Updated Imetelstat Clinical Data from Part 1 of IMerge in Myelodysplastic Syndromes to be Presented
MENLO PARK, Calif., May 17, 2018 (GLOBE NEWSWIRE) — Geron Corporation (Nasdaq:GERN) today announced that an abstract describing clinical data regarding the telomerase inhibitor imetelstat has been selected for an oral presentation at the 23rd Congress of the European Hematology Association (EHA) to be held in Stockholm, Sweden from June 14-17, 2018. The abstract was published today on the EHA website at https://ehaweb.org/congress.
Title: Imetelstat in RBC Transfusion-Dependent (TD) Lower Risk MDS Relapsed/Refractory to Erythropoiesis-Stimulating Agents (ESA) (IMerge): Updated Efficacy and Safety
Abstract Number: S1557
Date: Sunday, June 17
Time: 8:30-8:45 am CET
The abstract contains updated data (as of January 2018) from the first 32 patients enrolled in Part 1 of IMerge, the ongoing Phase 2/3 clinical trial of imetelstat in patients with lower risk myelodysplastic syndromes (MDS) being conducted by Janssen Research & Development, LLC.
In accordance with EHA policies, abstracts submitted to the Annual Congress of EHA are embargoed from the time of submission. To be eligible for presentation at the Annual Congress of EHA, any additional data or information to be presented at the Annual Congress may not be made public before the presentation.
Following the Annual Congress of EHA, the presentation slides will be available in the “R&D” section of Geron’s website (www.geron.com).
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 might have disease-modifying activity by inhibiting the progenitor cells of the malignant 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. 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.
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) disease-modifying activity of imetelstat by inhibiting the progenitor cells of the malignant clones associated with hematologic malignancies; (ii) the safety and efficacy of imetelstat; (iii) 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 (iv) 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 Janssen decides to continue to conduct IMerge; (ii) whether imetelstat is safe and efficacious and will succeed in IMerge by overcoming all of the clinical safety and efficacy, technical, scientific, manufacturing and regulatory challenges; (iii) whether the FDA or other health authorities permit IMerge to continue to proceed under the existing protocols or any amendments thereto; (iv) 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; (v) whether any future efficacy or safety results from any clinical trial of imetelstat may cause the benefit/risk profile of imetelstat to become unacceptable; and (vi) whether patent coverage of imetelstat enables Janssen to successfully commercialize imetelstat. Additional information on the above-stated 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 March 31, 2018. 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.
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