• Corautus Genetics Inc., of Atlanta, filed a response to the FDA's clinical hold on the GENASIS trial, which was imposed in April due to potential safety concerns with the delivery of its gene therapy product for angina. The VEGF-2 product is administered via the Stiletto catheter system from Boston Scientific Corp., of Natick, Mass. The rate of tamponade events experienced in the trial was 1.36 percent, or four out of 295 patients treated. The partners said they have appropriately investigated the events and have developed a plan for dealing with those issues in potential subsequent clinical trials evaluating VEGF-2 for severe angina. Corautus continues to gather data on both primary and secondary endpoints from the GENASIS trial, on a blinded basis, and expects that the findings could support the commencement of a Phase III trial. (See BioWorld Today, April 11, 2006.)

• Crucell NV, of Leiden, the Netherlands, began a dose-ranging study to test a vaccine against the H9N2 avian influenza virus. The randomized, blinded trial will oversee the vaccination of 560 healthy adults. Three types of vaccine will be tested for safety and immunogenicity: a non-adjuvanted whole virion vaccine, an alum-adjuvanted whole virion vaccine and a virosomal subunit vaccine.

• Icagen Inc., of Research Triangle Park, N.C., began a study to test ICA-17043 in pediatric sickle cell disease patients. The trial will involve 28 patients ages 6 to 16 across the U.S. They will receive the drug according to one of three dosing schedules over a period of 21 days, and results will be used to select doses for subsequent clinical evaluations of ICA-17043 in pediatric subjects. The small-molecule, ion channel inhibitor is taken orally and is being developed for once-a-day dosing.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said top-line, Phase II findings showed that MLN1202 was well tolerated and fully met its primary endpoint of a significant reduction in C-Reactive Protein (CRP) levels for months after a single dose. The results were statistically significant relative to the placebo control arm (p=0.0275), and no serious adverse events were observed in patients exposed to MLN1202. The humanized monoclonal antibody specifically targets the CCR2 chemokine receptor in patients at high risk for atherosclerotic cardiovascular disease.

• NeoRx Corp., of Seattle, began a Phase I/II trial evaluating its lead product picoplatin for the front-line treatment of hormone-refractory metastatic prostate cancer. The multicenter trial is designed to determine its safety and efficacy when administered every three weeks with docetaxel. Picoplatin is designed to overcome platinum resistance associated with the treatment of solid tumors. Separately, NeoRx is changing its name to Poniard Pharmaceuticals Inc., effective June 16.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said the FDA granted fast-track designation to the IL-1 Trap program for the improvement of chronic inflammation in patients with CIAS1-associated periodic syndromes. In April, the company completed enrollment in a pivotal study of the IL-1 Trap, and top-line efficacy data are expected by the end of the year. The product already has orphan drug status in that space.

• Tercica Inc., of Brisbane, Calif., said European regulators named Increlex (mecasermin [rDNA origin] injection) an orphan product for primary insulin-like growth factor-1 deficiency due to molecular or genetic defects, granting market exclusivity in the European Union for 10 years after marketing approval. The company said it continues to target a launch there next year, subject to approval. In the U.S., where Increlex has the same orphan designation, it received FDA approval late last summer.

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