US-based ViroMed's biopharmaceutical company division VM BioPharma has dosed the first patient in its Phase III clinical trial of a patented DNA-based gene therapy, VM202, to treat painful diabetic peripheral neuropathy (DPN).
Around 477 adult patients suffering from DPN will be involved in this double-blind, randomised, placebo-controlled, multicentre Phase III trial, which will be conducted over a period of nine months.
The trial intends to determine the safety and efficacy of VM202.
During the trial, patients will be randomised in a 2:1 ratio to either VM202 or placebo and will be differentiated by the current use of gabapentin and / or pregabalin.
Northwestern University's Feinberg School of Medicine neurology professor and Phase III trial principal investigator Dr Jack Kessler said: "The initiation of a pivotal clinical trial for VM202 is incredibly exciting, because we observed in the Phase II trial a rapid and significant reduction in DPN pain, along with signals that VM202 may elicit a disease-modifying effect.
"Current treatments for DPN are aimed at providing symptom management, and along with a high rate of patient failure, do not modify the underlying pathology of the condition."
DPN is a common ailment of diabetes, in which nerve damage triggers sudden and severe pain.
VM202 is a plasmid DNA consisting of the human hepatocyte growth factor (HGF) gene, which in vivo produces two isoforms of HGF proteins that naturally occur in the human body.
HGF is a growth factor that promotes angiogenesis and acts as a neurotrophic factor to peripheral nervous system.
VM202 is received by a cell and produces the HGF proteins after being injected into a patient's muscle, which are then released from the cell and may promote new blood vessel formation by activating various signaling pathways.
In this way, VM202 is believed to promote microvasculature and growth of nerve cells, thereby providing relief to patients with DPN.