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Biomira announces final Phase 2b survival results of Stimuvax(R) (formerly known as BLP25 Liposome Vaccine) trial in patients with non-small cell lung cancer
2006-04-28 06:00 ET - News Release
EDMONTON, April 28 /PRNewswire-FirstCall/ - Biomira Inc. today announced final survival results from an exploratory analysis of the Phase 2b clinical trial data. The randomized, open-label trial tested the clinical potential of Stimuvax(R) in patients with Stage IIIB and IV non-small cell lung cancer (NSCLC). The analysis confirms a median survival in Stage IIIB patients on vaccine being 30.6 months, while Stage IIIB patients on the control had a median survival of 13.3 months.
"Our enthusiasm around Stimuvax(R) continues," said Alex McPherson, MD, PhD, President and CEO of Biomira. "These data from the Phase 2b trial are encouraging and have been reviewed by an independent statistician, who confirms our findings. We are in the process of completing the transition of this exciting project to Merck KGaA of Darmstadt, Germany and we have begun manufacturing the vaccine required for the phase 3 study slated to start this summer. We are hopeful that this larger randomized trial will confirm the results seen in the phase 2b trial."
Stimuvax(R): Clinical Study Design and Results of Additional Analysis
The controlled, open-label Phase 2b trial enrolled 171 men and women with NSCLC whose disease was stable or who had responded to treatment following completion of their first-line standard chemotherapy with or without radiation therapy. Patients were randomized to either Stimuvax(R) plus best supportive care or to best supportive care alone. Best supportive care includes palliative radiation therapy and/or second line chemotherapy according to current standard clinical practice. The study was designed to document the safety profile of the vaccine and to evaluate efficacy by comparing survival in the two arms.
An earlier survival analysis reported in November 2004, indicated that the median survival in the pre-stratified subset of locoregional Stage IIIB patients on the vaccine arm had not been reached. Informal survival results from an additional exploratory analysis have now been confirmed showing a median survival in the Stage IIIB patients on vaccine being 30.6 months, while the Stage IIIB patients on the control had a median survival of 13.3 months.
Stimuvax(R)
Formerly known as BLP25 Liposome Vaccine (L-BLP25), Stimuvax(R) is a synthetic MUC1 peptide vaccine. Stimuvax(R) incorporates a 25-amino acid sequence of the MUC1 cancer mucin, encapsulated in a liposomal delivery system. The liposome enhances recognition of the cancer antigen by the immune system and facilitates better delivery. Stimuvax(R) is designed to induce an immune response to cancer cells.
Biomira
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).
Except for historical information contained herein, this release contains forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements, particularly those risks and uncertainties surrounding the efficacy of Stimuvax(R) to treat men and women with NSCLC, which may include risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such a difference include the risk that additional trials may not demonstrate the safety and efficacy required to satisfy the regulatory authorities, and other matters required to bringing products to market; dependence on the efforts of third parties, including suppliers and collaborators, dependence on intellectual property rights and the effectiveness thereof, difficulties or delays in manufacturing products, and regulatory developments involving products and manufacturing facilities. For more detailed information on the risks and uncertainties associated with the Company's product candidates and other activities see the Company's periodic reports filed with the applicable securities regulatory authorities in Canada and the United States Securities and Exchange Commission. The Company assumes no obligation to update any forward-looking statements.
Biomira Inc.
CONTACT: Biomira Company Contacts: Bill Wickson, Director, Communications
& Investor Relations, (780) 490-2818, bwickson@biomira.com; U.S. Media
Contact: Jonathan Birt, Financial Dynamics, (212) 850-5634,
jbirt@fd-us.com, After hours contact: bwickson@biomira.com; U.S. Investor
Contact: John Capodanno, Financial Dynamics, (212) 850-5705,
jcapodanno@fd-us.com; To request a free copy of this organization's annual
report, please go to www.news.ca and click on Tools for
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