Avigen issued three patents expanding AAV portfolio.

Avigen, Inc. (Alameda, CA; 510-748-7112) announced it has received three new patents, strengthening its expansive intellectual property portfolio in adeno-associated virus (AAV) vector technology. Two of the patents cover advances in the delivery of AAV. The third covers the cells used in Avigen's AAV manufacturing process, which result in significantly enhanced yields.

United States Patent 6,325,998 covers the use of recombinant AAV, free of both wild-type AAV and infectious helper virus, to deliver any therapeutic gene to muscle cells, including skeletal, smooth and cardiac muscle. United States Patent 6,335,011 covers methods for delivering genes via AAV to muscle tissue to treat any of the lysosomal storage diseases, including Gaucher's Disease and Hurler's Disease.

United States Patent 6,365,403 covers the compositions and cells Avigen has developed for high efficiency manufacturing of AAV. By optimizing the ratios of the AAV helper function proteins in the cells, Avigen has increased production efficiency 10 fold over previous techniques.

"Avigen has developed a significant intellectual property position in AAV," said Ken Chahine, Ph.D., J.D., Avigen's vice president of business development and intellectual property. "We now have 28 issued and 35 pending patent applications in the United States, with corresponding patent applications in numerous international markets, that provide extensive coverage of AAV as a gene delivery vehicle, both for methods of administration and a variety of disease indications, and of our proprietary virus-free AAV manufacturing process."

More than 80% of the population has been exposed to AAV, a simple virus that is not known to cause illness of any kind. Avigen's AAV vectors take advantage of the natural efficiency with which this virus delivers genes to cells. To produce an AAV vector viral genes are replaced with genes for therapeutic proteins. The vector is then injected into the patient. Once it enters the target cells, they begin to produce the necessary proteins to treat the disease. Avigen's proprietary manufacturing techniques enabled high-yield production of AAV vectors free of both wild-type AAV and infectious helper virus.

"We believe AAV vectors provide several potential advantages over other approaches to gene delivery, including efficacy and safety, and have focused exclusively on AAV since the company's inception. Our efforts have resulted in the most comprehensive portfolio of patents in this area. We are currently conducting clinical trials of the use of AAV for the treatment of hemophilia and have several research efforts underway in the areas of Parkinson's Disease, congestive heart failure and other disease indications," Chahine concluded.

Avigen is a leader in the development of gene therapy products based on its AAV (adeno associated virus) delivery platform technology. Avigen's proposed gene delivery products are designed for direct administration to patients in order to achieve expression of therapeutic proteins within the body.