• Alexza Pharmaceuticals Inc., of Mountain View, Calif., has initiated a Phase III clinical trial with AZ-004 (Staccato loxapine), an inhalation product candidate being developed to treat acute agitation in patients with schizophrenia or bipolar disorder. AZ-004 is being developed through Symphony Allegro, a product development partnership formed between Alexza and Symphony Capital, LLC. The trial is designed to enroll approximately 300 schizophrenic patients with acute agitation at 25 U.S. clinical centers.

• Argenta Discovery Ltd., of Harlow, UK, started a Phase II trial of ADC4022 in chronic obstructive pulmonary disease and steroid-insensitive asthma. The trial is designed to test the drug and an inhaled corticosteroid on markers of inflammation and pulmonary function and will involve patients with moderate to severe COPD treated over a four-week period. Results are expected later this year.

• GeoVax Labs Inc., of Atlanta, said its HIV/AIDS vaccine is moving into Phase IIa human trials by the HIV Vaccine Trials Network, a network supported by the National Institutes of Health. The newly planned Phase II trials are tentatively scheduled to start mid-2008 and will involve up to 500 participants at several locations in the U.S.

• GTC Biotherapeutics Inc., of Framingham, Mass., has completed enrollment in a pivotal study of ATryn for the treatment of patients with hereditary antithrombin deficiency undergoing high-risk surgical or childbirth procedures. A minimum of 31 evaluable patients are required for the trial. Results for 14 of these patients already were obtained from the previous study that supported ATryn's approval in the European Union for HD patients undergoing surgical procedures. Seventeen evaluable patients have been treated to complete the pivotal study. There were no clinically relevant DVTs or other thromboembolisms during the evaluation period in any of the patients treated in the pivotal study.

• Hyperion Therapeutics Inc., of South San Francisco, enrolled the first patient in a Phase II trial of Ammonul (sodium phenylacetate and sodium benzoate) injection in patients with Grade III or Grade IV hepatic encephalopathy. The study is designed to test the drug against standard of care in hospitalized adults. Ammonul has orphan drug designation for that indication in the U.S.

• Innovative Biosensors Inc., of Rockville, Md., has been selected for funding for a partnership with the University of Maryland to develop a miniaturized analysis system that could be used in industrial, environmental and clinical fields. The company will be working with A. James Clark School of Engineering at the university.

• InteKrin Therapeutics Inc., of Los Altos, Calif., has initiated a Phase IIb study in diabetic patients with its lead product candidate INT131, a non-TZD SPPARM (selective peroxisome proliferator-activated receptor modulator). INT131 was the result of a molecular design effort to address the product profile deficiencies of current TZD therapy, which present safety concerns. INT131 was selected specifically for its ability to reduce characteristic TZD adverse effects while retaining PPAR anti-diabetic efficacy. The placebo controlled, double-blind, Phase IIb study includes multiple doses of orally administered INT131 once daily, and Actos (pioglitazone) as an active comparator.

• MacuSight Inc., of Union City, Calif., reported positive preliminary data from a Phase I study in age-related macular degeneration, showing that its formulation of sirolimus (rapamycin) was safe and well tolerated in all doses tested with two different routes of administration. Results from the 30-patient study also showed improvements in visual acuity consistent with the anatomical retinal changes observed following a single injection of the drug. Findings were presented at the Bascom Palmer Eye Institute's Angiogenesis, Exudation and Degeneration 2008 meeting in Key Biscayne, Fla.