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Biomira initiates Phase 1 trial of PX-478 in patients with advanced metastatic cancers
Biomira initiates Phase 1 trial of PX-478 in patients with advanced metastatic cancers.
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[{"type":"text","content":"\n\n\n\nEDMONTON, Aug. 28 /CNW/ - Biomira Inc. (Nasdaq: BIOM) (TSX: BRA) today\nannounced that the first patient has been enrolled in a Phase 1 clinical trial\nof PX-478 in patients with advanced metastatic cancer. PX-478 is a novel small\nmolecule compound designed to inhibit the activity of hypoxia inducible factor\n(HIF)-1 alpha, a transcription factor that controls the expression of a number\nof genes important for growth and survival of cancer cells. Genes regulated by\nHIF-1 alpha contribute to diverse functions such as new blood vessel growth\n(angiogenesis), use of glucose for energy, and protection against apoptosis\n(programmed cell death).\n\n\n"HIF-1 alpha plays a critical role in the response of cancer cells to low\noxygen levels, stimulating processes that increase oxygen concentrations and\nallow tumors to grow and thrive," said Dr. Lynn Kirkpatrick, Ph.D., Chief\nScientific Officer of Biomira. "In our preclinical studies, PX-478 produced\nsignificant tumor regression and growth delay in a wide variety of models of\nhuman cancers, including lung, breast, prostate, colon, kidney, pancreas, and\novarian cancers. We believe this is the first small molecule agent to enter\nclinical trials that directly lowers levels of HIF-1 alpha protein in tumors."\n\n\nThe Phase 1 trial is expected to enroll up to 36 patients with advanced\nsolid tumors or lymphoma who have failed or are intolerant of standard\ntherapy. PX-478 will be administered orally on days 1 through 5 of a 21-day\ncycle. Primary objectives of the study include establishment of a maximum\ntolerated dose, evaluation of safety, and analyses of pharmacodynamic and\npharmacokinetic profiles of PX-478. Other objectives are to evaluate the\neffects of PX-478 on tumor blood flow and vascular permeability as measured by\nDCE-MRI, and to evaluate the anti-tumor activity of PX-478 in patients with\nadvanced malignancies.\n\n\n"We are very excited about the potential for PX-478 as an anti-cancer\ncompound with broad potential application," said Dr. Robert L. Kirkman, MD,\nPresident and Chief Executive Officer of Biomira. "We are also pleased with\nthe progress of our pipeline, as demonstrated by the initiation of this trial\non schedule. This is our second small molecule compound to enter clinical\ndevelopment, and we expect to file an ...