PRESENT STATUS OF THE TECHNOLOGY

Since this strategy has not been evaluated in a clinical study with humans, there is a need for such a study to validate these findings. A multicenter prospective randomized clinical trial will be performed at the Montreal Heart Institute. This study will involve 4-6 clinical centers across Canada chosen for the quality of previous work in interventional cariology research. The trial will be coordinated by the hemodynamica laboratory of the Montreal Heart Institute.

EXPECTED RESULTS

This study will give important information on the potential impact of local 17B-E after PCI and the role of this therapy to prevent restenosis. The importance of this strategy to promote a better vascular healing can be placed in perspective of the fact that brachytherapy may retard reendotheiliazation and impair vessel wall recovery leading to late thrombosis and a potential catch-up phenomena with the loss of the initial gains as a long-term follow-up. "It is our understanding from our results and the data available in the literature that local 17B-E offers a promising new approach to vessel passivation after PCI. It is our intent to pursue in this field and propose to the patient needing improved vascular healing an ESTRACURE solution including catheter and drug coated stent delivery of 17B-E Estradiol to improve clinical outcome. THE DATA OBTAINED MAY LEAD TO SIGNIFICANT ADVANCES IN THERAPEUTIC STRATEGIES TO IMPROVE PATIENT CARE AND REDUCE RESTENOSIS." (Montreal Heart Institute.)

RECENT MEDICAL ADVANCES (DRUG-COATED STENTS)

On Tuesday, September 4, 2001, researchers from Johnson & Johnson's Cordis Unit reported that their antibiotic-coated (drug Siolimus) stent reduced the incidence of restenosis to zero. These RAVEL findings were presented on that Tuesday at the European Society of Cardiology Annual Congress in Stockholm. Sirolimus is an immunosuppressant drug used to prevent kidney transplant rejection. It's in a class of drugs know as cell cycle inhibitors and works by preventing cell overgrowth.

Later in September, Boston Scientific reported promising result on the initial human tests of drug-coated stents, used in propping up clogged arteries. After six months, there were no signs of blood clots or scarring of the artery around the stent. "The results were extremely impressive and demonstrate that Boston Scientific 's...stents hold enormous promise as a dramatic new therapy for coronary artery disease," said Dr. Eberhard Grube of the Sieburg Heart Center in Germany.

The stent market is presently at 2.3 billion and its is expected to rise to over 4 billion in the next few years as prices increase and more people espouse this therapy.

IMPACT OF THESE NEW ADVANCES

These advances only serve to heighten the studies being done at the Montreal Heart Institute in findings a solution to restenosis. Going beyond the coating of a stent to the possibility of a one-dose application to remedy the problem, the Institute's findings go well beyond the initial case of restenosis to the possibility of a stentless approach that would eliminate restenosis. As Dr. Karl Karsch, head of Cardiology at Bristol University in England, says, "You're dealing with a systemic disease. Artherosclerosis is all over the body. You are just interfering at a lesion, you are not interfering with the disease." Moreover, angioplasty and stenting places an upper limit on how many stents a patient may have.

Thus the significance of what is being accomplished at the Montreal Heart Institute takes into account the possibility of a coated stent but also goes beyond this to isolate the gene involved in restenosis and to give equal protection to all vessels in the brain and in other vascular systems.

NATURAL SUBSTANCE

It is important to realize that the substance used by the Montreal study is a NATURAL SUBSTANCE and therefore is not subject to the restrictions surrounding other substances that must undergo FDA scrutiny.