Hello all. Just thought I’d post an update since it has been one month since I have been on the bomedemstat in the clinical trial. My platelets began at close to 1.5 million. I have been on the starter dose of 30 mg caplet once daily. After 30 days they are now at 800. No adverse effects were noted until this past week when I got a red, itchy rash type thing on both shins. Somewhat hot and slightly swollen. Cellulitis was ruled out. So…? Side effect? From something else? PV itself? Sometimes it can be so hard to tell. After a few days of topical steroid, it has resolved. The doc who is running the study spoke to the CEO of imago to look into others that may have experienced it. All in all, a pretty exciting result I think though. Wishing all those who celebrate, meaningful Passover and Easter holiday.
Bomedemstat Trial Update: Hello all. Just thought... - MPN Voice
Bomedemstat Trial Update
Hi! That is an exciting result… I did not know about this trial. It would be great to have another treatment option. Hopefully it will get FDA approval. Thanks for participating and best wishes for continued good progress.
Thank you! 🙏
I recall they use PLT count as the reference for a result. Your result is great, and seems a better way than chemo. (HU An) Thanks for being a real life connection to this important trial.
There is an ET trial going also. If you get this same result, you would see your PLT move to in range in another few weeks.
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<<bomedemstat demonstrated significant and durable hematologic control and symptom improvement while maintaining normal hemoglobin levels. The updated data demonstrated bomedemstat reduced a platelet count in the normal range within eight weeks, a primary clinical objective.>>
biospace.com/article/releas...
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They were supposed to report allele data for the ET trial, but have
not.
The MF trial for bomedemstat suggests there can be some, see
below. You might see this benefit also, has this subject come up in
your visits?
MF allele results:
<<... reduction in mutant allele frequency, or MAF>>
marketwatch.com/press-relea...
Thanks. I haven’t discussed the allele burden with him but I will on Tuesday.
Thanks, let us know if there is any new info available there. That would be a whole extra benefit.
Here are some endpoints from the ET study, PLT is the top benefit goal. Note allele data in conclusion, I would expect PV and ET would share some benefits:
Primary:
• Safety and tolerability
• Platelet count reduction (≤400 x 109/L)
in the absence of thromboembolic events
Secondary
• Durability of platelet and WBC count
reduction
• Changes in cytokine profiles
• Symptom reduction (MPN-SAF TSS)
• Changes in mutant allele frequencies
(MAF)
Conclusions:
• Bomedemstat (IMG-7289) is well tolerated in patients with ET
• Bomedemstat monotherapy is demonstrating clinical activity:
• Improvements in platelet and WBC counts while maintaining stable haemoglobin
• Symptomatic improvement for patients with significant MPN symptoms
This report is from last June, so the 24 weeks is up:
• Pending Data: changes in mutant allele frequencies as patients reach 24 weeks
• Development Plans
• The ET study remains open for enrollment (NCT04254978)
• Planning for pivotal study (usually means phase 3) in ET is underway
• Bomedemstat for the treatment of PV is currently enrolling (NCT04262141)
Sounds good Miriammusic,
Regarding the rash on your lower legs:
Did you wear some new clothes that were touching your calves and were they black? This happened to me once (cause inexplainable) and it also went away with cortisone. Unfortunately it kept returning every time I wore the skirt. I then threw the skirt away and all symptoms disappeared. The culprit was in the color!
It’s really a mystery. No new clothes touching the legs. Very painful and itchy. They thought for sure that it was cellulitis, until the other leg became symptomatic. Cellulitis is very rarely bilateral.
Fab news do you feel any better for lower platelets?
I haven’t noticed any big improvements in the fatigue. I mean sometimes I think I do but again it can be hard to tell. What is the normal fatigue at dealing with all of this and working full-time and living life and what is polycythemia fatigue? How low do your platelets have to be before you start feeling normal?
I have found a fatigue killer. It’s called Acetyl L-Carnitine. I take 2-3 500mg capsules a day. Morning, noon afternoon. If I exercise I take 2 right before exercising. I have a life again! That also helped me gain back some muscle (because I was able to exercise again)! A 72 yr old friend of mine had Covid a few months ago. He was extremely fatigued. Had trouble even walking to the bathroom. He started the ALCAR and is now taking walks in the forest. My doctor said I can probably take it the rest of my life. I had heart palpitations along with the fatigue from Anagrelide. After taking this, they stopped. It’s worth a try to get your life back.
healthline.com/nutrition/l-...
I recall you've mentioned it before, it seems possibly less potential interaction than NAC. I may try it in the 1-at-a-time routine. I will discuss with my Hem at tomorrow Tuesday's visit. I'm testing Curcumin now.
I'm less with fatigue than malaise, but I assume there is overlap.
It’s good to have a balance mixture of both Turmeric and Curcumin.
The ALCAR helped me build muscle again after a year of hardly moving. Antioxidants (Curcuma, ALCAR, NAC) should be taken far away from your meds, because they can interfere with them and they lose potency. 😉
My Hem agreed it's ok to try ALCAR. I'm ready to try any and every safe supp to reduce the burden.
He said it relates to muscle building, makes sense with the word "carn" (as in carnivore) in it.
My muscles are ok but if it helps me get out of the clouds I'm in.
I started ALCAR. I see in some reports it can affect HCT. Have you noticed any effect there?
Hi EPGuy.
I have been taking ALCAR for almost a year. I have anaemia since birth (hereditary). My hematocrit has not changed at all. It’s low as it’s been my whole life.
