• Advanced Cell Technology Inc., of Marlborough, Mass., completed Phase I trials in more than 40 patients testing its myoblast stem cell therapy in heart failure, advanced heart failure, myocardial infarction and ischemia. The trials involved transplantation of expanded autologous myoblast derived from a small biopsy of skeletal muscle in the leg and then transplanted back into the patient's scarred heart tissue. Data from the studies suggested the transplanted myoblast often improved heart function and led to an improvement in quality of life. ACT, which acquired the Myoblast program through its 2007 acquisition of Mytogen Inc., of Charlestown, Mass., has FDA approval to proceed with a Phase II trial, slated to start the first half of 2011.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said results published in the American Journal of Respiratory and Critical Care Medicine showed its Phase IIa study of ALN-RSV01 in lung transplant patients naturally infected with respiratory syncytial virus showed the inhaled drug's safety and tolerability. Results also demonstrated statistically significant improvements in clinical symptom scores and reductions in the incidence of bronchiolitis obliterans syndrome. The trial enrolled 24 lung transplant patients with RSV infections who were randomized to receive ALN-RSV01 or placebo once daily for three consecutive days.

• Cleveland BioLabs Inc., of Buffalo, N.Y., reported top-line results of the second human safety study for CBLB502, a potential treatment for acute radiation syndrome. Top-line results demonstrated a difference in biomarker response proportional to the dose applied as single intramuscular injections of CBLB502. The demonstration of such a dose difference was the primary goal of the trial. The primary adverse event associated with CBLB502 administration was a transient flu-like syndrome consistent with what was observed in the previous trial and which generally resolved within 24 hours. Subjects who carry a single mutation in the TLR5 gene, the target of CBLB502, which is found in about 5 percent of the general population, responded to CBLB502 in the same manner as normal subjects without the mutation.

• Keryx Biopharmaceuticals Inc., of New York, initiated a long-term Phase III trial of iron-based phosphate binder Zerenex (ferric citrate) for dialysis patients with end-stage renal disease. The randomized, open-label, 300-patient trial is being conducted under a special protocol assessment, as is an ongoing short-term study that is expected to wrap up later this year. (See BioWorld Today, May 7, 2010.)

• Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, initiated their second Phase III trial of MDV3100 in prostate cancer. The new study, dubbed PREVAIL, is a randomized, double-blind, placebo-controlled trial of 1,700 men with metastatic prostate cancer who have not yet received chemotherapy. The co-primary endpoints of the trial are overall survival and progression-free survival. MDV3100 is a triple-acting oral androgen receptor antagonist. (See BioWorld Today, March 19, 2009.)

• Synosia Therapeutics, of Basel, Switzerland, presented Phase I data showing that SYN-118 (CL02) was well tolerated and significantly improved motor scores in Parkinson's disease patients. The data were presented at the World Parkinson Congress. A randomized Phase II trial is ongoing. SYN-118 inhibits hydroxyphenylpyruvate dioxygenase.

• XOMA Ltd., of Berkeley, Calif., completed enrollment in two trials of XOMA 052 for Type II diabetes: 74 patients were enrolled into a Phase IIa trial and 240 patients were previously enrolled into a Phase IIb trial. Top-line Phase IIb data and interim Phase IIa data are expected in early 2011. XOMA 052 is an antibody that inhibits the inflammatory cytokine interleukin-1 beta.

• ZymoGenetics Inc., of Seattle, reported median overall survival of 12.4 months in its open-label, single-arm Phase IIa trial of recombinant Interleukin 21 in melanoma. Additionally, 53 percent of patients survived 12 months. A randomized Phase IIb trial is ongoing. ZymoGenetics is in the process of being acquired by New York-based Bristol-Myers Squibb Co. for $885 million. (See BioWorld Today, Sept. 9, 2010.)