As you know by now, I am following this technology pretty closely as it is very promising and their clinical studies produced some impressive results (one guy became a complete responder after two infusions). This fast tracking is for using the molecule as tracer, but I hope it will pave the way for a fast-track status for the therapeutic use as well!
This has nothing to do with the subject/contents of your post, but why do we use the word "pretty" as an informal adverb in English/American? E.g. "I am following this technology pretty closely." Sounds out of whack... but what the hell do I know? Pretty stupid post on my part.....I see you guys wearing the white coats and carrying those nets.....
You are pretty much right but it you want to be even righter, check out this video. It should pretty much make you a pretty good user of pretty as an adverb. Adjectives are for dummies. Here is the real deal :
Isn't 64Cu-SAR-bisPSMA just the imaging isotope for this treatment? I think that 67Cu-SAR-bisPSMA is the actual treatment molecule. The way I read the papers from Clarity is that they use the 64Cu as an imaging agent to determine the patient specific uptake potential of the actual therapeutic 67Cu. If the uptake of 64Cu is really low then there is little reason to give a patient the 67Cu. It's the whole concept of how a theranostic is meant to work. You use a one isotope variant to screen patients and the other to treat. This way you avoid unnecessary toxicity if the patient isn't really a candidate for treatment. It's great that 64Cu is being fast tracked, But I'd really like to see 67Cu get further along in trials so it can make it to market ASAP. Even better is that Clarity is now working on an Actinium version of their drug. That one may really prove to be effective at inducing a durable remission whereas the 67Cu may suffer from a similar problem that Pluvicto has of not being durable because the isotopes involved are just Beta emitters.
From what I understood it’s a matter of quantity and frequency (the infusion is repeated multiple times for therapy), but yes I would say it’s the same molecule!
I read the article in the link. This is indeed the diagnostic version of the drug, not the therapeutic version. Clarity has two distinct versions of this product. The only difference as far as I can tell is that the diagnostic version uses Copper 64 in its chelator and the therapeutic version uses Copper 67. Copper 64 emits positrons that are appropriate for PET imaging. Copper 67 is a Beta emitter that is appropriate for therapy. The cool think about this product is that it can image cancer using the same molecule that would be used to attack it. However only one of the two copper isotopes is used at a time. So first you use Copper 64 to image the cancer and determine if the patient is a good candidate for the copper 67 version that kills cancer. If the patient shows good uptake of the imaging version, then they dose the patient with the copper 67 version and kill some cancer.
This drug has other positives besides the diagnostic ability. It uses a double attachment to the target cancer cell so the molecule hangs on longer while the isotope does its thing. It also washes out of the blood slower than Pluvicto, so it stays in the blood stream longer and has more chance of getting to the tumors which typically have poor vascularization (blood supply). Also it's chelator (the part that holds the radioactive isotope) is stronger than on Pluvicto and this helps prevent the isotope from being lost into the blood stream and winding up in places it shouldn't go. All of this combines to make Clarity's drug more effective against PCa than Pluvicto.
They did. The thing that is getting fast tracked in the article is the Cu64 diagnostic version. It looks like it is on its own separate approval path from the therapeutic version. Makes sense as a diagnostic agent and a therapeutic agent have different goals and different toxicities. It looks like the diagnostic version Cu64 is already in a phase III trial. So we may see it on the market in the next year or two. Unfortunately the therapeutic version is just going to phase II so we're probably years out on that one. But to me I'm more interested in their Actinium version which is just entering phase I trails now. I suspect that one may be a game changer with its isotope and molecular structure. it could be something that as long as the toxicity profile isn't insane could really get after micrometastatic disease in a big way.
I contacted the study coordinator and it looks like they are using very small numbers of people and it also looks like things are going slowly. I am supposed to resume pluvicto but was hoping this would be ready soon. Looks like there will be too long a delay and I can not wait for clarity to get their shit together soon enough.
Yes, the therapeutic version is still something like 3-5 years out. But they are starting phase II trials, so maybe there's a way in to that. If not then there are other actinium based trials going on at other places that might be recruiting participants. There's also work being done with Astatine which is another Alpha emitter that looks like it hits PCs like dump truck full of TnT
My husband may start Pluvicto soon. Could you tell me your reactions was? He is afraid it will drain his body like chemo did. Ups, downs what ever you can tell me about it! Thank you!!
there are plenty of reactions to pluvicto on this forum. mine is just one experience. the general thinking is that one third of people have bad reactions or increased tumor growth and discontinue. one third have some effect and one third have amazing results?
i am more in the middle category. seems to have slowed progression a little but no miracles here . did not have any serious side effects other than fatigue. my blood counts did drop low enough that it was decided i needed a break.
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Galeterone for the treatment of advanced prostate cancer: the evidence to date
FDA just fast-tracked this. Phase IIb is scheduled to be complete in early 2022. Prevents reoccurrence via. immune system T helper cells.
