On November 6, 2015 CTI BioPharma Corp. (CTI) (NASDAQ and MTA: CTIC) reported that data highlighting two compounds (pacritinib and tosedostat) from the company’s investigational pipeline will be presented at the upcoming 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held December 5-8 in Orlando, FL – including three oral presentations (Press release, CTI BioPharma, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107857 [SID:1234508044]).
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The presentations will include data analyses from the Phase 3 PERSIST-1 trial of pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R that is currently under investigation for the treatment of patients with myelofibrosis and acute myeloid leukemia (AML) as well as findings from a Phase 2 study of tosedostat, an investigational oral selective inhibitor of aminopeptidases that has demonstrated anti-tumor responses in blood-related cancers and solid tumors in Phase 1-2 clinical trials.
"We look forward to the presentation of data for both pacritinib and tosedostat at this year’s ASH (Free ASH Whitepaper) annual meeting," said James A. Bianco, M.D., President and CEO of CTI BioPharma. "With six abstracts accepted, the data involving two of our investigational compounds is a further example of our focused commitment on advancing the development of our pipeline candidates."
A summary of the oral and poster presentations are below, and full abstracts can be accessed on the ASH (Free ASH Whitepaper) website at www.hematology.org.
Oral Presentations
Analysis of Outcomes by Patient Subgroups in Patients with Myelofibrosis Treated with Pacritinib vs Best Available Therapy (BAT) in the Phase III PERSIST-1 Trial
First Author: Alessandro M Vannucchi, M.D., Associate Professor of Hematology, University of Florence, Italy
Date/Time: Saturday, December 5 at 10:15 a.m. ET
Location: W224, Level 2
Oral Session: 634. Myeloproliferative Syndromes: Clinical: Early and Late Stage Trials in MPN
Abstract #58
Pacritinib, a Dual FLT3/JAK2 Inhibitor, Reduces IRAK-1 Signaling in Acute Myeloid Leukemia
First Author: Megan M Cleary, B.S., B.A, Knight Cancer Institute, Division of Hematology and Medical Oncology, Oregon Health & Science University, Portland, OR
Date/Time: Monday, December 7 at 11:45 a.m. ET
Location: Room W109
Oral Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel Targeting Approaches
Abstract #570
Tosedostat Plus Low Dose Cytarabine Induces a High Rate of Responses That Can be Predicted By Genetic Profiling in Elderly AML
First Author: Giuseppe Visani, M.D., Director of Hematology and Stem Cell Transplant Center at AORMN, Pesaro, Italy
Date/Time: Sunday, December 6 at 5:30 p.m. ET
Location: Room W109
Oral Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: New Drugs
Abstract #329
Poster Presentations
Relationship Between Patient-Reported Outcomes (PROs) and Health-Related Quality of Life (HRQoL) and Efficacy in Patients with Myelofibrosis in the Phase III PERSIST-1 Trial of Pacritinib Vs. Best Available Therapy (BAT)
First Author: Ruben Mesa, M.D., Chair, Hematology and Medical Oncology Division Mayo Clinic, Scottsdale, AZ
Date/Time: Saturday, December 5 at 5:30-7:30 p.m. ET
Location: Hall A, Level 2
Poster Session: 634. Myeloproliferative Syndromes: Clinical: Poster I
Abstract #1609
Targeting JAK2 by Gene Knockout or Pacritinib Treatment Reduces GVHD and Xenograft Rejection by Promoting Induced Treg Differentiation
First Author: Brian C. Betts, M.D., Medical Oncologist and Assistant Member of the Department of Blood and Marrow Transplant, Moffitt Cancer Center, Tampa, FL
Date/Time: Saturday, December 5 at 5:30-7:30 p.m. ET
Location: Hall A, Level 2
Poster Session: 702. Experimental Transplantation: Immune Function, GVHD and Graft-versus-Tumor Effects
Abstract #1874
Pacritinib (PAC) Synergistically Potentiates Azacitidine (5AZA) Cytotoxicity in Chronic Myelomonocytic Leukemia (CMML)
First Author: Yan Ma, M.D., H. Lee Moffitt Cancer Center, Tampa, FL
Date/Time: Saturday, December 5 at 5:30-7:30 p.m. ET
Location: Hall A, Level 2
Poster Session: 636. Myelodysplastic Syndromes – Basic and Translational Studies: Poster I
Abstract #1658
About Pacritinib
Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. 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, patients experiencing treatment-emergent thrombocytopenia on other JAK2 inhibitor therapy, or patients who are intolerant of, or whose symptoms are sub-optimally managed on other JAK2 inhibitor therapy. The FDA’s Fast Track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Pacritinib does not have regulatory approval and is not commercially available.
CTI BioPharma and Baxalta (NYSE:BXLT) are parties to a worldwide license agreement to develop and commercialize pacritinib. CTI BioPharma and Baxalta will jointly commercialize pacritinib in the U.S. while Baxalta has exclusive commercialization rights for all indications outside the U.S.
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.