Isotechnika announces promising results from phase 1 TAFA93 trials

By Lisa Kerner

Charlotte, N.C., Aug. 21 - Isotechnika Inc. said results from its phase 1a randomized, placebo-controlled, single ascending dose trial indicated that once-daily doses of 0.04, 0.08 and 0.16 mg/kg TAFA93 were safe and well-tolerated in healthy volunteers.

TAFA93, a pro-drug of rapamycin, is a novel small molecule mTOR inhibitor, a class of drugs currently used in the prevention of organ rejection in transplantation.

In addition, mTOR inhibitors have potential use in oncology and in cardiac stent technology, according to a company news release.

A similar phase 1b multiple-ascending dose trial conducted with TAFA93 suggested that the drug was very well-tolerated with no serious adverse events reported. In the study, 36 healthy volunteers were randomized to receive either a placebo or oral doses of TAFA93 (0.04, 0.08 or 0.16 mg/kg once daily) for 13 consecutive days.

Isotechnika said the successful completion of the phase 1 TAFA93 trials fulfills one of its commitments to Atrium Medical Corp. and allows Atrium to continue moving forward with its drug eluting stent technology program.

"Our theory is that having drug concentrations within a therapeutic window for a longer period of time may be beneficial giving immunosuppressive coverage for a more prolonged period of time," president and chief executive officer Randall Yatscoff said in the release.

Isotechnika is an international biopharmaceutical company based in Edmonton, Alta., focused on the discovery and development of novel immunosuppressive therapeutics.

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