Corautus hopes heart therapy passes big test
Erin Moriarty
Staff writer
An Atlanta company is working to give new hope to heart disease patients.
Corautus Genetics Inc. (Nasdaq: VEGF) is conducting the largest cardiovascular trial of its kind for a promising gene therapy that aims to help the body grow new blood vessels around a blocked artery. It would be considered a new alternative for those who have already had numerous surgeries and continue to suffer from angina or chest pain.
"The patients that we are dealing with are essentially out of other treatment options," said cardiologist Dr. Henry Liberman, director of the cardiac catherization lab at Emory Crawford Long Hospital. "Most of them have had multiple bypasses, angioplasties and other procedures, and yet continue to be disabled because of chest pain."
Corautus Genetics is currently conducting a Phase II clinical trial for the treatment at 30 hospitals across the nation, including two in Georgia -- Emory Crawford Long and Saint Joseph's Hospital. It will include 404 patients who have inoperable coronary artery disease, about 120 of which have been recruited so far.
"They've reached a point where the cardiologist will tell them there are no further options right now. There's no more vessels to put a stent in and there's no more room to do a bypass graft. They just run out of real estate," said Richard Otto, CEO of Corautus Genetics. "So what happens is these patients experience excruciating chest pain on minimal to no activity."
Dr. Liberman said he is pleased with the possibility of being able to help more of these patients.
"It's very difficult as a cardiologist to tell these patients that despite all the advances in technology there is nothing else that can be done," said Liberman, who is an associate professor of medicine at Emory University School of Medicine. "Their lifestyle has been severely compromised, but this offers them a hope for improving their life."
Liberman said the treatment-- if it is eventually approved by the Food and Drug Administration -- won't replace any existing treatments, but it could offer a new option for patients.
One of those patients is James "Wes" Moreland, 58, who has suffered from heart disease since the late 1980s. Moreland, who served 26 years in the U.S. Navy, was diagnosed during a routine military health evaluation.
A longtime runner who was always in good health, his heart disease got progressively worse over the years and he suffered more debilitating chest pains. Moreland, said his doctors told him his chance of success with another bypass was "abysmal."
I had no options left because I had already had quadruple bypass surgery and 10 to 11 catheterizations," said the Cartersville native.
So when Emory's Dr. Liberman told him about the clinical trial, Moreland didn't hesitate to enroll.
"There was no decision to be made," he said. "We were going into an area that was unknown, but if it would alleviate even some of my symptoms and help my heart, I was willing to try it."
The therapy works by using a catheter to inject the heart muscle in areas that are affected by blockages. The injection delivers the gene for VEGF-2, which stimulates the body to produce a protein that recruits new blood cells and makes new blood vessels. The procedure takes less than an hour, but patients must undergo a comprehensive series of tests beforehand.
The trial measures whether patients have shown improvement within three months, although some patients have made progress more quickly.
"I was having four to six attacks of angina a day before," said Moreland, who had the procedure three weeks ago. "The angina has been reduced and almost gone away. The biggest relief is that they've been able to cut in half one of the strongest medicines I was taking, which had been causing me a lot of fatigue."
The company plans to finish enrolling patients by March 2006, and hopefully get a preliminary report on how effective the therapy is by around August 2006, Otto said. The next step would be a Phase III trial, and then seeking FDA approval.
"We think there's a great opportunity to not only build a company here but also to help people who do not have any options left," Otto said.
Otto's passion for this gene therapy was what led him to take the helm at Corautus Genetics. After a successful career in the biomedical industry, the Atlanta native was enjoying a comfortable retirement. He was also an investor in Corautus's predecessor -- a company that was struggling.
Otto and his partner Robert Atwood, a longtime CFO for the former First Union Corp., took over the company in January 2002.
When we took over the company it was in horrible shape. It had $22 million of debt," Otto said. "We've turned it around and we've brought in $60 million in cash in the past two and a half years."
They have also established a distribution agreement with Boston Scientific Corp. (NYSE: BSX), in which Boston Scientific acquired a 17 percent stake in the Atlanta company.
"The company's leadership has done a great job on the financial management side, but they've also done a great job of advancing the technology," said Lee Herron, general manager of biosciences at the Atlanta Technology Development Center, the incubator Corautus graduated from. "There are not too many gene therapy companies nationwide that have advanced their technology as far as Corautus has."
Since Corautus is in the clinical-trial stage it does not yet have significant revenues, and the company continues to spend millions on the trial. Nonetheless, Otto says he is very pleased with the company's progress and glad to be part of this research.
"We've had very compelling results to date and we think we've got something of great significance," Otto said.
Reach Moriarty at emoriarty@bizjournals.com.
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