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Diamyd Phase II cancer pain study fails to meet primary objective

Diamyd Medical, a Swedish biotech company, has reported that Phase II NP2 Enkephalin study failed to meet primary objective of reducing pain in subjects with severe intractable cancer pain.

The double-blind study is to evaluate the effect of intradermal injection of NP2 Enkephalin on pain reported by subjects suffering from severe intractable pain due to cancer, and to confirm the safety of the treatment.

An initial data analysed from the 28 day double-blind main study period demonstrated that during day three to 14 following a single dose of study drug, the group that received NP2 Enkephalin reported on average no better improvement in pain score than the placebo treated group.

The treatment was well tolerated, confirming the safety of the company’s NTDDS technology.

Diamyd Medical president and CEO Peter Zerhouni said although the company had hoped for a better outcome regarding pain relief in the study, the treatment appeared safe which is an important finding for the whole NTDDS platform.

"We will continue our analysis of this study, including subgroups and the data from the open label extension period, to determine how to adapt the development plan for our NTDDS portfolio of drug candidates addressing diseases and symptoms within the nervous system which today cannot be adequately treated," Zerhouni added.

According to the company, data continues to be collected from an open label extension period of the study where subjects have received up to two additional doses of NP2 Enkephalin.