Ventrix announced that it has initiated a Phase 1 trial of VentriGel, an off-the-shelf, biomaterial scaffold designed to facilitate the repair of cardiac tissue following myocardial infarction (MI), commonly known as a heart attack.
The open-label trial will enroll patients who have experienced a first myocardial infarction within the past three years and have evidence of left ventricular dysfunction.
"We have demonstrated statistically significant efficacy for VentriGel in our preclinical studies and are hopeful to see the benefits translated to patients," said Paul Chamberlin, M.D., chief medical officer of Ventrix.
"For people who have survived heart attacks, congestive heart failure is a common, costly and potentially fatal condition, and treatment options are severely limited. With our approach, we hope to alter the negative remodeling post-MI that leads to heart failure."
"VentriGel is a novel biomaterial that has been specifically designed for cardiac repair," said Adam Kinsey, Ph.D., chief executive officer of Ventrix. "The initiation of this study is an important milestone for Ventrix as we work to advance a new option for patients suffering from the effects of a heart attack."
Approximately 785,000 new heart attack cases occur each year in the United States. Many of those patients will develop left ventricular dysfunction, a weakening of the heart’s ability to effectively pump blood. According to the American Heart Association, at least 22 percent of men and 46 percent of women will develop heart failure — a debilitating and burdensome condition — within six years of their first heart attack.
The Phase 1 clinical trial will enroll patients at three centers in the U.S. The study will evaluate the safety and feasibility of VentriGel delivered via catheter to the damaged cardiac tissue in patients who have experienced a decline in cardiac function after a heart attack.
In addition, secondary endpoints will be efficacy variables for halting the progression of heart failure, including the heart’s stroke volume, ejection fraction and scar mass.
VentriGel is a biomaterial scaffold designed specifically for the repair of damaged myocardium. It is injected via catheter in a minimally-invasive procedure that does not require surgery or general anesthesia.
Founded in 2009, Ventrix is a San Diego-based company developing solutions for repair of the heart.