Avigen Receives Patent Covering Wild-Type-Free AAV Production
"Wild-type AAV" refers to the naturally occurring adeno-associated virus that may contaminate the production of recombinant AAV vectors produced for clinical trials if appropriate manufacturing safeguards are not in place. Previously patented methods for producing wild-type-free AAV have been reported to contain contaminating wild-type AAV at levels as high as 10% of the total AAV vector product. Using Avigen's patented technology, no wild-type AAV can be detected using the most sensitive techniques currently available.
"Even though wild-type AAV is harmless, Avigen is making every effort to ensure that its AAV vector is the highest quality," said John Monahan, president and CEO of Avigen. "Moreover, unlike processes used by others, Avigen's AAV manufacturing does not use live adenovirus, a known human pathogen. Taken together, Avigen's AAV vectors are free of all contaminating virus and inherently safer than those produced by other methods."
"The issuance of this patent to Avigen further expands our strong proprietary position in AAV," says Kenneth G. Chahine, vice president of Business Development and Patent Counsel. "This patent is the seventh patent issued to Avigen relating to AAV-based gene therapy in the last year, giving Avigen one of the largest AAV vector patent estates in the field."
Earlier this month Avigen and collaborators presented an interim report on the ongoing Phase I clinical trial for Coagulin-B, its AAV vector containing the gene for factor IX for treating hemophilia B, at the American Society of Hematology in New Orleans (see Gene Therapy for Hemophilia B Shows Promise).
Patients with hemophilia B are deficient in a protein called factor IX that is required for blood to clot. Even at the lowest dose, Coagulin-B showed preliminary indications of therapeutic benefit. After delivering Coagulin-B(TM), factor IX activity was detected in the blood of the initial hemophilia patients treated, which correlated with a significant reduction of factor IX concentrate usage by these patients.
Avigen Inc. is a biotechnology company involved in the development of gene therapy products derived from adeno-associated virus for the treatment of inherited and acquired diseases. The cmpany's proposed gene therapy products are designed for in vivo administration to achieve the production of therapeutic proteins within the body.
For more information: Thomas J. Paulson, VP of Finance and CFO, Avigen Inc., 1201 Harbor Bay Pkwy., Ste. 1000, Alameda, CA 94502. Tel: 510-748-7150. Fax: 510-748-7155. Email: paulson@avigen.com.