On November 1, 2018 Geron Corporation (Nasdaq: GERN) reported that clinical data related to imetelstat, the Company’s first-in-class telomerase inhibitor, will be the subject of two oral presentations at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held in San Diego, California from December 1-4, 2018 (Press release, Geron, NOV 1, 2018, View Source [SID1234532271]). The abstracts, summarizing clinical data from Part 1 of IMerge in myelodysplastic syndromes and the IMbark primary analysis in myelofibrosis, were published today on the ASH (Free ASH Whitepaper) website at www.hematology.org.

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"We are pleased the abstracts for Part 1 of IMerge and IMbark were accepted for presentation at ASH (Free ASH Whitepaper)," said John A. Scarlett, M.D., Geron’s President and Chief Executive Officer. "We are looking forward to the oral presentations as they underscore imetelstat’s potential to address the unmet medical need in lower risk MDS and relapsed/refractory myelofibrosis."

Oral Presentations

Title: Imetelstat Treatment Leads to Durable Transfusion Independence (TI) in RBC Transfusion-Dependent (TD), Non-Del(5q) Lower Risk MDS Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Who Are Lenalidomide and HMA Naïve (Abstract #463)

Session Name: 637. Myelodysplastic Syndromes—Clinical Studies: Novel Therapeutics II
Session Date: Sunday, December 2, 2018
Session Time: 4:30 p.m. PT – 6:00 p.m. PT
Presentation Time: 4:30 p.m. PT

The oral presentation is expected to provide more mature efficacy and safety data from the combined initial and expansion cohorts in Part 1 of IMerge, a Phase 2 clinical trial of imetelstat in transfusion dependent, lower risk myelodysplastic syndromes (MDS) patients who are relapsed or refractory to an erythropoiesis stimulating agent (ESA), do not have a del(5q) chromosomal abnormality and are hypomethylating agent (HMA) and lenalidomide treatment naïve.

Title: Imetelstat Is Effective Treatment for Patients with Intermediate-2 or High-Risk Myelofibrosis Who Have Relapsed on or Are Refractory to Janus Kinase Inhibitor Therapy: Results of a Phase 2 Randomized Study of Two Dose Levels (Abstract #685)

Session Name: 634. Myeloproliferative Syndromes: Clinical: Emerging Therapies and Prognostic Scoring in Myelofibrosis and Other MPNs
Session Date: Monday, December 3, 2018
Session Time: 10:30 a.m. PT – 12:00 p.m. PT
Presentation Time: 10:30 a.m. PT

The oral presentation will highlight efficacy and safety data from a primary analysis of IMbark, a Phase 2 clinical trial that evaluated two starting dose levels of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered by intravenous infusion every three weeks) in more than 100 patients with Intermediate-2 or High-risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a JAK inhibitor. More mature data from the extension phase of IMbark, including median overall survival, is expected to be presented.

Analyst and Investor Event

On December 10, 2018, Geron plans to host a webcasted event for analysts and investors. At the event, an investigator from each of the IMbark and Part 1 of IMerge trials will reprise the oral presentations from the ASH (Free ASH Whitepaper) Annual Meeting. A press release with event details, including how to access a webcast link, will be available at the end of November.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat include a Phase 2/3 trial called IMerge in lower risk myelodysplastic syndromes (MDS) and a Phase 2 trial called IMbark in Intermediate-2 to High-risk myelofibrosis. Imetelstat received Fast Track designation from the United States Food and Drug Administration for the treatment of patients with transfusion-dependent anemia due to lower risk MDS who are non-del(5q) and refractory or resistant to an erythroid stimulating agent.