• Advanced Cell Technology Inc., of Marlborough, Mass., said it treated three additional patients in its U.S. trials testing retinal pigment epithelial cells derived from human embryonic stem cells. A Phase I/II study is in patients with dry age-related macular degeneration, while a separate study is testing the cells in Stargardt's macular dystrophy.

• Anthera Pharmaceuticals Inc., of Hayward, Calif., reported additional data from its Phase IIb PEARL-SC study at the Asian Lupus Summit meeting in Manila, Philippines, related to the effect of blisibimod on renal disease in lupus. Both the pooled blisibimod treatment group and the 200-mg weekly blisibimod treatment group showed a statistically significant treatment reduction in proteinuria. Top-line data from the PEARL-SC trial, presented in June, showed the drug missed its primary endpoint, defined as clinical improvement at 24 weeks in the SLE responder index, but further data showed that the BAFF inhibitor produced sustained and greater treatment effects vs. placebo using the six-, seven- and eight-point improvements in the SELENA-SLEDAI disease-scoring index in patients with systemic lupus erythematosus. (See BioWorld Today, June 29, 2012.)

• Coronado Biosciences Inc., of Burlington, Mass., said it started a Phase I/II dose-escalation trial of allogeneic natural killer (NK) cells activated by its CNDO-109 in patients in first complete remission from acute myeloid leukemia (AML) and who are deemed high risk for relapse. The study is designed to examine the safety of CNDO-109-activated allogeneic NK cells, as well as the relapse-free survival and overall survival in adults with AML. Up to 36 patients will be enrolled and all will be infused with a preparatory regimen of cyclophosphamide and fludarabine followed by a single dose of the CNDO-109-activated allogeneic NK cells.

• Elan Corp. plc, of Dublin, Ireland, said it enrolled the first patient in a Phase II trial of ELND005 for the treatment of agitation/aggression in patients with moderate to severe Alzheimer's disease. The objectives of the study are to evaluate the efficacy, safety and tolerability of the drug over 12 weeks of treatment in patients who are experiencing at least moderate levels of agitation/aggression. The trial will enroll 400 patients. Elan is partnered on development of the oral small molecule with Toronto-based Transition Therapeutics Inc.

• Kythera Biopharmaceuticals Inc., of Los Angeles, said interim results from Study ATX-101-11-26, an open-label, long-term study designed to test ATX-101, a facial injectable for the reduction of submental fat, found the product to be well tolerated, with a consistent safety profile compared to findings from previous Phase II and European Phase III trials. Though not designed to measure efficacy, results showed mean changes from baseline in submental fat at 12 weeks after last injection of -1.3 on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and -1.2 on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS). Additionally, 71.3 percent of subjects had at least a 1-grade improvement on the CR-SMFRS/PR-SMFRS composite and 14 percent had at least a 2-grade improvement. The company recently concluded enrollment in its pivotal program, with top-line data expected in the middle of 2013. Kythera partnered ex-North American rights to ATX-101 with Bayer AG, of Leverkusen, Germany, in 2010, and Bayer recently completed two pivotal Phase III studies overseas. (See BioWorld Today, Sept. 1, 2010, and April 26, 2012.)

• NovImmune SA, of Geneva, said it started dosing in a Phase I trial of NI-0101, a monoclonal antibody candidate targeting Toll-like receptor 4 (TLR4). The study will enroll healthy volunteers and will evaluate safety and tolerability, as well as pharmacokinetic and pharmacodynamics properties. NI-0101 previously demonstrated efficacy of TLR4 blockade in a range of preclinical models of arthritis, respiratory inflammation, organ injury and other autoimmune and inflammatory conditions.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said it completed patient enrollment in its pivotal Phase III NX02-0017 study testing NX-1207 in benign prostatic hyperplasia. Top-line results are expected in late 2013.