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The interim results of the HEALING II study announced in May at the Paris Course on Revascularization (EuroPCR 2005) have led to key clinical program developments, namely the design of the upcoming HEALING III randomized study and the start of the e-HEALING internet based registry. The final HEALING II results were presented on October 21, 2005 in Washington, DC at the Transcatheter Cardiovascular Therapeutics (TCT) by the principal investigator, Professor Patrick W. Serruys, MD, PhD, Chief of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.

The HEALING program, which stands for Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth, is a series of studies to evaluate the safety and efficacy of the Genous Bio-engineered stent. Unlike the drug eluting stent (DES) oncological approach, which relies on the release of potent cytostatic and cytotoxic compounds to inhibit tissue growth, Genous heralds the beginning of the new healing era in coronary stenting. Genous is an antibody coated stent that captures a patient's endothelial progenitor cells (EPCs) to accelerate the natural healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. They attach to the Genous stent's surface and rapidly form an endothelial layer over the stent, providing immediate protection against thrombus and minimizing restenosis.

The HEALING II study included 63 patients at 10 centers in Europe. Whole blood samples were analyzed to quantify the number of EPCs in each patient. Interim data from 30 patients with six months angiographic results were presented at EuroPCR and showed the quantity of EPCs strongly correlates with angiographic and IVUS outcomes. There were no target lesion revascularizations in patients with normal numbers of circulating EPCs.

Interestingly, most patients not on statin therapy were restricted to the low EPC group. Statins are a class of drugs used to lower cholesterol levels and prevent strokes. They are the most widely prescribed drugs in the world and have minimal side effects. In fact, most cardiovascular disease patients are already on statins. Statin therapy has also been found to augment the functionality and numbers of EPCs; therefore, the normalization of EPC levels with statin therapy in conjunction with Genous may lead to improved outcomes.

Consequently, OrbusNeich's HEALING III study is currently being planned as a randomized trial with angiographic follow up to assess Genous stents compared to bare metal stents both in conjunction with statin therapy. HEALING III principal investigator, Professor Serruys, said, "The data we have from HEALING II certainly provide strong indications that Genous works by healing the stent injury site. HEALING III is being designed to verify and substantiate these findings." The company will start the HEALING III study in late 2005 or early 2006.

Genous, which received CE mark last month, will initially be available only under a controlled release through an internet based registry, e-HEALING. This global registry will assess Genous' safety in terms of target vessel failure and thrombosis with 30 days and 12 months clinical follow up. The co- principal investigators are Professor Sigmund Silber, MD, PhD, Kardiologie Praxis, Munich, Germany, and Robbert de Winter, MD, PhD, Academic Medical Center (AMC), Amsterdam, The Netherlands. Cardialysis will be the clinical research organization managing the study collaborating with KIKA Medical by utilizing their internet based trial management technology.

The e-HEALING registry has been initiated by Dr de Winter and his colleagues at the AMC. Dr de Winter commented, "The consequence of natural healing is endogenous protection against the catastrophic events of stent thrombosis. e-HEALING's expected 5,000 patient enrollment at over 100 centers will be sufficiently big enough to generate the data we need to quantify this exciting technology's safety profile."

A concerning effect of DES has also been the prolonged or permanent inhibition of the formation of a confluent endothelial layer over the stent; thus necessitating long term or even permanent antiplatelet therapy to minimize the risk of thrombus. This is in contrast to the one month of antiplatelet therapy recommended in the HEALING studies. This reduction will benefit those patients who should not or cannot be on extended therapy, such as those patients needing surgery or dental work in the near future and in patients in which compliance may be difficult.

Most DES contain a micrometers thick polymer layer upon which the drug is loaded onto the stent, which has raised concerns regarding long term inflammation. With Genous, there is only a nanometers thin antibody layer and no polymer.

"I am confident that the clinical development of this groundbreaking technology will reinforce what we intuitively know of this pro-healing, EPC capture approach," explained Judith Jaeger, OrbusNeich's Director of Clinical Research. "The clinical development plan is designed to continue to provide evidence that the Genous stent in conjunction with optimal statin therapy will result in a safe and effective alternative treatment of patients with coronary artery disease lesions, particularly for those in which long term antiplatelet therapy is not feasible."

OrbusNeich's mission is to urgently deliver medical technology to patients of the world. It has a global reach, supplying medical devices for vascular disease in over 60 nations through sales offices in eight countries, manufacturing operations in The Netherlands and China, and research and development facilities in the United States and Germany. The product portfolio also includes the R stent, the Avita PTCA dilatation catheter, and the SafeCut dual wire dilatation catheter.

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Publication:Biotech Equipment Update
Date:Nov 1, 2005

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