• Calando Pharmaceuticals Inc., a Pasadena, Calif., subsidiary of Arrowhead Research Corp., said it will work with the City of Hope and the UCLA Jonsson Cancer Center on a Phase I trial expected to begin later this year. The trial will test Calando's lead drug candidate, CALAA-01, a nanoparticle containing nonchemically modified siRNA and a transferrin protein-targeting agent formulated with Calando's Rondel technology. The trial is planned in patients with unresectable or metastatic solid tumors.

• Crucell NV, of Leiden, the Netherlands, along with the Aeras Global TB Vaccine Foundation and the South African Tuberculosis Vaccine Initiative, launched a Phase I trial of an AdVac-based tuberculosis vaccine in South Africa. A similar study was launched in the U.S. six months earlier, and demonstrated safety in healthy adults. The nonprofit organization Aeras and Crucell began developing the vaccine candidate, called AERAS-402, in 2004 using Crucell's AdVac vaccine technology and PER.C6 manufacturing technology. The main parameters in the new study in healthy adults will be safety, tolerability and immunogenicity of AERAS-402.

• ImmunoCellular Therapeutics Ltd., of Los Angeles, began a Phase I trial of its lead brain tumor vaccine product candidate, a dendritic cell-based product. The trial is designed to evaluate safety/toxicity, feasibility and biological activity. It also is expected to provide a preliminary indication of whether the vaccine is generating an immune response in patients. About 30 glioblastoma patients are expected to be enrolled in the trial, which should take 12 to 18 months to complete.

• NicOx SA, of Sophia Antipolis, France, said preliminary data from 11 patients in a Phase IIa trial of NCX 1000 in portal hypertension did not demonstrate the efficacy required to support continuation of the study. NicOx and development partner Axcan Pharma Inc., of Mont St.-Hilaire, Quebec, agreed to not further pursue development of NCX 1000 and to terminate the trial. The double-blind, dose-escalating, proof-of-concept study was conducted in Spain. The primary endpoint was comparison to baseline of portal pressure in the fasting state on day 16 of treatment. A secondary endpoint was the same comparison following the consumption of a controlled meal. Additional endpoints were based on the response rate (defined in terms of portal pressure reduction) and the increase in liver blood flow. Axcan gained certain rights to the product, which is designed for treating chronic liver diseases, in a 2002 licensing deal.

• Tapestry Pharmaceuticals Inc., of Boulder, Colo., opened enrollment in a Phase II trial of its next-generation taxane, TPI287, in patients with hormone-refractory prostate cancer. The company plans to begin an additional Phase II study later this year in patients with glioblastoma multiforme, and a third trial is planned in pancreatic cancer. In all three studies, TPI287 will be given in an intravenous dosage form, though the company has a parallel program developing an oral formulation of the drug, which it plans to test in a Phase Ib/II trial in combination with temozolomide in primary brain cancer patients.

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