BELLEVUE, WA, Jan. 28 /PRNewswire-FirstCall/ - Oncothyreon Inc. (the “Company”) , a biotechnology company specializing in the development of innovative therapeutic products for the treatment of cancer, today provided a review of the Company’s clinical development plans and corporate objectives for 2008. Oncothyreon is developing both novel synthetic vaccines and targeted small molecules with the potential to improve the lives and outcomes of cancer patients.
“During 2008, our primary focus will continue to be the advancement of our clinical pipeline,” said Robert L. Kirkman, M.D., President and Chief Executive Officer of Oncothyreon. “We are committed to the rapid development of our product candidates as the best strategy for building long-term value for our shareholders and achieving our vision of developing important new cancer therapies.”
“As we advance our clinical programs, we also remain committed to prudent management of our financial resources,” continued Dr. Kirkman. “The manufacturing revenue and milestone payments we anticipate receiving under our collaboration with Merck KGaA of Darmstadt, Germany for Stimuvax(R) are expected to support the further development of this product without material additional investment by Oncothyreon. We believe Stimuvax has substantial upside potential if it is approved and marketed, as our agreements with Merck KGaA include significant commercialization milestones and royalties on Stimuvax sales. With respect to our small molecule programs, we are actively seeking a partner for one or more of our product candidates, in order to provide additional resources for these product candidates, while generating revenue to support ongoing development of other compounds in our pipeline.”
Oncothyreon provides the following update of its product development pipeline for 2008:
Stimuvax
The Phase 3 pivotal trial of Stimuvax in patients with non-small cell lung cancer (NSCLC), START (Stimulating Targeted Antigenic Responses To NSCLC), continues enrollment in 2008. This year Oncothyreon expects to manufacture and to continue to provide to Merck KGaA substantial quantities of both Stimuvax and placebo to support START and potentially other additional trials of Stimuvax. In addition, Oncothyreon will continue the development of a large-scale process in preparation for the manufacture of commercial quantities of Stimuvax. Oncothyreon expects to receive an additional milestone payment related to Stimuvax during 2008.
START is a multi-center, randomized, double-blind, placebo-controlled study that will evaluate patients with documented unresectable stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study is expected to involve more than 1,300 patients in approximately 30 countries.
PX-478
Enrollment is ongoing in the Phase 1 dose escalation trial of PX-478 in patients with advanced metastatic cancer. Initial pharmacodynamic data from the early patients in this trial has been submitted for potential presentation at a scientific meeting at mid-year. More complete clinical data from this trial is expected in the second half of 2008.
PX-478 is a small molecule inhibitor of hypoxia inducible factor-1a (HIF-1a), a component of a transcription factor that is an important regulator of the tumor response to hypoxia. Pre-clinical data have demonstrated that PX-478 can induce apoptosis, or programmed cell death, in experimental tumor models, as well as the down-regulation of factors that 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 such model systems across a range of cancers, including lung, ovarian, renal, prostate, colon, pancreatic, and breast cancer.
PX-866
The Company currently expects to file an Investigational New Drug (IND) application for PX-866 late in the first quarter of 2008. A Phase 1 trial of PX-866 in patients with advanced metastatic cancer is targeted to begin in the second quarter of 2008.
PX-866 is an inhibitor of the phosphatidylinositol-3-kinase (PI-3-kinase)/PTEN/Akt pathway, an important survival signaling pathway that is activated in many types of human cancer. The PI-3-kinase inhibitor PX-866 induces prolonged inhibition of tumor PI-3-kinase signaling following both oral and intravenous administration and has been shown to have potent in vivo anti-tumor activity in human ovarian and lung cancer, as well as intracranial glioblastoma, tumor models.
PX-12 Small Molecule
Enrollment is ongoing in the Phase 2 trial of PX-12 in patients with advanced pancreatic cancer whose tumors have progressed while being treated with gemcitabine or gemcitabine-containing regimens. Partial data from this trial is expected in the second half of 2008. An additional trial of PX-12 exploring a more-prolonged infusion regimen is currently expected to begin in the second quarter of 2008.
PX-12 is an irreversible inhibitor of thioredoxin (Trx-1), a protein that regulates many other proteins including hypoxia inducible factor (HIF)-1 alpha, vascular endothelial growth factor (VEGF) and activator protein 1 (AP-1). These factors play a critical role in cancer cell growth, survival and resistance to chemotherapy.
Pre-clinical Programs
In addition to its clinical stage product candidates, Oncothyreon has several pre-clinical programs in development. During 2008 the Company expects to select one program for clinical development in 2009. Potential candidates include BGLP-40, a completely synthetic MUC1-based liposomal glycolipopeptide cancer vaccine that utilizes Oncothyreon’s proprietary adjuvant PET-lipid A, and PX-316, a small molecule inhibitor of AKT-mediated survival signaling. The Company is also seeking partners for its proprietary adjuvants, as well as for a group of small molecules with potential applications in restenosis. In addition, Oncothyreon continues to evaluate external product development opportunities.
About Oncothyreon
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.
Forward-Looking Statements
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 payments Oncothyreon may expect to receive; manufacturing and other costs; the therapeutic and commercial potential of Stimuvax and other product candidates; future clinical development plans for various product candidates; the details of the clinical trials for various product candidates; the anticipated future size of the market for Stimuvax; and identifying and capitalizing on possible collaboration, strategic partnering, acquisition or divestiture opportunities. 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, the safety and efficacy of Stimuvax and other product candidates, the timing of commencement of clinical development of pre-clinical product candidates, the possibility of future milestone and royalty payments, and the likelihood of future partnering opportunities. There can be no guarantee that the results of earlier trials will be predictive of either safety or efficacy in future 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.
CONTACT: Investor and Media Relations Contact: Julie Rathbun, Rathbun
Communications, (206) 769-9219, ir@oncothyreon.com
