Anginera Clinical Development

Clinical Applications
Theregen's clinical development strategy for Anginera has been shaped by compelling animal and human data that suggest multiple cardiovascular therapeutic applications. Moreover, the company's accelerated time-to-market approach reflects invaluable guidance from leading clinicians and business development leaders.

Phase I – CABG Trial
The company's first clinical trial for Anginera is 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. The patient was undergoing coronary artery bypass graft (CABG) surgery at the time. Anginera patches were applied to the surface (epicardium) of the heart.

While the primary focus in the Phase I CABG trial is to test safety of the product, 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 is being conducted at Yale University, the University of Maryland and the University of Pennsylvania. The enrollment phase is complete and imaging studies are being analyzed.

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 receives a donor heart, his/her previously treated, diseased heart is removed and analyzed histologically to determine the effects of Anginera. The data obtained from the LVAD trial may show the benefits of Anginera to treat patients with Heart Failure. As with current CABG patient data, histological analysis of explanted hearts from the LVAD study has provided evidence of increases in arteriolar density.

Phase II Adjunctive Treatment for
Cardiac Dysfunction
Our plan is to start the Phase II trial in early 2009. The Phase II study will demonstrate improvement in cardiac function in patients with HF who are undergoing CABG surgery. We will treat patients suffering from Coronary Artery Disease and ischemia, with or without prior myocardial infarction. In this population, a portion of the heart is beating poorly, and we have the opportunity to improve both perfusion and local ventricular wall function.

In patients with ischemia and prior MI, Anginera treatment may limit the area of heart muscle damage by providing better local perfusion. It may also stimulate "hibernating myocardium" to improve ventricular wall function, and may not only improve function in the short term, but may prevent the progressive deterioration of function that leads to increasing heart failure. This is sometimes called "reverse remodeling."