Advancis Pharmaceutical Corp., of Germantown, Md., said the FDA confirmed that the company's successful Phase III trial and other data would be considered adequate for filing a new drug application via the 505(b)(2) regulatory pathway for its once-daily amoxicillin Pulsys product for pharyngitis/tonsillitis. Advancis expects to file the NDA in December or January. Cardiome Pharma Corp., of Vancouver, British Columbia, said top-line results from both the 300-mg and 600-mg dosing groups for its

CepTor expects to know if it has clearance to move Myodur into the clinic by Sept

Advanced Magnetics Inc., of Cambridge, Mass., completed enrollment in two of four multicenter Phase III studies of ferumoxytol as an intravenous iron replacement therapeutic for the treatment of anemia in chronic kidney disease patients, whether or not on dialysis. Arpida Ltd., of Basel, Switzerland, completed patient enrollment in ASSIST-1, the first of two Phase III trials with its lead investigational antibiotic iclaprim, in patients with complicated skin and skin-structure infections. The

Active Biotech AB, of Lund, Sweden, and Teva Pharmaceutical Industries Ltd., of Jerusalem, said a Phase IIb study designed to evaluate the safety and efficacy of laquinimod, a once-daily oral agent, in relapsing remitting multiple sclerosis patients, met its primary endpoint. The treatment significantly reduced the rate of inflammatory disease activity and demonstrated a considerable reduction in the number of clinical relapses compared to placebo. The Phase IIb multicenter, randomized, double

ACE BioSciences A/S, of Odense, Denmark, began Phase I trials of its lead product, ACE393, a vaccine for travelers' diarrhea caused by Campylobacter infection. The study will test the product's safety, tolerability and immunogenicity in up to 72 healthy subjects. In the first stage, subjects will receive a single intramuscular injection of the vaccine in escalating doses, starting at 25 mcg, rising to 100 mcg and finally 250 mcg. In the second stage, additional subjects will receive two

Addex Pharmaceuticals SA, of Geneva, started a Phase II trial of ADX10059 as an acute migraine treatment, after Phase I data indicated good tolerability across a broad dose range. Two additional Phase II studies are set to begin in acute anticipatory anxiety and for the prevention of acid reflux in patients with gastroesophageal reflux disease. ADX10059 is a selective, negative allosteric modulator of the metabotropic glutamate receptor 5, which is implicated in anxiety, migraine and other

Allos Therapeutics Inc., of Westminster, Colo., completed patient enrollment in its pivotal Phase III ENRICH study of Efaproxyn (efaproxiral) in women with brain metastases originating from breast cancer. ENRICH (Enhancing Whole-Brain Radiation Therapy In Patients with Breast Cancer and Hypoxic Brain Metastases) is designed to evaluate whole-brain radiation therapy with supplemental oxygen with or without Efaproxyn. A total of 360 patients were enrolled at 126 participating centers in the U.S

Cell Therapeutics Inc., of Seattle, said data from a Phase I study of weekly Xyotax given in combination with radiation for patients with esophageal or gastric cancer were published in the August edition of the American Journal of Clinical Oncology. Twenty-one patients were treated to evaluate the safety of the regimen and to determine the maximum tolerated dose of Xyotax in combination with 50.4 Gy of concurrent radiation. Of the 12 patients with loco-regional disease in whom tumor responses

GenVec Inc., of Gaithersburg, Md., said the first human therapeutic clinical trial involving the company's adenoviral-vector technology used in an HIV vaccine candidate will be conducted by the Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health in Bethesda, Md. The randomized, placebo-controlled study will measure safety and immunogenicity in 15 HIV-positive patients. MethylGene Inc., of Montreal, enrolled the first patient in a

Athenagen Inc., of South San Francisco, began testing ATG003 for age-related macular degeneration in a Phase I trial. A topical formulation of mecamylamine, ATG003 has shown efficacy in animal models and is a possible alternative to current therapies for AMD, which require frequent needle injections directly in the eye. The study represents the first human study of an eye drop antiangiogenic therapy for AMD, with a Phase II efficacy study expected to follow early next year. Introgen

