Geron Announces Opening of IMpactMF Phase 3 Clinical Trial in Refractory Myelofibrosis
Geron Corporation (Nasdaq: GERN) has announced the launch of the IMpactMF Phase 3 clinical trial for imetelstat, a telomerase inhibitor targeting refractory myelofibrosis (MF). This trial aims to enroll approximately 320 patients and assess the drug's ability to extend overall survival and improve symptoms, following promising Phase 2 results. The primary endpoint will focus on overall survival, with secondary endpoints covering various clinical outcomes. The trial incorporates over 150 sites globally, though potential COVID-19-related delays are acknowledged.
- Launch of IMpactMF Phase 3 trial for imetelstat, indicating progression in clinical development.
- Potential to enroll 320 patients, expanding the study's scope.
- IMpactMF aims to confirm positive Phase 2 trial outcomes, focusing on overall survival and symptom improvement.
- Risk of delays in trial enrollment and site openings due to the COVID-19 pandemic.
- Regulatory challenges and uncertainties surrounding clinical trial approvals could impact timelines.
FOSTER CITY, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced the opening for patient screening and enrollment of the IMpactMF Phase 3 clinical trial of imetelstat, a first-in-class telomerase inhibitor, in refractory myelofibrosis (MF).
“As Geron’s second registration-enabling Phase 3 trial in hematologic myeloid malignancies, the IMpactMF trial represents a milestone for our Company,” said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. “The IMpactMF trial will evaluate imetelstat in a poor-prognosis refractory MF patient population to confirm the clinical benefits of extended overall survival and symptom improvement observed in our IMbark Phase 2 trial, as well as the reductions in abnormal clones and mutation burden demonstrating disease-modifying activity of imetelstat.”
Geron plans for IMpactMF to evaluate imetelstat compared to best available therapy (BAT) in approximately 320 patients with Intermediate-2 or High-risk MF. Patients eligible for the trial will be required to be non-responsive, or refractory, to treatment with a JAK inhibitor. The primary efficacy endpoint for the Phase 3 trial is overall survival (OS). Secondary endpoints include symptom response, spleen response, progression free survival, duration of response, safety, pharmacokinetics and patient reported outcomes. Geron plans to engage over 150 sites to participate in IMpactMF across North America, South America, Europe and Asia, with the majority of clinical sites expected to be open for screening and enrollment in 2021, subject to potential delays or interruptions associated with the evolving and uncertain effects of the COVID-19 pandemic.
To learn more about IMpactMF and whether the study is enrolling patients in your area, please visit www.clinicaltrials.gov.
About Myelofibrosis (MF)
Myelofibrosis, a type of myeloproliferative neoplasm, is a chronic blood cancer in which abnormal or malignant precursor cells in the bone marrow proliferate rapidly, causing scar tissue, or fibrosis, to form. People with MF may have abnormally low or high numbers of circulating red blood cells, white blood cells or platelets, and abnormally high numbers of immature cells in the blood or bone marrow. MF patients can also suffer from debilitating constitutional symptoms, such as drenching night sweats, fatigue, severe itching, or pruritus, abdominal pain, fever and bone pain.
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About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Phase 2 clinical data strongly suggest that imetelstat has disease-modifying activity through the apoptosis of malignant stem and progenitor cells, which allows potential recovery of normal hematopoiesis. Geron is currently conducting two registration-enabling Phase 3 clinical trials of imetelstat: IMerge, a Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS), and IMpactMF, a Phase 3 trial in refractory myelofibrosis (MF). Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.
About Geron
Geron is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization 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 such statements, include, without limitation, those regarding: (i) that Geron plans to enroll approximately 320 patients and engage over 150 sites to participate in IMpactMF, and expects the majority of such clinical sites to be open for screening and enrollment in 2021; (ii) that clinical data strongly suggest imetelstat has disease-modifying activity; and (iii) 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 the Company is able to overcome all the clinical, safety, efficacy, operational, technical, scientific, intellectual property, manufacturing and regulatory challenges to enable approximately 320 patients to be enrolled and for over 150 medical centers globally to participate in IMpactMF; (ii) whether regulatory authorities permit the further development and commercialization of imetelstat on a timely basis, or at all, without any clinical holds; (iii) whether imetelstat is demonstrated to be safe and efficacious in IMpactMF and other clinical trials; (iv) whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (v) whether imetelstat actually demonstrates disease-modifying activity in patients; (vi) whether the Company maintains sufficient funding to complete IMpactMF; (vii) whether Geron overcomes all the potential delays, added expense and other adverse impacts caused by the continuing and evolving effects of the novel coronavirus (COVID-19) pandemic; and (viii) whether imetelstat has adequate patent protection and freedom to operate. 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 September 30, 2020. 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.
