Imetelstat sodium is under clinical development by Geron and currently in the Phase I and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.
According to GlobalData, the latest event to affect Imetelstat sodium’s likelihood of approval (LoA) and phase transition for Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF) took place on 26 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.
In addition, the same event on 26 Dec 2022 decreased Imetelstat sodium’s LoA and PTSR for Myelofibrosis, and increased PTSR for Post-Polycythemia Vera Myelofibrosis (PPV-MF).
GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Imetelstat sodium Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.
Imetelstat sodium overview
Imetelstat (JNJ-63935937) is under development for the treatment of intermediate-2-risk or high-risk myelofibrosis, intermediate-1 or intermediate-2 risk myelodysplastic syndrome, acute myeloid leukemia multiple myeloma, myeloproliferative neoplasms and lymphoid hematologic malignancy. The drug candidate is administered by intravenous infusion. It is a new molecular entity (NME). It is a 13-mer oligonucleotide N3'–P5' thio-phosphoramidate (NPS oligonucleotide) that is covalently attached to a C16 (palmitoyl) lipid moiety. GRN163L binds directly with high affinity to the template region of the RNA component of human telomerase (hTR), which lies in the active or catalytic site of hTERT, the telomerase reverse transcriptase. GRN163L binding to hTR results in direct, competitive inhibition of telomerase enzymatic activity. It is a new molecular entity. Imetelstat (GRN163L) was under development for the treatment of chronic lymphoproliferative disease including, small lymphocytic lymphoma (SLL), T cell prolymophocytic leukemia (T-PLL), B cell prolymphocytic leukemia (B-PLL), mantle cell lymphoma or other non-Hodgkins lymphoma in leukemic phase, Waldenstrom's macroglobulinemia, multiple myeloma, post-essential thrombocythemia myelofibrosis, post-polycythemia vera myelofibrosis, non-small cell lung cancer, solid tumors, neuroblastoma, polycythemia vera and breast cancer.
Geron is a late-stage clinical biopharmaceutical company that focuses on the development and commercialization of imetelstat, a first-in-class telomerase inhibitor in hematologic myeloid malignancies. The company’s clinical studies include IMerge, a Phase 2 trial in lower risk myelodysplastic syndromes; and IMbark, a Phase 2 clinical trial in intermediate or high-risk myelofibrosis. Imetelstat received Fast Track designation from the US FDA to treat patients with transfusion-dependent anemia due to lower or intermediate-risk myelodysplastic syndromes (MDS) and patients with intermediate or high-risk myelofibrosis (MF). The company utilizes core expertise in telomerase and telomere biology and its proprietary nucleic acid chemistry for the development of imetelstat. Geron is headquartered in Menlo Park, California, the US.
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