SEATTLE, Nov. 26, 2018 /PRNewswire/ -- CTI BioPharma Corp.
(NASDAQ:CTIC) today announced that the Company has received a
second round of questions related to the Day 180 List of
Outstanding Issues, for the marketing authorization application
(MAA) for pacritinib, from the European Medicines Agency (EMA). The
Company plans to submit responses to the EMA, which will include
data from the ongoing open label PAC203 trial, by the end of the
year. In addition, the Company is preparing for an Oral Explanation
meeting before the Committee for Medicinal Products for Human Use
(CHMP). A decision by CHMP on the MAA is expected in the first
quarter of 2019.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 and the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements include statements regarding our expectations regarding
the timing of and results from clinical trials and development
activities related to pacritinib, the potential efficacy, safety
profile, future development plans, addressable market, regulatory
success and commercial potential of pacritinib, the anticipated
timing of regulatory submissions and our interactions with
regulators, the efficacy of, and potential changes to, our clinical
trial designs and anticipated enrollment, including timing thereof,
our ability to successfully develop and achieve milestones in the
development of pacritinib, and the anticipated benefits of
pacritinib. These forward-looking statements are based on current
assumptions that involve risks, uncertainties and other factors
that may cause the actual results, events or developments to be
materially different from those expressed or implied by such
forward-looking statements. These risks and uncertainties, many of
which are beyond our control, include, but are not limited to:
clinical trials may not demonstrate safety and efficacy of any of
our or our collaborators' product candidates; our assumptions
regarding our planned expenditures and sufficiency of our cash to
fund operations may be incorrect; our efforts to advance the
development of pacritinib may not be successful; any of our or our
collaborators' product candidates may fail in development, may not
receive required regulatory approvals, or may be delayed to a point
where they are not commercially viable; we may not achieve
additional milestones in our proprietary or partnered programs; the
impact of competition; the impact of expanded product development
and clinical activities on operating expenses; adverse conditions
in the general domestic and global economic markets; as well as the
other risks identified in our filings with the Securities and
Exchange Commission. These forward-looking statements speak only as
of the date hereof and we assume no obligation to update these
forward-looking statements, and readers are cautioned not to place
undue reliance on such forward-looking statements.
"CTI BioPharma" and the CTI BioPharma logo are registered
trademarks or trademarks of CTI BioPharma Corp. in various
jurisdictions. All other trademarks belong to their respective
owner.
CTI BioPharma Contacts:
Julia Balanova (investors)
+1 646 378 2936
jbalanova@troutgroup.com
Rich Allan (media)
+1 646-378-2958
rallan@troutgroup.com
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SOURCE CTI BioPharma Corp.