Oncothyreon believes the following financial guidance to be correct as of the date provided. Oncothyreon is providing this guidance as a convenience to investors and assumes no obligation to update it. Expenses in 2009 are expected to be substantially less than in 2008, primarily as a result of transferring manufacturing and process development activities for Stimuvax to Merck KGaA and of the previously announced plan to restrict development activities to PX-478 and PX-866.
Oncothyreon currently expects cash used in operations in 2009 to be approximately $12 million. Oncothyreon Highlights for 2009 Oncothyreon's corporate highlights for the year 2009 to date include the following: - Expansion of the Phase 3 development program for Stimuvax with the initiation of the STRIDE trial in hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer by Oncothyreon's partner Merck KGaA. Stimuvax is also being studied in the Phase 3 START trial in non-small cell lung cancer (NSCLC).
Presentation of long-term data for Stimuvax in NSCLC at the International Association for the Study of Lung Cancer's 13th World Conference on Lung Cancer. The data involved 16 patients who received treatment with Stimuvax for between 2 and 8.2 years as part of the Phase 2b trial in patients with stage IIIb/IV NSCLC. As of the time of data analysis in April 2009, 10 of the 16 studied patients were alive without evidence of disease progression, of whom eight continued to receive therapy with Stimuvax after 6.3 to 8.2 years.
The remaining two living patients discontinued Stimuvax therapy after 2.4 and 5.8 years, respectively, and were without evidence of disease progression. - Presentation of preliminary results from the Phase 1 trial of PX-866, an inhibitor of PI-3 kinase, at the American Society of Clinical Oncology. The data demonstrated inhibition of PI-3 kinase activity at low doses, as well as stabilization of disease in six of 24 patients with previously progressive disease in the early dose cohorts in this ongoing dose escalation trial.
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