Continuation of the Phase III Clinical Trial of AGS-003
First written in FY2017. 2 of 4 entries say "Dropped", first in FY2018-Q2. Latest entry: FY2019-Q2.
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- FY2019-Q2DroppedAnnual report
「The license agreement with Argos Therapeutics, Inc. for the cell therapy product AGS-003 ended on 7 January 2019 because Argos filed for relief under Chapter 11 of the U.S. Bankruptcy Code with the U.S. Bankruptcy Court on 30 November 2018, and the court approved Argos's application to reject the license agreement.」
The license agreement for AGS-003 ended on 7 January 2019 following Argos's bankruptcy proceedings and court approval of its rejection of the license agreement. - FY2018-Q3RestatedAnnual report
「In the cell-processing business, sales of physician-directed immune cell processing for cancer, which had previously been the core business, fell sharply as the market environment in the cancer treatment field changed, including the wider adoption of immune checkpoint inhibitors,」
The disclosure describes the transition to structural reform in response to the sharp decline in cancer immune cell-processing sales and changes in the market environment. - FY2018-Q2DroppedAnnual report
「As Argos discontinued development of the licensed product, it abandoned plans to commercialize it,」
The disclosure stated that Argos had discontinued development and abandoned commercialization of the licensed product, changing from the previous policy of continuing the Phase III clinical trial of AGS-003. - FY2017First statedAnnual report
「The interim analysis results of the Phase III clinical trial in Europe and the United States for AGS-003, a regenerative medical product developed by Argos Therapeutics, Inc. of the United States for metastatic renal cell carcinoma, became available in February 2017. Although the independent data monitoring committee recommended discontinuing the trial, we consulted with the FDA and decided to continue it because the characteristics of the investigational product meant that its efficacy would take time to become apparent.」
After the independent data monitoring committee recommended discontinuation, the Company decided to continue the Phase III trial following consultations with the FDA.