CTI BIOPHARMA CORP. (NASDAQ:CTIC) Files An 8-K Other EventsItem 8.01. Other Events.
Submission of Responses to Day 120 List of Questions
As disclosed in its periodic filings, CTI BioPharma Corp. (the “Company”) previously submitted a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) for its lead development candidate, pacritinib. In July 2017, the MAA was validated by the EMA, which initiated the centralized review process by the Committee for Medicinal Products for Human Use (“CHMP”). In November 2017, as part of its review process, CHMP submitted its Day 120 List of Questions (“D120 LoQ”) to the Company and, on May 24, 2018, the Company submitted its responses to the D120 LoQ.
Final EMA GCP Inspection Report
The Company also reported that the EMA’s February 2018 final good clinical practices (“GCP”) inspection report concluded that the Company’s PERSIST-2 clinical trial of pacritinib was generally conducted in compliance with GCP and internationally accepted ethical standards, that the deficient safety reporting procedures identified did not pose a direct risk for data quality and that the results from the PERSIST-2 clinical trial can be used for the evaluation and assessment of the MAA.
In certain of the Company’s previous periodic filings, including its Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission (the “Commission”) on March 7, 2018 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2018 filed with the Commission on May 3, 2018, descriptions of the EMA’s January 2018 interim GCP inspection report stated that compliance was not verified in the areas of protocol compliance, safety reporting and data integrity, where significant deficiencies were cited. Such description of the January 2018 interim GCP inspection report is supplemented and updated by the information set forth in the immediately preceding paragraph.
About CTI BIOPHARMA CORP. (NASDAQ:CTIC)
CTI BioPharma Corp. (CTI) is a biopharmaceutical company focused on the acquisition, development and commercialization of targeted therapies covering a spectrum of blood-related cancers to patients and healthcare providers. The Company is primarily focused on commercializing PIXUVRI in select countries in the European Union, for multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL). It is also engaged in evaluating pacritinib for the treatment of adult patients with myelofibrosis. Its earlier stage product candidate, tosedostat, is an oral, once-daily aminopeptidase inhibitor that has demonstrated responses in patients with acute myeloid leukemia (AML). It also evaluates its pipeline candidate paclitaxel poliglumex (Opaxio), which targets solid tumors. It is evaluating Opaxio through cooperative group sponsored trials and investigator-sponsored trials (ISTs), such as the ongoing maintenance therapy trial in patients with ovarian cancer.