22 october...if weather forecast says it will rain, if you are done painting the fence, if you think the Browns are will lose anyway, if you really have nothing better to do:
results from arx517 will be presented, it looks promising, it had basically a 100% success rate in decreasing PSA about 50% minimum (in some cases more than 90% decrease) with a single dose, with minimal side effects (they say)...and I think the host will be dr Tagawa
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Maxone73
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Maxone73, I am currently in that trial with good results. I travel to Atlanta this afternoon for my 6th infusion. So far very good results as shown on imaging.
I have lived in the US, briefly, and I lived near Cleveland, that’s why I became a Browns supporter. And as the great Jerry Kramer told me during an interview when he got to know I was not a Green Bay supporter: “nobody’s perfect!” 😂😂
Here I am! Yes there are updates. Let me summarize.
The webcast on the 22nd provided some important and interesting confirmations, even if they still have to collect and stratify more statistical data.
First and foremost, there was an explanation about the mechanism of action of the drug, which, unlike what happened in previous trials (all suspended due to toxicity and adverse effects), proved to be very stable. The problem with the previous systems was mainly due to two factors: 1) the payload carried by the drug was released on the wrong target; 2) the drug was unstable and its half-life expired in a few hours (max 1 day). The molecule arx517 proved to be stable, managing not only to be more precise, but also to remain functional for 8 days after administration, allowing the payload to reach deeper diseased tissues and, above all, causing very few and mild side effects.
Now I am citing (pay attention to the fact that they refer to 23 patients, the initial population, but now they are 65 and still recruiting, as they have not yet found the highest tolerable dose):
"For efficacy, Ambrx reported that more than half of the 23 patients had a 50% or more reduction in prostate specific antigen, which is elevated in prostate cancer. Seventeen out of 21, or 81% of evaluable patients, also had a steep reduction in circulating tumor DNA. In a smaller analysis of six patients, half who had prior prostate-specific membrane antigen (PSMA)-targeted radionuclide therapy, had more or equal to 50% reduction in prostate specific antigen. And out of four evaluable patients, half had a 30% or more reduction in target lesions.
There were no treatment-related serious adverse events or dose limiting toxicities, a discontinuation rate of just 3.1% and fewer than 10% grade 3 treatment related adverse events—but no grade 4 or 5s.
Aung said the safety data are particularly important for these late-stage patients: “We don’t want to make them sicker.”
“I don't know if I've ever seen a late-stage cancer drug, after two years of clinical development, not having an [serious adverse event]. Not one,” O’Connor said in an interview."
AND, interestingly:
"Ambrx also saw in the small dataset the possibility that the treatment will work regardless of a patient’s PSMA biomarker levels, which would mean ARX517 could have access to a wide patient population. The trial did not screen for PSMA, so the patients had a mix of high and low levels.
“If we don't have to have a biomarker program, we do not want to have one,” O’Connor said."
I must say they looked quite happy, but you never know...I understand it's also a bit of a poker game between researchers, the company developing the drug, the potential investors and so on. But I think they will move on to phase 2 and 3 quickly since FDA is "on their side".
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