Ambrilia Biopharma Inc., of Montreal, reported findings from a Phase Ia study of its HIV protease inhibitor, PPL-100, showing that the drug is safe and well tolerated with a favorable pharmacokinetic profile. Results also indicated that the drug has a long elimination half-life. Data were reported at the XVI International AIDS Conference in Toronto. Argos Therapeutics Inc., of Durham, N.C., initiated dosing in a Phase I/II trial of AGS-003, a personalized immunotherapy for advanced kidney

DeCode Genetics Inc., of Reykjavik, Iceland, began enrolling patients in its Phase I development program for DG051, the company's follow-on compound for preventing heart attacks. The study will examine DG051, a small-molecule inhibitor of leukotriene A4 hydrolase. The compound is similar to DG031, its lead compound for the preventing heart attacks now in a Phase III trial. Depomed Inc., of Menlo Park, Calif., completed a Phase I trial to evaluate the delivery and absorption of a compound used

Ceragenix Pharmaceuticals Inc., of Denver, began enrolling patients in a trial to assess EpiCeram compared to Cutivate, a mid-strength steroid, in patients with moderate to severe atopic dermatitis. The company expects to have results in the fourth quarter. The study will consist of 90 children between the ages of 6 months and 18 years, with half receiving treatment with EpiCeram and the other half receiving the steroid for a four-week period. Ceragenix received 510(k) clearance in April from

CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, started a Phase I trial evaluating the administration of oral PXD101, a small-molecule histone deacetylase inhibitor, in patients with advanced solid tumors. The open-label, multicenter trial is designed to establish the maximum tolerated dose for oral PXD101 administered once or twice daily. Patients in the U.S. and Europe will be treated with oral PXD101 in a dose-escalation regimen and may continue to receive up

Karo Bio AB, of Huddinge, Sweden, expects to receive an undisclosed milestone payment from partner Madison, N.J.-based Wyeth, which has entered the clinic with a compound targeting LXR, a nuclear hormone receptor that regulates cholesterol metabolism

Cell Therapeutics Inc., of Seattle, said the Data Safety Monitoring Committee recommended that a Phase III study of pixantrone continue after preliminary data showed encouraging confirmed and unconfirmed complete response rates observed among the first 40 aggressive non-Hodgkin's lymphoma patients treated in the trial. Patients are randomized to receive either pixantrone or another single-agent drug to examine the complete response rate, time to tumor progression and overall survival. The

Novelos Therapeutics Inc., of Newton, Mass., said the FDA granted fast-track designation to NOV-002 for use in combination with first-line chemotherapy for advanced non-small-cell lung cancer. NOV-002 is a small-molecule drug based on oxidized glutathione that acts as a chemoprotectant and immunomodulator. The company recently finalized a special protocol assessment with the FDA for a pivotal Phase III trial in advanced NSCLC for NOV-002 in combination with first-line chemotherapy, and patient

Arpida Ltd., of Basel, Switzerland, received authorization from the UK Medicines and Healthcare products Regulatory Agency to start the first-in-man studies with AR-709. The authorization of the clinical trial application for AR-709 allows Arpida to initiate a microdose study in healthy volunteers in the UK. Hana Biosciences Inc., of South San Francisco, started a Phase I study of Sphingosome Encapsulated Vinorelbine in patients with advanced solid tumors. The study is designed to assess the

Biota Holdings Ltd., of Melbourne, Australia, said the Phase Ia safety trial of its human rhinovirus drug had been completed and that the drug received approval to continue into Phase Ib. BTA798 is an antiviral for the treatment of HRV, the common cold virus, known to cause significant clinical complications in sufferers of asthma and chronic obstructive pulmonary disease, the fourth-leading cause of death in the U.S. Cerexa Inc., of Alameda, Calif., disclosed positive top-line results for