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Geron Corporation (GERN)
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Imetelstat seems to have jumped all of the hurtles for being effective, safe and needed now in many blood cancers in many ways (repeated in detail), that have been reviewed and discussed over and over again . Dr. Rizo and JS are operating with 'inside information', that none of us have, and legally they are required to protect. The reviews at ASH2020 and at the EHA +KOL's have not been challenged, and have only gained in their significance. With so many positives, and minimal negatives, approvals and new partners are as close to a sure thing as one can get. The revival of the Cancer-Moonshot enhances all of Imetelstat's successes and potential in almost all cancers (combinations). We don't know how good Imetelstat is, and that is the speculation. The PPS will rise and fall based upon new information, and hedge fund (or others) manipulations. The upside is vast and the downside is limited.
Treatment with the telomerase inhibitor imetelstat at high doses has been shown to improve overall survival (OS) and other important parameters such as the degree of fibrosis, symptoms and splenic volume in patients with relapsed or refractory myelofibrosis (MF) (R / A) Janus kinase (JAK) enzyme inhibitor therapy, compared to treatment with a lower dose.
This is evidenced by the results of an Intent-To-treat (ITT) analysis of the IMbark study presented at the annual meeting of the American Society of Hematology (ASH).
Recently published on Oncology Nursing News.
High-Dose Imetelstat Improves Overall Survival and Offers Clinical Benefits in Intermediate-2 and High-Risk Myelofibrosis
a first-in-class, first-in-clinic telomerase inhibitor (GRN163L), which is currently in multiple Phase II trials in solid and hematological cancers.
Pelabresib could face competition from products with different biological targets that are in development as a therapeutic option for patients with MF with prior exposure to ruxolitinib, including as a monotherapy or in combination with ruxolitinib. These products include kinase inhibitors, telomerase inhibitors, Bcl-2 inhibitors, and other epigenetic inhibitors. Geron Corporation is conducting a Phase 2 trial evaluating imetelstat, a telomerase inhibitor, in patients with MF who have relapsed after or are refractory to prior treatment with a JAK inhibitor. Imago BioSciences, Inc., is conducting a Phase 1 trial of IMG-7289, an inhibitor of LSD1, which is an epigenetic target, in patients with MF. MEI Pharma, Inc., and Helsinn are conducting a Phase 2 trial of pracinostat, a histone deacetylase inhibitor in MF patients on treatment with ruxolitinib.
According to various Jam News services, the effectiveness of this drug (imetelstat or GRN163L) was tested in one study on human cells isolated from human tissues and in another study on animal models of prostate and brain cancer. GRN163L attacks not only the main tumor mass but also the cancer stem cells that are responsible for the growth of cancer.
lm a long term committed Long GERN holder, but my commitment has cost me hundreds of 1000's $$ in opportunity cost by missing out on several other biotech's that I follow but cashless due to huge Gern Position.
In 60 years of trading hundreds of different companies I’ve never owned stock with most potential and most manipulated as GERN; we can only hope there’s no negative surprises.
I think the President's announcement that the Cancer-Moonshot would be the nations #1 health priority (COVID-19 vaccines are now #1 by necessity), is a windfall for Imetelstat & Geron. Telomeres growth are of primary interest in all cancers, and Imetelstat is in a class by itself in interacting with telomeres and telomerase, proven in a variety of blood cancers now, and with vast potential in numerous cancer combinations. The Moonshot is about to launch.
Something of significance to consider - Imetelstat is currently on 5 Continets in two on going P3 Clinical Trials.
With today's addition of Argentina, Australia and Brazil for the IMpact P3 Clinical Trial - Imetelstat is now in Asia, Australia, Europe, North America and South America.
Global commercialization should be accelerated with doctors, clinicians and patients in 5 continets being exposed to Imetelstat right now. I suspect that a foundation of global oncological sites to springboard from will help expedite future commercial time horizons.
Today's listing of these 3 countries is a very big deal for Imetelstat and Geron. This will financially ratchet up any Partnership/BO scenario.......if warranted. Even better than that, is patients in even more locations have Imetelstat as an option in a clinical trial situation. Just something to ponder. -Laz
Uhm, anyone notice that the whole market was down big today? LABU, the biotech 3x ETF, was down 12%.
