Biomira initiates Phase 1 trial of PX-478 in patients with advanced metastatic cancers

30-Aug-2007

Biomira Inc. announced that the first patient has been enrolled in a Phase 1 clinical trial of PX-478 in patients with advanced metastatic cancer. PX-478 is a novel small molecule compound designed to inhibit the activity of hypoxia inducible factor (HIF)-1 alpha, a transcription factor that controls the Expression of a number of genes important for growth and survival of cancer cells. Genes regulated by HIF-1 alpha contribute to diverse functions such as new blood vessel growth (angiogenesis), use of glucose for energy, and protection against apoptosis (programmed cell death).

"HIF-1 alpha plays a critical role in the response of cancer cells to low oxygen levels, stimulating processes that increase oxygen concentrations and allow tumors to grow and thrive," said Dr. Lynn Kirkpatrick, Ph.D., Chief Scientific Officer of Biomira. "In our preclinical studies, PX-478 produced significant tumor regression and growth delay in a wide variety of models of human cancers, including lung, breast, prostate, colon, kidney, pancreas, and ovarian cancers. We believe this is the first small molecule agent to enter clinical trials that directly lowers levels of HIF-1 alpha protein in tumors."

The Phase 1 trial is expected to enroll up to 36 patients with advanced solid tumors or lymphoma who have failed or are intolerant of standard therapy. PX-478 will be administered orally on days 1 through 5 of a 21-day cycle. Primary objectives of the study include establishment of a maximum tolerated dose, evaluation of safety, and analyses of pharmacodynamic and pharmacokinetic profiles of PX-478. Other objectives are to evaluate the effects of PX-478 on tumor blood flow and vascular permeability as measured by DCE-MRI, and to evaluate the anti-tumor activity of PX-478 in patients with advanced malignancies.

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