Biomira Inc. Release: BLP25 Liposome Vaccine Phase 2 Study Interim Results Indicate No Safety Concerns With Reformulated Vaccine
EDMONTON, Nov. 17 /PRNewswire-FirstCall/ - Biomira Inc. today announced the interim results of a phase 2 non-small cell lung cancer (NSCLC) single-arm, multi-centre, open label study of BLP25 Liposome Vaccine (L-BLP25) showing that the new formulation of the vaccine is not different from the previous formulation from a safety perspective. The reformulated vaccine incorporated manufacturing changes intended to secure the future commercial supply of the vaccine.
Though not a head-to-head comparison, the phase 2 trial compared the new formulation of L-BLP25 to the formulation used in the phase 2b trial, which was completed in 2004. A comparison of baseline and post-four vaccination laboratory tests for each trial, and between trials was conducted. For the majority of patients in both trials, the laboratory results were within the normal range for both time points. Also examined, for the same time frame, were adverse events, and injection site reactions. Although the two trials have slightly different patient populations and different sample sizes, based on the information reviewed, there is no clinical rationale to indicate that the two vaccine formulations are different from a safety perspective. The new formulation incorporated manufacturing changes intended to secure the future commercial supply of the vaccine.
In October, Biomira and Merck KGaA of Darmstadt, Germany announced that follow-up of patients enrolled in the phase 2b trial had determined a median survival for the vaccinated subset of Stage IIIB locoregional patients of 30.6 months compared to 13.3 months observed for the same stage patients who did not receive the vaccine, a difference of 17.3 months.
Tests to resolve a contract manufacturing stability issue are ongoing, with results expected in the first quarter of 2006.
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 28,600 employees in 54 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.
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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, trial reviews and analyses and regulatory reviews, the safety and efficacy of the product, the ability to retain collaborative partners and the ability to secure and manufacture vaccine supplies and the resolution of a recent manufacturing problem by an outside vendor of the vaccine. 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.Biomira Inc.
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