Anginera Clinical Development

Clinical Overview

In our initial human clinical trials, Anginera has induced improved perfusion in heart muscle, and in preclinical studies has been shown to mitigate negative remodeling associated with myocardial ischemia. In an animal model, the Anginera patch demonstrated preservation of heart muscle function after myocardial infarction. Phase I human data have been consistent with the animal results. The animal data and the Phase I human data suggest that the use of Anginera in patients who have suffered from a heart attack, or in patients who have chronic ischemia without prior heart attack, could preserve healthy heart tissue, leading to better long term cardiac function, prevention of heart failure, and better quality of life.

Phase I – CABG Trial

The Company's first clinical trial for Anginera was as an adjunct therapy in patients undergoing coronary artery bypass graft (CABG) surgery. Theregen's Phase I safety trial began when Anginera was successfully placed for the first time on a patient's diseased heart by a surgical team of Yale physicians at the Veteran's Administration Hospital in West Haven, Conn. Anginera patches were applied to the surface (epicardium) of the heart.

While the primary focus in the Phase I CABG trial was to test the safety of Anginera, Theregen has demonstrated that Anginera's biologic activity promotes the formation of structurally and functionally significant blood vessels in diseased cardiac tissue. This therapy could represent a significant advance in the treatment of diffuse small vessel disease. The study was conducted at Yale University, the University of Maryland and the University of Pennsylvania.

Phase I – LVAD Trial

A second multi-center Phase I trial was initiated to examine the role of Anginera on bridge-to-transplant patients in conjunction with a Left Ventricular Assist Device (LVAD). When a patient received a donor heart, his/her previously treated, diseased heart was removed and analyzed histologically to determine the effects of Anginera. Histological analysis of heart tissue from patients in the LVAD study has provided evidence of increased arteriolar density for portions of the heart that were treated with Anginera.

Phase II – Sole Therapy for Treatment of Refractory Angina Pectoris

Theregen plans to initiate a multi-center Phase II safety and efficacy trial for Anginera as a treatment for refractory Angina Pectoris. The study design focuses on patients with myocardial ischemia who suffer from Angina Pectoris and are refractory (unresponsive) to available therapies. These so-called .no option. patients will have a reversible perfusion defect or hibernating myocardium as determined by cardiac imaging. This patient population represents a substantial unmet medical need.

Such disease is potentially treatable with Anginera as a sole therapy through delivery of the product's array of growth factors and cytokines that induce a strong arteriogenic and wound repair effect.