TAFA93
Phase 1 Results
A TAFA93 Phase 1a single center, randomized, placebo-controlled, Single Ascending Dose (SAD) trial commenced in July, 2004. The results indicated that doses of 0.04, 0.08 and 0.16 mg/kg TAFA93 taken once daily were safe and well tolerated in healthy volunteers. No serious adverse events were reported. The data obtained from the Phase 1a trial was used to ascertain the most appropriate dose levels for the Phase 1b clinical trial.
During the first quarter of 2006, a Phase 1b, single center, randomized, placebo-controlled, Multiple-Ascending Dose (MAD), double-blind trial was conducted with TAFA93. The primary objective of this study was to assess the tolerability, safety and pharmacokinetics of multiple doses of TAFA93 in healthy volunteers. Thirty six subjects were randomized to receive either placebo or oral doses of TAFA93 (0.04, 0.08 or 0.16 mg/kg once daily) for 13 consecutive days.
Overall, the Phase 1b TAFA93 trial suggested that the drug was very well tolerated. No serious adverse events were reported during the trial. TAFA93 administration in the dose range of 0.04 mg/kg to 0.16 mg/kg resulted in dose-proportional rapamycin pharmacokinetics, following both single and multiple doses with stable and linear pharmacokinetics. In addition, the pharmacokinetic profiles display less peak-to-trough variability due to a modified input of the drug, when compared to historical rapamycin data.
The successful completion of the Phase 1 TAFA93 trials fulfills one of our commitments to Atrium Medical Corporation ("Atrium") and allows Atrium to continue moving forward with their drug eluting stent technology program.