Imetelstat sodium is under clinical development by Geron and currently in Phase III for Post-Polycythemia Vera Myelofibrosis (PPV-MF). According to GlobalData, Phase III drugs for Post-Polycythemia Vera Myelofibrosis (PPV-MF) have an 80% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Imetelstat sodium’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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Data Insights Likelihood of Approval and Phase Transition Success Rate Model - Imetelstat Sodium in Post-Polycythemia Vera Myelofibrosis (PPV-MF)

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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Imetelstat sodium overview

Imetelstat Sodium (Imetelstat, Rytelo) is an antineoplastic agent. It is formulated as lyophilized powder for solution for intravenous route of administration. Rytelo is indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).
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, juvenile myelomonocytic leukemia (JMML) 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, multiple myeloma, myeloproliferative neoplasms and breast cancer.

Geron overview

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. It’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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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.