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November 26, 2012

Push to find 'Holy Grail' treatment marks historic milestone

A quest for the medical Holy Grail of regenerating a patient's heart tissue to help millions of sufferers and potentially make billions of dollars recently hit a historic milestone, when a Mayo Clinic-developed treatment was given the green light to move into the final stages of testing.

Belgium-based Cardio3 BioSciences licensed Mayo Clinic's research in this area in 2007. That research was led by Mayo Clinic's Dr. Andre Terzic and Dr. Atta Behfar.

6a00d83451cc8269e20133f247d05f970b-800wiThe therapy involves taking stem cells from a patient's  bone marrow and through a proprietary process called Cardiopoiesis, re-programs those cells to become heart cells. The cells are then injected back into the patient's heart to repair damaged tissue.

Cardio3 describes the ongoing ties to Mayo Clinic on its web site, "The company's current relationship with Mayo Clinic is essentially based on the technology license agreement, through which the company acquired at arms’ length rights to the majority of its current intellectual property portfolio and which has created a long-term research relationship with Mayo Clinic."

Cardio3 is a  privately owned company that has raised about $57.6 million in financing since it launched. The breakdown of its investors on its website shows Mayo Clinic controls 25 percent of the company's capitalization. In 2011, Cardio3 deepened the already close relationship by establishing its U.S. headquarters in Rochester on the third floor of the Minnesota Biobusiness Center.

It estimated that about 23 million people worldwide are afflicted with congestive heart failure and 2 million new cases are diagnosed each year worldwide. It is a disorder on the increase in the U.S., in particular. Analysts have estimated a successful treatment for congestive heart failure could bring in about $1 billion a year for whatever company that brings it to market.

Many biotechnology firms have been working on their own approaches, but it appears Cardio3 is ahead of others pursuing treatments involving stem cells.

Cardio3 and Mayo Clinic have marked many positive results during Phase I and Phase II clinical trials, while working on this treatment now called C3BS-CQR-1 over the years. Now Cardio3 has been given the green light to follow up its Phase II trial that was conducted between 2009 and 2010 in Belgium, Serbia and Switzerland.

"Heart failure remains a significant unmet clinical need associated with high morbidity, mortality and escalating healthcare costs. We believe C3BS-CQR-1 has a potential to become an alternative to heart transplantation, which is the only curative treatment for heart failure available today," stated Dr Christian Homsy, CEO of Cardio3 BioSciences, in the company's recent announcement. "Our Phase III trial is the first to begin anywhere in the world for a regenerative therapy for this indication. We look forward to confirming the promising results we have already seen in our Phase II study."

The Phase III trial will take place in Belgium. The trial will recruit a minimum of 240 patients with chronic advanced symptomatic heart failure.

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