Diamyd Medical completes enrollment in NP2 Enkephalin Phase II study for cancer pain

The last study participant has been recruited to Diamyd Medical's (STO:DIAMB)(Pink Sheets:DMYDY) Phase II study in which cancer pain is treated with the drug candidate NP2 Enkephalin. The study is thus fully enrolled and results are expected to be reported in five to seven weeks.

The purpose of the Phase II study is to evaluate NP2 Enkephalin for the treatment of severe and chronic cancer pain. It is the first sizeable and placebo-controlled clinical trial of a drug candidate based on Diamyd Medical's patented Nerve Targeting Drug Delivery System, a unique technology for delivery of therapeutics directly to the nervous system.

"After an intense effort to recruit the last few subjects, the Phase II study is now fully enrolled and we will soon be able to evaluate whether our unique concept to treat severe pain works also in this larger study," says Peter Zerhouni, President and CEO of Diamyd Medical. "With the study results we hope to establish proof of principle for this innovative method to treat pain by delivering therapeutics directly to the nervous system. If the concept proves successful, it will provide many new opportunities to treat pain and other medical problems in the nervous system for which there are currently no effective treatments available."

The Phase II study comprises approximately 32 subjects with severe cancer pain and is being conducted at 18 clinics in the United States. It is a multicenter, placebo controlled, double-blind and randomized study. There is a four-week, double-blind study period where the subjects' pain scores are being monitored and recorded. The first results from the study are expected to be reported in five to seven weeks. After the four week blinded study period all patients are offered up to two doses of active NP2 Enkephalin in an unblinded study extension. The follow-up will collect pain scores following repeat dosing as well as provide additional safety data.

NP2 Enkephalin is the furthest advanced drug candidate within the NTDDS platform and delivers the natural painkilling substance enkephalin directly to the nervous system for the treatment of pain. Substantial and sustained pain relief has previously been observed in a Phase I study with the purpose to evaluate the safety of NP2 Enkephalin and the NTDDS platform. The study was designed as a dose-escalation study with three different doses, comprising ten subjects with medium to severe cancer pain refractory to maximal doses of pain medication. The results of the study were presented in the autumn of 2010. No serious side-effects related to the treatment have been reported by any of the participants in the study.