FDA Approves New Heart Disease Therapy

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Dr. Roger Hajjar, NanoCor scientific co-founder, and director of the Cardiovascular more. A Chapel Hill biotech heard good news from the U.S. Food and Drug Administration on Friday. The regulatory body accepted an investigational new drug application from NanoCor Therapeutics, Inc. Relating to Carfostin, an experimental cardiac gene therapy in development for the treatment of congestive heart failure.

Simply accepting the application is still a long way from approving a finished drug, of course, but is seen as an important milestone for drug developers. Now, NanoCor may begin testing its therapy in human patients, and the company says it intends to initiate a Phase 1 trial in patients with advanced chronic heart failure in this second half of this year. In 2009, NanoCor raised $6 million to fund preclinical development.

“CHF is a major cause of morbidity and mortality, and there is a critical need to explore new therapeutic approaches,” said Dr. Roger Hajjar, NanoCor scientific co-founder, and director of the Cardiovascular Research Center of Icahn School of Medicine at Mount Sinai, New York.

“Gene therapy is a viable option for the treatment of CHF, and our proprietary technology platform allows for targeted and minimally-invasive delivery of the therapeutic to the heart.”

Heart disease is the leading cause of death worldwide with congestive heart failure being the final stage of many heart diseases. About 5 million patients in the United States suffer from CHF and it is one of the most common reasons for hospitalization in patients 65 and older. CHF is a condition in which the heart is unable to supply sufficient amounts of blood and oxygen to the body. CHF can result from conditions that weaken the heart muscle, cause stiffening of the heart muscles, or increase oxygen demand by the body tissue beyond the heart’s capability to deliver. Jason deBruyn covers the biopharmaceutical and healthcare industries.

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