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Home » ISOTECHNIKA RELEASES RESULTS FROM TRIALS OF MTOR INHIBITOR
ISOTECHNIKA RELEASES RESULTS FROM TRIALS OF MTOR INHIBITOR
August 22, 2006
Isotechnika announced promising results from its Phase I trials of TAFA93. TAFA93, a pro-drug of rapamycin, is a small-molecule mTOR inhibitor. Drugs in this class are currently used to prevent of organ transplant rejection, but they also have potential use in oncology and for drug-eluting stents.
The Phase Ia single-center, randomized, placebo-controlled, single-ascending-dose trial began in July 2004. The results indicate that doses of 0.04, 0.08 and 0.16 mg/kg of TAFA93 taken once daily were safe and well-tolerated in healthy volunteers. The data from the Phase Ia trial was used to ascertain the most appropriate dose levels for the Phase Ib trial.
Earlier this year a Phase Ib, single-center, randomized, placebo-controlled, multiple-ascending-dose, 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. The subjects were randomized to receive either placebo or oral doses of the drug (0.04, 0.08 or 0.16 mg/kg once daily) for 13 days. The trial data suggest that the drug was well-tolerated.
KEYWORDS Drug Pipeline Alert
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