CTI Announces Data Presentations at the 55th American Society of Hematology Annual Meeting - Pacritinib Phase 2 Analysis of Myelofibrosis Patients with Thrombocytopenia (Low Platelets) Accepted for Oral Presentation -
SEATTLE, Nov. 7, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced the upcoming presentations of data highlighting pacritinib, a novel, oral JAK2/FLT3 inhibitor, and tosedostat, an aminopeptidase inhibitor, at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 7-10, 2013 in New Orleans, LA.
The presentations will include data from additional analyses of completed Phase 2 trials of pacritinib in patients with myelofibrosis and data from investigator-sponsored clinical trials of tosedostat for first line acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) and a separate study in relapsed patients. A summary of the presentations is below, and full abstracts can be accessed on the ASH website at www.hematology.org.
Pacritinib, a Dual JAK2/FLT3 Inhibitor: An Integrated Efficacy and Safety Analysis of Phase II Trial Data in Patients with Primary and Secondary Myelofibrosis (MF) and Platelet Counts ≤ 100,000 µL
- First Author: Dr. Srdan Verstovsek, MD Anderson Cancer Center, Houston, TX
- Date/Time: Monday, December 9, 2013 at 11:30 a.m. CT
- Location: Theater C
- Oral Session: 634, Myeloproliferative Syndromes: Clinical I
- Abstract #395
A Phase I/II Study of Cytarabine or Azacitidine in Combination with Tosedostat in Older Patients with AML or High-Risk MDS
- First Author: Dr. Courtney DiNardo, MD Anderson Cancer Center, Houston, TX
- Date/Time: Sunday, December 8, 2013, 6:30-8:30 p.m. CT
- Location: Hall E
- Poster Presentation: 615, Acute Myeloid Leukemia: Therapy, excluding Transplantation: Poster II
- Abstract #2698
A Phase II Study of Tosedostat (TST) in Combination with Either Cytarabine or Decitabine in Newly Diagnosed Older Patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
- First Author: Dr. Raya Mawad, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA
- Date/Time: Monday, December 9, 2013, 6:00-8:00 p.m. CT
- Location: Hall E
- Poster Presentation: 615, Acute Myeloid Leukemia: Therapy, excluding Transplantation: Poster III
- Abstract #3926
Exposure-Response Analysis for Pacritinib (SB1518), a Novel Oral JAK2/FLT3 Inhibitor, In Patients With Myelofibrosis
- First Author: Dr. Suliman Al-Fayoumi, Cell Therapeutics, Inc., Seattle, WA
- Date/Time: Monday, December 9, 2013 at 6:00-8:00 p.m. CT
- Location: Hall E
- Poster Presentation: 634, Myeloproliferative Syndromes: Clinical: Poster III
- Abstract #4080
Pacritinib is an oral tyrosine kinase inhibitor (TKI) with dual activity against JAK2 and FLT3. The JAK family of enzymes are 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.
CTI is pursuing a broad approach to advancing pacritinib 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 will be in patients with low platelet counts, the PERSIST-2 trial, which is expected to begin in the fourth quarter of 2013. In October 2013, we reached agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment, or SPA, for the PERSIST-2 pivotal trial. A SPA is a written agreement between CTI and the FDA regarding the design, endpoints and planned statistical analysis approach of the trial to be used in support of a potential New Drug Application, or NDA, submission.
Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated significant anti-tumor responses in blood-related cancers and solid tumors in Phase 1-2 clinical trials. CTI has exclusive marketing and co-development rights to Chroma Therapeutics Ltd.'s drug candidate tosedostat in North, Central and South America.
About Cell Therapeutics, Inc.
CTI (NASDAQ and MTA: CTIC) is a biopharmaceutical company committed to the development and commercialization of an integrated portfolio of oncology products aimed at making cancer more treatable. CTI is headquartered in Seattle, WA. For additional information and to sign up for email alerts and get RSS feeds, please visit www.CellTherapeutics.com.
This press release includes forward-looking statements 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 CTI's securities. Such statements include, but are not limited to, statements regarding CTI's expectations with respect to the development of CTI and its product and product candidate portfolio, the expected commencement of the PERSIST-2 clinical trial in the fourth quarter of 2013 and the expected efficacy and potential benefits of pacritinib (including that 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). Risks that contribute to the uncertain nature of the forward-looking statements include, among others, risks associated with the biopharmaceutical industry in general and with CTI and its product and product candidate portfolio in particular including, among others, risks associated with the following: that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials, that CTI cannot predict or guarantee the outcome of preclinical and clinical studies, that the second Phase 3 clinical trial of pacritinib will not occur as planned, that CTI may not obtain favorable determinations by other regulatory, patent and administrative governmental authorities, that CTI may experience delays in the commencement of preclinical and clinical studies, risks related to the costs of developing pacritinib and CTI's other product candidates, and other risks, including, without limitation, competitive factors, technological developments, that CTI's operating expenses continue to exceed its net revenues, that CTI may not be able to sustain its current cost controls or further reduce its operating expenses, that CTI may not achieve previously announced goals and objectives as or when projected, that CTI's average net operating burn rate may increase, that CTI will continue to need to raise capital to fund its operating expenses, but may not be able to raise sufficient amounts to fund its continued operation as well as other risks listed or described from time to time in CTI's most recent filings with the Securities and Exchange Commission on Forms 10-K, 10-Q and 8-K. Except as required by law, CTI does not intend to update any of the statements in this press release upon further developments.
SOURCE Cell Therapeutics, Inc.