• AGI Therapeutics Inc., of Dublin, Ireland, initiated a randomized, double-blind, placebo-controlled Phase II trial of AGI-004 for chemotherapy-induced diarrhea. AGI-004 is a controlled-release transdermal patch containing the nicotinic antagonist mecamylamine.

• Alexza Pharmaceuticals Inc., of Palo Alto, Calif., initiated a Phase I trial with AZ-007 (Staccato zaleplon), an inhaled formulation of Sonata (zaleplon, King Pharmaceuticals Inc.) designed for insomnia patients who have difficulty falling asleep or who need middle-of-the-night dosing. The company also said it will initiate the first of two planned Phase III trials with schizophrenia and biopolar disorder drug AZ-004 (Staccato loxapine) by the end of the first quarter, and it continues to advance four other Staccato products through clinical trials.

• Forest Laboratories Inc., of New York, said Phase III data indicated Alzheimer's patients treated with a once-daily formulation of Namenda (memantine HCI) experienced statistically significant benefits in cognition and clinical global status compared to placebo. Forest markets twice-daily Namenda for Alzheimer's disease and plans to file a new drug application for the once-daily version.

• Lpath Inc., of San Diego, said the FDA cleared its investigational new drug application seeking to begin clinical trials with Asonep (previously known as Sphingomab), a humanized monoclonal antibody that neutralizes the bioactive lipid Sphingosine-1-Phosphate. The company plans to begin an open-label, single-arm, dose-escalation Phase I trial in solid tumors.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., reported additional data from its two Phase III trials of Puricase (pegloticase) for treatment-failure gout. In December, the company said both trials met their primary endpoint of normalizing plasma uric acid. New data showed the drug also significantly improved secondary endpoints including clinical outcomes such as tender and swollen joints, the clinician's global assessment, a subgroup analysis of complete responders and quality of life. The drug also showed a trend toward reducing gout flares. Savient plans to a file biologics license application with the FDA this year. (See BioWorld Today, Dec. 14, 2007.)

• TorreyPines Therapeutics Inc., of La Jolla, Calif., said data from a double-blind, placebo-controlled, Phase I dose-escalation trial indicated the subcutaneous formulation of the analgesic tezampanel is well tolerated at several doses. The subcutaneous formulation previously demonstrated efficacy in a Phase IIb migraine trial, and the intravenous formulation of the drug has shown efficacy in five Phase II chronic pain trials. TorreyPines also is developing an oral prodrug of tezampanel known as NGX426. Tezampanel is an AMPA/kainate antagonist.