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NP2, developed by the company's U.S. subsidiary, Diamyd, Inc., producesenkephalin locally in the targeted sensory neurons to block pain signalsbefore they are transmitted through the spinal cord to the brain. This maysignificantly reduce or eliminate the need for systemic pain treatment andavoid associated side effects.
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"We have made significant progress in advancing NP2, the first of severalproduct candidates, towards the clinic in a timely and effective manner," saidMichael Christini, President of Diamyd, Inc. "With NP2, we have laid thegroundwork for the rapid development of additional drug candidates such as theNTDDS-GAD product to treat pain in diabetes. The ability to deliver andexpress gene products directly in neurons that project into the spinal cord isextremely innovative and provides Diamyd with numerous possibilities to treatpain and other peripheral nervous system diseases."
The proposed Phase I clinical trial will be conducted at the University ofMichigan in Ann Arbor. Dr. David Fink, Professor and Chair of the Departmentof Neurology, at the University of Michigan will be the principleinvestigator. The trial will be designed as a dose-escalation study and isintended to test the safety of NP2. In total 12 patients who suffer fromsevere cancer-related pain are planned to be enrolled.
"We are very pleased with the progress of the NTDDS program in Pittsburghsince acquiring Nurel Therapeutics 18 months ago," said Anders Essen-Moller,CEO of Diamyd Medical. "Not only may the NP2 project in itself result in amajor therapeutic, but shareholder value is also built with the establishmentof a broad platform technology that should yield numerous product candidatesfor which collaborations with third parties will be sought. In addition, ourDiamyd Inc. lab facilities and expertise in manufacturing and preclinicalareas have been fully used to move the company's lead product, the GAD-baseddiabetes vaccine Diamyd(R), towards Phase III trials later this year."
About Diamyd's NTDDS Technology for Treatment of Pain
Diamyd Medical owns the exclusive worldwide license rights to a portfolioof patents for the Nerve Targeting Drug Delivery System (NTDDS). This systemis based on a replication incompetent viral delivery system that can expressnumerous therapeutic genes. The NTDDS has a natural affinity for nerve cells.Diamyd's initial NTDDS projects are focused upon peripheral and centralnervous system applications. To that end, Diamyd seeks to combine the naturalbiology of the NTDDS (local nerve targeting) with therapeutic agents that arenaturally found in the body and have a known therapeutic effect (e.g., GAD orenkephalin for treatment of pain, and neurotrophic factors for nerve damage).Thus, Diamyd believes that NTDDS proposes a new and broad class of nervoussystem disease therapies.
Pain is transmitted through a series of neurons that run from the skin tothe brain. Pain signaling can be inhibited in several ways using the synapsebetween the peripheral and central nervous systems. This synapse providesinput from the skin or organs as the first order neuron. The output from thissynapse, the second order neuron, is within the spinal cord and projects intothe brain to complete the pain pathway.
Three main compounds, enkephalins, GABA and endomorphins, naturallyregulate pain transmissi
