CardioVascular BioTherapeutics Inc., of Las Vegas, reported findings from its Phase I trial of its human fibrolast growth factor (FGF-1), showing that the drug candidate was safe and biologically active when injected into the heart muscle of patients with severe heart disease. No significant, unexpected adverse events attributable to the drug were reported and preliminary indications of bioactivity were noted, though the trial was not designed to demonstrate efficacy. The data were presented at the American Heart Association annual scientific meeting in Orlando.
Other meeting results included:
• CV Therapeutics Inc., of Palo Alto, Calif., said data from its MERLIN TIMI-36 study showed that Ranexa (ranolazine extended-release tablets) reduced the relative risk of the primary composite endpoint of cardiovascular death, myocardial infarction or recurrent ischemia by 21 percent compared to placebo in 1,935 patients with elevated level of b-type natriuretic peptide. The company, which reported initial results from the study in March, submitted a supplemental new drug application last month, based on those results, for expansion of Ranexa's label to include first-line angina treatment.
• Regado Biosciences Inc., of Durham, N.C., said data from a Phase Ic study of its REG1 Anticoagulation System, a two-component system comprised of aptamer-based anticoagulant RB006 and its matched antidote, RB007, supported RB007's ability to reverse the anticoagulant effect of RB006, either completely or partially, depending on the level of dosing of RB007. The study, which enrolled healthy volunteers, showed that repeated doses of RB006 achieved highly reproducible increases in activated partial thromboplastin time, and that, subsequently, repeat doses of RB007 reversed the aPTT levels dose-dependently and reproducibly.
• Resverlogix Corp., of Calgary, Alberta, reported preclinical data showing that RVX-208 increases serum levels of ApoA-1 and improves high-density lipoprotein-mediated cholesterol efflux in African green monkeys. Data showed that the drug increased pre-beta HDL subparticles, which improved HDL's ability to mediate cholesterol efflux. Resverlogix is developing RVX-208 for cardiovascular disease indications.