Promedior CT treating MF

[huntingonthebluffs]

Fishermanagents, not sure this is something discuss-able on your site but thank you for your comments and interest in following Promedior, Inc. PRM151 and bringing it to our attention on the SA board. Has this drug has been overlooked by most watching this space or just me? I am relatively new to these boards and related diseases and had heard very little about it. However, when you make note of it, I know it is worth my review. I wonder if it might have helped my deceased relative who died of MF in June 2015 even though he was being treated at the Mayo Clinic at Rochester, MN (not one of the CT sites).

The information available on the CT site at: https://clinicaltrials.gov/ct2/show/stu ... ocs=Y#locn

was interesting to me from several comparative points to the Imetelstat MF CT, such as the focus of the study, duration of treatment, detail on various outcome measures studied, detail criteria on eligibility, the clinical sites which specify the actual medical entity participating in the various cities, countries, etc. Not sure if this drug would be entirely competitive with Imetelstat in regards to MF or somehow usable in conjunction with it. Is it possible you and other ImetelChat members could add some comparative analysis and /or other thoughts? Thanks again.

[Fishermangents]

Hi, Hunt. PRM151 is 'one of the two most exciting new drugs' according to Ruben Mesa. The other one is imetelstat.

PRM151 is 'dissolving' fibrosis. It is a human made biological substance, that travels around your body to clean up scar tissue and fibrotic tissue. Promedior has found out how to make a synthetic version of that substance. They also found out that patients with lung fibrosis or myelofibrosis have all this substance being transported to the lungs and the bone marrow respectively. Adding this substance through iv injection supports the body in breaking down the fibrosis.

Just like Jakafi, PRM151 doesn't affect the underlying disease. But if the bone marrow clears up various symptoms may improve (e.g. anemia). Despite that, in some cases disease progression has been observed, while bone marrow fibrosis decreased. That means that PRM151 is probably not capable of selectively attack the malignant clone. It probably means another drug to improve symptoms and maybe to improve QOL and (who knows) LE. The drug is not being tested so long, so matters as impact on LE are difficult to judge. A friend of mine with PPV-MFjust started in this P2 trial. I believe doctors generally feel comfortable about the safety profile of the drug.

more info:
http://www.bloodjournal.org/content/126 ... ecked=true
https://www.promedior.com/news/releases ... 0Data.html

As only imetelstat seems to affect the underlying disease it will have an advantage over drugs like PRM151 and Jakafi. On the other hand, PRM151 may be another competitor in the palliative area. Good for patients who do not respond to imetelstat, for sure.

[huntingonthebluffs]

Thanks for the info Fishermanagents, it’s easy to see why you are impressed with this drug. Potentially treating fibrosis in areas beyond bone marrow and pulmonary conditions was a surprise to me as well. Would be interesting to know if PRM-151 has any R/R issues like Jakifi or other palliative MF treatments or if it would have the same results after the patient becomes R/R to Jakifi or other treatments. I didn’t see anything indicating mutation dependencies and the CT focuses on PMF versus Jakifi R/R MF. In addition to addressing the fibrosis, I believe I saw mention of a 25% reduction in spleen size which seems amazing. Wonder if this potentially could help a patient, late in the MF cycle, recover blood health, reduce spleen size and develop adequate strength necessary to consider a SCT or preferably depending on mutation, be a candidate for an Imetelstat CT or orphan drug treatment? Also, thinking about possibility of helping those that are R/R to Jakafi, maybe it is possible this drug could reverse limitations of Imetelstat treatment after becoming R/R to Jakafi, etc.? Seems this is an option that could help most MF patients to a significant degree even if it doesn’t cure, it might buy the time to alternatives like a SCT or Imetelstat, etc., especially important where essentially few or no possibilities exist.

[huntingonthebluffs]

Dr. T., as Anonymous Wizard pointed out again today on SA, is on record as encouraging MF patients to look to CT’s for treatments versus Jakafi. Since he didn’t specifically mention Imetelstat by name (maybe due to legal considerations) could his statements include drugs in CT’s besides Imetelstat? If so, Promedior’s CT is probably on his list along with Imetelstat to help patients. Even then, realistically, patients probably numbering in the thousands are not likely something a couple CT’s could support. I wonder then, what would Dr. T.’s thinking include given his comments on seeking treatment via CT’s?

[Fishermangents]

Actually, I don't know what Dr.T. thinks about PRM151. I can't remember him saying something explicit about that. Would be interesting to find out. I do know what his colleague at Mayo, Rubin Mesa, said about it. And off course Srdan Verstovsek is positive about PRM151 too. He is the one who started it up for MF in the first place, after having seen promising results in pulmonary fibrosis. My impression is that PRM151 is going through the testing process pretty smoothly. It seems to be beneficial for a relative large patient population, while having a favorable toxicity profile. In general doctors are reluctant with mentioning new drugs in early testing phase. It also took a while before Mesa started to mention imetelstat in his presentations.

[huntingonthebluffs]

Thanks, Fishermanagents, that’s what I thought. Either way, I don’t think all the new MF patients (I think it’s something like 3000/year) could be covered by CT’s so it must have just been a comment he hoped would get back to the FDA / EMA, etc. to make the argument that they need to get this process moving! In that light, I hope a little competition coming to light might help JNJ/Jansen/Geron, hear the footsteps and pick up the pace here to get Imetelstat to the market. These are the players that can make a difference and they all need to step it up. I hope they are reading these posts, honestly while they certainly should know all this, I'm not sure they get it.