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Biomira files investigational new drug application for PX-478, a novel inhibitor of hypoxia-inducible factor-1 alpha
Biomira files investigational new drug application for PX-478, a novel inhibitor of hypoxia-inducible factor-1 alpha.
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[{"type":"text","content":"\n\n\n\nEDMONTON, July 3 /CNW/ - Biomira Inc. (Nasdaq: BIOM) (TSX: BRA) today\nannounced that it has submitted an investigational new drug (IND) application\nto the U.S. Food and Drug Administration for PX-478. PX-478 has been shown in\npreclinical studies to inhibit hypoxia-inducible factor (HIF)-1 alpha, a\nprotein that controls the transcription of a number of genes whose products\nare important for tumor growth and survival. In these preclinical studies,\nPX-478 has produced significant tumor regression and growth delay in multiple\nmodels of human cancers, including cancers of the lung, breast, prostate,\ncolon, kidney, pancreas and ovary.\n\n\n"HIF-1 alpha plays a critical role in the response of tumor cells to low\noxygen, a situation seen in tumors where existing blood vessels are\ninsufficient to supply needed oxygen," said Dr. Lynn Kirkpatrick, Chief\nScientific Officer of Biomira. "In areas of low oxygen and as tumors grow,\nthey adapt their metabolism due to decreased oxygen and nutrients and attract\nnew blood vessels to bring in more oxygen, a process known as angiogenesis.\nBoth the altered metabolism and angiogenesis are under the control of\nHIF-1 alpha. Consequently, HIF-1 alpha is a drug target that provides a\nmulti-pronged approach for cancer therapy. We believe that PX-478 will be the\nfirst small molecule to enter clinical development that acts directly to lower\nHIF-1 alpha protein levels."\n\n\n"With the filing of this IND for PX-478, we are advancing the development\nof another promising compound," said Dr. Robert L. Kirkman, M.D., President\nand Chief Executive Officer of Biomira. "Upon clearance of the IND, we intend\nto initiate a Phase 1 trial for this compound in the third quarter of 2007. We\nalso are on track to advance our other pipeline programs, including initiating\nanother Phase 2 trial for PX-12 and filing an IND for PX-866 by the end of the\nyear. At that point we will have four programs in clinical development,\nreflecting the diversity and promise of our product pipeline."\n\n\nAbout PX-478\n\n\nPX-478 is a potent inhibitor of HIF-1 alpha, a protein target whose\nlevels are elevated in a wide range of tumors. The protein is a key factor in\nthe response of a cancer cell to hypoxia (lack of oxygen), including the\nangiogenic cascade that allows tumo...