Comprehensive Summary of Preclinical and Clinical Data for Pacritinib Published in Drugs of the Future
SEATTLE, July 3, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced that a comprehensive article summarizing preclinical and clinical data for pacritinib, an oral JAK2/FLT3 inhibitor, authored by Srdan Verstovsek, M.D., Ph.D., et al., was published in the journal Drugs of the Future 2013. The article reviews the preclinical pharmacology and pharmacokinetics in addition to the safety and efficacy results from the Phase 1 and 2 clinical studies of pacritinib in patients with myelofibrosis and lymphoma.
The authors conclude that the clinical trials to date support the safety, efficacy and predictable pharmacokinetic profile of pacritinib. The hematological adverse events have been uncommon and no dose reductions for thrombocytopenia were necessary in the Phase 2 studies. In the two studies that enrolled patients with myelofibrosis, pacritinib led to disease response, improvement in splenomegaly (enlargement of the spleen) and lowered white blood cell count, and symptom reduction in patients with and without thrombocytopenia, or low blood cell count.
The link to the publication is available at www.CellTherapeutics.com.
Pacritinib is currently being evaluated in a randomized Phase 3 clinical trial, known as PERSIST-1, in patients with myelofibrosis. Because of pacritinib's relative lack of bone marrow suppression, there are no study entry restrictions due to thrombocytopenia or anemia and patients with platelet and red blood cell transfusion dependence are allowed to enroll in the ongoing PERSIST-1 trial. More details on this study can be found at www.clinicaltrials.gov. Pacritinib has orphan drug designation in the United States and Europe.
Myelofibrosis is classified as a myeloproliferative neoplasm and is a chronic bone marrow disorder. Myelofibrosis is caused by the accumulation of malignant bone marrow cells that triggers an inflammatory response, scarring the bone marrow and limiting its ability to produce red blood cells prompting the spleen and liver to take over this function. Symptoms that arise from this disease include enlargement of the spleen, anemia, extreme fatigue and pain. It is estimated that the prevalence of myelofibrosis is approximately 30,000 in the United States.1
Pacritinib is an oral, once-a-day, 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.
About Cell Therapeutics, Inc.
Cell Therapeutics (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.
Safe Harbor Statement
This press release includes forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning the Company's development and prospects. Such statements involve a number of risks and uncertainties the outcome of which could materially and/or adversely affect actual future results and the market price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of pacritinib include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pacritinib in particular, including, without limitation, the potential failure of pacritinib to prove safe and effective for the treatment of patients with myelofibrosis, either alone or in combination regimens, as determined by the U.S. Food and Drug Administration and/or the European Medicines Agency; that pacritinib may not satisfy a medical need not currently addressed with existing non-selective JAK1/JAK2 inhibitors; that adverse events from treatment with pacritinib may not be controllable; that the PERSIST-1 clinical trial of pacritinib may not occur as planned; that 270 patients may not enroll in the PERSIST-1 clinical trial; that the second Phase 3 clinical trial of pacritinib may not occur as planned; that CTI may not be able to successfully implement its plans, strategies and objectives related to the development of pacritinib; that CTI may not be able to continue to raise capital as needed to fund its operations and other risks, including, without limitation, competitive factors, technological developments, costs of developing, producing and selling PIXUVRI, pacritinib and CTI's other product candidates; and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
1. MPN Research Foundation. Available at http://www.mpnresearchfoundation.org/Primary-Myelofibrosis. Accessed May 2013.
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SOURCE Cell Therapeutics, Inc.