Search found 128 matches
- Fri Mar 22, 2024 4:10 am
- Forum: ImetelChat
- Topic: Ferroptosis Article (NIH)
- Replies: 4
- Views: 869
Re: Ferroptosis Article (NIH)
I still need to read through the articles, but I believe my prior comment is likely incorrect in that I'm not sure it would ever be desirable to inhibit ferroptosis as part of a treatment. Instead, I believe some chemo drugs also inhibit ferroptosis when administered. This inhibition of ferroptosis ...
- Fri Mar 22, 2024 1:19 am
- Forum: ImetelChat
- Topic: Ferroptosis Article (NIH)
- Replies: 4
- Views: 869
Re: Ferroptosis Article (NIH)
Reposting the ferroptosis (in cancer) article put forward by Bigfun....
https://www.ncbi.nlm.nih.gov/pmc/articl ... 0of%20GPX4
https://www.ncbi.nlm.nih.gov/pmc/articl ... 0of%20GPX4
- Fri Mar 22, 2024 1:16 am
- Forum: ImetelChat
- Topic: Ferroptosis Article (NIH)
- Replies: 4
- Views: 869
Ferroptosis Article (NIH)
Here's a good (long) article discussing the topic of ferroptosis in neurological diseases. "Emerging Mechanisms and Targeted Therapy of Ferroptosis in Neurological Diseases and Neuro-oncology" https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9274504/ I've only scanned the article, but it appears in some...
- Fri Mar 22, 2024 1:01 am
- Forum: ImetelChat
- Topic: Patients #3 and #9 had both been on Luspatercept.
- Replies: 4
- Views: 1087
Re: Patients #3 and #9 had both been on Luspatercept.
Slide #20 of Geron's current (March) investor presentation conveys their current beliefs in the LR-MDS indication. The slide has a visual showing their expectations and is accompanied by the following statements. * Imetelstat is expected to be used in the second-line regardless of frontline use with...
- Thu Mar 21, 2024 8:59 pm
- Forum: ImetelChat
- Topic: Patients #3 and #9 had both been on Luspatercept.
- Replies: 4
- Views: 1087
Patients #3 and #9 had both been on Luspatercept.
Both of our ODAC patient success stories (#3 and #9) involved each patient being on Luspatercept prior to Imetelstat. Patient #3 was on Luspatercept from Aug'22 to Feb'23 (~6 months). You can hear her comments at the 4:34:40 mark. Basically, she states that Luspatercept "helped some (she thinks) but...
- Thu Mar 21, 2024 12:56 pm
- Forum: ImetelChat
- Topic: Are they getting more positive results
- Replies: 6
- Views: 1247
Re: Are they getting more positive results
Bigfun, I came across the same article, and I've been pondering the exact same question as you. More specifically, does this revelation that Imetelstat can induce ferroptosis simply help explain our responses in the heme space, OR could it result in additional use in other diseases? Like you stated,...
- Tue Mar 19, 2024 12:18 am
- Forum: ImetelChat
- Topic: Significant events coming
- Replies: 2
- Views: 1119
Re: Significant events coming
Dr. Scarlett has indicated they will partner as a means of facilitating EU distribution and sales. Further, I believe he has allowed for the possibility of going with a simple distribution partner (i.e. not a big pharma partner) to assist with EU sales. I agree a Big Pharma (BP) partner would make a...
- Mon Mar 18, 2024 11:19 pm
- Forum: ImetelChat
- Topic: “Next Generation TI Program“
- Replies: 2
- Views: 856
Re: “Next Generation TI Program“
Lekola_ You're correct, Geron is working to develop a new Telomerase Inhibitor. No details are available yet, but the reasons are outlined below.... 1) In hopes of achieving improved efficacy and/or toxicity (safety) profile. 2) In hopes of transitioning from an infusion-based treatment to an oral (...
- Sat Mar 16, 2024 4:04 pm
- Forum: ImetelChat
- Topic: Public Hearing Comments (Patient #3; Patient #9)
- Replies: 4
- Views: 885
Public Hearing Comments (Patient #3; Patient #9)
For those of you who didn't watch/listen to the ADCOM meeting, I recommend you listen to the public comments from Patient #3. Her story begins at the 4:32:07 mark of the video. https://www.youtube.com/watch?v=Om-cKKBsMS4 Many of us have "hung-in-there" for quite a while.....hoping the drug (and comp...
- Fri Mar 15, 2024 5:22 am
- Forum: ImetelChat
- Topic: Quite Surprising that....
- Replies: 10
- Views: 2873
Quite Surprising that....
The ADCOM chairperson (Ravi) would vote "No" to the Benefit/Risk question. How could a practicing physician knowingly withhold a treatment that is going to benefit 40% of their sick patients? In this case, we're talking about a treatment that is going to allow a significant portion of your patients ...
