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Replies to post #1672 on Argos Therapeutics Inc fka ARGSQ
finesand
03/01/18 10:46 PM
#1673 RE: finesand #1672
The FDA agreed with the Company's plan to continue the trial in accordance with the current protocol to 290 events, the pre-specified number of events at which the analysis of overall survival, the primary endpoint, is to be conducted. The Company believes that 290 events will have occurred by late 2017 or early 2018. The Company also proposed to submit, and the FDA agreed to review, a protocol amendment to increase the pre-specified number of events for the primary analysis of overall survival beyond 290 events, which the Company believes could enhance its ability to detect whether Rocapuldencel-T has a delayed treatment effect. The Company can extend the study past 290 events without needing to enroll additional patients.
The favorable results of this study provide support for Argos' ongoing HIV eradication study in which AGS-004 is being administered in combination with vorinostat, a latency-reversing drug. This study is being conducted at the University of North Carolina, with planned enrollment of up to 12 patients and with initial data expected in early 2018. Funding for the development of AGS-004 for the treatment of HIV is being provided by the National Institutes of Health and the Collaboratory of Research for AIDS Eradication.
Study Start Date : March 2016 Estimated Primary Completion Date : March 2018 Estimated Study Completion Date : December 2019