Myelofibrosis (MF)

Geron Announces Publication of Analyses Comparing Real World Data to IMbark Phase 2 in Annals of Hematology

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Monday, October 11, 2021
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, People, Company, Private Securities Litigation Reform Act, Fatigue, Patient, Pharmacokinetics, Publication, Risk, Fibrosis, MDS, Microdeletion syndrome, Department, Real world data, BAT, Fast Track, H. Lee Moffitt Cancer Center & Research Institute, MF, Survival, Blood, Safety, Bone marrow, Apoptosis, OS, RWD, Population, Itch, Imetelstat, Geron Corporation, U.S. Securities and Exchange Commission, Real, Lymphatic system, ESA, Security (finance), Hematology, Myeloproliferative neoplasm, Bone pain, Corporation, Fever, Disease, JAK, Primary myelofibrosis, Abdominal pain, Nasdaq, Pharmaceutical industry, Myelofibrosis (MF), Imetelstat, Geron, MYELOFIBROSIS (MF), IMETELSTAT, GERON

Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, today announced the publication in the Annals of Hematology of a paper entitled Favorable Overall Survival with Imetelstat in Relapsed/Refractory Myelofibrosis Patients Compared with Real World Data, which details statistical analyses comparing data from the Companys IMbark Phase 2 clinical trial to closely matched Real World Data (RWD).

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, today announced the publication in the Annals of Hematology of a paper entitled Favorable Overall Survival with Imetelstat in Relapsed/Refractory Myelofibrosis Patients Compared with Real World Data, which details statistical analyses comparing data from the Companys IMbark Phase 2 clinical trial to closely matched Real World Data (RWD).
  • The paper describes several statistical adjustment methods and multiple sensitivity analyses to improve comparability of the data set from the Companys IMbark Phase 2 trial and RWD to mimic the effect of a randomized trial.
  • While acknowledging the limitations of RWD analyses, the authors conclude that the results of these analyses warrant further prospective evaluation of imetelstat in a Phase 3 setting with OS as a primary endpoint.
  • Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.

Geron Announces Publication of IMbark Phase 2 Data in Journal of Clinical Oncology

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Thursday, June 17, 2021
Research, Medical devices, FDA, Clinical trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, Life sciences, Health sciences, Health, Stem cells, Geron Corporation, Clinical trial, Imetelstat, Lestaurtinib, Myelofibrosis (MF), Imetelstat, Geron, MYELOFIBROSIS (MF), IMETELSTAT, GERON

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced the publication of data from the IMbark Phase 2 clinical trial in the Journal of Clinical Oncology in a paper entitled, Randomized, Single-Blind, Multicenter Phase II Study of Two Doses of Imetelstat in Relapsed or Refractory Myelofibrosis.

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced the publication of data from the IMbark Phase 2 clinical trial in the Journal of Clinical Oncology in a paper entitled, Randomized, Single-Blind, Multicenter Phase II Study of Two Doses of Imetelstat in Relapsed or Refractory Myelofibrosis.
  • We are pleased with the publication of our IMbark Phase 2 data in the high-impact Journal of Clinical Oncology.
  • We look forward to confirming these results in our ongoing IMpactMF Phase 3 clinical trial in refractory MF.
  • The publication reports efficacy, safety and biomarker results from the IMbark Phase 2 clinical trial and is available online.

Incyte and Cellenkos Enter into Global Development Collaboration Agreement for CK0804

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Wednesday, December 30, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Incyte, Life sciences, Companies, Industries, Myelofibrosis (MF), LIMBER, Ruxolitinib (Jakafi®), CK0804, Incyte, Cellenkos®, Inc.

In addition, Incyte has an exclusive option to acquire sole rights to develop and commercialize CK0804, and genetically-modified variants of CK0804, in benign and malignant hematology indications.

Key Points: 
  • In addition, Incyte has an exclusive option to acquire sole rights to develop and commercialize CK0804, and genetically-modified variants of CK0804, in benign and malignant hematology indications.
  • We are delighted to partner with Incyte, a global biopharmaceutical company, to further study and develop CK0804.
  • In addition, per the agreement, Incyte will have an option to acquire an exclusive global license to develop and commercialize the program.
  • Upon exercising the global licensing option, Incyte would be responsible for all activities and costs associated with research, development and commercialization of the program.

Geron Announces Opening of IMpactMF Phase 3 Clinical Trial in Refractory Myelofibrosis

Retrieved on: 
Friday, December 11, 2020
Biotechnology, Hospitals, Health, Pharmaceutical, Oncology, Clinical medicine, Geron Corporation, Imetelstat, Life sciences, Janus kinase inhibitor, Biotechnology, Primary myelofibrosis, Myelodysplastic syndrome, Myelofibrosis (MF), Imetelstat, Geron

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).

Key Points: 
  • 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 Gerons 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., Gerons Chief Medical Officer.
  • Patients eligible for the trial will be required to be non-responsive, or refractory, to treatment with a JAK inhibitor.
  • 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).