• Alliance Pharmaceutical Corp., of San Diego, received the final approvals required to start a Phase IIb trial for Oxygen (perfluorochemical emulsion) to prevent postoperative ileus resulting from hypoxia during major surgery. The study is expected to enroll up to 128 patients undergoing primary coronary artery bypass graft surgery under cardiopulmonary bypass, and they will be randomized to receive either a dose of saline or a dose of Oxygent five to 10 minutes before bypass is begun. Dose levels of 1.5 ml/kg, 3 ml/kg and 4.5 ml/kg will be tested. Oxygent is an intravascular oxygen therapeutic designed to carry oxygen to tissues through the bloodstream in patients undergoing surgical procedures.

• Cell Therapeutics Inc., of Seattle, said it agrees with the FDA's request for the design of its trial of pixantrone in relapsed or refractory indolent non-Hodgkin's lymphoma. Earlier this month, pixantrone received fast-track designation. The trial will examine the time to disease progression for the combination regimen of fludarabine, pixantrone and rituximab compared to the combination of fludarabine and rituximab in patients who have failed up to five prior treatments for refractory or relapsed NHL. The study is expected to enroll 300 patients beginning this quarter, with interim data by mid-2008.

• Celladon Corp., of La Jolla, Calif., and Targeted Genetics Corp., of Seattle, initiated a Phase I trial of Mydicar (AAV1/SERCA2a) in patients with cardiomyopathy and symptoms of heart failure. Mydicar uses an adeno-associated virus vector to deliver the SERCA2a gene to heart muscle tissue. The trial is designed to evaluate a single coronary artery infusion of four dose levels of the product in subjects with ischemic or non-ischemic cardiomyopathy and NYHA Class III/IV symptoms of heart failure. Twelve subjects will be enrolled in Stage I of the trial, which will be the open-label, dose-escalating portion, while the Stage II will randomize 33 patients to receive either Mydicar or placebo. Targeted Genetics and Celladon agreed to collaborate in early 2005 to develop Mydicar for congestive heart failure.

• Danube Pharmaceuticals Inc., of New York, initiated a Phase II study of DNB-001 in 60 patients with ocular hypertension. The trial's primary objective is to evaluate the efficacy of the compound, an oral therapy designed to work with a dual mechanism of action to lower intraocular pressure. The secondary objective is to test the safety of DNB-001 administered over a four-week period. Results are expected by the end of the year, and pending those data, Danube expects to pursue global development of the compound in glaucoma. The company also is in the process of beginning a second Phase II study of DNB-001 to test its cardiac and renal protective effects in patients with coronary artery and kidney disease undergoing coronary artery angioplasty. That study is set to begin in the third quarter.

• Genaera Corp., of Plymouth Meeting, Pa., said dosing of subjects began in study MSI-1436C-101, a Phase I trial of trodusquemine (MSI- 1436). MSI-1436, being developed for obesity, works centrally and peripherally to regulate insulin and leptin receptor signaling through inhibition of its target enzyme, protein tyrosine phosphatase 1B, or PTP-1B, Genaera said. The randomized, vehicle-controlled study is enrolling 35 healthy overweight and obese volunteers to evaluate safety, tolerability and pharmacokinetics of ascending single doses of intravenously administered MSI- 1436. The trial of the appetite suppressant is expected to be completed in the second half of 2007.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said updated results from its ongoing Phase II trial of ISIS 301012 in patients with homozygous familial hypercholesteremia show that the three patients who completed 12 weeks of treatment at 300 mg/week achieved 45 percent, 50 percent and 51 percent additional reductions in LDL-cholesterol beyond that achieved with maximally tolerated lipid-lowering therapy, with reductions in apoB of 45 percent, 43 percent and 54 percent. ISIS 301012, which has been granted orphan status for homozygous FH, is expected to begin registration-directed studies later this year.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., resumed clinical development of MLN0002 and initiated patient dosing in a clinical program designed to evaluate the compound, which is derived from an engineered, commercially scaleable cell line. MLN0002, a monoclonal antibody designed to bind to the T-cell integrin alpha 4 beta 7, is believed to have potential in gastrointestinal diseases, such as ulcerative colitis. The program consists of two studies: a Phase II dose-ranging trial in ulcerative colitis patients and a Phase I study in normal healthy volunteers. A previous Phase II study of MLN0002, derived from an earlier cell line, was well tolerated and achieved a statistically significant improvement, though there were reports of serious side effects mainly related to exacerbations of underlying ulcerative colitis occurring in 15 percent of patients in the treatment group compared to 10 percent in the placebo group.

• Opexa Therapeutics Inc., of The Woodlands, Texas, completed patient enrollment in a 150-patient Phase IIb study of subcutaneous Tovaxin T cell vaccination in subjects with clinically isolated syndrome or relapsing/remitting multiple sclerosis. Patients will receive 52 weeks of treatment and will undergo safety and efficacy assessments using primary criterion of gadolinium-enhancing lesions and secondary criterion of annualized relapse rate. Opexa anticipates collecting descriptive analysis data on the first 75 subjects to reach the six-month mark later this year. Full data results are expected in the second half of 2008.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., filed a new trial protocol to study bavituximab in patients co-infected with hepatitis C virus and HIV. The study is designed to assess the safety and pharmacokinetics of the compound in about 24 patients chronically infected with both diseases, and patient cohorts will receive ascending dose levels of bavituximab weekly for up to eight weeks. HCV and HIV viral titers and other biomarkers will be tracked, although they are not formal study endpoints. Bavituximab, a monoclonal antibody, is a phophatidylserine immunotherapeutic designed to target and bind to cellular components that are not normally present on the outside of cells, but which become exposed on certain virally infected cells.