Diamyd Medical´s (STO:DIAMB)(Pink Sheets:DMYDY) US Phase II clinical trial, evaluating the ability of the candidate drug NP2 Enkephalin to reduce cancer pain, is posted on the ClinicalTrials.gov website.
Diamyd's Phase II multi-center, randomized, double-blind, placebo controlled clinical trial with the candidate drug NP2 Enkephalin is recruiting approximately 32 subjects with severe cancer pain. The study is designed to provide an evaluation of the safety and effect of NP2 Enkephalin with regards to pain relief, other pain medication usage and quality of life. The trial has a four week double-blind main study period and an open label study extension wherein all patients will be offered up to two additional doses of active NP2 Enkephalin.
The trial finalization date has preliminary been set to one year from start date on ClinicalTrials.gov. Diamyd will give a more detailed prognosis for finalization as soon as this can be better estimated from the ongoing recruitment.
NTDDS (Nerve Targeting Drug Delivery System) represents a new class of pharmaceutical products that delivers gene-based drugs directly to nerve cells, providing a direct effect in the cells targeted by the treatment. The drug candidate NP2 Enkephalin has been engineered to deliver the human Enkephalin gene, which naturally produces opioid peptides involved in pain control, directly to the site of pain in the nervous system.
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