• Cytori Therapeutics Inc., of San Diego, said the first clinical trial of adipose (fat) tissue-derived stem and regenerative cells (ADRCs) for the treatment of no-option chronic heart disease patients showed the procedure was safe and feasible; it demonstrated a statistically significant improvement in maximum oxygen (MVO2) consumption and patients' aerobic capacity measured as metabolic equivalents; and it reduced the extent of infarct size in the left ventricle. The results showed absolute improvement in MVO2 by 0.6 mL/kg/min in the treated group vs. 2.8 mL/kg/min worsening in the placebo group from baseline to six months, based on matched-pair analysis. The difference was statistically significant (p < 0.05). For the entire cohort of patients, mean MVO2 improved from 16.6 mL/kg/min at baseline to 17.2 mL/kg/min at six months in cell-treated patients, and worsened from 19 mL/kg/min to 15.5 mL/kg/min in the placebo group. Shares of Cytori (NASDAQ:CYTX) fell 6 cents to close at $5.39 Friday.
• Dynavax Technologies Corp., of Berkeley, Calif., completed the first immunizations of more than 2,000 subjects enrolled in its Phase III study of Heplisav, its hepatitis B vaccine. That starts a 12-month follow-up on those subjects and sets the study's completion for May 2011. Dynavax said that event supported its goal of a biologics license application submission in the second half of 2011.
• Nile Therapeutics Inc., of San Francisco, completed the dose escalation stage of an ongoing Phase II study of CD-NP in patients with acute decompensated heart failure. The study has been expanded to permit additional dose exploration prior to proceeding to larger Phase II studies. To date, 52 of the approximately 75 patients intended for inclusion in the CT005 study have been enrolled. Full data from the study are expected in late 2010.