• Biota Holdings Ltd., of Melbourne, Australia, said it successfully completed the second stage of a Phase I trial of BTA798, a small-molecule inhibitor of human rhinovirus, a cause of the common cold. The drug was shown to be safe and well tolerated at all doses in 32 healthy volunteers. The company's initial goal is to develop the product, which targets the capsid protein on HRV, for treating high-risk patients.

• Chroma Therapeutics Ltd., of Oxford, UK, said its oral cancer therapy, CHR-2797, entered its first Phase II trial, a study in elderly patients with treatment-refractory acute myeloid leukemia. Encouraging data were seen in a recently reported Phase I study in patients with hematological malignancies who were treated for up to three months. The product, an inhibitor of aminopeptidases, also is being evaluated as a treatment for solid tumors in two Phase I studies, as a monotherapy and in combination with chemotherapy.

• Clinical Data Inc., of Newton, Mass., said its PGxHealth Division completed enrollment in a pivotal Phase III study of Vilazodone for the treatment of depression. The 410-patient, randomized, double-blind, placebo-controlled trial was launched in the first quarter of 2006. Top-line efficacy and genetic biomarkers results are expected in the third quarter. Vilazodone is designed as both a selective serotonin reuptake inhibitor and a 5HT1A partial agonist.

• DiObex Inc., of San Francisco, said a Phase IIa trial of DIO-902 in Type II diabetics showed significant reductions in total and LDL cholesterol, as well as trends toward an improvement in glycemic control, in all doses vs. placebo. Mean levels of C-reactive protein also were significantly reduced, it said. DIO-902 is a cortisol synthesis inhibitor, one of two enantiomers contained within racemic ketoconazole, a marketed drug. DiObex plans to initiate a 16-week Phase IIb dose-ranging study of DIO-902 in mid-2007.

• DOR BioPharma Inc., of Miami, said it received clearance from the FDA to conduct a Phase II trial of orBec for the prevention of graft-vs.-host disease. The trial is supported in part by a National Institute of Health grant awarded to the Fred Hutchinson Cancer Research Center. The randomized, double-blind, placebo-controlled trial will enroll 138 patients and evaluate efficacy in preventing acute GVHD after hematopoietic cell transplantation with myeloablative conditioning regimens. Enrollment is expected to begin in the second quarter. The product is an oral formulation of beclomethasone dipropionate.

• Erimos Pharmaceuticals Inc., of Raleigh, N.C., began dosing patients in a Phase I/II study of terameprocol (EM-1421), a small molecule designed to prevent the production and activation of survivin, in patients with recurrent high-grade glioma brain tumors that are unresponsive to conventional therapy. The 30-patient trial, designed to evaluate antitumor activity and pharmacokinetics, is being conducted in conjunction with the New Approaches to Brain Tumor Therapy CNS Consortium, which is funded by the National Cancer Institute. Terameprocol, a derivative of nordihydroguaiaretic acid, was licensed from Johns Hopkins University.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., said it obtained sufficient preliminary data on pharmacokinetics to believe an ongoing Phase III trial likely will achieve its primary endpoint of meeting the FDA pharmacokinetic guidelines for testosterone therapy. The testosterone undecanoate (Nebido) product is a long-acting injectable therapy under development for treating hypogonadism. The study was designed to supplement the European clinical trial database generated by Bayer Schering Pharma AG, of Berlin, which licensed U.S. rights to Indevus in July 2005. The product is approved in more than 75 countries. The trial is expected to conclude in late May. (See BioWorld Today, Aug. 1, 2005.)

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said data from its ongoing Phase II trial of ISIS 301012 in patients with homozygous familial hypercholesterolemia (HoFH) were presented at the American College of Cardiology meeting in New Orleans. Early data showed a significant lipid-lowering activity from ISIS 301012 treatment. The product was safe and well tolerated. ISIS 301012 has orphan drug status for the treatment of homozygous FH, and Isis said it plans to begin registration-directed studies for FH in 2007. Isis also presented additional data from two ongoing studies of the compound in polygenic hypercholesterolemia.

• KAI Pharmaceuticals Inc., of South San Francisco, said a Phase I/II trial evaluating KAI-9803 for reperfusion injury showed early indications that it may reduce damage to the heart and improve cardiac function in heart attack patients undergoing treatment with balloon angioplasty. The trial also demonstrated safety. KAI-9803 is an isozyme-selective delta protein kinase C inhibitor designed to reduce injury associated with a heart attack. The trial evaluated KAI-9803 in 154 patients who suffered from acute anterior ST-segment elevation myocardial infarction. It found patients receiving intracoronary injections of KAI-9803 experienced less damage to the heart muscle than patients who received placebo. KAI also is evaluating intravenous administration of the compound, and plans to start a Phase I study this month.

• Ocera Therapeutics Inc., of San Diego, said a Phase II exploratory study of AST-120 in patients with active pouchitis was initiated at the Cleveland Clinic. It will evaluate safety and efficacy. Ocera also said it met the 50 percent enrollment target in its 240-patient pivotal Phase III trial of AST-120 in fistulizing Crohn's disease. That FHAST1 trial is designed to assess the efficacy and safety of AST-120 in inducing a reduction in the number of draining fistulas in Crohn's disease.

• Scios Inc., a Mountain View, Calif., a subsidiary of Johnson & Johnson, said an exploratory, 920-patient Phase II study of Natrecor (nesiritide) showed a neutral effect on the primary endpoint, a composite of death and cardiorenal hospitalization at 12 weeks. Natrecor is approved for treating patients with acutely decompensated congestive heart failure who have dyspnea (shortness of breath) at rest or with minimal activity. The FUSION II study was designed to assess safety and outcomes at six months of once- or twice-weekly infusions of nesiritide vs. placebo in persistently symptomatic chronic decompensated heart failure patients. The study demonstrated comparable renal and mortality effects in both arms. In addition, there was no statistically significant difference in the primary endpoint between drug and placebo when added to optimal therapies.

• Semafore Pharmaceuticals Inc., of Indianapolis, said it initiated a Phase I trial of its lead PI3 kinase inhibitor, SF1126, in patients with solid tumors. The open-label, ascending-dose trial is assessing safety, pharmacokinetic and pharmacodynamic parameters in patients with relapsed solid cancers thought to be driven by PI3 kinase activation or loss of the associated PTEN function. Those include a range of cancer types. Semafore said SF1126 is the first known broad-spectrum PI3K inhibitor to enter human trials. Preclinically, it was shown to inhibit angiogenesis and cellular proliferation, induce apoptosis, block pro-survival signals and produce synergistic antitumor effects in combination with chemotherapy.

• The Medicines Co., of Parsippany, N.J., said one-year findings from the ACUITY trial show that acute coronary syndrome patients receiving Angiomax (bivalirudin) alone had similar rates of ischemic clinical outcomes compared with more complicated standard therapy. At one year, the mortality rate of patients in the Angiomax group was 3.8 percent, compared to 4.4 percent in the control group. Data also showed that there were nearly 50 percent fewer episodes of major bleeding in the Angiomax arm vs. the control arm. Angiomax is marketed as an anti-clotting agent. Data were presented at the American College of Cardiology's annual scientific session in New Orleans.