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Updated Survival Results From BLP25 Liposome Vaccine (L-BLP25) Phase IIb Study From Patients With Stage IIIB Non-Small Cell Lung Cancer (NSCLC) Presented

Posted on: Monday, 16 May 2005, 09:00 CDT

EDMONTON, May 16 /PRNewswire-FirstCall/ -- Biomira Inc. (TSX:BRA) of Edmonton, Alberta, Canada and Merck KGaA of Darmstadt, Germany, announced today that a poster discussion on Saturday, May 14, 2005 at the ASCO meeting detailed the updated annual survival results from the Phase IIb NSCLC study in patients with Stage IIIB disease. The data were from the trial's last formal analysis that was conducted in November 2004 and discussed in general terms in December 2004. Dr. Nevin Murray, a Clinical Investigator with the Phase IIb study, was the lead author on the poster. Dr. Murray is from the BC Cancer Agency, Vancouver, British Columbia. His poster was entitled, "A Liposomal MUC1 Vaccine for Treatment of Non-Small Cell Lung Cancer (NSCLC); Updated Survival Results from Patients with Stage IIIB Disease". Dr. Charles Rudin of Johns Hopkins led the discussion portion of the presentation.

At the time of the November 2004 survival update, conducted approximately two years after the last patient had been enrolled in the trial, the median survival of patients with Stage IIIB locoregional disease who received best supportive care was 13.3 months and that the median survival had not yet been reached for those of the same disease stage who received vaccine. This means that more than 50 per cent of the patients on the vaccine arm in this subset were still alive at that time. The difference in survival between the two groups remains non-significant (p(equal sign)0.0924). However, the median survival of the vaccine arm will be no less than 23 months and the hazard ratio remains 0.5652 (A hazard ratio of less than one indicates a decrease in the risk of death). The one-year, two-year, and three-year survival differences continue to suggest a positive survival impact for those who received vaccine.

"Despite the relatively small number of Stage IIIB patients in each arm of the study, I believe the data support moving forward with a Phase III trial, to see if we can show a statistically significant advantage for patients in the vaccine arm," said Dr. Murray. "I look forward to participating in that larger study as quickly as possible."

"We are very encouraged with the results of this trial," said Alex McPherson, MD, PhD, President and CEO of Biomira Inc. "The two-year survival data which show 33.3 per cent of patients on the best supportive care arm remained alive, while 57.1 per cent of patients on the vaccine arm were still alive. The three-year survival data are also very promising, but these data are less mature."

Both Biomira(R) and our collaborator, Merck are keenly interested in obtaining the median survival information from the Stage IIIB vaccinated patients. Therefore, we plan to amend the protocol to allow further survival documentation to be collected, as the trial was not originally designed with this further analysis in mind. We estimate this analysis will be complete by the end of 2005.

Another L-BLP25 investigator will present a second poster from the Phase IIb study on May 17 at ASCO. Dr. Denis Soulieres is from Hopital Notre-Dame du CHUM Centre D'Oncologie in Montreal, Quebec. His presentation entitled, "A Liposomal MUC1 Vaccine for Treatment of Non-Small Cell Lung Cancer (NSCLC): Differences in QOL Assessments for Stage IIIBLR and IV Patients," will be part of the poster session. "QOL" is defined as Quality of Life.

In April, we announced the start of a L-BLP25 Phase II Safety Study to assess the safety of the vaccine formulation that we expect to use in the Phase III trial. This formulation incorporates manufacturing changes put in place to help ensure the future commercial supply of the vaccine. The Phase II Safety Study is expected to involve eight sites in Canada and will enroll up to 20 men and women with NSCLC. We expect enrolment to be fully completed in the third quarter of 2005. The large multi-national Phase III study is expected to commence toward the end of 2005.

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.

About the Companies

Our key collaboration in developing therapeutic cancer vaccines is with Merck KGaA. 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.

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).

Abstract Numbers:

1. Abstract ID: 7037 - Scientific Program in the Lung Cancer I Poster

Discussion Abstract Title: A Liposomal MUC1 vaccine for treatment of

non-small cell lung cancer (NSCLC); updated survival results from

patients with stage IIIb disease Presenter: Dr. Nevin Murray

2. Abstract ID: 7209 - Scientific Program in the Lung Cancer General

Poster Session Abstract Title: A Liposomal MUC1 vaccine for treatment

of non-small cell lung cancer (NSCLC): Differences in QOL assessments

for Stage IIIBLR and IV patients

Presenter: Dr. Denis Soulieres

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 and results of clinical trials, whether promising or statistically significant results here indicated will be replicated in larger trials which may follow, availability or adequacy of financing, the sales and marketing of commercial products or the efficacy of products. 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. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

BIOMIRA INC. 2011 - 94 St. Edmonton, AB, Canada T6N 1H1

Tel: (780) 450-3761 Fax: (780) 463-0871

http://www.biomira.com/

Biomira Inc.

CONTACT: Biomira Company Contacts: Bill Wickson, Manager, PublicRelations, (780) 490-2818, After hours contact: bwickson@biomira.com; JaneTulloch, Director, Investor Relations, (780) 490-2812; U.S. Media: DanielBudwick, Media Relations, (212) 477-9007 ext. 14; Merck KGaA Contact, PhyllisCarter, Mobile: +49 61-51/72-7144;To request a free copy of this organization's annual report, please go tohttp://www.newswire.ca/ and click on reports@cnw.

Source: PRNewswire-FirstCall

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