I was not part of this study group, but nevertheless, these results are discouraging. Alzheimer's Maverick TauRx Tries To Weave Success From Failed Trial The results of my group (TRx-237-005) will be out 4th quarter this year, but I doubt FDA approval given the failure of this group. In another article, Experimental Tau Protein Drug Tangled Up in Late-Stage Alzheimer's Study Failure, "Our overall opinion is that this was a negative study," said Dean Hartley, director of science initiatives at the Alzheimer's Association. "No difference between LMTX and control on cognitive and behavioral changes falls below FDA's regulatory requirements for approval of an Alzheimer's drug," Hartley added.
I have no idea how long the open-label I am on will continue.
8/4/2016 update: After meeting with my neurologist, we agreed that I would continue with what I have been taking (LMTX open label, namenda, donepezil).
He confirmed stable test results since I began the trial, and also agrees with me in not trusting the 15% test results from Slovenia as adequate proof to change to mono-therapy. He and I both hope LMTM will end up being approved, but if not, there are other tau inhibitor therapies in the works.
Hello megan,
ReplyDeleteDo not be anxious. My advise to you is stop all the existing drugs like aircept and namenda which you are taking because from the phase 3 result, it is clearly shown that 136 patients in monotherapy had achieve 85% stop progression which is highly significant. The p value is 0.0001 means 1only in 1000 patient will have error. The furthermore the scan shown statistical significant brain anthropy reduce by 38%. Whereas those on combination of drugs shows no significant. It only means if u take other drugs together with lmtx, lmtx become placebo not much effect anymore. All these info is in taurx press release. Do not read into the media too much. One of my friend a doctor in America, has decided to change to monotherapy as of today to try out for few months. His wife has been taking nameda and Exelon patches together with lmtx. But he make a decision after looking at phase 3 result to go alone with lmtx from today. The mild trial will be good as Dr W says in the press release it support the current trial result also on monotherapy. In fact phase 2 was also on monotherapy as the press release says and result was the same as phase 3 85% stop progression. Pray hard.
http://taurx.com/press-releases/
ReplyDeleteGo for monotherapy!
Meagan, in the press release it says it has changed the taurx has chabged the endpoint for for trx237-005 just before the data lock in. So the trial will only measured on monotherapy for both primary and secondary endpoint. Therefore i believe the result will be very good as Dr W say in the press release that this mild trial result will support the same result as in the current release mildmoderate result on monotherapy. Do not be disheartened.
ReplyDeleteHi megan,
ReplyDeleteFor your reading.
http://www.medicalnewstoday.com/articles/311990.php
Dear Megan,
ReplyDeleteI am also a very concerned party for the availability of LMTX. As you are part of the 005 trial and on a blinded basis (50% chance) thinks that you have received the real drug and felt its effectiveness, may I ask when during the course of your trial, were you on Monotherapy too, or were you taking other medications (like Aricept and Memantine)?
Thank you very much for helping us shed light on the right use of LMTX
Yes, I was in the 005 group, and was on donepezil (Aricept) and memnataine (Namenda) before, during, and continuing after the trial. I am now on open label.
DeleteHi Meagan
ReplyDeleteprof W said initial analysis on TRX005 trial patients on mono lmtx treatment (u are in this subgroup) patients are mostly from America). Results also show strong performance of mono lmtx but weak performance of patients mixing with other a.d drugs. You could have been doing so much better if you had been on mono. I personally know of a TRX015 trial lmtx mono patient reversal case (not slowdown of progression). REVERSAL!
Hi CW,
DeleteYour words were like an Angel's words when you mention about the REVERSAL. It is possible to get access to LMTX now?
The study results for my group were supposed to be published in October 2016...not yet published, Switching endpoints not good as far as FDA approval. I have experienced decline and confirmed with neurologist tests. I will continue on open label, but I suspect it will be discontinued at some point. The only ones that were successful mono were the reports from Slovenia, which alone are not considered adequate for FDA
DeleteInteresting potential. Hmm.
ReplyDeleteHi Megan
ReplyDeleteBeen dropping in here from time to time. Just wondering how you are. I've been reading the articles on LMTM of the TauRx Phase 3 trials.
LMTM mono-therapy works, even if the combo-therapy with other AD drugs does not work for most people.
Real people on the LMTM TauRx Phase 3 trial know it, as they can feel the positive difference that this drug makes in their daily lives.
Perhaps Phase 2 and 3 participants who have seen the real benefits of this drug LMTM need to lobby to FDA! Every AD drug trial on amyloid has failed, and here we have ONE drug attacking the Tau protein that works! It needs people who have benefited from this to write to the FDA and explain what this drug has done for them.
Without this LMTM drug, I fear that many people who were stable for the last two years or more while on LMTX/ LMTM may succumb to this terrible disease without the drug. It is my hope that something can be done to help all AD sufferers!
Wishing you well, Megan. All the best.
Regards. JK
The study results for my group were supposed to be published in October 2016...not yet published, Switching endpoints not good as far as FDA approval. I have experienced decline and confirmed with neurologist tests. I will continue on open label, but I suspect it will be discontinued at some point. The only ones that were successful mono were the reports from Slovenia, which alone are not considered adequate for FDA
DeleteHi Megan
DeleteI just met up with a friend who had attended a conference where Prof Wischik had briefed on the TauRx Phase 3 trial results and she clarified the following:
a) You mentioned: "Switching endpoints not good as far as FDA approval."
CLARIFICATION: The study 005 which you were on had its end-points changed BEFORE data-lock and hence in accordance with proper procedure acceptable to the FDA. In other words, this was BEFORE unblinding and hence totally acceptable.
b) You mentioned: "The only ones that were successful mono were the reports from Slovenia, which alone are not considered adequate for FDA."
