Thanks, not very good news, but I think Bell’s palsy is a known, reversible, side effect of Birinapant in its cancer trials.
:( you think any hope they may continue trials ?
In clinical trials, birinapant has been associated with the onset of cranial nerve palsies, meaning a weakness or paralysis of the areas served by the affected cranial nerve. Across the entirety of the clinical program to date, there have been 18 cases of cranial nerve palsy, of which all but two have been mild to moderate in severity. These events have been transient and responsive to therapy. Some subjects who reported a cranial nerve palsy elected to continue birinapant treatment, and none had a recurrent event of cranial nerve palsy.
The majority of events have affected the VII cranial nerve and caused a Bell’s palsy, i.e., a weakness affecting one side of the face. All but one case of Bell’s palsy has occurred in subjects receiving a weekly cumulative dose of birinapant of 22mg/m2 or higher. However, one event was reported in a subject receiving a cumulative dose of 4.2mg/m2. The onset of Bell’s palsy typically occurs after the third dose of birinapant and is preceded by a prodromal syndrome of headache, ear or eye pain. Thus, we believe it may be possible to mitigate the onset of the cranial nerve palsy by intervening with either non-steroidal anti-inflammatory drugs ( NSAIDs) or corticosteroids at the time of the prodromal syndrome and deferring the next dose of birinapant. This procedure is being implemented in all of the clinical programs.
http://ir.tetralogicpharma.com/secfiling.cfm?filingid=1558370-15-186&cik=
it all depends if it can be recovered easily, prevented, controlled
if we consider hcc treatment you can bear sides like that if the other choice is death....if it is to clear an inactive hbv it must be a reversible side
The Bell's palsy caused by BIRINAPANT is not the same as regular spontaneous Bell's palsy. It will typically disappear fast upon discontinuation of the drug. Methyl cobalamin injections will speed up recovery and might possibly have preventative effects. However i doubt that the situation is handled this way.
We do not know at which dose level and what frequency this problem occurred. One can only hope that the trial will continue after it has cleared up.
thanks man !! the part hope in your nickname is well deserved, study as well btw :)
Good to know. This initially worried me as I do know someone that got Bell's out of the blue and is still completely debilitated for over 2 years now, without much improvement and tons of therapy.
Do you think they will restart the trial if others want to go forward, or do you think the FDA will shut it down? You are very knowledgeable and I am very new to the background of how trials function. I was really hoping for great news from this one, as I know we all were. Let's just hope it's not a complete wash.
it is hard to predict how the fda will react. the recovery process from the palsy and speed will also determine that. it should only take 2 weeks to recover, but i dont know if they will use methylcobalamine to speed up recovery.
We can't wait for full recovery in two weeks & proceed with their trials. Finger crossed!!!!
Oh my. Looks like the hope for Binirpant has quickly turned around. I wonder if there's a condition this person had which triggered this side effect.
I'm so sad after hear this news. No longer any hope for deleting HBV out the body? F**k HBV :(
Be optimistic sure scientists know that the trial will face some dangerous side effects and sure they are working on and how resolve these problems.hope they will continue and find solutions.
Yes i hope as i read also that bell palsy can be cure using another drugs... maybe it can be added as compound
It is sad that everytime we get a little hope on a cure some other things come up. Hope they not just playing games with us
That was the first think came to my mind, they might probably got a huge money from the some big pharma, hope the almighty God see our humbleness.
Are there any news about birinapant?
Is birinapant commercially available and is it advisable to take it despite the palsy it causes.
I can see it available here
http://www.molbase.com/en/search.html?search_keyword=birinapant&gclid=CjwKEAjw5J6sBRDp3ty_17KZyWsSJABgp-Oaax-4mad86DDgQqD-pebYC9MjBobpTX1aZ-1Aa5Y-0xoCGHPw_wcB
I am asking this because it might already b available as cancer curing agent
study will finish soon so hope they will publish some update
https://clinicaltrials.gov/ct2/show/NCT02288208?term=birinapant&rank=2
I thought birinapant is currently on hold as it caused issues during trials
Hope they'll surprise us with some thing since they are not on hold by FDA just tetra stopped the trial from more disaster.
& i remember studyforhope said the bell's pelsy just needs two weeks for the full recovery so my assumption is to wait some data from them as scheduled.
The Birinapant HBV clinical trial is on-going, but is not recruiting. The public has not been told how many patients still remained in the trial and whether anything has changed - a wall of silence.
Sure you can buy Birinapant, but it is for research use only. Why would anyone try it if it hasnot yet been proven safe or effective? Also, it has not been approved as a drug for cancer, it is still in Phase 2.
I am disappointed to read some members tried ntz tdf and IFN combo for 1year but still can't clear the b virus