Imetelstat will be approved, not soon enough, to be sure, but it will be approved. Relax.
Go Geron. Improve lives. Save lives. Make money.
“Imetelstat is associated with freedom from transfusion for at least 2 months in almost 40% of patients with lower-risk myelodysplastic syndrome who require transfusions regularly and who have not yet had lenalidomide or a hypomethylating agent. In addition, the mutation burden, or disease clone, declines in some responding patients,” Steensma said
Myelofibrosis, high dose imetelstat improves survival in patients relapsed or refractory to JAK inhibitors. # ASH20
Fan this is from 2018...Regarding JAX...
Treating NOD/SCID/IL2Rγnull (NSG) mice transplanted with normal or MF splenic CD34+ cells directly with vehicle alone, MM, or imetelstat
NSG mice were purchased from The Jackson Laboratory (Bar Harbor, ME). All experiments were approved by the Animal Care Committee of ISMMS. Initially, in order to identify the dose of imetelstat that was tolerated by NSG mice and that minimally affected the behavior of normal CD34+ cells, CB CD34+ cells from 8 to 10 donors were pooled and were transplanted (5 × 105 per mouse) via the tail vein into 8- to 9-week-old sublethally irradiated (240 cGy) NSG mice. These mice were then injected a week after transplantation intraperitoneally with 5, 15, and 30 mg/kg of imetelstat or MM thrice weekly for 4 to 8 weeks. Two to 3 months after the discontinuation of imetelstat or MM administration, the mice were euthanized and the cells were recovered from the BM of the femurs, tibias, and humeri. The presence of human (h) CD45+, CD14+, CD33+, CD41a+, CD19+, CD3+, and CD34+ cells was determined by mAb staining and flow cytometric analysis.
In order to examine the effects of imetelstat on MF HSCs, MF splenic CD34+ cells (3 × 105 to 5 × 105 per mouse, n = 3) that had previously been shown to achieve significant degrees of human cell chimerism 4 months after their transplantation into NSG mice were used. CD34+ cells from these spleens were transplanted into NSG mice and after a week were treated with imetelstat or MM at the dose of 15 mg/kg for 4 weeks. Three months after the discontinuation of drug treatment, the presence of cells belonging to various human hematopoietic cell lineages in the BMs of recipient mice was quantitated as described previously. In addition, the hCD45+ cells in the BM of the recipient mice were selected using a FACSAria cell sorters (BD). The percentage of JAK2V617F/JAK2total present in the genomic DNA of selected hCD45+ cells from the mice receiving splenic CD34+ cells from a patient with a granulocyte JAK2V617F allele burden of 85.1% was determined using a quantitative real-time (RT)–PCR with an allelic discrimination method.30,31 We considered human engraftment to have occurred in NSG mice if hCD45+ cells were present at ≥0.1% of the nucleated cells in murine BM.
BP, you have it right. Would be happy with July 2022 if enrollment proceeds nicely, but am prepared for December. Somewhere in that time frame, we're going to need more cash, if you assume ~$100M/year burn rate. We'll know more next month.
Now what could be exciting in the near future would be if Phase II data had further matured. No idea How many patients are still on Imetelstat from Phase II nor if they're still receiving a benefit.
Thank you for your message. The trial sponsor for NCT02598661 has been updated to Geron Corporation, which will be available on the website after our daily update.
Thank you again for your interest in CKB. Please feel free to contact us with any questions or comments.
Taofei Yin, PhD
Clinical Scientific Curator
The Jackson Laboratory
JAX Genomic Medicine
10 Discovery Drive
Farmington, CT 06032
The Jackson Laboratory
Clinical Trial Detail
NCT ID NCT02598661
Title Study to Evaluate Imetelstat (JNJ-63935937) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Phase Phase III
Variant Requirements No
Sponsors Janssen Research & Development, LLC
Age Groups: adult
Covered Countries USA | CAN
Janssen never left the Building
The Jackson Laboratory is based in Maine with over 2,000 staff frin Google
Lets see what tomorrow brings
Guys, please stop clowning over the daily price gyrations. None of that matters. Buy in and wait. The only thing that matters is buyout, partnership, or approval. Because those are the only conditions that will make us real money. Until then, chill.
GERN's cash in the bank is worth over half of GERN's current share price. GERN is so undervalued here.
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