Good news has come from Geron (GERN) - a firm we liked and mentioned several times as a reference where researchers and firms involved in embryonic stem cells resorted to when they faced problems and needed help. Although Geron had an excellent research and numerous patents covering many aspects of embryonic stem cells, the firm decided to dispose of its stem cell program and pursue its drug development program, which among various approaches, most of it revolve around the telomere, which is tips the ends of chromosomes.
On Wednesday morning, the American Society of Hematology posted an abstract on its website about early promising results of an early small study of Geron's drug imetelstat on myelofibrosis (MF) with an overall response rate of 44%. Imetelstat acts as a competitive enzyme inhibitor that binds to and blocks the active site of the enzyme telomerase. Inhibition of telomerase activity in tumor cells by imetelstat results in telomere shortening, which leads to cell cycle arrest or cell death (apoptosis).
The posted abstract stated that "The current study signifies the potential value of telomerase-based treatment strategies in MF and identifies imetelstat as an active drug in that regard. The observed morphologic and molecular remissions confirm selective anti-clonal activity, which has thus far eluded other drugs in MF, including JAK inhibitors. The association between response and spliceosome mutations suggests a broader application for the drug in myeloid malignancies."
Thirty-three patients were accrued - the first 18 patients enrolled and followed for a minimum of 3 months or discontinued are presented in this abstract: 11 cohort A and 7 cohort B; 44% PMF, 33% post-PV MF and 22% post-ET MF.
Prohost Comments: Although still in very early development, we agree that Geron's drug imetelstat results are promising. It is wrong, however for critics of Incyte (INCY) to think that Geron's drug would throw Incyte's drug Jakafi from the window.
The critics claim that all incyte's drug does effectively is shrink the spleen with no other beneficial effect on the bone marrow or overall survival. These claims are just not true. In a recent study, Incyte's drug Jakafi has proven to shrink the spleen, which no other drug was capable of offering, and improve overall survival (OS) in patients with MF.
The positive Incyte drug results came from two ongoing clinical trials of Jakafi (ruxolitinib), which were presented at the 18th Congress of the European Hematology Association (EHA) in Stockholm, Sweden. In a three-year follow-up analysis of the Phase III COMFORT-II study, treatment with Jakafi, which is marketed as Jakavi by Novartis (NVS) outside the United States, demonstrate that using the drug was associated with improved overall survival and sustained reductions in spleen size compared to the best available therapy.
To read the study click here, or read Incyte's press release of June 16, 2013.
Results from an exploratory analysis of bone marrow fibrosis data from an ongoing Phase I/II single-arm, open-label clinical trial for Jakafi (ruxolitinib) were presented at the 2013 American Society of Clinical Oncology (OTC:ASCO) Annual Meeting in Chicago. Fibrosis of the bone marrow, a cardinal feature of myelofibrosis (MF) was shown to stabilize or reverse after 24 and 48 months of Jakafi treatment in the majority of patients with MF, a magnitude of an effect not seen with long-term treatment with hydroxyurea.
We congratulate Geron. But we cannot ignore appreciating incyte for the success of its drug Jakafi, which the critics rushed to demean minutes following the good news from Geron. While we contemplate Incyte's rich pipeline and the promises of the many other trials with ruxolitiniband and with the rest of the pipeline drugs, we wish Geron all the best for the success of early results of its promising drug imetelstat. We also wish that in a few years, Geron's pipeline will be as rich and promising as that of Incyte.
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