NP2, the company’s first drug candidate in its nerve targeting drug delivery system (NTDDS) gene therapy platform, will be the subject of a pre-IND meeting with the FDA on August 29, 2007.
Pending a favorable review by the agency, Diamyd plans to file the NP2 IND application and initiate a Phase I clinical study later this year.
NP2, developed by the company’s US subsidiary, Diamyd, Inc., produces enkephalin locally in the targeted sensory neurons to block pain signals before they are transmitted through the spinal cord to the brain. The company says this may significantly reduce or eliminate the need for systemic pain treatment and avoid associated side effects.
“With NP2, we have laid the groundwork for the rapid development of additional drug candidates such as the 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,” said Michael Christini, president of Diamyd.
The Phase I clinical trial is designed as a dose-escalation study and is intended to test the safety of NP2. During the trial, 12 patients who suffer from severe cancer-related pain are planned to be enrolled.