• Algeta ASA, of Oslo, Norway, said it started a Phase I ascending dose study in the U.S. for its lead product Alpharadin (radium-223 chloride) in men with hormone-refractory prostate cancer that has metastasized to the skeleton. The study will evaluate the pharmacokinetics and biodistribution of Alpharadin in relation to dose. Each patient will be administered a single intravenous injection of Alpharadin, and the activity will be measured in the whole body and regions of interest, including the skeleton and the sites of bone metastases.

• Allon Therapeutics Inc., of Vancouver, British Columbia, said a pharmacokinetics study confirmed that AL-108 and AL-208 penetrate the blood-brain barrier of healthy adults and Alzheimer's patients in sufficient quantities to enable a therapeutic effect. Results showed that sufficient amounts of both drugs were found in the cerebrospinal fluid of adults and Alzheimer's patients, and the amounts were dose proportional and safe and well tolerated by subjects. Allon is developing AL-108 in Alzheimer's disease - a Phase IIb study is expected to start later this year - and in schizophrenia-related cognitive impairment. AL-208 is being developed as a treatment for the ischemic damage resulting from acute brain injuries and is in Phase II testing to prevent mild cognitive impairment resulting from ischemic damage during coronary artery bypass graft surgery.

• Cell Therapeutics Inc., of Seattle, said the European Organization for Research and Treatment of Cancer completed enrollment in randomized Phase II trial of brostallicin in patients with newly diagnosed advanced or metastatic soft-tissue sarcoma who have had no prior chemotherapy. The primary endpoint is progression-free survival at six months. The final data analysis is expected in early 2009.

• EPIX Pharmaceuticals Inc., of Lexington, Mass., started a Phase IIb right-heart catheter study of PRX-08066, a serotonin Type 2B receptor antagonist, in patients with chronic obstructive pulmonary disease and moderate to severe pulmonary hypertension. The single-arm, open-label study is designed to evaluate the mean pulmonary artery blood pressure change from baseline as measured directly by right-heart catheterization and also will measure the change from baseline in the standard six-minute walk distance test after three months of treatment. Patients will be treated with 500 mg PRX-08066 on day one of the trial, followed by twice-daily dosing of 300 mg of the drug for three months.

• Javelin Pharmaceuticals Inc., of Cambridge, Mass., said pharmacokinetic data showed that the dosing schedule followed in a recent study of PMI-150 (intranasal ketamine for acute pain) candidate resulted in mean plasma ketamine concentrations within the target analgesic range. A meta-analysis of efficacy results from a separate study of PMI-150 showed that a single device delivering 30 mg ketamine hydrochloride provided equivalent analgesia to a 5-mg dose of intravenous morphine. Data were presented at the Department of Defense's 2008 Advanced Technology Applications for Combat Casualty Care meeting in St. Petersburg, Fla.

• Medarex Inc., of Princeton, N.J., said partner, MedImmune Inc., of Gaithersburg, Md., started a Phase IIa trial of MEDI-545, a fully human monoclonal antibody targeting interferon-alpha. The 80-patient study is designed to test the safety and tolerability of multiple subcutaneous dose schedules of MEDI-545 or placebo in adults with moderate to severe active lupus. MEDI-545 was generated by Medarex's UltiMAb system, and Medarex received an undisclosed milestone payment upon start of the Phase II study. MedImmune also is conducting a Phase I trial of MEDI-545 in idiopathic inflammatory myositis, an immunological disease characterized by chronic muscle inflammation, pain and weakness.

• Neurobiological Technologies Inc., of Emeryville, Calif., said enrollment in its two Phase III studies evaluating Viprinex (ancrod) for the treatment of acute ischemic stroke has reached the level of patients necessary to conduct a planned interim analysis across the two studies. NTI is studying the safety and effectiveness of Viprinex in treating acute ischemic stroke when given within six hours of stroke onset. Results of the interim analysis are expected in January 2009.

• Novalar Pharmaceuticals Inc., of San Diego, said data published in the August 2008 issue of the Journal of the American Dental Association showed that anesthetic reversal agent OraVerse (phentolamine mesylate) safely and effectively reduced the duration of soft-tissue anesthesia in patients receiving standard local anesthetic injections in two Phase III trials. Median recovery times in the lower lip and tongue were 70 minutes and 60 minutes compared with 155 minutes and 125 minutes in the control group. Median recovery time in the upper lip was 50 minutes for the OraVerse group vs. 133 minutes in the control arm. OraVerse was approved by the FDA in May, and Novalar expects to launch the product with a specialty sales force in the first half of 2009.

• Oncolytics Biotech Inc., of Calgary, Alberta, said the National Cancer Institute started enrolling patients in a Phase II trial of systemically administered Reolysin in metastatic melanoma. Reolysin is the company's formulation of the human reovirus. The trial is expected to recruit up to 47 patients who will receive Reolysin at a dose of 3x1010 TCID50 per day on days one through five of each 28-day cycle for up to 12 cycles. The primary objectives are to assess the antitumor effects, as well as safety, while secondary objectives will include progression-free survival and overall survival.

• Pharmaxis Ltd., of Sydney, Australia, said results from its Phase II trial of DPM-CF-202 in cystic fibrosis showed it achieved its primary endpoint of demonstrating a dose-dependent improvement in lung function as measured by forced vital capacity (FVC) and the amount of air that can be forcibly exhaled in one second (FEV1). The 400-mg treatment group showed FEV1 increased by 8.6 percent, the 240-mg treatment group showed FEV1 increased by 4.6 percent, the 120-mg treatment group increased by 3.7 percent, and in the 40-mg treatment group, FEV1 decreased by -1.6 percent. FVC changed by +7.9 percent on 400 mg, +3.9 percent in the 240-mg group, +1.5 percent in the 120-mg group, and -0.6 percent in the 40-mg group.

• PolyMedix Inc., of Radnor, Pa., said it is cleared to start trials with its anticoagulant reversing agent PMX-60056, a new class of drug called heptagonist as a reversing agent for heparin, under the investigational new drug application filed with the FDA. The first Phase I trial will be a dose-escalation study assessing the safety of PMX-60056. Upon successful completion, Polymedix will initiate a proof-of-concept study evaluating both safety and efficacy of PMX-60056.

• Threshold Pharmaceuticals Inc., of Redwood City, Calif., has initiated a clinical trial of TH-302 in combination with various chemotherapeutic agents in patients with advanced solid tumors. TH-302 is a proprietary hypoxia-activated prodrug that specifically targets tumor hypoxia. The clinical trial design will include three separate treatment arms that will each examine TH-302 in combination with one of the following chemotherapeutic agents: gemcitabine, docetaxel or pemetrexed.