- Thu Mar 14, 2024 9:49 pm
- Forum: ImetelChat
- Topic: Awesome Job by Dr. Faye Feller
- Replies: 5
- Views: 861
Awesome Job by Dr. Faye Feller
I just wanted to highlight the great preparation, composure, and representation by Faye and team. You did an excellent job representing Geron patients, employees, and investors alike. A textbook example of how to anticipate, prepare, and deliver under extreme pressure & stress. Thank you (and team) ...
- Wed Mar 13, 2024 8:17 pm
- Forum: ImetelChat
- Topic: CKTC
- Replies: 8
- Views: 1948
Re: CKTC
For full consideration, we also have..... * A relatively sick (sicker) patient population (transfusion burden) than prior/competitive studies. * A subset of patients who have been transfusion free for 1+ years. * FDA has already allowed imetelstat to be available for this indication via EAP.....with...
- Wed Mar 13, 2024 4:02 pm
- Forum: ImetelChat
- Topic: CKTC
- Replies: 8
- Views: 1948
Re: CKTC
FYI....The initial (agreed upon) trial design did NOT specify which criteria was to be used for HI-E. Thus, it seems fair & reasonable (and proper) for Geron to use the updated 2018 IWG criteria....which is designed to distinguish a statistical difference at ~4 months (16 wks) instead of ~2 months (...
- Wed Mar 13, 2024 4:46 am
- Forum: ImetelChat
- Topic: Basic Considerations....
- Replies: 13
- Views: 2648
Re: Basic Considerations....
They (FDA) do acknowledge the trial met both its Primary & Key Secondary endpoints (p.39 summary). At least we got that acknowledgement out of them.....which should be the most important consideration along with Safety. Along the lines of your comment, it seems rather obvious the 2018 criteria would...
- Wed Mar 13, 2024 4:08 am
- Forum: ImetelChat
- Topic: Basic Considerations....
- Replies: 13
- Views: 2648
Re: Basic Considerations....
Geron has anticipated the question, and provided the following rationale for using the 2018 criteria.... Analysis of HI-E was also performed using the revised IWG 2018 criteria for HI-E (Platzbecker, 2019) , which is considered more clinically relevant in MDS than the previous IWG 2006 criteria beca...
- Wed Mar 13, 2024 12:51 am
- Forum: ImetelChat
- Topic: Basic Considerations....
- Replies: 13
- Views: 2648
Basic Considerations....
Q: Is there an unmet medical (treatment) need in this patient population? Q: Did the FDA approve the trial design? Q: Did the P3 trial meet its primary endpoint? Q: Did the P3 trial meet one (or more) of its secondary endpoints? Q: Acceptable safety profile? Acceptable dosage protocol to adjust/mana...
- Tue Mar 12, 2024 6:51 pm
- Forum: ImetelChat
- Topic: Hy’s law
- Replies: 8
- Views: 1295
Re: Hy’s law
Here's the full & exact language in the FDA summary.... "Two events meeting the laboratory definition of Hy’s law cases were observed in the imetelstat arm. Of these, one was in a patient who had abnormalities in bilirubin at baseline and had no clear pattern of worsening during treatment. The other...
- Tue Mar 12, 2024 6:10 pm
- Forum: ImetelChat
- Topic: Hy’s law
- Replies: 8
- Views: 1295
Re: Hy’s law
I haven't seen what you're referring to, but we had an official (and positive) report submitted on this very topic....with no cases of Hy's Law observed.
https://www.regulations.gov/comment/FDA ... -0016-0004
https://www.regulations.gov/comment/FDA ... -0016-0004
- Tue Mar 12, 2024 6:02 pm
- Forum: ImetelChat
- Topic: Risk vs. Benefit
- Replies: 6
- Views: 1728
Risk vs. Benefit
RISK : * A patient who experiences a Grade 3/4 event WITHOUT realizing an improvement in their A) transfusion frequency, B) transfusion burden, or C) Hemoglobin levels. BENEFIT : * A patient who realizes a meaningful improvement in their A) transfusion frequency, B) transfusion burden, or C) Hemogl...
- Tue Mar 12, 2024 5:10 pm
- Forum: ImetelChat
- Topic: Reminder of meaningful benefits to non-TI patients....
- Replies: 0
- Views: 761
Reminder of meaningful benefits to non-TI patients....
I just wanted to remind folks that the so-called "non-responder" group included.... 1) Very sick patients coming into the trial with high (>6 units) transfusion burdens. 2) Patients who realized a meaningful reduction in their transfusion burden (but maybe didn't realize full T-I status) 3) Patients...