Aa
bad news on binarapant ?
I just read this news now.. it is sad to hear it.. any one know about this issue ?
http://seekingalpha.com/news/2493936-tetralogic-stops-enrollment-in-birinapant-hep-b-trial-shares-plummet
http://seekingalpha.com/news/2493936-tetralogic-stops-enrollment-in-birinapant-hep-b-trial-shares-plummet
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
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
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=
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=
Thanks, not very good news, but I think Bell’s palsy is a known, reversible, side effect of Birinapant in its cancer trials.
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