New drug for our European friends
Posted , 8 users are following.
Google B P H News I'd post the link but it would be deleted
0 likes, 21 replies
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Notes on New drug for our European friends
Peter02 uncklefester
Posted
Do you know anything about a new drug called Fexapotide Triflutate? Just been trying to get some info on it but seems difficult? Cures low grade prostate cancer & BPH?
uncklefester Peter02
Posted
The drug just finished phase 3 clinical trials. It's hard to find information on it not sure why. I'd be interested to see if it actually shrinks the prostate or just relaxes the muscles in the urinary tract.
Peter02 uncklefester
Posted
uncklefester Peter02
Posted
It would be nice if it did kill cells. Like Jim I approach these new procedures with a healthy dose of skepticism. Sometimes The Eternal Optimist In Me Takes over. Let's cross our fingers
uncklefester Peter02
Posted
jimjames uncklefester
Posted
Thanks for the heads up.
From the published data:
"Measurements of maximum urine flow (Qmax) showed an overall improvement of 1.77 mL per second in the patients receiving topsalysin."
"Those treated with PRX302 saw a 7.6-point improvement (in IPSS Score), while those treated with saline solution vehicle had a 6.58-point overall improvement (p = 0.043)."
For participants receiving PRX302 (Sophiris), average change from the 4.5-point baseline was a sustained 1.6- to 1.7-point improvement from weeks 18 through 52, which was statistically significantly superior to vehicle for every post-baseline visit beginning at week 18 (reaching p = 0.004).
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Personally, I don't see enough improvement to be persuasive for the prostate injectivle drug Sophiris.
Wonder what this "4 minute" injection will cost
Jim
uncklefester jimjames
Posted
1.77 ml/sec added flow doesn't seem to be a substantial increase but an overall improvement of 7.6 IPASSE score seems significant . I know the saline solution was 6.58 but how long did that last. I wish there was more information on this drug. If the 4 minute injection enabled you to get off yams losing it would be a God send to many
jimjames uncklefester
Posted
My point had in part to do in part with the saline comparison. Improvements were at the same point in time so in that sense durability is unknown for either. Sticking a needle in the prostate as a control, has also shown benefits in other studies so it could be just that or even the placebo effect. And the 1.77ml increase was not even in average flow but for max flow. I just don't see much benefit here.
Jim
jimjames
Posted
Jim
Howard31850 uncklefester
Posted
Hi uncklefester,
Be very careful of Nymox. They have been under investigation several times for securities fraud. Every time the stock drops the ceo puts out a new bulletin about great results and new research to be "published in peer-reviewed journal in the next 2 months". It seems to work every few months so he can sell more stock.
Sophiris is a legitimate company but they are bedeviled by placebo effects which seem to mirror their drug response for longer and longer periods of time. They came applying for FDA permission to extend their trials out another 6 months because they cannot believe the placebo effect lasts for so long!
I am pinning my hopes on this company so one day I won't have to CIC!
Take care
Neil
Howard31850 uncklefester
Posted
I hope the mod lets my post through - it contains the facts about these companies which should be posted here. Anyway - don't believe it - if the mod doesn't let it through I'll find another way to get you the facts.
uncklefester Howard31850
Posted
Hi Neil I've been watching the PRX302 made by Sophiris and another drug made by Nymox. I'm on the fence about their study but maybe we will see more information if they start using it in Europe. If its not much trouble PM the links you posted. I know there is skepticism from Google search.
Peter02 Howard31850
Posted
Howard31850 uncklefester
Posted
Hi uncklefester and peter - I will try to dig out the links to this information and PM them to you. You will note with nymox that all the PR is just around an application - well any one can make an application. The results they hype are old data and they are always promising new study results but they never come out. I don't know how this guy keeps going. He is good at financial engineering by getting headlines.
Sophiris has great in vitro results but never seem to be able to replicate them in vivo beyond the placebo effect. It's been a while but I will go through my notes and get something for you. Someday there will be an injectible solution to BPH but I don't believe these guys have it.
jimjames Howard31850
Posted
Right now it sounds like a shot of saline makes the most sense in terms of risks versus rewards. Be it the placebo effect or some sort or some unknown benefit of the needle (and possibly the saline) itself. I haven't read the side effect profile of the saline group but if there are no side effects something to think about or investigate. And yes, hopefully better injectibles will be studied.
Jim
uncklefester Howard31850
Posted
I agree with the your coments regarding the company N Y M O X. I'm still on the fence regarding S O P H I R I S As I mentioned before if this drug gets approved for use in Europe we will at least have an idea if its going to help with BPH
uncklefester
Posted
This an older article from mid 2016. I can't find any updates. I guess we'll see.
S o p h i r i s Bio Inc., recently released six-month biopsy data from the first seven prostate cancer patients treated with its drug candidate PRX302 (topsalysin) in a Phase 2a proof-of-concept clinical trial. PRX302 is being developed for the treatment of lower urinary tract symptoms of benign prostatic hyperplasia (BPH) and of localized low- to intermediate-risk prostate cancer.
Howard31850 uncklefester
Posted
Hi uncklefester,
I'm sorry I haven't been able to dig out that info for you yet but I will. On Sophiris you can go to their web site and they have poster sessions going back a few years on their trials. You'll see on their data that the drug curves barely sit above the placebo curves.
They have a novel technology where their drug is activated by PSA and then makes holes through the membranes of the BPH cells which destroys them. This works great in the lab but when tried in the body the body's defences detect the dead cells and triggers inflammation which causes more hyperplasia which replaces the dead cells as fast as they destroyed. So many of these new ideas work great in the testube on isolated cells but fail in the context of the whole body.
As for Nymox, nobody really knows the mechanism of action because they keep promising to publish the details but never do. It is speculated they just use botox for the injection!
I will try to dig out the reports - it is from last year.
Neil
uncklefester Howard31850
Posted
Hi Neil, no need to apologize. I knew Nymox had its share of possibly faulty results. For some reason when I first read the article I thought it was about Sophiris. I don't know how I got it mixed up. Anyway, I agree the results from both of the companies leave a lot of questions. I'll be interested if the European FDA allows this drug to be wased. No need to dig up your research on thge companies for me. I've found enough aticles that showing the LUTS improvements gained by both drugs are minimal when compared to the plecebo group. Oh well, I can dream can't I?