• Arpida Ltd., of Basel, Switzerland, reported data from a Phase I trial exploring the possible interaction between its intravenous iclaprim and warfarin, an agent used for the prophylaxis of thrombosis and embolism. The study, which involved 24 healthy volunteers, found that intravenous iclaprim had no significant effect on the pharmacokinetics and pharmacodynamics of warfarin, and results confirmed the safety and tolerability profile of iclaprim. Arpida expects to include those data in the new drug application to be filed shortly seeking marketing approval of iclaprim in complicated skin and skin structure infections.

• Array BioPharma Inc., of Boulder, Colo., has commenced dosing ARRY-797, a novel, small-molecule p38 inhibitor, in a Phase II trial to evaluate its efficacy for pain in dental patients undergoing third molar extraction. The Phase II trial is a randomized, double-blind, placebo-controlled, parallel-group efficacy study. The objective is to assess the safety, tolerability and analgesic efficacy of ARRY-797 dosed either after the operation or both before and after surgery.

• Cardiome Pharma Corp., of Vancouver, British Columbia, initiated dosing in its Phase I study of GED-aPC, an engineered analogue of recombinant human activated protein C designed with enhanced anti-inflammatory, anti-thrombotic and strong binding to endothelial protein C receptor properties. The study will involve 24 healthy subjects, with each subject receiving a 15-minute loading dose at the start of a 24-hour continuous intravenous infusion of GED-aPC. Results are expected in the first half of 2008.

• Cytochroma Inc., of Markham, Ontario, has begun dosing in a Phase I/II trial of CTAP101 capsules, the company's product candidate for the treatment of vitamin D insufficiency in chronic kidney disease. The four-week, open-label trial is designed to establish the pharmacokinetic profile and safety of CTAP101 Capsules in subjects with vitamin D insufficiency. The product's pharmacokinetic profile will be characterized at low-, mid- and high-dosages in subjects with normal renal function, and at a single mid-dosage in subjects with Stage 3 and 4 CKD. The safety endpoints for the trial include serum and urine calcium, serum phosphorus and the serum calcium times serum phosphorus product.

• Cytos Biotechnology AG, of Zurich, Switzerland, reported results from three Phase IIa trials of CYT004-MelQbG10, a therapeutic vaccine, in malignant melanoma patients, showing that all dose regimes of the drug tested were found to be safe and well tolerated, with adverse events including mostly mild to moderate injection site reactions. Upon vaccination, Melan-A (MART-1)-specific CD8 T-cell responses could be detected directly ex vivo in 14 of 22 patients, indicating a good T-cell immunogenicity of the vaccine candidate. In patients responding to the vaccine, the melanoma-specific CD8 T cells increased by a median factor of three. CYT004-MelQbG10 was generated from Cytos' Immunodrug platform, which applies immunostimulatory DNA sequences to induce targeted T-cell responses.

• Hana Biosciences, of South San Francisco, has dosed the first two patients in a Phase II clinical trial of Marqibo (vincristine sulfate injection, Optisome) for the treatment of metastatic malignant uveal melanoma. The primary objective is to assess the efficacy of Marqibo as determined by response rates in patients with metastatic malignant uveal melanoma. Secondary objectives are to assess the safety and antitumor activity of Marqibo as determined by response duration, time to progression and overall survival. Patients are adults with uveal melanoma and confirmed metastatic disease that is untreated or that has progressed following one prior therapy. Hana expects to enroll up to 30 patients in this clinical trial, which is being conducted at the University of Texas MD Anderson Cancer Center.

• LifeCycle Pharma A/S, of Horsholm, Denmark, has completed patient enrollment in its Phase II clinical trial of LCP-AtorFen for the treatment of mixed dyslipidemia. The trial will compare LCP-AtorFen, the company's fixed-dose combination product candidate of atorvastatin and lowest dose fenofibrate, with Lipitor (40-mg atorvastatin calcium tablets) and Tricor (145-mg fenofibrate tablets). The company also announced it has initiated a 52-week, open-label extension study to capture additional safety and efficacy data on the use of LCP AtorFen in patients with mixed dyslipidemia. The 12-week Phase II multicenter, double-blind, randomized, active-controlled clinical trial enrolled a total of 220 patients (targeted 200 patients) with mixed dyslipidemia, across 14 centers in the U.S.

• Neurologix Inc., of Fort Lee, N.J., said data from a Phase I trial of its gene transfer treatment for advanced Parkinson's disease demonstrated the ability to quiet the abnormal brain activity that is correlated with the motor deficits characterizing the disease. The study involved 12 patients with advanced disease who each received an injection of an adeno-associated virus vector carrying an inhibitory gene (glutamic acid decarboxylase) into one side of the subthalmic nucleus, with the other side serving as an untreated control. Improvements in both clinical symptoms and abnormal brain network activity were seen predominantly on the treated side of the brain at six months following treatment. Those data were published in the online version of The Proceedings of the National Academy of Sciences.

• Protherics plc, of London, has enrolled and treated the last patient in the Phase IIb Digibind Efficacy Evaluation in Pre-eclampsia (DEEP) study in severe pre-eclampsia The study is a placebo-controlled investigation of the efficacy and safety of London-based GlaxoSmithKline's Digibind in 50 patients with severe pre-eclampsia. The study enrolled women experiencing severe pre-eclampsia in the 24th-34th week of pregnancy, and for whom the delivery of the baby was considered necessary within 72 hours to prevent possible life-threatening complications for the mother and baby. Primary endpoints are the use of antihypertensive medication and creatinine clearance. Secondary endpoints include the time to delivery of the baby. The study is on track to report in the first half of 2008.