On November 30, 2020 CTI BioPharma Corp. (Nasdaq: CTIC) reported that an article highlighting pacritinib data was published in Blood Advances (Press release, CTI BioPharma, NOV 30, 2020, View Source [SID1234572006]). The article, titled "Determining the Recommended Dose of Pacritinib: Results from the PAC203 Phase 2 Dose-Finding Study in Patients with Advanced Myelofibrosis" is available online via this link.
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"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 Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "As our application will consist of a data package from the PERSIST-1, PERSIST-2 and PAC203 Phase 2 trials, with the ongoing Phase 3 PACIFICA trial expected to be completed as a post-marketing commitment, the data published today support our belief that pacritinib has the potential to become an important treatment in this disease setting, pending regulatory approval."
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 PACIFICA study of pacritinib in patients with myelofibrosis with severe thrombocytopenia.
About Pacritinib
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.