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news.Diamyd Medical has released the results of NP2 Enkephalin Phase I dose-escalation clinical trial in patients suffering from chronic pain due to malignancy.
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The trial was designed to investigate the safety of three different doses of NP2 Enkephalin and also to investigate efficacy measurements of pain relief in subjects suffering from chronic pain due to malignancy.
In the trial, substantial and sustained pain relief was noted in the middle and high dose cohorts in both pain measurement methods used in the study; the numeric rating scale (NRS) which is a scale of 0-10 and the Short Form McGill Pain Questionnaire (SF-MPQ) which is a quantitative compilation of 15 descriptive pain measures.
However, in the highest dose cohort, a ~80% decrease in the combined average weekly NRS scores was observed over the first four weeks.
Results are to be confirmed in an ongoing Phase II, randomized, double blind, placebo controlled clinical trial of NP2 Enkephalin in 32 patients with severe intractable cancer pain at approximately 10 clinical sites in the US.
The study is currently enrolling participants.