CLARIFICATION: I'm afraid you were misinformed. In the 015 Mild/Moderate trial, 50% of those in mono-therapy were from US and Western Europe. In your trial arm of 005, all 100% mono-therapy were from US and Europe. All cases in mono-therapy showed vast improvements with LMTM at statistically significant values.
My friend's analysis, after attending the briefing, was that LMTM mono-therapy works. The scientific data for 015 arm of the trial has already been published in Lancet, the most prestigious peer-reviewed scientific journal, first online in Nov, and also in hardcopy in Dec 2016. If the findings weren't true or robust, it wouldn't have been accepted for publication in Lancet, arguably the most prestigious scientific journal reviewed by scientists. I think the 005 study results should be published in due course.
Megan, I'm really sorry to hear that you have experienced decline. But I understand you were on combination drugs with another two AD drugs.
***But it is the MONO-Therapy that works! If you are already on decline while on combi-therapy, you may want to consider the results published in Lancet about mono-therapy, and switch yourself to mono-therapy too.
It's your call, but please, please Megan, do not lose hope!
Just wanted to share with you what I had learnt from my friend. Hope it helps.
Take care, Megan. All the best.
Regards. JK
The findings of the TauRx Phase 3 LMTM trial has been published in the prestigious peer-reviewed medical journal, The Lancet.
ReplyDeletehttp://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31275-2/fulltext?rss%3Dyes
The study results for my group were supposed to be published in October 2016...not yet published, Switching endpoints not good as far as FDA approval. I have experienced decline and confirmed with neurologist tests. I will continue on open label, but I suspect it will be discontinued at some point. The only ones that were successful mono were the reports from Slovenia, which alone are not considered adequate for FDA
ReplyDeleteHi Megan
ReplyDeleteI just met up with a friend who had attended a conference where Prof Wischik had briefed on the TauRx Phase 3 trial results and she clarified the following:
a) You mentioned: "Switching endpoints not good as far as FDA approval."
CLARIFICATION: The study 005 which you were on had its end-points changed BEFORE data-lock and hence in accordance with proper procedure acceptable to the FDA. In other words, this was BEFORE unblinding and hence totally acceptable.
b) You mentioned: "The only ones that were successful mono were the reports from Slovenia, which alone are not considered adequate for FDA."
CLARIFICATION: I'm afraid you were misinformed. In the 015 Mild/Moderate trial, 50% of those in mono-therapy were from US and Western Europe. In your trial arm of 005, all 100% mono-therapy were from US and Europe. All cases in mono-therapy showed vast improvements with LMTM at statistically significant values.
My friend's analysis, after attending the briefing, was that LMTM mono-therapy works. The scientific data for 015 arm of the trial has already been published in Lancet, the most prestigious peer-reviewed scientific journal, first online in Nov, and also in hardcopy in Dec 2016. If the findings weren't true or robust, it wouldn't have been accepted for publication in Lancet, arguably the most prestigious scientific journal reviewed by scientists. I think the 005 study results should be published in due course.
Megan, I'm really sorry to hear that you have experienced decline. But I understand you were on combination drugs with another two AD drugs.
***But it is the MONO-Therapy that works! If you are already on decline while on combi-therapy, you may want to consider the results published in Lancet about mono-therapy, and switch yourself to mono-therapy too.
It's your call, but please, please Megan, do not lose hope!
Just wanted to share with you what I had learnt from my friend. Hope it helps.
Take care, Megan. All the best.
Regards. JK
Megan
ReplyDeleteI really suggest you ask your doctor to read the Lancet article ASAP, and then discuss with him on whether to go on mono-therapy. I personally think it is your BEST SHOT.
It's your call, with the help of your doctor's input - but only after reading the Lancet article carefully.
Regards. JK
Hi JK,
DeleteUnfortunately, the sponsor for my trial has stopped sponsorship, so I will not have access to the drug at all after February 23.
Any future tau inhibitor ph3 clinical trial from other companies are years away. For Mild/Moderate trial TRX-015, only 55% of patients are from Russia/Eastern Europe while 45% from western countries. For Mild category TRX-005 trial, 100% of the trial patient population are from USA, Western Europe and Australia, none from Russia and Slovenia.
ReplyDeleteThis drug definitely works for mono theraphy. There are 3 independent trials namely Ph3 TRX-015, Ph3 TRX-005 and Rember Ph2 all shows mono theraphy works.
Any future new trial Taurx is going to conduct will be 4mg. Taurx has since trial results discovered that 4mg twice a day is actually an active dose and works about the same as 100mg twice a day but with much lesser side effects. You can consider cutting up your 100mg pill into 25 equal parts. Take 4mg twice a day. If 25 equal parts is too difficult to cut, then cut it into 10 equal parts and take one 10mg a day. Before you start new mono theraphy, you need to stop taking Aricept / Namenda for about 4 months to clear them away from your body system. Whatever 100mg pills you have left, conserve them properly.
This is a moot point for me. I can't access the open label anymore as the sponsor for my trial has dropped out.
DeleteMegan, the above contributor is knowledgeable and makes a lot of sense. Any 100mg LMTM pill you have left can go a long way if you divide and consume them in the way suggested by the above contributor, but most importantly, it must be based on monotherapy.
DeleteI strongly suggest you get your Principal Investigator to approach the company for compassionate treatment. This is allowed, and it is your best bet. Please don't give up hope so soon.
Regards. JK
Ph1 of Taurx's new TRX038 trial will involve patients on 4mg twice a day and 10mg once a day. The new TRX038 trial will require patients to stop taking Aricept/Namenda for 4 months.
ReplyDeleteIf you have one months supply left, that's 60 pills of 100mg. Cut it up into 10 portions per pill to be taken once a day. You can continue to have LMTX 10mg once a day for 600 days.
J.L.