CTI BioPharma Corp [NASDAQ: CTIC] was in the green all through last week, and looks set to start the week in gain. This is after the company announced that it had entered an agreement with the U.S. Food and Drug Administration (FDA) to present an NDA (Non-disclosure Agreement) for a possible accelerated approval of using pactrinib drug for the treatment of myelofibrosis patients suffering from severe thrombocytopenia after a Pre-NDA meeting.
The NDA agreement draws its data from the company’s completed phase 3 PERSIST-1 and PERSIST-2 as well as Phase 2 PAC203 dose-ranging trial. FDA agreed to a rolling NDA submission that will begin in the next few weeks. They expect to have completed the submission in the first quarter of 2021.
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In a statement, the President and Chief Executive Officer of CTI Biopharma, M.D., Ph.D., R.Craig, said that they have been working in collaboration with the FDA since they completed tests for PAC203 Phase 2 dose-ranging trial in an attempt to get a working approval pathway for pacritinib in myelofibrosis patients with severe thrombocytopenia especially in patients that exhibit unmet medical needs as a result of reduced survival and limited therapeutic solutions. He further added that during their recent Pre-NDA meeting, they came up with a data package from PERSIST-1, PERSist-2 and PAC203 Phase trails that will see approval application accelerated. Severe thrombocytopenia in myelofibrosis patients is a consequence of drug or disease related toxicity from current therapies. As of the moment, there is no drug that specifically used to treat the needs of these patients. It is only pacritinib, through multiple clinical trials that has shown evident potential as treatment-naive and second-line myelofibrosis patients in 2021.
Pactrinib is an oral kinase inhibitor under investigation with specifity for FLT3, JAK2, IRAK1 and CSF1R. JAK belongs to a family of enzymes that are central component in signal transduction pathways. These enzymes help in the growth and development of blood cells, immune responses and cytokine expressions. These kinases develop mutations that are directly linked to the growth of various blood-related cancers like myeloproliferative neoplasms, lymphoma and leukaemia. Due to pacritinib’s inhibition of c-fms, IRAK1, JAK2 and FLT3, the kinase profile of this medication also has potential in therapeutic treatment of other conditions like myelodysplastic syndrome (MDS), myeloid leukaemia (AML) as well as chronic lymphocytic leukaemia (CLL).
Pactrinib received an approval for the treatment of post-polycythemia vera MF, primary myelofibrosis (MF) and post-essential thrombocythemia.
About CTI BioPharma Corp
CTI BioPharma is a biopharmaceutical company aimed at researching, developing and commercializing novel targeted therapies for cancers related to blood. Of late, the company has begun researching on pactrinib to treat hospitalized Covid-19 patients.