Following are clinical findings presented at the American Heart Association Scientific Sessions in Orlando, Fl. (Also see page 9.)
• Acusphere Inc., of Watertown, Mass., said data from its Phase III RAMP-1 (real time assessment of myocardial perfusion) and RAMP-2 clinical trials of Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension indicated it is an effective, well-tolerated, minimally invasive approach to evaluating chest pain patients at risk for heart attack. Data showed that, when compared to nuclear stress - the most frequently used imaging procedure for the assessment of coronary heart disease - Imagify Perfusion Stress Echo was shown to be just as good at determining whether or not a patient has disease (accuracy), superior in ruling out disease in patients with a lower prevalence of disease (specificity) and superior in detecting disease in patients with a higher prevalence of disease (sensitivity).
• BioLineRx Ltd., of Jerusalem, said data from preclinical trials of BL-1040, a resorbable implant to treat acute myocardial infarction, demonstrated that it is effective in improving cardiac function and preventing deterioration of myocardium post-myocardial infarction in pigs. BL-1040 is injected via the coronary artery during catheterization as a liquid that polymerizes within damaged heart tissue and forms a protective scaffold to enhance the mechanical strength of the heart muscle during recovery and repair. The scaffold prevents the pathological enlargement of the left ventricle that occurs following a heart attack and improves cardiac function. BL-1040 is naturally excreted from the body within six weeks of injection. Patients who have undergone an acute MI with severe heart damage are the most likely to benefit from BL-1040.
• CV Therapeutics Inc., of Palo Alto, Calif., said data from a prospectively identified analysis of 2,220 diabetic patients from the MERLIN TIMI-36 study showed that Ranexa (ranolazine extended-release tablets) significantly reduced hemoglobin A1c (HbA1c), increased the number of patients achieving the clinical HbA1c treatment target of 7 percent or less and reduced the incidence of newly increased HbA1c in patients without diabetes at baseline. In patients with diabetes treated with Ranexa in the study, at four months, HbA1c had declined approximately 0.7 percentage points, from a starting mean baseline of 7.5 to 6.8 percent, and 0.43 percentage points compared to placebo (p<0.001). Patients taking Ranexa were significantly more likely (p<0.001) to achieve the HbA1c treatment target of less than 7 percent, with 59 percent of diabetic patients on Ranexa achieving this target at four months.
• Cytos Biotechnology AG, of Zurich, Switzerland, reported results from a Phase IIa trial of CYT006-AngQb in 72 patients with mild to moderate hypertension, showing that both doses (100 mcg and 300 mcg) were safe and well tolerated, and no vaccine-related adverse events were reported in the follow-up period from months four to 12. Data also showed that all patients who received the vaccine mounted a strong antibody response against angiotensin II that was dose-dependent and long-lived but reversible with a half-life of about four months. Efficacy also was dose-dependent and a significant reduction of the mean ambulatory daytime blood pressure was observed in the 300 mcg dose group. Systolic blood pressure was reduced by 5.6 mmHg and diastolic blood pressure by 2.8 mmHg from baseline.
• Encysive Pharmaceuticals Inc., of Houston, said open-label observational data from Columbia University suggested that sitaxsentan (THELIN), a selective endothelin A receptor antagonist, may improve symptoms associated with Eisenmenger syndrome (ES). A retrospective chart review was performed on 14 consecutive ES patients (10 females, four males; age 27 +/- 11 years) initiating open-label sitaxsentan therapy (100 mg tablets daily) between 2002 and 2006. Baseline data were compared to short- and long-term follow-up data at 12 weeks and at approximately one year. There was a significant decrease in the pulmonary vascular resistance (PVR) to systemic vascular resistance ratio, consistent with pulmonary selectivity in these patients. The improvements in PVR index and six-minute walk distance were not significant. During the one-year follow-up, those ES patients had no significant change in resting systemic arterial oxygen saturation.
• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said MLN1202, a humanized monoclonal antibody, met its primary endpoint of reducing C-reactive protein (CRP) levels in a Phase II trial in patients at high-risk for atherosclerotic cardiovascular disease. The trial randomized 108 patients to receive a single dose of MLN1202 or placebo and then followed patients for 16 weeks. Data showed that a single dose of MLN1202 led to a median reduction in CRP of 26.7 percent relative to placebo on day 57 after dosing, and was significantly reduced up to day 85. In the MLN1202-treated group, 11.3 percent experienced a reduction of CRP level to less than or equal to 2 mg/L compared to 1.9 percent in the placebo arm. The company also identified a genomic biomarker for use in selecting patients most likely to respond to MLN1202, and said that biomarker was seen in 53 percent of the overall study population.
• Regado Biosciences Inc., of Durham, N.C., said data from Phase Ia and Phase Ib dose-escalation studies of its REG1 Anticoagulation System, a two-component system consisting of aptamer-based anticoagulant RB006 and matched antidote RB007, showed that RB006 completely inhibited the activity of Factor IXa, a protein essential to blood clotting, and that RB006's activity was rapidly and safely reversed by RB007. The Phase Ia study enrolled 84 healthy volunteers and the Phase Ib study enrolled 50 patients with stable coronary artery disease who were receiving aspirin with or without clopidogrel.
• Synvista Therapeutics Inc., of Montvale, N.J., presented prospective evidence it said showed that tight glucose monitoring and control can dramatically benefit certain identifiable patients with diabetes. The data came from a prospective population-based study of more than 3,000 individuals age 55 or older with diabetes mellitus, who were tested for Hp type and followed for two years in a registry. It was observed that Hp2-2 was associated with a highly significant increase in incidence of nonfatal-myocardial infarction, stroke and cardiovascular death and that only patients with the Hp2-2 genotype (as compared to patients with genotypes Hp1-2 or Hp1-1) were shown to have a significant decrease in major cardiovascular events if their HbA1c was maintained below 7.0, the generally recommended target for tight glycemic control.
• VIA Pharmaceuticals, of San Francisco, presented preclinical data showing that VIA-2291 significantly inhibited vascular inflammation in a mouse model of atherosclerosis. Mice given the compound had a significant decline in the extent of atherosclerosis detected after a four-week regimen given orally once a day. In addition, immunohistochemistry with a monocyte/macrophage specific antibody (anti-MOMA2) showed a similar inhibitory effect on this cell type within the remaining aortic lesions. Mice administered VIA-2291 displayed 35 percent less MOMA-2 reactivity counts per square millimeter of lesion.