ALAMEDA, Calif., May 23, 2002 /PRNewswire-FirstCall via COMTEX/ -- Avigen, Inc. (AVGN) announced an important addition to its growing adeno-associated virus (AAV) vector patent portfolio with the issuance of United States Patent No. 6,376,237 titled "High-Efficiency Wild-Type-Free AAV Helper Functions." This composition of matter patent covers AAV vector free of wild-type AAV as determined by a very sensitive PCR assay.
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Avigen's innovative production process increases yields while effectively eliminating contamination from either wild-type AAV or helper virus. Wild-type AAV is an unmodified AAV virus. To transform it into an AAV vector, all of the virus's genetic material is removed and replaced by the required therapeutic gene for the indication being treated. Wild-Type AAV contamination can occur when AAV vectors are manufactured with some competing production methods. In addition, some competing AAV manufacturing processes use an infectious and potentially toxic helper virus to enable replication, which is difficult to purify out of the final product. Avigen's patented process completely avoids the need for these potential toxins by using only a non-toxic subset of helper virus genes to enable replication, thereby eliminating the possibility of contaminating the end product with a potentially toxic helper virus. This also greatly simplifies the purification of the end product, contributing to higher yields.
"I am pleased that the Patent Office recognized that the technology covered in Avigen's patent is an advancement over competitor patents. Previous patents taught methods of producing AAV that generated a significant amount of wild type-AAV contamination," said John Monahan, Ph.D., Avigen's President and CEO.
"The ability to produce significant quantities of AAV vector, free of wild-type and infectious helper virus, is critical to the development of commercially useful AAV-based, gene therapy products. With our high- efficiency process Avigen's current manufacturing facility has sufficient capacity to provide AAV vector to support the commercial launch of our lead product currently in Phase 1 clinical trial, Coagulin-B(TM) for the treatment of hemophilia B, additional clinical trials planned for next year, and our growing research programs in Parkinson's Disease, congestive heart failure and several other disease indications," said Monahan.
"We believe AAV vectors provide important potential advantages over other approaches to gene delivery because they have the potential to effectively and safely produce significant gene expression for extended periods. Avigen has focused exclusively on AAV since inception, and our efforts have resulted in the most comprehensive portfolio of patents in this area with 29 issued and 34 pending patent applications in the United States. Our patents provide extensive coverage of AAV manufacturing and AAV vector based gene therapy for a wide variety of diseases and tissue targets. Based on our intellectual property and our proven manufacturing capabilities, we believe Avigen is the leader in development of AAV-based gene delivery technology," Monahan concluded. |
