CTI BioPharma Announces Publication of Article Highlighting Pacritinib Data from the PAC203 Phase 2 Study in Myelofibrosis in Blood Advances
"Having recently announced the start of a rolling NDA submission for pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia, a patient population with reduced survival and limited therapeutic options, we continue to be committed to adding to the growing body of evidence underscoring the efficacy and safety profile of pacritinib," said
PAC203 Phase 2 was an open-label, randomized, dose-finding trial of pacritinib in patients with myelofibrosis who were previously treated with ruxolitinib. Patients were randomized 1:1:1 to pacritinib 100 mg daily (QD), 100 mg BID, or 200 mg BID. The trial demonstrated that pacritinib 200 mg BID had a favorable benefit risk profile. Spleen volume response (SVR) rates were highest among patients treated with pacritinib 200 mg BID who had a baseline platelet count of less than 50 x 109/L. Overall, the study data supported the selection of the pacritinib 200 mg BID for use in the ongoing Phase 3
Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, IRAK1, and CSF1R. 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. In addition to myelofibrosis, 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 inhibition of c-fms, IRAK1, JAK2 and FLT3.
About CTI BioPharma Corp.
We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active late-stage development, for the treatment of adult patients with myelofibrosis. In addition, we have recently started developing pacritinib for use in hospitalized patients with severe COVID-19, in response to the COVID-19 pandemic. We are headquartered in
Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: our ability to successfully demonstrate the safety and efficacy of pacritinib; our ability to complete a rolling NDA for pacritinib in the timeline currently anticipated; our ability to receive regulatory approval for pacritinib pursuant to the accelerated approval pathway or at all; our planned commercialization of pacritinib; our ability to enter into potential partnerships relating to our commercial launch of pacritinib; and those risks more fully discussed in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended
CTI BioPharma Investor Contacts:
View original content to download multimedia:http://www.prnewswire.com/news-releases/cti-biopharma-announces-publication-of-article-highlighting-pacritinib-data-from-the-pac203-phase-2-study-in-myelofibrosis-in-blood-advances-301181337.html