• Advanced Cell Technology Inc., of Los Angeles, said a case study on the company's myoblast program for treating heart failure was presented at the International Society for Cardiovascular Translational Research World Symposium. In the study, 23 patients were randomized to receive various doses of autologous skeletal myoblast cells. After one year, treated patients showed improved quality of life, tissue regrowth and heart function. ACT plans to initiate a Phase II trial using the approach.

• AGI Dermatics, of Freeport, N.Y., said clinical research indicates that the ability of bicyclic monoterpene diols (BMTds) to reduce collagenase MMP-1 secretion and increase collagen production is dependent on the TNF-alpha signaling in the fibrolasts. AGI has said that those two mechanisms are needed to treat photoaged skin. Those data were presented at the American Academy of Dermatology in San Antonio.

• Biota Holdings Ltd., of Melbourne, Australia, completed enrollment in a Phase II trial of CS8958, its long-acting neuraminidase inhibitor for flu. The trial is being conducted in Japan by Tokyo-based Daiichi-Sankyo Co. Ltd.

• Genetic Immunity LLC, of McLean, Va., presented data on its Phase II DermaVir HIV patch at the 15th Annual Conference on Retroviruses and Opportunistic Infections. In the study, nine HIV patients on antiretroviral drug therapy were treated with the patch, which delivers multiple HIV antigens encoding plasmid DNA. The patch was not associated with dose-limiting toxicities, and its use caused T-cell responses that were detected for a year.

• Horizon Therapeutics Inc., of Palo Alto, Calif., completed enrollment of a target 1,500 patients in two Phase III trials of HZT-501, a nonsteroidal anti-inflammatory drug (NSAID) combined with a gastroprotective agent. The two randomized, blinded trials will evaluate the ability of HZT-501 to reduce the risk of ibuprofen-associated ulcers in patients being treated for pain. Data are expected in the fall.

• Kamada Ltd., of Ness Ziona, Israel, said it is preparing to begin a Phase II trial with aerosolized Alpha-1 Antitrypsin for bronchiectasis. The company also is developing the drug for other lung diseases.

• Keryx Biopharmaceuticals Inc., of New York, completed the treatment portion of its pivotal Phase III trial of Sulonex (sulodexide oral gelcap) for persistent microalbuminuria associated with Type II diabetes. The randomized, double-blind, placebo-controlled, 1,056-patient trial will evaluate the ability of Sulonex to reduce albumin/creatinine ratios. Top-line data are expected in March, followed by full data in the second or third quarter and a new drug application filing by the end of the year. Sulonex, a kidney-protecting drug known as a glycosaminoglycan, also is being studied in a Phase IV trial.

• La Jolla Pharmaceutical Co., of San Diego, said it enrolled 607 of 740 patients in its ongoing Phase III trial of Riquent (abetimus sodium) for lupus. The company expects to complete enrollment and conduct its first interim efficacy analysis in the second quarter. The trial is designed to satisfy the requirements set in a 2004 approvable letter. (See BioWorld Today, Oct. 18, 2004.)

• Pro-Pharmaceuticals Inc., of Newton, Mass., said additional data from a Phase II colorectal cancer study showed that Davanat extended median survival by more than six months, according to an analysis of 14 out of 20 patients in the trial. The company previously reported that Davanat extended median progression-free survival to 8.4 weeks in the overall trial population. Davanat is a carbohydrate polymer composed of mannose and galactose.

• Unigene Laboratories Inc., of Fairfield, N.J., initiated a Phase I/II trial of oral calcitonin for osteoporosis. The trial will use an improved formulation of the drug that achieved a biological response in all patients in a trial completed last fall. Unigene previously launched Fortical, a nasal formulation of calcitonin for osteoporosis, with Upsher-Smith Laboratories Inc. (See BioWorld Today, Aug. 16, 2005.)

• Xencor Inc., of Monrovia, Calif., initiated a Phase I trial with lead candidate XmAb2513 in Hodgkin's lymphoma and anaplastic large cell lymphoma. The open-label, dose-escalation study will evaluate safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and dosing. XmAb2513 is a humanized monoclonal antibody that targets the antigen CD30.