SEATTLE, Oct. 1, 2018 /PRNewswire/ -- CTI BioPharma
Corp. (NASDAQ:CTIC) today announced that following a planned second
interim data review of the PAC203 study by the Independent Data
Monitoring Committee (IDMC), the study will continue to the full
enrollment of 150 patients. The IDMC did not identify significant
drug- or dose-related safety concerns and specifically did not
identify any concerns around hemorrhagic or cardiac toxicity.
Following consultation with the U.S. Food and Drug Administration
(FDA) and the IDMC, the Company restricted this interim analysis to
a safety review thereby allowing the study to continue to full
enrollment. Continuing to full enrollment allows collection of a
complete dataset (including efficacy, safety, pharmacokinetic and
pharmacodynamic data) that will be used to determine the optimal
dose for further development. Prior to the second interim analysis
and with the agreement of the IDMC, the Company had submitted a
protocol amendment to the FDA, establishing safety reviews as the
basis for the second interim analysis and for subsequent interim
analyses.
"Continuing the PAC203 study with all three treatment arms
allows us to obtain the maximum amount of data to determine the
optimal dose for our planned Phase 3 registrational study, which is
expected to address a patient population with severe
thrombocytopenia," said Adam R.
Craig, M.D., Ph.D., President and Chief Executive Officer of
CTI BioPharma.
"The PAC203 study is on track to complete its objective and we
continue to expect to complete enrollment by the end of 2018. We
plan to present clinical data at an upcoming medical conference,
potentially at the ASCO conference in 2019."
The PAC203 study is evaluating the safety and efficacy of three
dosing schedules (100 mg once daily, 100 mg twice daily and 200 mg
twice daily) over 24 weeks in patients with myelofibrosis
previously treated with ruxolitinib. More information on the PAC203
trial can be found at ClinicalTrials.gov at
https://clinicaltrials.gov/ct2/show/NCT03165734.
About Pacritinib
Pacritinib is an investigational oral kinase inhibitor with
specificity for JAK2, FLT3, IRAK1 and CSF1R. The JAK family of
enzymes is a central component in signal transduction pathways,
which are critical to normal blood cell growth and development, as
well as inflammatory cytokine expression and immune responses.
Mutations in these kinases have been shown to be directly related
to the development of a variety of blood-related cancers, including
myeloproliferative neoplasms, leukemia and lymphoma. In addition to
myelofibrosis, the kinase profile of pacritinib suggests its
potential therapeutic utility in conditions such as acute myeloid
leukemia (AML), myelodysplastic syndrome (MDS), chronic
myelomonocytic leukemia (CMML), and chronic lymphocytic leukemia
(CLL), due to its inhibition of c-fms, IRAK1, JAK2 and FLT3.
About Myelofibrosis and Myeloproliferative Neoplasms
Myelofibrosis is one of three main types of myeloproliferative
neoplasms (MPN), which are a closely related group of progressive
blood cancers. The three main types of MPNs are primary
myelofibrosis (PMF), polycethemia vera (PV) and essential
thrombocythemia (ET).
Myelofibrosis is a serious and life-threatening bone marrow
disorder caused by the accumulation of malignant bone marrow cells
that triggers an inflammatory response and scars the bone marrow.
The replacement of bone marrow with scar tissue limits its ability
to produce red blood cells, prompting the spleen and liver to take
over this function. Symptoms that arise from this disease include
enlargement of the spleen, anemia, extreme fatigue and pain.
The estimated prevalence of MPNs suggest there are approximately
300,000 people living with the disease in the U.S., of which
myelofibrosis accounts for approximately 18,000 patients. In
Europe, there is a wide variation
of prevalence observed across data sources. Myelofibrosis has a
median age of 64 at the time of diagnosis and is a progressive
disease with approximately 20 percent of patients eventually
developing acute myeloid leukemia (AML). The median survival for
high-risk myelofibrosis patients is less than 1.5 years, while the
median survival for patients with myelofibrosis overall is
approximately 6 years.
About CTI BioPharma Corp.
CTI BioPharma Corp. is a biopharmaceutical company focused on the
acquisition, development and commercialization of novel targeted
therapies covering a spectrum of blood-related cancers that offer a
unique benefit to patients and healthcare providers. The CTI
BioPharma lead product candidate, pacritinib, is being developed
for the treatment of patients with myelofibrosis. CTI BioPharma is
headquartered in Seattle,
Washington.
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, the efficacy of, and potential
changes to, our clinical trial designs and anticipated enrollment,
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 pactritinib 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 Investor Contacts:
Julia Balanova (investors)
+1 646-378-2936
jbalanova@troutgroup.com
Rich Allan (media)
+1 646-378-2958
rallan@troutgroup.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/cti-biopharma-announces-the-continuation-of-pac203-study-following-interim-data-review-300720970.html
SOURCE CTI BioPharma Corp.