• Amarillo Biosciences Inc., of Amarillo, Texas, said preliminary results of a Phase II trial showed the rate of influenza-like illness was significantly reduced from 71 percent to 43 percent in interferon-treated subjects who received Fluvax influenza vaccine prior to the study, compared to subjects in the placebo group who were vaccinated. The trial recruited 200 healthy volunteers to receive a once-daily dose of oral interferon or placebo for 16 weeks during cold and flu season in Australia, followed by a four-week follow-up period. The study was funded by the Department of Health Western Australia and Amarillo Biosciences, which supplied the low-dose interferon-alpha and matching placebo used in the trial.

• Keryx Biopharmaceuticals Inc., of New York, reached agreement with the FDA on a special protocol assessment for a Phase III trial of PI3K/Akt pathway inhibitor perifosine (KRX-0401) in patients with refractory metastatic colorectal cancer. The X-PECT (Xeloda + Perifosine Evaluation in Colorectal cancer Treatment) trial will randomize about 430 patients who have failed available therapy to receive either Xeloda (capecitabine, Roche AG) in combination with perifosine vs. Xeloda alone. The primary endpoint is overall survival, with secondary endpoints including overall response rate, progression-free survival and safety. Perifosine currently is in Phase III testing under a separate SPA for relapsed/refractory multiple myeloma. The drug is partnered with London-based AstraZeneca plc. (See BioWorld Today, Aug. 4, 2009.)

• Seattle Genetics Inc., of Bothell, Wash., and Millennium Pharmaceuticals Inc., of Cambridge, Mass., a unit of Takeda Pharmaceutical Co. Ltd., started a Phase I trial of antibody drug conjugate brentuximab vedotin (SGN-35) in combination with chemotherapy in newly diagnosed Hodgkin lymphoma patients. The study will test the brentuximab vedotin plus doxorubicin, bleomycin, vinblastine and dacarbazine. About 40 patients will be enrolled. Seattle Genetics currently is evaluating brentuximab vedotin in a pivotal study in relapsed and refractory Hodgkin lymphoma under a special protocol assessment with the FDA.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said results from a preliminary analysis from a 28-day Phase IIa trial showed that VX-809, an oral cystic fibrosis transmembrane conductance regulatory protein (CFTR) corrector, was well tolerated across all doses tested in cystic fibrosis patients who are homozygous for the F508del mutation. The drug also showed a statistically significant decline in sweat chloride at both the 100-mg and 200-mg once-daily doses and also showed a dose response in change in sweat chloride across all four dose groups. Vertex plans to initiate a combination trial of VX-809 and VX-770, a CFTR potentiator, in the second half of this year. Both drugs are being developed with support from Cystic Fibrosis Foundations Therapeutics Inc.