Renova Therapeutics receives additional NIH grant to continue paracrine gene therapy research for congestive heart failure

SAN DIEGO, Feb. 23, 2016 /PRNewswire-USNewswire/ -- The National Institutes of Health (NIH) awarded Renova™ Therapeutics a $802,500 grant to support the company's continued preclinical gene therapy research for congestive heart failure (CHF). This is the first portion of a second NIH grant – totaling $1.6 million – that the San Diego-based biopharmaceutical company is receiving for this particular research, which is focused on increasing heart function by intravenous delivery of the urocortin-2 gene via an adeno-associated viral vector.

The NIH grant – part of a phase II grant in a three-phase funding structure – was awarded through the agency's Small Business Technology Transfer program. The grant helps fund the continued research of Renova Therapeutics and its scientific team headed by co-founder H. Kirk Hammond, MD, whose paracrine gene therapy approach has been shown to dramatically improve animal models of congestive heart failure and type 2 diabetes.

Paracrine gene therapy is a novel, patented approach developed by Dr. Hammond, who is Professor of Medicine at the University of California, San Diego, and a cardiologist at the San Diego Veterans' Affairs Healthcare System. This approach involves sustained activity following systemic delivery of a gene therapy to the blood, and distribution to other organs where it can exert beneficial effects on target organs from a distance. This single-IV-injection approach is a foundation for Renova Therapeutics products that have the potential to bring about permanent improvements in cardiovascular and metabolic diseases.

The approach has already shown promise in mouse models of CHF, also previously funded by the NIH: A one-time intravenous dose of the therapeutic urocortin-2 gene delivered via non-replicable AAV8 safely and efficiently increased function of the failing heart.¹  

"With this support from the NIH, we've been able to make tremendous progress in the cardiovascular gene therapy field," says Jack W. Reich, Ph.D., CEO and Co-Founder of Renova Therapeutics. "What we're working on is a true innovation for a large patient population that has seen only incremental improvements in medicines, resulting in small changes in outcomes. With paracrine gene therapy, we're talking about the potential to attenuate the debilitating effects of heart failure with a simple IV injection, a common procedure that can be administered in any doctor's office."

CHF is a progressive, fatal disease characterized by the heart's inability to pump sufficient blood to meet the body's demands, afflicting approximately 6 million people in the United States and 28 million people globally. Survival rates are distressing: Despite advances in treatment, community-based studies still indicate that more than 20% of patients die within one year of diagnosis and 50% die within five years.²

The urocortin-2 gene therapy for CHF is one of several product candidates in the Renova Therapeutics pipeline, and the second gene therapy for CHF patients. The NIH grant provides an opportunity to continue this research, with hopes of eventually commencing first-in-human studies for this revolutionary therapy.

Learn more about Renova Therapeutics and its gene therapy pipeline here: www.renovatherapeutics.com.

About Renova Therapeutics
Renova™ Therapeutics is developing definitive, one-time gene therapy treatments to restore the health of people suffering from chronic diseases. The first two indications the company is pursuing are therapies for congestive heart failure (CHF) and type 2 diabetes, two of the most common and devastating chronic diseases in the world. The company's lead investigational product, RT-100, is a new type of treatment that delivers a therapeutic gene directly to damaged heart tissue during a routine outpatient procedure and has the potential to renew heart function in millions of patients with CHF. The company's product pipeline also includes a second-generation therapy for CHF patients and a groundbreaking therapy in pre-clinical stage for sufferers of type 2 diabetes. Renova Therapeutics was founded in 2009 and is led by an experienced management team in biopharmaceuticals and gene therapy. For additional information about the company, please visit www.renovatherapeutics.com.

References:
¹ http://www.ncbi.nlm.nih.gov/pubmed/25760560
² Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics-2015 update: a report from the american heart association. Circulation. 2015;131(4):e29-e322.

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