ALCAR is a saviour for me. I’ve managed to reduce from four to two capsules taken at breakfast about 9am and my second one around 3-4pm. I have ample energy. If I have a strenuous day, I’ll take 3 or even four as needed. Important is that my body is not „used to it“ or addicted. It may be that in a year I might not need it. We’ll see when that time comes. 🙂
Hope this will be good for you!!
I think the HCT increase was in patients that had liver disease or other condition that made Hb too low, so the increase there was a good thing. But good or bad, yours is not affected. I assume you don't want more. MPNs in general of course don't look for that increase.
I'm on just 500/day of Alcor to start. So far (4 days) no days were extra bad so I can say for sure it's not made things worse, important requirement. I'm also taking Curcumin as noted. I may up the dose if it continues to look ok.
There were studies of Alcor + INF in the Hep C INF treatment days. It seemed helpful for their needs.
I don't really have energy problem, more malaise. Maybe I just power thru fatigue and don't notice that part, so confusing. Naps don't make much diff usually except to be pleasantly unconscious for some of the bad spell.
Powering through is what I did all my life and I burned out my thyroid and adrenals, not to mention what it did to my psyche. I was a doer, no matter what. Compared to most people, I've lived 4 lives already. This is definietly one of the reason I had so many problems!! Eventually, my body gave up. I was taking so many meds! In the end, that made eveything worse. Eventually the ET came. I'm lucky I'm still alive or not half paralized. I've had 6 TIAs and my daughter is only 18. the TIA have left their toll on my memory.
I have banned all chemicals and additives from my food and home. They don't come through our door! I dread going to eat out or eating at someone else's house. I taste the chemical industry on my plate.
Since the hit I received from the Pfizer and the neck injury a year ago, 2 Alcar (1g) helped me stand up and cook. Eventually, I was able to clean the bathroom, then more. After a few months, I was able to go to aerobics and walk along all the steps for about 20". After 2 months, I made it to 1,5 hours of exercise or fast walking. This helped me build up muscle without cramps and without taxing my adrenals further. On the training days, I took 1g Alcar before exercising. After that, I rested for 1 hour. then one Alcar (500mg) in the afternoon. In the beginning I tried 3 together (1,5g) and I was running around! Felt like I was 25 again!
This is an interesting study. I have post Et Mf but with high platelets. I take 1000 mg of hu daily but my platelets are usually in the 700’s to 800’s. This could eventually be a new alternative. Thanks so much for posting your results.
Glad to hear the good news. It sounds like things are going pretty well. Thank you for volunteering to be part of the clinical trial. This is the only way treatment options will move forward for treating MPNs.
As it happens, i was sitting next the the Imago Biosciences table at the MPN conference May 15 and had a chance to chat with the industry reps. The work with Bomedemstat is very interesting and promising. The use of a LSD-1 inhibitor could be a significant step forward in our treatment options.
For those interested, this is a nice quick video on this topic.
healio.com/news/hematology-...
I got curious and looked at previously reported adverse effects with Bomedemstat and found this previously reported issue with pyoderma. I have no idea if this is in any way related to what you experienced.
mpn-hub.com/medical-informa...
Thanks for updating us. Please let us know how things go.
Yikes! That condition looks vicious. No I had no ulcers or pus. Just red, itchy, swollen, hot to touch. Really mimicked cellulitis. Medical mystery lol
In the 1st link I get a video on Vonjo (pacritinib) the recently approved Jak inhibitor.
Try again. Link should go to Bomedemstat
healio.com/news/hematology-...
That works.
He notes that the "feature" of Bomed of reducing PLT can be a "bug" in MF when PLT is already low, so ET actually could be a better place to try it. But ET has fewer complications so it takes longer to find benefits vs in MF.
They are looking at clonal evolution and marry histology , but so far they are not telling in the ET arm.
Also could b useful for MF when thrombocytosis still evident. One of the ongoing commentaries about MF tx was nuancing the meds to the patient's presentation. Patients with thrombocytopenia or anemia need a different approach from those who do not. the good news being that there are now an increasing number of more favorable treatment approaches. .
Makes sense. I was not aware till recently that MF can often have normal to high PLT.
So many MF patients are good candidates for Bomed. In the video it seemed he was more concerned about the PLT reduction, but that would be in the sub set with low plt, where the new Vonjo is likely indicated instead.
I think for some of the new Jak inhibitors (Vonjo, Momelotinib) an MF patient may not qualify vs Rux until PLT or iron gets too low. But maybe these new ones will be first line Tx for some.
Glad the issue was not too severe. That full blown pyoderma gangrenosum does sound truly nasty. Maybe it was just a milder undetermined medication AE. Or maybe totally unrelated. That is why these clinical trials are so important.
I do get eczema, unrelated to the Besremi as well as some pop-up rashes and broad areas of itching that are related to the Besremi. Fortunately topical Eucrisa takes care of the small rashes and Claritin/Benadryl takes care of the itching. No big deal. The benefits are totally worth it.
Hope you find similar success with your trial.
Thanks for the update and glad it is looking so positive. Thanks for participating in the trial!
Sounds promising. 7 months on HU with little reduction in platelets and peripheral neuropathy as a side effect. Now off the HU and waiting, hoping for the PN to subside. I know they are trialling Bomedemstat in Australia. Fingers crossed this will offer a real alternative to HU. Could be years away though.
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