SEATTLE, Dec. 1, 2014 /PRNewswire/ -- CTI BioPharma Corp. (CTI) (NASDAQ and MTA: CTIC) today announced the upcoming presentations of data highlighting pacritinib, an oral multikinase inhibitor with dual activity against JAK2 and FLT3, and tosedostat, an oral selective inhibitor of aminopeptidases, at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 6-9 in San Francisco, CA.
The presentations will include data on the activity of pacritinib in stroma adherent acute myeloid leukemia (AML) cells, a profile of kinase inhibition across several cell signaling pathways with pacritinib treatment and analysis of a Phase 2 trial of treatment with tosedostat in combination with cytarabine or decitabine in patients with AML or myelodysplastic syndrome (MDS). A summary of the presentations is below, and full abstracts can be accessed on the ASH website at www.hematology.org.
Pacritinib Suppresses Leukemic Outgrowth from FLT3-ITD Positive Stroma-Adherent Primary AML Cells
First Author: Ceri Marrin, MBBCh, Department of Haematology, Institute of Cancer & Genetics, Cardiff University, Cardiff, United Kingdom
Date/Time: Monday, December 8 at 8:15 a.m. PT
Location: South Building, Esplanade 301 (Moscone Center)
Oral Session: 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Molecular Targets and Drug Sensitivity in Myeloid Diseases
Comprehensive Kinase Profile of Pacritinib, a Non-Myelosuppressive JAK2 Kinase Inhibitor in Phase 3 Development in Primary and Post ET/PV Myelofibrosis
First Author: Jack Singer, M.D., CTI BioPharma, Seattle, WA
Date/Time: Saturday, December 6 at 5:30-7:30 p.m. PT
Location: West Building, Level 1 (Moscone Center)
Poster Session: 635. Myeloproliferative Syndromes: Basic Science: Poster I
A Randomized Phase II Study of Tosedostat in Combination with Either Cytarabine or Decitabine in Newly Diagnosed Older Patients with Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
First Author: Raya Mawad, M.D., Clinical Research Division, Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA
Date/Time: Monday, December 8 at 6:00-8:00 p.m. PT
Location: North Building, Hall E (Moscone Center)
Poster Session: 613. Acute Myeloid Leukemia: Clinical Studies: Poster III
The following abstract was selected to be published in a special online-only issue of the journal Blood, ASH's official journal, on the Blood website at www.bloodjournal.org/ash-annual-meeting-abstracts following the meeting.
A Comparative Analysis of Dual JAK2/FLT3 Inhibitors Revealed the Effectiveness of Pacritinib in Combating Genetic Resistance
First Author: Meenu Kesarwani, Ph.D., Cincinnati Children's Hospital Medical Center, Cincinnati, OH
Pacritinib is a next generation oral multikinase inhibitor with dual activity against 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. Pacritinib may offer an advantage over other JAK inhibitors through effective treatment of symptoms while having less treatment-emergent thrombocytopenia and anemia than has been seen in currently approved and in-development JAK inhibitors.
Based on pacritinib's efficacy and tolerability profile demonstrated to date, CTI is pursuing a broad approach to advancing this therapy for patients with myelofibrosis by conducting two Phase 3 clinical trials: one in a broad set of patients without limitations on blood platelet counts, the PERSIST-1 trial, and the other in patients with low platelet counts, the PERSIST-2 trial. The PERSIST-1 trial has completed enrollment with top-line results expected in the first quarter of 2015. The PERSIST-2 trial is actively enrolling patients.
In November 2013, CTI and Baxter International (Baxter) entered into a worldwide license agreement to develop and commercialize pacritinib in which CTI and Baxter will jointly commercialize pacritinib in the U.S. and Baxter has exclusive commercialization rights for all indications outside the U.S.
Tosedostat is an oral aminopeptidase inhibitor that has demonstrated anti-tumor responses in blood-related cancers and solid tumors in Phase 1–2 clinical trials. Presently, an ongoing Phase 2/3 trial is being conducted by the National Cancer Research Institute Haematological Oncology Study Group under the sponsorship of Cardiff University. In this Phase 2/3 trial, referred to as the AML Less Intensive (LI-1) trial, patients will be randomized to standard treatment, low dose cytarabine, versus one of five novel investigational treatments, one of which is tosedostat, each in combination with low dose cytarabine. Overall survival will serve as the primary endpoint of this trial.
About CTI BioPharma
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 has a commercial presence in Europe and a late-stage development pipeline, including pacritinib, CTI's lead product candidate that is currently being studied in a Phase 3 program for the treatment of patients with myelofibrosis. CTI 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.
In Europe: CTI Life Sciences Limited, Milan Branch
+39 02 94751572
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SOURCE CTI BioPharma Corp.