SEATTLE, Nov. 30, 2020 /PRNewswire/ -- CTI BioPharma
Corp. (Nasdaq: CTIC) today announced that an article highlighting
pacritinib data was published in Blood Advances. The
article, titled "Determining the Recommended Dose of Pacritinib:
Results from the PAC203 Phase 2 Dose-Finding Study in Patients with
Advanced Myelofibrosis" is available online via this link.
"Having recently announced the start of a rolling NDA submission
for pacritinib as a treatment for myelofibrosis patients with
severe thrombocytopenia, a patient population with reduced survival
and limited therapeutic options, we continue to be committed to
adding to the growing body of evidence underscoring the efficacy
and safety profile of pacritinib," said Adam R. Craig, M.D., Ph.D., President and Chief
Executive Officer of CTI Biopharma. "As our application will
consist of a data package from the PERSIST-1, PERSIST-2 and PAC203
Phase 2 trials, with the ongoing Phase 3 PACIFICA trial expected to
be completed as a post-marketing commitment, the data published
today support our belief that pacritinib has the potential to
become an important treatment in this disease setting, pending
regulatory approval."
PAC203 Phase 2 was an open-label, randomized, dose-finding trial
of pacritinib in patients with myelofibrosis who were previously
treated with ruxolitinib. Patients were randomized 1:1:1 to
pacritinib 100 mg daily (QD), 100 mg BID, or 200 mg BID. The
trial demonstrated that pacritinib 200 mg BID had a favorable
benefit risk profile. Spleen volume response (SVR) rates were
highest among patients treated with pacritinib 200 mg BID who had a
baseline platelet count of less than 50 x
109/L. Overall, the study data supported the
selection of the pacritinib 200 mg BID for use in the ongoing Phase
3 PACIFICA study of pacritinib in patients with myelofibrosis with
severe thrombocytopenia.
About Pacritinib
Pacritinib is an investigational oral kinase inhibitor with
specificity for JAK2, 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 CTI BioPharma Corp.
We are a biopharmaceutical company focused on the acquisition,
development and commercialization of novel targeted therapies for
blood-related cancers that offer a unique benefit to patients and
their healthcare providers. We concentrate our efforts on
treatments that target blood-related cancers where there is an
unmet medical need. In particular, we are focused on evaluating
pacritinib, our sole product candidate currently in active
late-stage development, for the treatment of adult patients with
myelofibrosis. In addition, we have recently started developing
pacritinib for use in hospitalized patients with severe COVID-19,
in response to the COVID-19 pandemic. We are headquartered in
Seattle, Washington.
Forward-Looking Statements
Statements included in this press release that are not historical
in nature are 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
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 include, but are not limited to: our ability to
successfully demonstrate the safety and efficacy of pacritinib; our
ability to complete a rolling NDA for pacritinib in the timeline
currently anticipated; our ability to receive regulatory approval
for pacritinib pursuant to the accelerated approval pathway or at
all; our planned commercialization of pacritinib; our ability to
enter into potential partnerships relating to our commercial launch
of pacritinib; and those risks more fully discussed in the section
entitled "Risk Factors" in our Annual Report on Form 10-K for the
year ended December 31, 2019 and
subsequent quarterly reports on Form 10-Q. 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:
Maeve Conneighton/Maghan Meyers
+212-600-1902
cti@argotpartners.com
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SOURCE CTI BioPharma Corp.