• Advanced Cell Technology Inc., of Los Angeles, said six-month data from its myoblast Phase Ib program demonstrated safety, with no evidence for increased risk of arrhythmia. The myoblast therapy involves the transplantation of expanded autologous adult progenitor stem cells derived from a small biopsy of skeletal muscle from a patient's leg, the expansion of those myoblasts in the lab followed by transplantation into the patient's scarred heart tissue using 3-D eletromechanical mapping-based catheter procedure. Data were presented at the Transcatheter Cardiovascular Therapeutic conference in Washington.

• Aradigm Corp., of Hayward, Calif., said Phase I data demonstrated that inhaling water solution of nicotine using the company's AERx Essence palm-size inhaler results in very rapid absorption of nicotine into the blood stream and appears to be associated with acute reduction of craving for cigarettes. Those data were presented at the National Conference on Tobacco or Health in Minneapolis.

• Callisto Pharmaceuticals Inc., of New York, said it plans to open a Phase II extension trial of Atiprimod in patients with low-to-intermediate-grade neuroendocrine carcinoma. That trial will allow patients who successfully completed the company's Phase II proof-of-concept study to continue to receive the drug provided that they continue to show stable disease or better or continue to show at least a 20 percent decrease in symptoms. The primary objectives of the extension study are to evaluate safety and efficacy of long-term treatment.

• Diamyd Medical AB, of Stockholm, Sweden, said it plans to begin a Phase III trial of its Diamyd diabetes vaccine in early 2008 rather than late 2007. Sufficient amounts of the vaccine's active ingredient, an autoantigen called GAD65, have been produced and are being tested.

• Epix Pharmaceuticals Inc., of Lexington, Mass., said it has finished enrollment of 330 patients ahead of schedule for its Phase IIb trial in the U.S. of PRX-00023 in major depressive disorder. Also, the company completed enrollment for Phase IIa of PRX-03140 in Alzheimer's disease. Data from the MDD trial should be released in first-quarter 2008, and from the AD trial at year-end. PRX-00023 is a 5-HT1A partial agonist, and PRX-03140 is selective for the 5-HT4 receptor in the brain; preclinical studies have shown that it may improve cognitive function. GlaxoSmithKline, of London, has an exclusive option to license PRX-03140 for further development and worldwide commercialization following the drug's clinical proof of concept.

• Flamel Technologies SA, of Lyon, France, reported positive preliminary data from a trial comparing IFN-alpha-XL vs. ViraferonPeg (marketed as PegIntron in the U.S. by Schering-Plough Corp.) in patients with chronic hepatitis C virus infection. Results showed a marked reduction in side effects for patients in the IFN-alpha-XL group compared to those receiving PegIntron and a marked reduction in viral load for nonresponder genotype 1 patients in the IFN-alpha-XL group vs. Pegintron. Flamel said it plans to present full data at a future medical conference and is seeking a licensing partner.

• Genaera Corp., of Plymouth Meeting, Pa., reported interim data from a Phase I study of trodusquemine showing the drug to be safe and well tolerated in healthy, overweight and obese volunteers, at doses well above the anticipated therapeutic dose level with no evidence of serious adverse events. Those results were reported at the obesity meeting in New Orleans. Genaera also presented preclinical results confirming the high level of selectivity of MSI-1436 as a powerful inhibitor of PTP-1B when compared to a range of enzymatic and nonenzymatic targets.

• Ipsat Therapies Ltd., of Helsinki, Finland, said its Phase IIb study of Ipsat P1A, a beta-lactamase compound designed to inactivate residual amounts of antibiotics in patient' gastrointestinal tracts after parenteral antibiotic administration, met both primary endpoints. The study randomized hospitalized patients treated with intravenous ampicillin for serious respiratory infections and was designed to evaluate the preventative effect of oral administration of Ipsat P1A on the changes in intestinal microflora, development of antimicrobial resistance and GI side effects. Data showed that administration of Ipsat P1A prevented those effects and also reduced the emergence of ampicillin-resistant coliforms by more than threefold compared to placebo.

• Osiris Therapeutics Inc., of Baltimore, said it has launched its Phase II trial for Prochymal, an I.V. formulation of its mesenchymal stem cells product, in Type I diabetes. The Juvenile Diabetes Research Foundation has awarded $4 million toward funding the trial, a double-blind, placebo-controlled study of the drug in conjunction with standard of care enrolling 60 patients. The primary endpoint will compare the amount of C-peptide produced using a Mixed Meal Tolerance Test in those receiving Prochymal to patients on placebo.

• VIA Pharmaceuticals, of San Francisco, said it will add a third Phase II trial for VIA-2291, a once-daily, oral, small-molecule drug that targets 5-LO, for atherosclerosis. The study involving about 50 patients will use positron emission tomography with fluorodeoxyglucose tracer to measure the reduction of vascular inflammation over 24 weeks. Endpoints include reduction of plaque inflammation.