KPAX002 as a treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): a prospective, randomized trial, 2018, Montoya et al

Press release from KPAX Pharmaceuticals - they don't seem to consider the results as negative, unsurprisingly.
The study's results identified that KPAX002 was most effective in subjects with more severe ME/CFS symptoms and those with both fatigue and pain; two key subgroups that responded best to the treatment. ME/CFS patients in these groups had more than double the level of improvement after treatment with KPAX002 as patients taking the placebo. KPAX002 was also found to be safe and well tolerated.
......
"We believe the results of this multicenter clinical trial support the continued development of KPAX002 as a first-line therapy for fatigue and cognitive deficits secondary to ME/CFS and other age-related mitochondrial diseases," states Jon D. Kaiser, MD, CEO of K-PAX Pharmaceuticals. He continues, "In addition to ME/CFS, there is ample research to support the assertion that Alzheimer's and Parkinson's diseases are also progressive mitochondrial diseases with the potential to respond to KPAX002. We are planning future clinical trials in these disease states as well."
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https://www.prnewswire.com/news-rel...chronic-fatigue-syndrome-mecfs-300633260.html
 
So, does
a first-line therapy for fatigue and cognitive deficits secondary to ME/CFS and other age-related mitochondrial diseases
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mean they consider ME to be an age related mitochondrial disease? If so how do they explain erm..children with ME?

Or am I overthinking what would appear to be a poor choice of words, or random scientific sounding brain fart?
 
Wonko said:
So, does mean they consider ME to be an age related mitochondrial disease? If so how do they explain erm..children with ME?

Or am I overthinking what would appear to be a poor choice of words, or random scientific sounding brain fart?
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You are not overthinking, your exposing flaws in their logic. Their motive makes some sense but it really does sound like they are just chasing dollar signs as i have mentioned in the other threads addressing this "drug"
 
Andy said:
Press release from KPAX Pharmaceuticals - they don't seem to consider the results as negative, unsurprisingly.

https://www.prnewswire.com/news-rel...chronic-fatigue-syndrome-mecfs-300633260.html
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Is anyone here going to contact the researchers and ask for their comment on this press release? Their research is being misrepresented and misused by the drug company.

@dave30th it looks like it's not just BPS null trials that suffer from spin. This is a clear case of a press release that claims success for a null trial.
 
Trish said:
Is anyone here going to contact the researchers and ask for their comment on this press release? Their research is being misrepresented and misused by the drug company.

@dave30th it looks like it's not just BPS null trials that suffer from spin. This is a clear case of a press release that claims success for a null trial.
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Between this and the researchers behind the shopping bag trial on top of everything else happening i think we have enough to keep David Tuller going for quite a while, i'll need to double my donation (which will then be matched/doubled again) to pay his salary :)
 
Trish said:
Is anyone here going to contact the researchers and ask for their comment on this press release? Their research is being misrepresented and misused by the drug company.
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Yes, I was very confused when I saw the press release as opposed to the study results.
 
KPAX002 for Chronic Fatigue Syndrome part 2: controlled study says no

https://questioning-answers.blogspo...atigue-syndrome-controlled-study-says-no.html
Questioning Answers said:
Well the results of the "phase 2 randomized, double-blinded, placebo-controlled trial" on KPAX002 published by Jose Montoya and colleagues [1] that, from an intention-to-treat point of view, reported no significant statistical difference in self-reported group scores of fatigue and other measures between active treatment and a placebo. In keeping with the phase 2 label attached to the trial - looking at both initial clinical results and also any side- or adverse effects - authors reported no statistically significant difference in the frequency of reported adverse effects between KPAX002 and a placebo over the 12 weeks of study.
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Questioning Answers said:
Second, I'm a little bit disappointed that the authors weren't more forthright in how the results weren't statistically significant on any and all measures included for study.
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Questioning Answers said:
Finally, once again, I note that under the heading 'Disclosure of conflict of interest', the word 'none' appears as per the last research occasion [2]. Personally, and with no malice intended, I would have listed the detail that at least one of the authors is an employee of the manufacturer of KPXA002 given the affiliation details and email address for further correspondence provided on the paper.
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Questioning Answers said:
But for now, the answer must be that controlled study of the formulation did not meet clinical endpoints in a statistical sense, and hence KPAX002 cannot be said to be superior to placebo for CFS/ME.
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