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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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). 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, breast cancer and  lymphoid hematologic malignancy.

Geron overview

Geron is a biopharmaceutical company. It is focused on developing therapies to enhance the lives of patients with hematologic malignancies. Its product portfolio includes the investigational telomerase inhibitor, imetelstat, which was approved by the US Food and Drug Administration (FDA) under the brand name Rytelo for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) characterized by transfusion-dependent anemia. The company is also advancing imetelstat in multiple myeloid malignancies, including various clinical trials targeting high-risk myelofibrosis; combination therapies and higher-risk MDS and acute myeloid leukemia. Geron is headquartered in Foster City, California, US.

For a complete picture of Imetelstat sodium’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 12 April 2024

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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.