Search found 128 matches

by Hoosier Investor
Fri Mar 22, 2024 4:10 am
Forum: ImetelChat
Topic: Ferroptosis Article (NIH)
Replies: 4
Views: 780

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 ...
by Hoosier Investor
Fri Mar 22, 2024 1:19 am
Forum: ImetelChat
Topic: Ferroptosis Article (NIH)
Replies: 4
Views: 780

Re: Ferroptosis Article (NIH)

Reposting the ferroptosis (in cancer) article put forward by Bigfun....

https://www.ncbi.nlm.nih.gov/pmc/articl ... 0of%20GPX4
by Hoosier Investor
Fri Mar 22, 2024 1:16 am
Forum: ImetelChat
Topic: Ferroptosis Article (NIH)
Replies: 4
Views: 780

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...
by Hoosier Investor
Fri Mar 22, 2024 1:01 am
Forum: ImetelChat
Topic: Patients #3 and #9 had both been on Luspatercept.
Replies: 4
Views: 969

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...
by Hoosier Investor
Thu Mar 21, 2024 8:59 pm
Forum: ImetelChat
Topic: Patients #3 and #9 had both been on Luspatercept.
Replies: 4
Views: 969

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...
by Hoosier Investor
Thu Mar 21, 2024 12:56 pm
Forum: ImetelChat
Topic: Are they getting more positive results
Replies: 6
Views: 1110

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,...
by Hoosier Investor
Tue Mar 19, 2024 12:18 am
Forum: ImetelChat
Topic: Significant events coming
Replies: 2
Views: 1042

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...
by Hoosier Investor
Mon Mar 18, 2024 11:19 pm
Forum: ImetelChat
Topic: “Next Generation TI Program“
Replies: 2
Views: 792

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 (...
by Hoosier Investor
Sat Mar 16, 2024 4:04 pm
Forum: ImetelChat
Topic: Public Hearing Comments (Patient #3; Patient #9)
Replies: 4
Views: 813

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...
by Hoosier Investor
Fri Mar 15, 2024 5:22 am
Forum: ImetelChat
Topic: Quite Surprising that....
Replies: 10
Views: 2698

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 ...
by Hoosier Investor
Thu Mar 14, 2024 9:49 pm
Forum: ImetelChat
Topic: Awesome Job by Dr. Faye Feller
Replies: 5
Views: 825

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) ...
by Hoosier Investor
Wed Mar 13, 2024 8:17 pm
Forum: ImetelChat
Topic: CKTC
Replies: 8
Views: 1840

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...
by Hoosier Investor
Wed Mar 13, 2024 4:02 pm
Forum: ImetelChat
Topic: CKTC
Replies: 8
Views: 1840

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 (...
by Hoosier Investor
Wed Mar 13, 2024 4:46 am
Forum: ImetelChat
Topic: Basic Considerations....
Replies: 13
Views: 2529

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...
by Hoosier Investor
Wed Mar 13, 2024 4:08 am
Forum: ImetelChat
Topic: Basic Considerations....
Replies: 13
Views: 2529

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...
by Hoosier Investor
Wed Mar 13, 2024 12:51 am
Forum: ImetelChat
Topic: Basic Considerations....
Replies: 13
Views: 2529

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...
by Hoosier Investor
Tue Mar 12, 2024 6:51 pm
Forum: ImetelChat
Topic: Hy’s law
Replies: 8
Views: 1219

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...
by Hoosier Investor
Tue Mar 12, 2024 6:10 pm
Forum: ImetelChat
Topic: Hy’s law
Replies: 8
Views: 1219

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
by Hoosier Investor
Tue Mar 12, 2024 6:02 pm
Forum: ImetelChat
Topic: Risk vs. Benefit
Replies: 6
Views: 1662

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...
by Hoosier Investor
Tue Mar 12, 2024 5:10 pm
Forum: ImetelChat
Topic: Reminder of meaningful benefits to non-TI patients....
Replies: 0
Views: 618

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...