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news.Diamyd Medical has received approval from the FDA to initiate a Phase I study in chronic pain using NP2, the company's first drug candidate in its Nerve Targeting Drug Delivery System or NTDDS gene therapy platform.
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The Phase I clinical trial, designed as a dose-escalation study to test the safety of NP2 will be conducted at the University of Michigan in Ann Arbor. In total 12 patients who suffer from severe cancer-related pain are planned to be enrolled with the option to expand the trial to enroll up to 24 patients pending review of initial results.
NP2, developed by the company’s US subsidiary, Diamyd, in Pittsburgh, produces enkephalin directly in sensory neurons to block pain signals before they are transmitted through the spinal cord to the brain. Blocking pain with a locally-targeted therapeutic in this fashion may reduce or eliminate the need for conventional systemic pain treatment and thereby avoid associated side effects.
Michael Christini, president of Diamyd, Inc. said: “The NTDDS platform provides a whole new mechanism for therapeutic delivery of drugs to the nervous system and we have great optimism that it will have broad application to the benefit of Diamyd Medical and potential collaborators.”