The FDA’s decision allows the company to start a Phase 1 clinical trial of PWT33597, a proprietary, selective, dual inhibitor of PI3K kinase alpha and mTOR.
The Phase 1 trial is planned to assess the safety of escalating doses of PWT33597 in patients who are suffering from advanced solid tumors.
The study will also provide a rich data set of pharmacokinetic and pharmacodynamic measurements, as well as an early assessment of clinical activity.