Ongoing Trial Updates

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j6proulx
Posts: 23
Joined: Mon Jun 25, 2018 10:20 pm

Ongoing Trial Updates

Post by j6proulx » Tue Aug 21, 2018 12:19 am

One of the aspects of the current status of imetelstat's evolution that is so curious to me is the ongoing updates to all of the clinical trials, not just IMbark and IMerge. There was an update on August 7 on an old trial evaluating imetelstat in younger patients with relapsed or refractory solid tumors. The trial status was "withdrawn" back in 2014 and didn't appear to enroll any patients and yet, the trial status was updated this month. There is even an update to a trial listing for GRN1005 (withdrawn in 2014), with feverish updates on 4/3/18, 4/5/18, 4/12/18, 4/14/18, 4/18/18, 4/28/18, 5/5/18, 5/15/18, 5/16/18, 5/23/18, 6/1/18, 6/9/18, 6/12/18, 6/15/18, 6/16/18, 6/19/18, 6/23/18, 6/27/18, 7/3/18, 7/13/18, 7/14/18, 7/20/18, 7/25/18, 7/26/18, 8/7/18, 8/9/18, 8/10/18 and finally 8/14/18. It could be unrelated to Janssen's possible coordination with the FDA and the upcoming continuation decision, but these frequent trial updates are very interesting.

https://clinicaltrials.gov/ct2/history/NCT02011126

https://clinicaltrials.gov/ct2/history/NCT01679743

j6p

biopearl123
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Joined: Fri Jul 20, 2018 5:13 pm

Re: Ongoing Trial Updates

Post by biopearl123 » Tue Aug 21, 2018 1:02 am

J6, very nice find. I haven’t looked at the GRN1005 study for years and yet there are all 49 (!!!) updates. Geron said the FDA would look at the totality of the data and I guess they are sure lookin’! Interesting that the study has changed from a therapeutic study to a diagnostic one. bp

j6proulx
Posts: 23
Joined: Mon Jun 25, 2018 10:20 pm

Re: Ongoing Trial Updates

Post by j6proulx » Thu Aug 23, 2018 4:23 pm

The study status for GRN1005 was updated again yesterday.
https://clinicaltrials.gov/ct2/history/ ... 5&C=merged
Very curious.

j6p

huntingonthebluffs
Posts: 246
Joined: Wed Feb 24, 2016 12:00 am

Re: Ongoing Trial Updates

Post by huntingonthebluffs » Thu Aug 23, 2018 5:57 pm

Appreciate your sleuthing! Based on the persistence it certainly seems to be meaningful activity. What are thoughts on possibilities for such activity? Could "right to try" or CT reincarnation have anything to do with it? Whatever it is, I suspect it is a pointer to activity behind the scenes in preparation for the many future trials to come using Imetelstat in combination with other drugs.

j6proulx
Posts: 23
Joined: Mon Jun 25, 2018 10:20 pm

Re: Ongoing Trial Updates

Post by j6proulx » Thu Aug 23, 2018 8:39 pm

I had not considered the "right to try" or compassionate use as a possible explanation. That would be very compelling.

biopearl123
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Joined: Fri Jul 20, 2018 5:13 pm

Re: Ongoing Trial Updates

Post by biopearl123 » Thu Aug 23, 2018 9:34 pm

J6, I have interpreted this a little differently and (perhaps less optimistically.). As I recall, GRN1005 was based a a vehicle that permeated the blood brain barrier and was hoped to allow easier entry for an Imetelstat conjugation into the CNS. After evaluation the license was returned to the (I think it was) Canadian company that originally tried it with another antineoplastic agent with some success. I am not sure what happened after that. Of course in keeping with the old Geron, I think the clinical trials site was not updated. While I do think there are broad hints that CNS tumors are on Janssen's list for future study, I suspect the recent flurry of activity to update this study is more a function of the sins of Okarama (record keeping issues among others) being visited upon Scarlett and Janssen. I think they are trying to rectify everything that did not meet FDA standards, even ghosts of studies past, so the FDA will look favorably on the current hematologic studies that are in the forefront and perhaps ease the way toward studies of CNS neoplasms as well. There was good older data in vitro to support this re sensitivity of some CNS tumor cell types to Imetelstat. I continue to suspect that because recurrences are probably related to cancer stem cells that there is considerable interest in pursuing Imetelstat. Thank you for finding and highlighting these recent updates, I see this as yet another flashing green light. Regards, bp

j6proulx
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Joined: Mon Jun 25, 2018 10:20 pm

Re: Ongoing Trial Updates

Post by j6proulx » Fri Sep 14, 2018 4:46 pm

Just a minor curiosity item ... the study status for the withdrawn GRN1005 study in brain metastases from breast or lung cancer continues to be updated quite regularly:

https://clinicaltrials.gov/ct2/history/NCT01679743

I'd love to know what that's all about.

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