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news.Pathway Therapeutics has received the US Food and Drug Administration's (FDA) acceptance for submission of cancer drug PWT33597 investigational new drug (IND).
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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.