Biomira Selects PX-866 as Clinical Development Candidate and Presents Promising Preclinical Data at AACR-IND filing expected by end of 2007-
EDMONTON, April 16, 2007 /PRNewswire-FirstCall/ - Biomira Inc. today announced that it has selected PX-866 as its next clinical development candidate. PX-866 is an inhibitor of the phosphatidylinositol-3-kinase (PI3 kinase)/ PTEN/AKT pathway, an important survival signaling pathway that is activated in many types of human cancer, including glioblastoma. Preclinical data presented this past weekend at the American Association of Cancer Research (AACR) annual meeting demonstrate that PX-866 has activity in an intracranial model of glioma.
"The preclinical data for PX-866, including those presented at AACR, are very promising and warrant advancing this small molecule compound to clinical development," said Robert L. Kirkman, M.D., President and Chief Executive Officer of Biomira. "The data presented this weekend are particularly compelling, as they provide evidence of PX-866 activity in an intracranial model of glioma, a disease that accounts for 77 percent of all malignant brain cancers and is refractory to conventional therapies. We are in the process of completing preclinical studies designed to support the expected filing of an investigational new drug (IND) application for PX-866 later this year. Expanding and advancing our clinical pipeline is a key priority for Biomira, and we are on track to have four programs in clinical development by the end of 2007."
Preclinical data presented at AACR by Dr. Dimpy Koul of The University of Texas M. D. Anderson Cancer Center (MDACC) (Abstract #278) showed that PX-866 treatment resulted in growth inhibition in three different glioma cell lines. The magnitude of the inhibition depended on the status of PTEN in the cell lines, with PTEN-negative cells showing greater sensitivity to PX-866. Treatment with PX-866 inhibited activation of AKT and other downstream targets of PI3K. A dose-dependent increase in autophagy, a type of programmed cell death, was observed and PX-866 also inhibited invasive and angiogenic capabilities of cultured glioma cells. In animals, PX-866 inhibited subcutaneous tumor growth by 84 percent after 4 weeks of oral dosing and increased median survival of animals with intracranial tumors. The authors conclude that PX-866 is a highly promising PI3 kinase inhibitor in glioblastomas and other tumors with aberrant PTEN/PI3K expression, which include advanced ovarian, breast and prostate cancers, as well as lung and head and neck cancers.
Dr. Koul and colleagues at MDACC conducted the studies in collaboration with Dr. Lynn Kirkpatrick, Biomira's Chief Scientific Officer, under a grant from the U.S. National Institutes of Health.
PX-866 is an inhibitor of the phosphatidylinositol-3-kinase (PI3 kinase)/PTEN/AKT pathway, an important survival signaling pathway that is activated in many types of human cancer. PI3 kinase is overexpressed in a number of human cancers, especially ovarian, colon, head and neck, urinary tract, and cervical cancers, where it leads to increased proliferation and inhibition of apoptosis (programmed cell death). In preclinical studies, PX-866 has been shown to induce prolonged inhibition of tumor PI3 kinase signaling following both oral and intravenous administration. The compound also has been shown to have good in vivo anti-tumor activity in tumor models of human ovarian and lung cancer, as well as intracranial glioblastoma.
Biomira is a biotechnology company specializing in the development of innovative therapeutic products for the treatment of cancer. Biomira's goal is to develop and commercialize novel synthetic vaccines and targeted small molecules that have the potential to improve the lives and outcomes of cancer patients.
This press release contains forward-looking statements, including, without limitation, statements related to the pre-clinical and clinical development of PX-866; the therapeutic and commercial potential of PX-866; the filing of an investigational new drug application for PX-866 and the timing thereof; and future clinical development plans. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes", "anticipates", "plans", "expects", "will", "intends", "potential", "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Biomira's current expectations. Forward-looking statements involve risks and uncertainties. Various factors could cause actual results to differ materially from those projected in forward-looking statements, including those predicting the clinical development of PX-866; the therapeutic and commercial potential of PX-866; the filing of an investigational new drug application for PX-866 and the timing thereof, and future clinical development plans. There can be no guarantee that the results of earlier trials will be predictive of either safety or efficacy in future trials. Biomira expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
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Posted: April 2007