SEATTLE, July 2, 2018 /PRNewswire/ -- CTI BioPharma
Corp. (NASDAQ:CTIC) today announced that following a planned
interim data review by the Independent Data Monitoring Committee
(IDMC) of PAC203, the study will continue without modification and
that a second interim review will be conducted in the third quarter
of 2018. The IDMC did not identify any drug- or dose-related safety
concerns and specifically did not identify any concerns about
cardiac or bleeding events.
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. The study is designed to
enroll up to 150 patients and is expected to complete enrollment
before the end of 2018. 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.
CTI BioPharma has a late-stage development pipeline, including
pacritinib 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 are not based on historical fact, and include statements
regarding our expectations regarding, the timing of and results
from clinical trials and pre-clinical 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
IND and other 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 pacritinib, 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 our
pipeline 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.