MENLO PARK, Calif., Nov. 03, 2016 (GLOBE NEWSWIRE) — Geron Corporation (Nasdaq:GERN) today announced that four abstracts related to the imetelstat program have been accepted for presentation at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition to be held in San Diego, California from December 3-6, 2016. The abstracts were published today on the ASH website at www.hematology.org.
Oral Presentation
One abstract containing non-clinical data on imetelstat was selected for oral presentation. These data extend previous preclinical work conducted in a patient-derived model of acute myeloid leukemia.
Title: The preclinical efficacy of a novel telomerase inhibitor, imetelstat, in AML – a randomized trial in patient-derived xenografts (Abstract #578)
Session Name: 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Targeting Leukemia-Initiating Cells
Session Date: Monday, December 5, 2016
Presentation Time: 7:15 a.m. PT
Poster Presentations
Three abstracts related to imetelstat were selected for presentation as posters. One abstract investigates the potential impact of imetelstat on leukemia stem cells in a non-clinical model of chronic myeloid leukemia. The second abstract reports new data on telomere length dynamics from essential thrombocythemia patients providing further support that imetelstat treatment may suppress the neoplastic clones underlying the disease. The third abstract presents an analysis of treatment patterns and outcomes of patients with myelofibrosis from the United States medical claims databases that underscores the need for additional treatment options in that disease.
Title: Telomerase Inhibition with Imetelstat Eradicates β-catenin Activated Blast Crisis Chronic Myeloid Leukemia Stem Cells (Abstract #3065)
Session Name: 632. Chronic Myeloid Leukemia: Therapy: Poster II
Session Date: Sunday, December 4, 2016
Session Time: 6:00 p.m. – 8:00 p.m. PT
Title: Dynamics of Telomere Length Reflect the Clonal Suppression Seen with the Telomerase Inhibitor Imetelstat in Patients with Essential Thrombocythemia (Abstract #1938)
Session Name: 634. Myeloproliferative Syndromes: Clinical: Poster I
Session Date: Saturday, December 3, 2016
Session Time: 5:30 p.m. – 7:30 p.m. PT
Title: Characterization of Disease, Treatment Patterns, and Outcomes of Patients with Myelofibrosis: Analysis of 2 United States Commercial Claims Databases (Abstract #4769)
Session Name: 904. Outcomes Research – Malignant Conditions: Poster III
Session Date: Monday, December 5, 2016
Session Time: 6:00 p.m. – 8:00 p.m. PT
In accordance with ASH policies, abstracts submitted to the ASH Annual Meeting are embargoed from the time of submission. To be eligible for presentation at the ASH Annual Meeting, information contained in the abstract, as well as additional data and information to be presented at the Annual Meeting, may not be made public before the abstract has been presented in connection with the ASH Annual Meeting.
About Imetelstat
Imetelstat (GRN163L; JNJ-63935937) is a potent and specific inhibitor of telomerase that is administered by intravenous infusion. This first-in-class compound, discovered by Geron, is a specially designed and modified short oligonucleotide, which targets and binds directly with high affinity to the active site of telomerase. Preliminary clinical data suggest imetelstat has disease-modifying activity by inhibiting malignant progenitor cell clones associated with hematologic malignancies in a relatively select manner. Most commonly reported adverse events in imetelstat clinical studies include fatigue, gastrointestinal symptoms and cytopenias. Patients in these studies also experienced elevated liver enzymes, which resolved to normal or baseline in the majority of patients followed after imetelstat treatment was withdrawn. Imetelstat has not been approved for marketing by any regulatory authority.
About the Collaboration with Janssen
On November 13, 2014, Geron entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc., to develop and commercialize imetelstat for oncology, including hematologic myeloid malignancies, and all other human therapeutics uses. Under the terms of the agreement, Geron received an upfront payment of $35 million and is eligible to receive additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. All regulatory, development, manufacturing and promotional activities related to imetelstat are being managed through a joint governance structure, with Janssen responsible for these activities.
About Geron
Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding: (i) imetelstat having activity in other hematologic myeloid malignancies, including acute myeloid leukemia or chronic myeloid leukemia; (ii) imetelstat treatment suppressing the neoplastic clones underlying the disease in hematologic myeloid malignancies; (iii) the safety and efficacy of imetelstat; (iv) the potential receipt by Geron of additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, and royalties from sales of imetelstat; and (v) other statements that are not historical facts, constitute forward-looking statements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (i) whether imetelstat will succeed in IMbarkTM and IMergeTM and potential future clinical trials by overcoming all of the clinical safety and efficacy, technical, scientific, manufacturing and regulatory challenges; (ii) Geron’s dependence on Janssen for the development, regulatory approval, manufacture and commercialization of imetelstat, including the risks that if Janssen were to breach or terminate the collaboration agreement or otherwise fail to successfully develop and commercialize imetelstat and in a timely manner, or at all, Geron would not obtain the anticipated financial and other benefits of the collaboration agreement with Janssen and the clinical development or commercialization of imetelstat could be delayed or terminated; (iii) the fact that Geron may not receive any milestone, royalty or other payments from Janssen because Janssen may terminate the collaboration agreement for any reason; (iv) whether imetelstat is safe and efficacious, and whether any future efficacy or safety results may cause the benefit/risk profile of imetelstat to become unacceptable and (v) whether imetelstat can be applied to any or to multiple hematologic malignancies. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors,” including Geron’s quarterly report on Form 10-Q for the quarter ended June 30, 2016. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
CONTACT: CONTACT: Anna Krassowska, Ph.D. Investor and Media Relations 650-473-7765 [email protected] [email protected]