SEATTLE and DEERFIELD, Ill., June 10, 2015 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) and Baxter International’s BioScience business (NYSE:BAX) today announced that Patient Reported Outcomes (PROs) data from the Phase 3 PERSIST-1 trial, evaluating pacritinib in patients with myelofibrosis, will be highlighted in a late-breaking oral presentation at the upcoming 20th Congress of the European Hematology Association (EHA), June 11-14, Vienna. Pacritinib is an investigational oral multikinase inhibitor with specificity for JAK2 and FLT3. These data were also selected for inclusion in the official EHA Press Briefing on Friday, June 12, 2015 at 08:30 CEST.
Myelofibrosis is associated with significantly reduced quality of life and shortened survival. 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. Among other complications, most patients with myelofibrosis present with enlarged spleens (splenomegaly) as well as many other potentially devastating physical symptoms such as: abdominal discomfort, bone pain, feeling full after eating little, severe itching, night sweats, and tiredness.
Full details for the abstracts involving pacritinib in this year’s EHA program are below:
Title: Patient-Reported Outcomes (PROS) in PERSIST-1: A Randomized, Multi-Country Phase III Trial of the JAK2 Inhibitor Pacritinib (PAC) VS. Best Available Therapy (BAT) in Myelofibrosis (MF)
First Author: Ruben Mesa, M.D., Deputy Director, Mayo Clinic Cancer Center, Chair of the Division of Hematology & Medical Oncology, Mayo Clinic Cancer Center, Scottsdale, AZ and one of the principal investigators for PERSIST-1
Date/Time: Sunday, June 14 at 12:15 CEST
Location: Room A7
Presentation Type: Oral Presentation
Abstract #: LB2072
This abstract is under a press embargo until Friday, June 12 at 09:30 CEST.
Title: PERSIST-1: A Phase III Study of Pacritinib (PAC) vs Best Available Therapy (BAT) in Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (PPV-MF) or Post-Essential Thrombocythemia MF (PET-MF)
First Author: Claire Harrison, M.D., Consultant Hematologist, Guy’s and St. Thomas’ NHS Foundation Trust, Guy’s Hospital, London, United Kingdom and one of the principal investigators for PERSIST-1
Date/Time: Friday, June 12 at 17:15 to 18:45 CEST
Location: Poster area (Hall C)
Presentation Type: Poster
Abstract #: LB314
The full abstract can be viewed here.
About Pacritinib
Pacritinib is an oral multikinase inhibitor with specificity for JAK2 and FLT3. 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. 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 potent inhibition of c-fms, IRAK1, JAK2, and FLT3.1
About CTI BioPharma Corp.
CTI BioPharma Corp. (NASDAQ and MTA: CTIC) 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 and a late-stage development pipeline, including pacritinib, CTI BioPharma’s lead product candidate, which is currently being studied in a Phase 3 program 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.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
Forward Looking Statements
This press release includes forward-looking statements related to pacritinib and related clinical trials conducted pursuant to a collaboration between Baxter International Inc. and CTI BioPharma Corp., 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, statements regarding expectations with respect to the potential therapeutic utility of pacritinib, the ability of the PERSIST-1 and PERSIST-2 trials to support a potential regulatory submission, the anticipated completion of enrollment, and the ability of pacritinib to meet unmet medical needs and future regulatory, development and commercialization plans. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. A number of results and uncertainties could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; 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 issuer’s most recent filings on Form 10-K and other Securities and Exchange Commission filings. Neither Baxter nor CTI BioPharma undertakes to update its forward-looking statements.
1. Singer J et al., ASH 2014 Abstract #1874: Comprehensive Kinase Profile of Pacritinib, a Non-Myelosuppressive JAK2 Kinase Inhibitor in Phase 3 Development in Primary and Post ET/PV Myelofibrosis.
CTI BioPharma Contact:
Monique Greer
206-272-4343
mgreer@ctibiopharma.com
Baxter Investor Contact:
Mary Kay Ladone
224-948-3371
Baxter Media Contact:
Kellie Hotz
224-948-5353
media@baxter.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/cti-biopharma-and-baxter-announce-patient-reported-outcomes-pros-from-pacritinib-phase-3-in-patients-with-myelofibrosis-to-be-presented-in-late-breaking-session-at-eha-300096802.html
SOURCE CTI BioPharma Corp.; Baxter
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