• Aastrom Biosciences Inc., of Ann Arbor, Mich., said the first patient was treated with its autologous stem cell therapy for dilated cardiomyopathy. Aastrom's Cardiac Repair Cell product is aimed at regenerating damaged heart tissue in patients with severely impaired cardiac function. The company previously began treating patients in a European compassionate-use study, with data expected this year.

• Amkor Pharmaceuticals Inc., of Seattle, is nearing the end of Phase I trials for Neu2000KL, a multimechanism neuroprotectant being developed for the treatment of ischemic stroke and sudden cardiac arrest. To date, the company has enrolled 95 subjects and expects to enroll the remaining seven subjects during the next two months.

• Anthera Pharmaceuticals Inc., of San Mateo, Calif., reported preliminary results of a second Phase IIb clinical trial of A-002, for the treatment of cardiovascular disease showed it lowered both secretory phospholipase A2 and LDL-C levels. The multicenter, randomized, double-blind, placebo-controlled trial enrolled approximately 140 patients with stable coronary heart disease in the U.S. Subjects were randomized to receive one of two different daily doses of A-002 or placebo for up to eight weeks. Patients also received doctor-determined standard-of-care therapies. The primary endpoint was reduction in secretory phospholipase A2 levels. Secondary endpoints included a number of lipid and inflammatory biomarkers. The company plans to present data from the Phase IIb trial at scientific meetings in 2008.

• BioInvent International AB, of Lund, Sweden, received approval from the Danish Medicines Agency to initiate a Phase I clinical trial of BI-204, an antibody that targets oxidized forms of harmful LDL cholesterol. BioInvent and San Francisco-based Genentech Inc. are co-developing BI-204 under an agreement signed in January 2007. The trial will be carried out in Denmark. BI-204 is being developed as a drug for the secondary prevention of cardiac events, such as heart attack or stroke, in high-risk patients. The double-blind, dose-escalation trial will test both single and multiple doses of BI-204 administered either intravenously or subcutaneously.

• Celsion Corp., of Columbia, Md., received a supportive written response from the FDA in relation to its proposed registrational study for use of ThermoDox in patients with recurrent breast cancer at the chest wall. Celsion intends to proceed with its plans to begin the Phase II study in the second half of 2008. It is anticipated that the open-label study will enroll up to a maximum of 100 patients in approximately 10 U.S. centers.

• Cogentus Pharmaceuticals Inc., of Menlo Park, Calif., enrolled the first patient in its pivotal Phase III study of CGT-2168, an antiplatelet drug single pill that combines clopidogrel (Plavix, Bristol-Myers Squibb Co. and Sanofi-Aventis) and gastroprotectant omeprazole. The COGENT (Clipidogrel and the Optimization of Gastrointestinal Events Trials)-1 is part of Cogentus' clinical program, which is expected to enroll more than 4,000 patients in the U.S., Canada, Europe and South America.

• Isolagen Inc., of Exton, Pa., said injections have been completed in the pivotal Phase III multicenter, double-blind, randomized, placebo-controlled clinical trials evaluating the Isolagen Therapy for the treatment of nasolabial folds, or wrinkles. Subjects have advanced to the follow-up period of the study. It also said it has completed injections in the Phase II open-label study designed to gather safety and application information on the use of the therapy for the full face. The subjects in the study also have advanced to the follow-up period.

• Kamada, of Weizmann Science Park, Israel, successfully concluded Phase I clinical studies testing the safety and tolerability of the aerosolized version of its flagship product Alpha-1 Antitrypsin using an optimized eFlow Electronic Nebulizer to treat various lung diseases. Kamada already has obtained orphan drug designation from both the FDA and the European Medicines Agency for aerosolized AAT for the treatment of congenital emphysema and cystic fibrosis.

• Kosan Biosciences Inc., of Hayward, Calif., has initiated a Phase II trial of alvespimycin, its second-generation Hsp90 inhibitor, in patients with HER2-positive metastatic breast cancer. Alvespimycin has demonstrated the potential to disrupt the activity of multiple oncogenes and cell signaling pathways implicated in tumor growth, including HER2, a key signaling pathway in breast cancer. The objective of the trial is to evaluate the safety and anticancer activity of alvespimycin as a single agent in patients who previously have not received Herceptin for metastatic disease except in an adjuvant setting.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., has initiated a Phase II clinical program for PRO 140, an investigational drug for the treatment of HIV. Two Phase II trials in HIV-infected individuals will investigate multiple dose levels of PRO 140 via intravenous and subcutaneous routes of administration. Intravenous PRO 140 has the potential for infrequent (e.g., monthly) dosing, whereas subcutaneous PRO 140 may enable self-administration as infrequently as every two weeks. The objective of the studies is to identify an optimal dosing regimen for evaluation in pivotal clinical trials as well the drug's safety and tolerability. PRO 140 is a humanized monoclonal antibody directed against CCR5, a portal that most forms of HIV use to enter immune system cells.

• Protox Therapeutics Inc., of Vancouver, British Columbia, received institutional review board approvals to proceed with its Phase IIa clinical trial evaluating PRX302 for the treatment of localized recurrent prostate cancer. The company expects to enroll the first of 30 patients this quarter. PRX302, a targeted PSA activated pore-forming pro-toxin, has shown promising signs of clinical and biologic activity in two Phase I trials.

• Tolerx Inc., of Cambridge, Mass., said it had a successful completion of a Phase Ib clinical study of TRX1, a novel humanized anti-CD4 monoclonal antibody, in subjects with refractory cutaneous lupus erythematosus. The study was designed to assess the safety, tolerability, and pharmacokinetics of TRX1. Tolerx has received an unspecified milestone payment from Genentech Inc., of South San Francisco, in conjunction with the completion of the study.

• ZymoGenetics Inc., of Seattle, said partner Merck Serono, an affiliate of Merck KGaA, of Darmstadt, Germany, has received a special protocol assessment from the FDA for a Phase II/III trial with atacicept in patients with general systemic lupus erythematosus. The trial is a randomized, double-blind placebo-controlled multicenter clinical study that will be conducted internationally and involve about 500 patients with general SLE. The trial will evaluate the efficacy and safety of atacicept compared to placebo in the prevention of SLE flares in this population.