Diamyd said it will recruit approximately 32 subjects with severe cancer pain and follow their pain scores and concomitant opioid pain medication usage in the multi-center, randomized, double-blind and placebo controlled study.
The trial has a four week double-blind main study period and following this period, all patients will be offered up to two additional doses of active NP2 Enkephalin in an open label study extension.
Diamyd Inc, the US subsidiary of Diamyd Medical, CEO Darren Wolfe said based on the encouraging results of the Phase I trial investigating NP2 Enkephalin as a potential therapy for chronic pain, Diamyd has been able to rapidly initiate this new study in cancer patients with chronic severe pain.
Diamyd has previously announced that substantial and sustained reduction in pain scores were reported in its Phase I clinical trial intended to test the safety of NP2 Enkephalin and the company’s Nerve Targeting Drug Delivery System (NTDDS) in patients with intractable pain due to cancer.
Diamyd Medical CEO and president Elisabeth Lindner said with the Phase II study Diamyd intends to show proof-of-concept for the NP2 Enkephalin treatment, which is the furthest advanced project in our portfolio of pain-relieving drug candidates based on the proprietary NTDDS platform.