Oncothyreon's PX-478 is Effective in Preclinical Model of Human Lung Cancer
BELLEVUE, WA, February 25, 2008 /PRNewswire-FirstCall/ - Oncothyreon Inc. (the "Company") today announced the presentation of data demonstrating the effectiveness of PX-478 in a preclinical model of human lung cancer at the 8th Annual Targeted Therapies of the Treatment of Lung Cancer meeting of the International Association for the Study of Lung Cancer in Santa Monica, California. The data were presented on February 22, 2008, by Jorg J. Jacoby, Ph.D., Instructor, University of Texas M.D. Anderson Cancer Center, Houston. Oncothyreon's PX-478 is a small molecule inhibitor of hypoxia inducible factor (HIF)-1 alpha currently in a Phase 1 trial in patients with advanced metastatic cancer and lymphoma.
The study employed a model of lung cancer in mice, which closely mimics the disease in humans. Treatment with oral PX-478 for five days resulted in significant inhibition of tumor growth, marked reduction in lymph nodes metastases, decreased volume of pleural effusions, and significantly improved survival. PX-478 was effective in models of both non-small cell lung cancer and small cell lung cancer that express HIF-1 alpha.
"These data suggest that antagonism of HIF-1 alpha with PX-478 significantly inhibits the growth and spread of lung cancers expressing HI-1 alpha and will prove valuable in planning clinical trials of this novel agent," said Roy Herbst, M.D., Professor, Thoracic/Head & Neck Medical Oncology, M.D. Anderson Cancer Center, and senior author of the current study. "We look forward to conducting further studies of PX-478 in combination with other agents used in the treatment of these diseases, and to participating in future clinical trials of this highly promising drug candidate."
Enrollment is ongoing in the Phase 1 dose escalation trial of PX-478 in patients with advanced metastatic cancer and lymphoma. Clinical data from this trial are expected in the second half of 2008.
PX-478 is a novel small molecule compound that inhibits 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 including new blood vessel growth (angiogenesis), use of glucose for energy, and protection against apoptosis (programmed cell death).
Preclinical data have demonstrated that PX-478 can induce apoptosis in experimental tumor models, as well as the down-regulation of factors which control angiogenesis, such as vascular endothelial growth factor (VEGF). PX-478 is effective when delivered orally in animal models, and has shown marked tumor regressions and growth inhibition in model systems across a range of cancers, including lung, ovarian, renal, prostatic, colon, pancreatic, and breast cancer. The wide variety of models that show sensitivity to PX-478 represents a large potential market for this product candidate. The ability to combine PX-478 with radiation therapy may further expand the opportunities for this novel compound.
Oncothyreon is a biotechnology company specializing in the development of innovative therapeutic products for the treatment of cancer. Oncothyreon'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. For more information, visit www.oncothyreon.com.
In order to provide Oncothyreon's investors with an understanding of its current intentions and future prospects, this release contains statements that are forward looking, including statements related to the ongoing Phase 1 trial of PX-478; the therapeutic and commercial potential of PX-478; and future clinical development plans for PX-478. These forward-looking statements represent Oncothyreon's intentions, plans, expectations and beliefs and are based on its management's experience and assessment of historical and future trends and the application of key assumptions relating to future events and circumstances.
Forward-looking statements involve risks and uncertainties, including risks and uncertainties related to Oncothyreon's business and the general economic environment. Many of these risks and uncertainties are beyond Oncothyreon's control. These risks, uncertainties and other factors could cause our actual results to differ materially from those projected in forward-looking statements. Risks, uncertainties, and assumptions include those predicting the timing, duration and results of clinical trials, the timing and results of regulatory reviews, and the safety and efficacy of PX-478. There can be no guarantee that the results of preclinical studies will be predictive of either safety or efficacy in future clinical trials. These and other risks and uncertainties are described in the reports and other documents filed by either Biomira Inc. or Oncothyreon Inc. with the SEC and/or Canadian regulatory authorities.
Although Oncothyreon believes that any forward-looking statements contained herein are reasonable, it can give no assurance that its expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For a detailed description of the risks and uncertainties associated with Oncothyreon, you are encouraged to review the official corporate documents filed by either Biomira Inc. or Oncothyreon Inc. with the securities regulators in United States and Canada with the SEC and on SEDAR. Oncothyreon is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
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Posted: February 2008