Novel Angina Trial Seeks Volunteers

If you have a patient experiencing refractory angina and you’ve exhausted the standard of care, there is good news.

Lehigh Valley Heart and Vascular Institute has been chosen as one of only 16 sites to participate in the expansion phase of a clinical trial for an exciting new investigational product called XC001.

Produced by XyloCor Therapeutics, XC001 has been designed to promote revascularization around the heart. The hope is that new blood vessels will bypass diseased ones, improve blood flow and decrease recurring pain for anginas that are not responding to medication and stents, says Ronald Freudenberger, MD, Physician in Chief, Lehigh Valley Heart and Vascular Institute.

“XC001 is essentially a gene therapy. We’re delivering a gene the body already makes to the heart via direct injection in the hopes the person’s own heart cells will create more of a naturally existing protein in a process called gene transfer. It would be an incredible advance if we can show that it works,” Freudenberger says.

The current study is a phase 1/2 expansion trial seeking 21 volunteers across participating centers for a 13-month commitment. Geared toward further establishing safety and tolerability, the open-label study will explore use of the highest safe dose of the drug established in a 12-person phase 1 study and will consist of a one-time injection of the investigational product directly to the muscle tissue of the heart by an experienced surgeon. Volunteers will then make nine clinic visits over the first six months of the trial. One final clinic visit will be required one year after initial drug administration.

“At this point, it’s for people who don’t have other options – those who are still having chest pain after proven treatments,” Freudenberger says.

“But for patients facing that incredibly unpleasant squeezing sensation when they exert themselves, this could potentially be an exciting opportunity to be part of advancing medical science while experiencing a reduction or even relief of symptoms.”

The trial is the first of its kind ever mounted in the Lehigh Valley.

“This gene therapy trial represents one of the most innovative types of research ongoing in cardiac care today. Being involved on the ground floor of developing these types of novel therapies is part of our mission, and I think the fact that we’ve been asked to participate recognizes our excellence in research and clinical care,” Freudenberger says

For more information, call 888-402-LVHN.