ImetelChat

Momelotinib has an interesting history. It was developed by an Australian biotech years ago. That company was bought by YM BioSciences in 2011, and YM BioSciences was bought by Gilead in 2013. In 2018, Sierra Oncology bought momelotinib off the scrap heap from Gilead for only $3 million upfront, wit...

The target goal of imetelstat in MDS is improving a patient’s quality of life by reducing the need for, and hopefully, eliminating transfusions for as long as possible. Many subjective and objective factors go into a doctor’s decision to transfuse. Considering those many competing factors, statistic...

While there is nothing any of us can do to expedite the FDA approval process, we can all do something to help alleviate the blood supply shortage: Give blood.

@biopearl123

It's very possible this sub-study is being conducted in response to a "suggestion" by the agency. A few million dollars spent pales in comparison to a CRL or approval with a "black box warning."

This is clearly a study separate and distinct from the prior Phase 2/3 study. The Phase 2 portion (Part 1) was open-label, the Phase 3 portion (Part 2) was double-blind, and randomized in a 2:1 ratio to receive either imetelstat or placebo. This Vascular Repolarization study is single-blinded. The p...

https://clinicaltrials.gov/ct2/show/NCT02598661 Trial update posted 11/24/21 Study Description Detailed Description, paragraph 4 In a separate Ventricular Repolarization substudy of Part 2, approximately 45 participants will be enrolled and randomized 2:1 to receive either imetelstat or placebo. If ...

There are dozens of marketed drugs that affect the QT interval on the ECG. The change from baseline in QTc interval was added to the IMerge trial as a secondary outcome measure in September of 2017. So they must have picked up a signal they didn’t like, and thus the reason for the Ventricular Repola...

From a post I made on Seeing Alpha back in March of 2017 regarding Janssen's preclinical work on combining imetelstat and venetoclax. This resulted in a patent being filed by Janssen that is now owned by Geron. https://www.freepatentsonline.com/y2018/0036336.html "I’m not sure everyone is fully unde...

Good find. Yes, that was bone marrow failure causally related to imetelstat. The affected patient was in the 9.4 mg/kg treatment arm. I’m curious if the treatment caused one of the other bone marrow failure disorders, such as aplastic anemia? That would be a good question for the company.

I can only imagine the time and money spent on focus groups and marketing consultants to come up with these five possibilities: Voytelo, Rytelo, Imstedy, Telryza, and Imtellig. Might as well trademark each of them. After all, what's a few hundred thousand more in legal fees at this point? lol

It's the trade (brand) name under which Geron plans to sell imetelstat.

BTW, Fenaux, Steensma, Komrokji, and the crew were all on board with APR-246 as the ability to reactivate p53 is a holy grail. PMVPharma (PMVP) is also working on targeting p53. The company has barely started Phase 1 and it’s already sporting a market cap north of $2 billion.

APRE is a cautionary tale for naïve biotech investors who become overly confident that a small Phase 2 trial's positive results will successfully translate to positive, statistically significant results in a more extensive Phase 3 trial.

To refine my statements above and more accurately compare apples to apples, cumulative duration of TI, defined as the sum of all periods of 8 week TI during treatment, was a median of 92.3 weeks for imetelstat and 79.9 weeks for luspatercept. To be fair to Scarlett, technically, he is correct that o...

Scarlett has been downplaying the competitive threat of luspatercept for years. And he’s been disingenuous in a number of ways when comparing imetelstat to luspatercept. The most glaring example is his characterization of transfusion independence durability. Scarlett likes to quote imetelstat’s medi...

In addition to UT running an enormous MPN research operation, Tefferi is probably one of the reasons Mesa left Mayo for UT after being at Mayo his entire career, including medical school.

@biopearl, It is painfully apparent many patients came off imetelstat too early. Imetelstat is a potent drug whose benefits can linger long after discontinuation. If there is a conscious effort on the part of investigators to not “emphasize” those lingering benefits, it might have to do with salvage...

Speaking of KOL’s, I noted in a 6/17 post, Srdan Verstovsek (Dr. “Ruxolitinib”) of MD Anderson will be co-Principal Investigator with John Mascarenhas of Ichan School of Medicine for the upcoming Phase 3 IMpactMF trial. Dr. Verstovek was Principal Investigator for Incyte’s Phase 3 COMFORT trial that...

Here's the exact wording: "Participants who meet progressive disease criteria and discontinue BAT, may crossover to receive imetelstat treatment after sponsor's approval." Allowing a crossover is more appealing, both ethically and from a recruitment standpoint. But it creates challenges in trial res...

If they truly haven’t gotten to the half-way point yet, this is going to take forever to enroll. At this rate, they could fully enroll the new MF trial before the MDS trial. BTW, the new MF trial is interesting. They’re allowing a crossover from the Comparator Arm to the Imtetelstat Arm upon disease...