$AGEN Report Filing (8-k)
Post# of 29735
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Current Report Filing (8-k) | ||||||||||||||||||||||||||||||
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UNITED STATES FORM 8-K CURRENT REPORT September 5, 2013 AGENUS INC.
781-674-4400 Item 8.01 Other events Agenus Inc. announced today that GlaxoSmithKline’s ( NYSE : GSK) DERMA i study, a Phase 3 randomized, blinded, placebo-controlled MAGE-A3 cancer immunotherapeutic ii (CI) trial, which contains Agenus’QS-21 Stimulon ® adjuvant iii , a component of GSK’s novel adjuvant system AS15, did not meet its first co-primary endpoint. In an independent analysis, the study did not significantly extend the disease-free survival (DFS) iv period when compared to placebo in the overall MAGE-A3 positive trial population. In line with the Independent Data Monitoring Committee’s (IDMC) unanimous recommendation, GSK will continue the study until the second co-primary endpoint is assessed. This co-primary endpoint is based on predefined criterion that was agreed upon by regulatory authorities. This analysis, which is based on gene signature, is designed to prospectively identify patients who may have the capability to be more immunologically responsive and therefore can potentially benefit from treatment. If further analysis shows that the predefined gene signature subset data are successful, there is the potential that a regulatory filing could be considered. GSK anticipates that these data will be available in 2015. Until then, GSK will remain blinded to all safety and efficacy data. The full text of the press release issued in connection with the announcement is being filed as Exhibit 99.1 to this current report on Form 8-K. i Adjuvant immunotherapy with MAGE-A3 in melanoma GSK 2132231A Antigen-Specific Cancer Immunotherapeutic in patients with resected melanoma. Item 9.01 Financial Statements and Exhibits (d) Exhibits The following exhibit is filed herewith: 99.1 Press Release dated September 5, 2013 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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