GERN up 23% after hours on this PR re: NEJM article; check editorial, too, nejm.org :
| Dual Publications in the New England Journal of Medicine Highlight Transformative Potential of Imetelstat in Hematologic Myeloid Malignancies | Results From Two Separate Clinical Studies Suggest Disease-Modifying ActivityMENLO PARK, Calif., Sept. 02, 2015 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced the publication of two papers in The New England Journal of Medicine (NEJM) in which the company’s telomerase inhibitor, imetelstat, was shown to have disease-modifying activity thought to be associated with selective inhibition of the malignant progenitor cell clones responsible for the underlying disease in two hematologic myeloid malignancies, essential thrombocythemia (ET) and myelofibrosis (MF). The papers are available online in the September 3rd issue at www.NEJM.org.
“The data in the ET and MF study publications in The New England Journal of Medicine provide compelling evidence that use of a telomerase inhibitor, such as imetelstat, may result in ground-breaking changes in how we approach the future treatment of hematologic myeloid malignancies,” said John A. Scarlett, Geron’s President and Chief Executive Officer.
In the Phase 2 clinical study evaluating imetelstat in ET, all patients achieved a hematologic response, with the majority achieving a hematologic complete response. Rapid and substantial molecular responses observed in the study suggested therapeutic activity of imetelstat on the growth of malignant progenitor cell clones that drive ET. The safety and efficacy results reported in the NEJM publication are consistent with the preliminary data from this study previously presented in part at the annual meetings of the American Society of Hematology in December 2012 and December 2014, and the European Hematology Association annual meeting in June 2013.
“This study was a first look at what happens when you treat ET patients with a drug that has a totally novel mechanism of action,” said Dr. David Snyder, City of Hope, Duarte, CA, and co-principal investigator of the ET study. “In the study, imetelstat had a clinically significant effect on disease burden in ET patients.”
“The molecular responses suggest that imetelstat may have broad activity across hematologic myeloid malignancies which warrants further clinical study in other myeloproliferative neoplasms,” noted Prof. Dr. med. Gabriela M. Baerlocher, Inselspital, Bern University Hospital and University of Bern, Switzerland, and co-principal investigator of the ET study.
In the Phase 2 pilot study evaluating imetelstat in MF patients, unprecedented complete and partial remissions, including reversal of bone marrow fibrosis and molecular responses, were observed. These results suggest the potential value of telomerase-targeting strategies for the treatment of MF, and identify imetelstat as an active drug in this disease. The safety and efficacy results reported in the NEJM publication are consistent with the preliminary data from this study previously presented in part at the annual meetings of the American Society of Hematology in December 2013 and December 2014.
“The clinical and molecular remissions seen in the study suggest selective anti-clonal activity, not previously documented in current drug treatment of MF,” commented Dr. Ayalew Tefferi, Mayo Clinic, Rochester, MN, and principal investigator of the MF pilot study. “A much larger multi-center clinical study is needed to confirm these findings and to further investigate the mechanism by which imetelstat induces clinical responses in some patients.”
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