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news.Diamyd Medical has reported that it is submitting an investigational new drug application for NP2, the company's pain drug candidate in its nerve targeting drug delivery system gene therapy platform, to the FDA.
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Following the approval of the investigational new drug (IND) application, Diamyd plans to initiate a Phase I clinical study. The trial will be designed as a dose-escalation study to test the safety of NP2. 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 the initial results. NP2 is developed by the company’s US subsidiary, Diamyd, Inc.
Michael Christini, president of Diamyd, Inc., said: “With NP2, we have laid the groundwork for the rapid development of additional drug candidates such as the nerve targeting drug delivery system-GAD (NTDDS-GAD) product to treat pain in diabetes. The ability to deliver and express gene products directly in neurons that project into the spinal cord is extremely innovative and provides Diamyd with numerous possibilities to treat pain and other peripheral nervous system diseases.”