Company Enormously Encouraged by L-BLP25 Phase IIb Results to Date EDMONTON, May 18 /CNW/ - Biomira Inc. (Nasdaq:BIOM) (TSX:BRA) announced the following highlights of today's Annual General and Special Meeting of its shareholders. The meeting was chaired by the Board Chairman, Eric E. Baker, and followed by an address by the Company President and CEO, Alex McPherson, MD, PhD. Dr. McPherson's comments focused primarily on the Company's lead product candidate, BLP25 Liposome Vaccine (L-BLP25) and other aspects of the corporate strategic focus. "We are enormously encouraged with the data that came out in December 2004, from our last formal analysis of the Phase IIb study in non-small cell lung cancer (NSCLC), which was a protocol specified survival update," said Alex McPherson. The details of this survival update were presented at the 41st annual meeting of the American Society of Clinical Oncology (ASCO) held in Orlando, FL, last week. Specifically, the presentation at ASCO described the characteristics of patients and their survival outcomes, based on disease Stage at study entry, with most of the presentation being dedicated to describing the outcome of the 65-patient subset with Stage IIIB locoregional disease. In this subset, patients who received L-BLP25 survived considerably longer than those with the same Stage disease who received best supportive care. The difference in survival between patients who received vaccine and those who did not remains statistically non-significant (p(equal sign)0.0924). Given the relatively small numbers of patients in each group, this is not surprising. However, Biomira and Merck KGaA of Darmstadt, Germany, the collaborator for L-BLP25, are more encouraged with the median survival for the vaccine arm. At the time of the November 2004 formal analysis, the median survival in the vaccine arm was still not reached, but we know it will not be less than 23 months with a hazard ratio of 0.5652. A hazard ratio of less than one indicates a decrease in the risk of death. Patients who did not receive vaccine survived a median 13.3 months. The one-year, two-year and three-year survival differences continue to suggest a very positive survival impact for those who received the vaccine. A second poster at ASCO described the patients' quality of life outcomes by Stage of disease. Statistically significant differences in quality of life were identified at two separate time-points on the trial for patients with Stage IIIB locoregional disease, favoring patients who received vaccine. No differences were found between the patients with Stage IIIB with pleural effusion and Stage IV disease. "The results of this trial remain very encouraging," said Dr. McPherson. "The two-year survival data 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. The quality of life data for vaccinated patients with Stage IIIB locoregional disease, is also encouraging. We see an important trend in our data that is worth exploring in a Phase III study, and adding patients with Stage IIIA unresectable disease to our trial will increase the potential market, should we be successful." "We, along with our collaborator, Merck KGaA of Darmstadt, Germany, are keenly interested in obtaining the median survival information from the Stage IIIB vaccinated patients," said Dr. McPherson. "Therefore, we plan to amend the protocol to allow further survival documentation to be collected. We need to do this as the trial was not originally designed with this further analysis in mind. We estimate this analysis may be complete by the end of 2005." Biomira is currently enrolling patients in a L-BLP25 Phase II safety study in preparation for the large multinational pivotal Phase III study, expected to commence towards the end of 2005. The Phase II safety study incorporates manufacturing changes to the vaccine intended to secure the future commercial supply of the vaccine. The Phase II study is expected to enroll approximately 20 patients in eight sites across Canada and should complete enrolment in the third quarter of 2005. "Scheduling these changes now ensures that the resulting pivotal data will be considered representative of the commercial supply of the vaccine," said McPherson. "This small study is scheduled to be conducted in parallel with preparations for the larger confirmatory study and is not expected to affect timelines for starting that larger study." L-BLP25, for the NSCLC indication, received fast track designation from the U.S. Food and Drug Administration (FDA) in September, 2004. Fast track status is intended for product candidates that may one day treat serious or life-threatening conditions and demonstrate the potential to address an unmet medical need. According to the World Health Organization, there are more than 1.2 million cases of NSCLC each year causing 1.1 million deaths annually. In 2004, in the U.S. alone there were 173,000 new cases diagnosed. Lung cancer is the cause of approximately 30 per cent of cancer deaths in the United States and NSCLC accounts for almost 80 per cent of all lung cancers. The planned Phase III study is expected to focus on patients with Stage IIIA unresectable disease and Stage IIIB locoregional disease. These patients account for approximately 25 per cent of NSCLC patients. Synthetic Biologics Unit Last month we created a Synthetic Biologics Business Unit. This business unit was created to take advantage of the tremendous potential in chemically synthesized biologicals for use in protective and therapeutic vaccines. The business unit is lead by Rao Koganty, PhD. "This new business unit will dedicate resources to take advantage of a remarkable industry need," said Alex McPherson. "We have developed technologies that can be used by any company developing non-competing vaccine technology. Dr. Koganty's expertise in this will complement our current programs and provide new upside business potential." Synthetic organic chemistry has been the foundation of our vaccine development program. Our scientists design and synthesize both antigens and immune stimulants, essential components of every vaccine, to achieve safety, specificity, purity and dependability in performance. Synthetic structures carry an impeccable structural definition that eludes natural macromolecules. With structural definition, you are assured of consistency in production and performance. Our products are proven safe and superior in performance and we are able to provide a variety of synthetic immune stimulants (adjuvants) that will assist companies in vaccine development and clinical testing. Biomira's Board of Directors approved the appointment of Dr. Koganty to Vice President and General Manager of the Synthetic Biologics Unit at the Board Meeting today, which was held prior to the Annual General and Special Meeting. Business Development Biomira is seeking partners for two other product candidates. The first is Theratope(R) vaccine. Theratope completed a Phase III study in 2003. While results were not statistically significant in the overall patient population, a large subset of women, those treated with concurrent hormonal therapy appeared to see clinical benefit. These results were reported at last year's ASCO Annual Meeting. Biomira is also seeking a collaborator for a completely synthetic MUC1 based liposomal glycolipopeptide cancer vaccine, BGLP40, which we believe may provide benefit in several cancer indications. BGLP40 is an advanced vaccine designed to evoke both a cellular and humoral immune response against major cancer-associated epitopes expressed on adenocarcinomas. A collaborator to assist in clinical development through to commercialization is being sought. Finance At the end of the first quarter 2005, Biomira had U.S. $28.3 million or $34.1 million Canadian in cash and short-term investments. The Company believes that it has funds to sustain it well into 2006 at the current expenditure rate. "We have a strong corporate alliance and the finances to see us through to a point where we can make strategic decisions on the path forward for L-BLP25," said McPherson. "We are working hard to control spending while looking at opportunities to increase shareholder value through strategic in-licensing and out-licensing opportunities," concluded Dr. McPherson. The Company 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). Web cast Details: Biomira's Web cast of the Annual General and Special Meeting will be archived on the Biomira Web site at: http://www.biomira.com/investors/presentations/. 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 and additional analyses, potential meetings with regulatory authorities, 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.