• Algeta ASA, of Oslo, Norway, initiated an open-label study of lead product Alpharadin in hormone refractory prostate cancer and skeletal metastases. The 10-patient study will evaluate dosimetry, biodistribution, excretion and pharmacokinetics. Alpharadin, a radium-223-based targeted therapeutic, is slated to begin Phase III trials in 2008.

• Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., has begun a multicenter Phase I pharmacologic clinical trial of CYC116, an orally-available inhibitor of Aurora kinases A and B, and VEGFR2, in patients with advanced solid tumors. The study is the first of two clinical trials the company plans to begin this year to evaluate CYC116's potential in solid and hematological tumors. The multicenter trial will gauge the safety and tolerability of CYC116 in patients with advanced solid tumors. The primary objective is to determine the maximum tolerated dose. Secondary objectives are to evaluate the pharmacokinetic and pharmacodynamic effects of the drug and to document anti-tumor activity. In separate news, Cyclacel started a Phase I trial of CYC116, an oral inhibitor of Aurora kinases A and B and VEGFR2, in patients with advanced solid tumors. It's the first of two studies expected to start this year, and is designed with the primary objective of determining a maximum tolerated dose. Secondary objectives are to evaluate the pharmacokinetic and pharmacodynamics effects of the drug and to document antitumor activity.

• Keryx Biopharmaceuticals Inc., of New York, said four posters were presented at the 11th International Myeloma Workshop in Kos, Greece, demonstrating the clinical activity of KRX-0401 (perifosine) in patients with advanced multiple myeloma and Waldenstrom's macroglobulinemia. Perifosine is being evaluated in three ongoing, multicenter trials for patients with relapsed or relapsed/refractory multiple myeloma, including in combination with dexamethasone, in combination with Velcade (bortezomib) and in combination with Revlimid (lenalidomide) plus dexamethasone. The bortezomib arm reported an overall response rate (partial response and minimal response) of 31 percent. In the arm testing perifosine plus low dose dexamethasone, 78 percent of patients had at least stable disease, including 26 percent that had a partial or minimal response. In the study of perifosine in combination with lenalidomide and dexamethasone, preliminary results demonstrated early encouraging results, with 50 percent of patients achieving a partial response or better.

• MedImmune Inc., of Gaithersburg, Md., and Abbott, of Abbott Park, Ill., said data published in the Journal of Pediatrics showed a 49 percent decrease in recurrent wheezing in premature infants who previously received Synagis (palivizumab) and did not progress to chronic lung disease, compared to those who did not receive Synagis. Synagis is approved for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV). MedImmune was acquired by London-based AstraZeneca plc for $15.2 billion earlier this year. (See BioWorld Today, April 24, 2007.)

• NicOx SA, of Sophia Antipolis, France, initiated its third pivotal Phase III trial of naproxcinod (HCT 3012) in osteoarthritis. The 13-week, double-blind, placebo- and naproxen-controlled trial will enroll 800 patients with osteoarthritis of the hip to determine naproxcinod's efficacy compared to placebo as measured by the WOMAC pain subscale, the WOMAC function subscale and the subject's rating of disease status. Data are expected in mid-2008 and will be combined with data from two Phase III trials in osteoarthritis on the knee, one of which met its primary endpoints and the other of which is ongoing. NicOx said a component of its regulatory filing will be a pooled analysis of blood pressure from all three trials, which the company believes will help differentiate naproxcinod from current anti-inflammatory treatments.