• Arpida Ltd., of Basel, Switzerland, initiated a Phase II trial of the intravenous antibiotic iclaprim in hospital-acquired pneumonia, ventilator-associated pneumonia and health care-associated pneumonia. The randomized, double-blind study will compare iclaprim to vancomycin and should be completed next year. Arpida also said a Phase I study with oral iclaprim resulted in no serious adverse events. Finally, Arpida said it plans to submit the first modules of its new drug application for intravenous iclaprim in complicated skin and skin structure infections before the end of the year, with the full NDA submission completed by February 2008.

• AVAX Technologies Inc., of Philadelphia, completed its Phase I/II dose-ranging trial of therapeutic cancer vaccine MVax in melanoma. In its first placebo-controlled trial, MVax at the high dose (5x106 cells) resulted in T-cell responses in 76 percent of patients, while the placebo arm was ineffective. There were no serious adverse events attributed to the drug. Last month, AVAX initiated a double-blind, randomized, placebo-controlled pivotal Phase III trial of MVax in melanoma patients with lung metastases. (See BioWorld Today, Nov. 14, 2007.)

• Chimerix Inc., of Research Triangle Park, N.C., initiated a multidose Phase I trial in healthy volunteers with smallpox drug CMX001. Previous Phase I trials have shown single doses of CMX001 to be well tolerated and provide excellent drug exposure. CMX001 is a lipid mimic of cidofovir (marketed by Gilead Sciences Inc. as Vistide in HIV).

• DuoCort Pharma AB, of Helsingborg, Sweden, said enrollment is complete in the pivotal Phase II/III clinical trial evaluating 5-mg and 20-mg DuoCort dual-release hydrocortisone tablets for the treatment of adrenal insufficiency - the inability of the body to produce sufficient amounts of the essential hormone cortisol. With a target of 56 patients, the five sites participating in the trial have enrolled 59 patients. Given the small patient numbers in the rare disease, inclusion of identified patients is continuing and will close at year-end. Interim data from the study are expected to be available in the third quarter of 2008. The trial is a controlled study assessing the pharmacokinetics, safety and tolerability of once-daily DuoCort in comparison to conventional thrice-daily oral hydrocortisone therapy in patients with primary adrenal insufficiency (Addison's disease).

• Sidney Kimmel Cancer Center, of San Diego, said the FDA cleared it to begin a Phase I trial of a MUC-1-targeted breast cancer vaccine designed to replace a potent immunostimulatory signal that is often missing in older people. The vaccine, which was developed by SKCC President and CEO Albert Deisseroth, has been shown in preclinical studies to boost immunity within 14 to 21 days and provide responses that last for at least a year. The trial is slated to begin in the first quarter of 2008.

• Trubion Pharmaceuticals Inc., of Seattle, said partner Wyeth Pharmaceuticals, of Madison, N.J., has initiated a Phase I/II clinical trial of TRU-015, Trubion's lead small modular immuno pharmaceutical (SMIP) drug candidate, for the treatment of non-Hodgkin's lymphoma. The nonrandomized, open-label, uncontrolled, single-group assignment clinical trial is designed to evaluate the safety and efficacy of TRU-015 in subjects with NHL. Trubion is co-developing TRU-015 and other CD20-directed therapies with Wyeth Pharmaceuticals, a division of Wyeth. The Phase I/II clinical trial is expected to enroll approximately 120 NHL subjects who have undergone two or more prior therapies and have relapsed or refractory disease.