Biomira has submitted an investigational new drug application to the FDA for PX-478, a novel inhibitor of a protein that controls genes whose products are important for tumor growth and survival.
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In preclinical studies, PX-478 produced significant tumor regression and growth delay in multiple models of human cancers, including cancers of the lung, breast, prostate, colon, kidney, pancreas and ovary.
“HIF-1 alpha is a drug target that provides a multi-pronged approach for cancer therapy. We believe that PX-478 will be the first small molecule to enter clinical development that acts directly to lower HIF-1 alpha protein levels,” said Dr Lynn Kirkpatrick, chief scientific officer of Biomira.
Upon clearance of the IND, Biomira intends to initiate a phase 1 trial for this compound in the third quarter of 2007.