SEATTLE, Dec. 6, 2020 /PRNewswire/ -- CTI BioPharma Corp.
(Nasdaq: CTIC) today announced an oral presentation supporting the
Company's pacritinib development program in the prevention of acute
graft versus host disease (GVHD) at the 62nd American Society of
Hematology (ASH) Annual Meeting & Exposition, being held
virtually December 5-8, 2020. The
results are from an investigator-sponsored Phase 1/2 study
conducted at the Mayo Clinic and Moffit Cancer Center.
"The data presented today at ASH highlights the potential for
the expanded use of pacritinib. Acute GVHD following allogeneic
hematopoietic cell transplantation results in higher rates of
morbidity and mortality, compromises the anti-leukemic response of
the graft and occurs despite standard immunosuppressive
prophylaxis, rendering it an area where new therapeutic options are
needed," said Adam R. Craig, M.D.,
Ph.D., President and Chief Executive Officer of CTI Biopharma.
"These data demonstrate that in this Phase 1/2 study, adding
pacritinib to the standard prophylaxis of sirolimus and low-dose
tacrolimus resulted in a significant reduction in the expected
acute GVHD rates in patients within the first 100 days of therapy
as compared to historical data, without compromising
transplantation outcomes and without any new safety concerns. We
are encouraged by these data, and look forward to further
evaluating pacritinib's efficacy and safety in this indication in
the on-going Phase 2 clinical trial."
All presentation materials will be available at ctibiopharma.com
following the presentations.
Biological and Clinical Impact of JAK2/mTOR Blockade in GVHD
Prevention: Preclinical and Phase 1 / 2 Study
Results
Results from an investigator-sponsored (Mayo Clinic
and Moffit Cancer Center) Phase 1/2 study of GVHD prophylaxis for
allogeneic hematopoietic cell transplantation (alloHCT) using
pacritinib, sirolimus, low-dose tacrolimus are being presented
today, Sunday, December 6 at
10 a.m. PT in an oral presentation
session.
Abstract: No. 355
Summary: This single-arm Phase 1/2 study (NCT02891603) tested
the safety, pharmacodynamics and efficacy of pacritinib when
administered with sirolimus plus low-dose tacrolimus (PAC/SIR/TAC)
after alloHCT. A 3+3 dose escalation design was planned using three
doses of pacritinib (100 mg QD, 100 mg BID, 200 mg BID) in
combination with standard sirolimus and low-dose tacrolimus
immunosuppressive therapy. Efficacy endpoints included acute GVHD
(aGVHD) rate at day 100.
PAC 100 mg twice daily (BID), dose level 2, was selected as the
recommended Phase 2 dose based on its biological activity and
safety profile. Preliminary evidence of the benefit of adding
pacritinib to standard immunosuppressive therapy in reducing the
rates of aGVHD was reported, with a 25% rate of grade 2-4 aGVHD
across all dose cohorts, and 17% at the recommended Phase 2 dose of
100 mg BID, as compared to grade 2-4 aGVHD incidence rate of 43%
expected with sirolimus plus low-dose tacrolimus administered
alone1. No compromise in alloHCT outcome or major safety
concerns were observed. Futher, there was no evidence of
cytopenias, impaired immune reconstitution, or cytomegalovirus
(CMV) reactivation. A Phase 2 clinical trial to fully evaluate
efficacy in GVHD prevention is ongoing (NCT02891603).
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 the prevention of acute graft versus host
disease and 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, 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 in
various indications; 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
1. Pidala et al, Oral Presentation, Abstract 355, ASH 2020.
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