Juventas enrolls first patient in phase 2 gene therapy clinical trial

John Rundback, Medical Director of the Interventional Institute at Holy Name Medical Center in Teaneck, New Jersey enrolled the first patient. The trial will recruit additional patients at approximately 25 leading clinical centers in the United States.

STOP-PAD will be administered to patients with advanced PAD that have undergone a below the knee (BTK) revascularization procedure and are suffering with non-healing wounds often associated with this disease.

Subjects will be randomized to receive JVS-100 or placebo, administered via intramuscular injection to the affected limb within 48 hours of the BTK revascularization procedure and again three months later to evaluate the potential of JVS-100 to improve outcomes. The primary endpoints for the study will be wound healing three and six month following the procedure.

Rundback said: "We are excited to be part of the STOP-PAD study and to have enrolled the first patient in this ground-breaking trial.

"The use of an advanced biologic as an adjunctive therapy to improve outcomes associated with below the knee revascularization is an exciting and innovative step forward for the field, and may establish a new standard of care for treating diabetic and other patients with difficult and leg-threatening vascular wounds who otherwise face the possibility of amputation."

"Significant advances during the last decade for below the knee endovascular intervention are allowing us to consistently improve blood flow to the limbs of patients with advanced PAD," states Mehdi Shishehbor, DO, MPH, PhD, Director of Endovascular Services at Cleveland Clinic and principal investigator for the STOP-PAD trial.

"However, a large percentage of these individuals continue to suffer with non-healing wounds on their feet that interfere with their mobility and day-to-day living. In previous clinical studies, JVS-100 has demonstrated the ability to improve micro-vascular blood flow and accelerate dermal wound closure. We are excited to further study the potential for JVS-100 to address this unmet medical need in patients with advanced peripheral artery disease in addition to revascularization."

Peripheral artery disease is characterized by the narrowing or obstruction of the arteries in the limbs, which diminishes or prevents blood flow resulting in severe pain, limitations in ambulation, non-healing wounds and, in severe cases, the need to amputate the affected limb. The FDA granted Fast Track designation to JVS-100 for accelerating the healing of chronic ulcers in patients with advanced PAD.

Juventas Therapeutics president and CEO Rahul Aras said: "We are pleased to advance JVS-100 for treatment of patients with advanced PAD.

"The Fast Track designation will permit greater access to the FDA for the purpose of expediting the development of JVS-100, including its review and potential approval for this indication."