SEATTLE, Nov. 21, 2016 /PRNewswire/ -- CTI BioPharma
Corp. (CTI) (NASDAQ and MTA: CTIC) today announced that data from
the randomized Phase 3 PERSIST-2 clinical trial comparing the
investigational agent pacritinib, an oral multikinase inhibitor,
with physician-specified best available therapy (BAT), including
ruxolitinib, for treatment of patients with myelofibrosis whose
baseline platelet counts are less than 100,000 per microliter will
be presented in a late-breaking oral presentation at the upcoming
58th American Society of Hematology (ASH) Annual
Meeting, being held December 3-6 in
San Diego, CA.
Myelofibrosis is associated with significantly reduced quality
of life and shortened survival. Spleen enlargement (splenomegaly)
is a common and debilitating symptom of myelofibrosis. As the
disease progresses, the body slows production of important blood
cells and within one year of diagnosis the incidence of
disease-related thrombocytopenia (very low blood platelet counts),
severe anemia and red blood cell transfusion requirements increase
significantly.
Details of the PERSIST-2 presentation, two additional poster
presentations regarding pacritinib, as well as poster presentations
highlighting PIXUVRI® (pixantrone) and tosedostat, are
below. Full abstracts can be accessed on the ASH website at
www.hematology.org.
PERSIST-2 Oral Presentation
Results of the PERSIST-2 Phase 3 Study of Pacritinib (PAC)
Versus Best Available Therapy (BAT), Including Ruxolitinib (RUX),
in Patients with Myelofibrosis (MF) and Platelet Counts Less Than
100,000/µL
First Author: John
Mascarenhas, M.D., Tisch Cancer Institute, Icahn School of
Medicine at Mount Sinai, New York,
NY
Date/Time: Tuesday, December 6 at
8:30 a.m. PT
Location: Hall AB
Oral Session: Late-Breaking Abstracts
Abstract #LBA-5
Poster Presentations
Pacritinib
Relationship of JAK2V617F Allelic Burden (AB) to
Demographics, Disease Characteristics, and Response to Therapy in
PERSIST-1, A Randomized Phase 3 Study of Pacritinib (PAC) Versus
Best Available Therapy (BAT) in Patients (Pts) with Primary and
Secondary Myelofibrosis (MF)First Author: Alessandro M. Vannucchi, M.D., CRIMM, AOU
Careggi, University of Florence,
Florence, Italy
Date/Time: Sunday, December 4 at
6:00-8:00 p.m. PT
Location: Hall GH
Poster Session: 634. Myeloproliferative Syndromes: Clinical: Poster
II
Abstract #3131
Pacritinib Targets IRAK1 and Shows Synergy with HDAC and BET
Inhibitors in Acute Myeloid Leukemia
First Author: Anupriva
Agarwal, Ph.D., Knight Cancer Institute, Division of Hematology and
Medical Oncology, Oregon Health & Science University,
Portland, OR
Date/Time: Sunday, December 4 at 6:00-8:00 p.m. PT
Location: Hall GH
Poster Session: 802. Chemical Biology and Experimental
Therapeutics: Poster II
Abstract #3514
Pixantrone
The Combination of Pixantrone, Etoposide, Bendamustine and,
in CD20+ Tumors, Rituximab (PREBEN) Shows Promising
Feasibility/Efficacy in Heavily Pre-Treated Aggressive Lymphomas of
B- And T-Cell Phenotype – Results of the Pre-Trial Experience
Leading to a Nordic Phase 1/2 Study (the PREBEN Trial)
First
Author: Michael R. Clausen, M.D.,
Hematology, Aarhus University Hospital, Aarhus, Denmark
Date/Time: Saturday, December 3 at
5:30-7:30 pm PT
Location: Hall GH
Poster Session: 623. Mantle Cell, Follicular, and Other Indolent
B-Cell Lymphoma – Clinical Studies: Poster I
Abstract #1782
Tosedostat
A Phase 1 Dose-Escalation Study of the Class 1 Selective
Histone Deacetylase Inhibitor CHR-3996 in Combination with
Tosedostat for Patients with Relapsed, Refractory Multiple Myeloma:
Results of the MUK Three Trial
First Author: Rakesh Popat, MBBS, Ph.D., University College
London Hospitals NHS Foundation Trust, London, UK
Date/Time: Sunday, December 4 at
6:00-8:00 p.m. PT
Location: Hall GH
Poster Session: 653. Myeloma: Therapy, excluding Transplantation:
Poster II
Abstract #3321
About the Phase 3 Development Program of Pacritinib
Pacritinib was evaluated in two Phase 3 clinical trials, known
as the PERSIST program, for patients with myelofibrosis, with one
trial in a broad set of patients without limitations on platelet
counts, the PERSIST-1 trial; and the other in patients with low
platelet counts, the PERSIST-2 trial. In August 2014, pacritinib was granted Fast Track
designation by the FDA for the treatment of intermediate and high
risk myelofibrosis including, but not limited to, patients with
disease-related thrombocytopenia (low platelet counts); patients
experiencing treatment-emergent thrombocytopenia on other JAK2
inhibitor therapy; or patients who are intolerant of, or whose
symptoms are not well controlled (sub-optimally managed) on other
JAK2 therapy.
