamics and pharmacokinetics in hemodialysis patients with stable baseline Hgb levels between 10 and 12.5 g/dL. Results showed that the mean Hgb level of 90 patients who completed six months of treatment was maintained within +1 g/dL. The company said that data, presented at the National Kidney Foundation meeting in Orlando, Fla., appear to support once-monthly dosing and anticipate testing the drug in pivotal trials.

• Array BioPharma Inc., of Boulder, Colo., said partner AstraZeneca plc, of London, dosed the first cancer patient in a Phase I trial of ARRY-704, triggering a $2 million milestone payment to Array. ARRY-704 is a selective, orally active MEK inhibitor aimed at blocking signal transduction pathways implicated in cancer cell proliferation and survival. The companies began collaborating in 2003 to co-develop and co-commercialize Array's lead MEK program, ARRY-886, as well as select additional candidates to advance through development.

• Cytokinetics Inc., of South San Francisco, started a Phase II program to test CK-1827452, a cardiac myosin activator, in patients with either acutely decompensated or chronic heart failure. The first patient has been dosed in the first Phase IIa trial, which is designed to evaluate an intravenous formulation of CK-1827452 in patients with stable heart failure. The trial's primary objective is safety and tolerability, and secondary objectives are to establish a relationship between plasma concentration and pharmacodynamic effect and to determine pharmacokinetics. CK-1827452 is partnered with Thousand Oaks, Calif.-based Amgen Inc., as part of a potential $725 million heart disease alliance signed in January. (See BioWorld Today, Jan. 4, 2007.)

• GlaxoSmithKline plc, of London, said it plans to test Promacta (eltrombopag olamine) in 50 patients previously treated for chronic idiopathic thrombocytopenic purpura to evaluate a repeated dosing schedule of three six-week cycles. The aim of the study is to determine safety and efficacy of repeated short-term treatment in chronic ITP patients. Promacta was licensed from Ligand Pharmaceuticals Inc., of San Diego, which received a $2 million milestone payment in December after GSK initiated a Phase III trial of Promacta in a long-term setting in previously treated patients with chronic ITP.

• Idenix Pharmaceuticals Inc., of Cambridge, Mass., reported results from two Phase IIb studies testing valopicitabine in combination with pegylated interferon alfa-2a in both treatment-naïve and treatment-experienced patients with genotype-1 hepatitis C virus. Data from the first study showed that, after the 48-week treatment period, 53 percent (18 of 34) treatment-naïve patients treated with 200 mg/day valopicitabine plus pegylated interferon achieved undetectable HCV levels. The second study, which was testing the combination in treatment-experienced patients, said the end-of-treatment sustained viral response (SVR) rates and post-treatment SVR rates were comparable for patients receiving valopicitabine plus pegylated interferon and those receiving pegylated interferon plus ribavirin. Of patients treated with valopicitabine in combination with pegylated interferon, none achieved an SVR, compared to one patient retreated with pegylated interferon and ribavirin. Valopicitabine is an HCV RNA polymerase inhibitor. Data were presented at the European Association for the Study of the Liver annual meeting in Barcelona, Spain.

• Liponex Inc., of Ottawa, Canada, said further analysis of its Phase I/II trial of CRD5 indicated that all blood chemistry and blood pressure measurements were within the normal or expected ranges and the drug was shown to be safe in dyslipidemic patients. CRD5 also was well tolerated in the patient group, with the exception of the reported gastrointestinal adverse events that led to the cessation of the 5 gram dosing phase. The company reported last month that the study missed its endpoint, as CRD5 failed to significantly increase high-density lipoprotein in dyslipidemic patients. There also was a high patient-to-patient variation in response, which might have been affected by other medications taken by some patients during the trial. When data from those patients were removed, CRD5 appeared to be more effective in those in baseline plasma HDL-cholesterol levels of less than 0.9 mM, a level that is considered to be abnormal and is associated with elevated risk of development heart disease. Liponex has started preclinical work on different formulations of the drug for further development. (See BioWorld Today, March 9, 2007.)

• XOMA Ltd., of Berkeley, Calif., said it plans to initiate two Phase I trials this year of XOMA 052, an anti-inflammatory monoclonal antibody targeting interleukin 1-beta in Type II diabetes patients. The trials will be designed to address the role of IL-1beta in the disease. XOMA also intends to expand the compound's development into additional autoimmune/inflammatory indications, including osteoarthritis, rheumatoid arthritis, systemic juvenile idiopathic arthritis and others.

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