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disease or death, whichever comes first.
iv Access to a proportion of the data (the training set) will allow for the unbiased generation of a mathematical model to assess the third co primary endpoint in the remainder of the data (the test set).
Agenus is a biopharmaceutical company developing a portfolio of immuno oncology candidates, including checkpoint modulators (CPMs), heat shock protein vaccines and adjuvants. The company's proprietary discovery engine Retrocyte Display is designed to rapidly generate high quality therapeutic antibody drug candidates using a high throughput approach incorporating full length IgG format human antibody libraries expressed in mammalian B lineage cells. A portfolio of checkpoint modulator programs is advancing in preclinical development. The company's heat shock protein vaccines for cancer and infectious disease are in Phase 2 studies. Agenus' QS 21 Stimulon adjuvant platform is extensively partnered with GlaxoSmithKline and Janssen and includes several candidates in Phase 3 trials. Among Agenus and its partners, 23 programs are in clinical development.
GSK's MAGE A3 Cancer Immunotherapeutic Phase 3 Study in Non Small Cell Lung Cancer Misses First Co Primary Endpoints
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In this study, patients were given up to 13 intramuscular injections of either the MAGE A3 immunotherapeutic or placebo over a period of 27 months.
The Independent Data Monitoring Committee for the MAGRIT study indicated that a review of the safety information raised no specific concern for the continuation of the trial.
GSK announced that it will continue the study until an analysis of the third co primary endpoint is complete. This analysis is based on gene signature and designed to prospectively identify MAGE A3 positive patients who may benefit more from treatment. If further analysis shows that the predefined gene signature subset data are successful, there is the potential for regulatory filing. GSK anticipates that these data should be available in 2015. Until then, GSK will remain blinded to all safety and efficacy data.
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also continuing to evaluate whether a gene signature can identify a population that would benefit from the same investigational MAGE A3 cancer immunotherapeutic in DERMA, another Phase 3 trial in melanoma, which reported on the first co primary endpoint in September 2013.
LEXINGTON, Mass. (BUSINESS WIRE) Agenus Inc. (Nasdaq: AGEN) today announced that GlaxoSmithKline's (NYSE: GSK) MAGRITi study, a Phase 3 randomized, blinded, placebo controlled MAGE A3ii cancer immunotherapeutic trial in non small cell lung cancer patients, which contains Agenus'QS 21 Stimulon adjuvant, did not meet its first or second co primary endpoint. The study did not significantly extend the disease free survival (DFS)iii period when compared to placebo in the overall MAGE A3 positive patients or patients who did not receive chemotherapy.
Stimulon and Retrocyte Display are registered trademarks of Agenus Inc. and its subsidiaries.
GSK currently remains blinded to further details of the analysis of the first two co primary endpoints in order to allow for the unbiased generation of a mathematical model to assess the third co primary endpointiv, which is expected to be known in 2015. GSK is Michael Kors Hamilton Wallet
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iii DFS is defined as the time from randomization to the date of first recurrence of the Michael Kors Purse Outlet
This press release contains forward looking statements, including statements regarding the Company's and/or its licensees' clinical trial activities, the publication of data, and the potential application of technologies and product candidates in the prevention and treatment of diseases. These forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our Annual Report on Form 10 K filed with the Securities and Exchange Commission for the year ended December 31, 2013. Agenus cautions investors not to place considerable reliance on the forward looking statements contained in this release. These statements speak only as of the date of this document, and Agenus undertakes no obligation to update or revise the statements. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Agenus' business is subject to substantial risks and uncertainties, including those identified above. When evaluating Agenus' business and securities, investors should Michael Kors Purse Black With Gold Studs give careful consideration to these risks and uncertainties.
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