Intrexon subsidiary Precigen has dosed the first patient in a Phase l clinical trial of INXN-4001 for the treatment of heart failure.
The open-label, non-randomised, single-group assignment trial aims to examine the safety of INXN-4001 in left ventricular assist device (LVAD) patients as measured by the incidence rate of all adverse events occurring up to six months post-treatment.
The trial will also evaluate the ability of LVAD patients to wean from the LVAD device, their quality of life and their overall daily activity.
Approximately 12 subjects will be included in the trial, which is sponsored by Precigen's majority-owned subsidiary Xogenex.
Precigen president Helen Sabzevari said: “This milestone represents an additional first for Precigen and for heart failure patients as it is also the first use of the retrograde coronary sinus infusion (RCSI) procedure in left ventricular assist device (LVAD) patients.”
INXN-4001 is an investigational, non-viral, multi-gene plasmid designed to express three different human proteins.
The triple-effector plasmid can address various malfunctions of cardiomyocytes, the muscle cells that make up the heart tissue, in patients with heart failure.
Heart failure is a major cause of death worldwide and is estimated to increase by 46% by 2030 according to the American Heart Association’s new 2017 Heart Disease and Stroke Statistics Update publication.