EDMONTON and DARMSTADT, Germany, April 20 /CNW/ - Biomira Inc. (Nasdaq: BIOM) (TSX: BRA) and Merck KGaA of Darmstadt, Germany, today announced the start of a Phase II, single-arm, multi-centre, open label study of BLP25 Liposome Vaccine (L-BLP25). The trial will assess the safety of the formulation of L-BLP25 that the Companies expect to use in the upcoming Phase III study. This formulation incorporates manufacturing changes intended to secure the future commercial supply of the vaccine. Enrolment of the 20-patient trial involving men and women with non-small cell lung cancer (NSCLC) from eight clinical trial sites in Canada is expected to be completed in the third quarter of 2005, with initial results anticipated before the end of 2005. Data obtained in 2004 from the NSCLC Phase IIb trial showed the greatest survival advantage in vaccinated patients with Stage IIIB locoregional (LR) disease. The new Phase II trial will include patients with unresectable Stage III disease. Thus, Stage IIIB LR patients will be included as well as, for the first time, patients with Stage IIIA disease. All patients in the Phase II trial must have demonstrated either stable disease or a clinical response after primary therapy of combined modality treatment (chemotherapy and radiation therapy). These same criteria are to be used for the planned Phase III trial. "The start of this Phase II trial is another step toward commencing our large, multi-national Phase III study, which we hope to begin by the end of this year," said Alex McPherson, MD, PhD, President and CEO. "If appropriate data from this Phase II trial are obtained, they may be used in discussions with Canadian regulatory authorities concerning the potential for early approval of this product candidate." Discussions over recent months with Health Canada indicate that safety data from this Phase II study will be needed before Health Canada will consider whether the product might be eligible for early approval based on survival data from the earlier Phase IIb study. The Companies, given recent feedback obtained from the US FDA, will not pursue early approval in the US. Nonetheless, the Companies are encouraged by the helpful comments from the US FDA regarding our clinical registration plans. About Lung Cancer In 2004, approximately 174,000 new cases of lung were diagnosed in the U.S. - 54 per cent of them in men and 46 per cent in women. Approximately 160,000 people will have died of this disease in the U.S. alone in 2004. Similar per capita rates of incidence and mortality occur in Canada. NSCLC accounts for approximately 75 to 80 per cent of all primary lung cancers. At the time of diagnosis, only 25 per cent of patients are potentially curable by surgery. The Companies Biomira is a biotechnology company specializing in the development of innovative therapeutic approaches to cancer management. Biomira's commitment to the treatment of cancer currently focuses on the development of synthetic vaccines and novel strategies for cancer immunotherapy. We are The Cancer Vaccine People(TM). Merck is a global pharmaceutical and chemical company with sales of EUR 5.9 billion in 2004, a history that began in 1668, and a future shaped by 28,900 employees in 52 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds a 73 per cent interest and free shareholders own the remaining 27 per cent. The former U.S. subsidiary, Merck & Co., has been completely independent of the Merck Group since 1917. Merck KGaA has built a strategic oncology portfolio by developing and in-licensing product candidates in four areas - monoclonal antibodies, therapeutic vaccines, immunocytokines and angiogenesis inhibitors. EMD Pharmaceuticals Inc., the U.S. affiliate of Merck KGaA, is a fully integrated pharmaceutical company with an initial emphasis on launching new products in oncology. Located in Durham, N.C., EMD focuses on meeting patient and physician needs with pioneering pharmaceutical products and services. This release may contain forward-looking statements. Various factors could cause actual results to differ materially from those projected in forward-looking statements, including those predicting the timing, duration and results of clinical trials, criteria for eligibility to participate in the trial, trial reviews and analyses and regulatory reviews, or the safety and efficacy of the product. Although the Company believes that the forward-looking statements contained herein are reasonable, it can give no assurance that the Company's expectations are correct or that the Company will have sufficient resources to fund clinical trials. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.