Biomira Announces Completion of Enrolment in BLP25 Liposome Vaccine Phase 2 Safety Study

Main Category: Lung Cancer
Article Date: 18 Sep 2005 - 16:00 PDT

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Biomira Inc announced that it has completed the enrolment of a 20-patient phase 2, single-arm, multi-centre, open label study of BLP25 Liposome Vaccine (L-BLP25). The drug is being developed in collaboration with Merck KGaA of Darmstadt, Germany.

The phase 2 trial will assess the safety of the formulation of L-BLP25 that the Companies plan to use in the upcoming phase 3 study. The phase 3 trial design is currently being discussed with the FDA. The formulation incorporates manufacturing changes intended to secure the future commercial supply of the vaccine. Initial results from the 20-patient trial involving men and women with non-small cell lung cancer (NSCLC) from eight clinical trial sites in Canada are anticipated before the end of 2005.

"The completion of enrolment for this phase 2 safety study is another important step toward commencing our large, multi-national phase 3 study, which we expect to begin by the end of this year," said Alex McPherson, MD, PhD, President and CEO.

About Lung Cancer

In 2004, approximately 174,000 new cases of lung were diagnosed in the U.S. Approximately 160,000 people are estimated to have died of this disease in the U.S. alone in 2004. NSCLC accounts for approximately 75 to 80 percent of all primary lung cancers. At the time of diagnosis, only 25 per cent of patients are potentially curable by surgery.

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. (http://www.emdpharmaceuticals.com), 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 (http://www.biomira.com) 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.

http://www.biomira.com

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