Clinical studies under the CTI BioPharma investigational new
drug (IND) for pacritinib are currently subject to a full clinical
hold issued by the U.S. Food and Drug Administration in
February 2016.
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, or AML, myelodysplastic syndrome, or MDS, chronic
myelomonocytic leukemia, or CMML, and chronic lymphocytic leukemia,
or CLL, due to its inhibition of c-fms, IRAK1, JAK2 and FLT3.
About PIXUVRI® (pixantrone)
PIXUVRI is a novel aza-anthracenedione with unique structural
and physiochemical properties. PIXUVRI was structurally designed so
that it cannot bind iron and perpetuate oxygen radical production
or form a long-lived hydroxyl metabolite -- both of which are the
putative mechanisms for anthracycline induced acute and chronic
cardiotoxicity.
In May 2012, the European Commission granted
conditional marketing authorization for PIXUVRI as a monotherapy
for the treatment of adult patients with multiply relapsed or
refractory aggressive NHL. The benefit of PIXUVRI treatment
has not been established in patients when used as fifth line or
greater chemotherapy in patients who are refractory to last
therapy. The Summary of Product Characteristics (SmPC) has the full
prescribing information, including the safety and efficacy profile
of PIXUVRI in the approved indication. The SmPC is
available at www.pixuvri.eu. PIXUVRI does not have marketing
approval in the United
States.
About Tosedostat
Tosedostat is an investigational oral aminopeptidase inhibitor
that has demonstrated anti-tumor responses in blood-related cancers
and solid tumors in Phase 1-2 clinical trials. Tosedostat is
currently being evaluated in multiple Phase 2 clinical trials for
the treatment of patients with AML or high-risk MDS. Tosedostat is
not approved or commercially available.
About CTI BioPharma
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 commercial presence in Europe with respect to PIXUVRI® and
a late-stage development pipeline, including pacritinib for the
treatment of patients with myelofibrosis. CTI BioPharma is
headquartered in Seattle,
Washington, with offices in London and Milan under the name CTI Life Sciences
Limited. For additional information and to sign up for email alerts
and get RSS feeds, please visit www.ctibiopharma.com.
Forward-Looking Statements
This press release includes forward-looking statements, which
are within the meaning of the Safe Harbor provisions of the Private
Securities Litigation Reform Act of 1995. Such statements are
subject to a number of risks and uncertainties, the outcome of
which could materially and/or adversely affect actual future
results and the trading price of the issuers' securities. Such
statements include, but are not limited to, expectations with
respect to our ability to be able to interpret clinical trial data
and results despite not satisfying the pre-specified minimum
evaluable patient goal and expectations with respect to the
potential therapeutic utility of pacritinib, including pacritinib's
potential to achieve treatment goals across patients with
myelofibrosis, regardless of baseline characteristics, such as
starting platelet count and in particular, its potential to reduce
spleen volume and symptom burden and improve HRQoL. Investors are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this release. In
particular, this press release addresses select preliminary
clinical trial data and results, and should be evaluated together
with information regarding primary and secondary endpoints, safety
and additional data once such data has been more fully analyzed and
is made publicly available. In addition, meaningful interpretation
of PERSIST-2 may not be possible because the pre-specified minimum
evaluable patient goal was not met. The statements are based on
assumptions about many important factors and information currently
available to us to the extent we have thus far had an opportunity
to fully and carefully evaluate such information in light of all
surrounding facts, circumstances, recommendations and analyses. A
number of results and uncertainties could cause actual results to
differ materially from those in the forward-looking statements,
including: satisfaction of regulatory and other requirements; that
trial results observed to date may differ from future results or
that different conclusions or considerations may qualify such
results once existing data has been more fully evaluated; actions
of regulatory bodies and other governmental authorities; other
clinical trial results; changes in laws and regulations; product
quality, product efficacy, study protocol, data integrity or
patient safety issues; product development risks; and other risks
identified in each of the issuer's most recent filings on Forms
10-K and 10-Q and other Securities and Exchange Commission filings.
Except as required by law, CTI Biopharma does not intend to update
any of the statements in this press release upon further
developments.
PIXUVRI is a registered trademark of CTI BioPharma Corp.
CTI BioPharma Contact:
Ed Bell
+1 206-272-4345
ebell@ctibiopharma.com
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