• Adventrx Pharmaceuticals Inc., of San Diego, said safety results from its marketing-enabling bioequivalence clinical study of ANX-530 (vinorelbine emulsion) demonstrated a statistically significant reduction in injection site reactions when compared with Navelbine (vinorelbine tartrate). ANX-530 was determined to be safe and well tolerated with no significant differences in any safety parameters, the firm said. Adventrx said it plans to submit a new drug application under a 505(b)(2) filing for ANX-530 in the fourth quarter.

• Arpida Ltd., of Reinach, Switzerland, said it was cleared by the FDA to start a Phase II intravenous-to-oral switch trial with iclaprim in patients with complicated skin and skin structure infections. The objective of the 60-patient study is to assess clinical efficacy of an oral capsule formulation of iclaprim as step-down therapy in comparison with IV vancomycin, with the primary endpoint measured by the clinical cure rate at the test-of-cure visit. Secondary objectives include bacteriological outcomes and safety and tolerability data.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., said it initiated a Phase II, double-blind, placebo- and active-controlled, dose-finding clinical trial to evaluate the safety and efficacy of becocalcidiol for the treatment of psoriasis. The study of 300 patients with mild to moderate psoriasis will evaluate three concentrations of becocalcidiol administered once daily over 12 weeks compared with a vehicle and active control. CollaGenex in May 2007 licensed becocalcidiol, a patented vitamin D analogue, from QuatRx Pharmaceuticals Co., of Ann Arbor, Mich. Becocalcidiol does not appear to induce hypercalcemia, a significant dose-limiting toxicity found in other vitamin D-based treatments for psoriasis, the firm said.

• Nventa Biopharmaceuticals Corp., of San Diego, said an assessment of the second cohort of patients in a Phase I clinical trial of HspE7, a therapeutic vaccine candidate for diseases caused by the human papillomavirus, showed that safety data were normal. The dosing of the third cohort of patients is expected shortly. Nventa said it also is collecting immunological data that may provide an early indication of potential efficacy of the compound. All patients are being typed for class I and II human leukocyte antigen subtypes and are being evaluated for cytokine responses, anti-HspE7 antibodies and cellular immunology. The trial is expected to dose up to five cohorts comprising 24 patients.

• Resverlogix Corp., of Calgary, Alberta, reported preliminary data from the RVX-208 Phase I study in 40 healthy volunteers so far, showing that no safety and tolerance problems have been encountered at any of the doses given. The full Phase I study is expected to involve 80 subjects in three arms: single-dose escalation, food vs. fasted effect on pharmacokinetics and three cohorts with seven-day multiple dosing. Upon completion of the trial, Resverlogix said it hopes to meet with the FDA to expedite plans for a Phase II trial. The company also is considering follow-on studies in cardiovascular disease patients with potential collaborators. RVX-208 is a small molecule aimed at increasing the production of ApoA-1 and HDL.

• VGX Pharmaceuticals Inc., of Blue Bell, Pa., said the FDA accepted its investigational new drug application for VGX-1027, an oral, small-molecule compound that has shown preclinical activity against inflammatory diseases such as rheumatoid arthritis and Type I diabetes. The drug is an immune modulator designed to inhibit the production of several pro-inflammatory cytokines primarily by blocking NF-kB and the early transient inhibition of p38 MAP kinase signaling pathways. VGX plans to conduct single ascending-dose and multiple ascending-dose Phase I studies before moving into Phase II trials in RA and Type I diabetes.

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