United States : FDA Grants Additional Fast Track Designation for OGX-011 in Combination with First Line Chemotherapy.OncoGenex Pharmaceuticals, Inc. announced that OGX-011, also known as custirsen sodium, received an additional Fast Track Designation from the U.S. Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for progressive metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. in combination with first-line docetaxel treatment. OncoGenex had previously received Fast Track Designation for second-line docetaxel treatment with OGX-011 in combination with docetaxel for treatment of progressive metastatic prostate cancer following docetaxel. "An expansion of the current Fast Track Designation to include OGX-011 in combination with first-line docetaxel treatment, in addition to second-line docetaxel treatment of patients with progressive metastatic prostate cancer, is consistent with our current development plans in prostate cancer," said Scott Cormack, Chief Executive Officer of OncoGenex Pharmaceuticals. "We intend to execute Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. protocols, which now have completed Special Protocol Assessments (SPA's) for first-line and second-line chemotherapy treatment, and these Fast Track Designations along with the SPA's should help us move expeditiously toward commercialization of OGX-011 in prostate cancer." The request for Fast Track designation was based on data from the randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , Phase 2 study (Study OGX-011-03) that suggested OGX-011 in combination with first-line docetaxel treatment may improve survival in patients with castrate castrate /cas·trate/ (kas´trat) 1. to deprive of the gonads, rendering the individual incapable of reproduction. 2. a castrated individual. cas·trate v. 1. resistant prostate cancer (CRPC). The median overall survival in patients with CRPC who were treated with OGX-011 plus first-line docetaxel was 23.8 months (95% Confidence Interval (CI) from 16.2 to infinity) compared to 16.9 months (95% CI from 12.8 to 25.8) for patients treated with docetaxel alone with a hazard ratio of 0.61 (95% CI from 0.36 to 1.02). Copyright : Euclid Infotech Pvt. Ltd. Provided by Syndigate.info an Albawaba.com company |
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