Wednesday May 2
Source: PR Newswire
Patent Covers AAV Compositions Containing Classes of Genes Which Include Cytokines, Tumor Suppressors, and Suicide Genes Specific Genes Include Beta-Interferon, Interleukins 1-12, GM-CSF, and p53
ALAMEDA, Calif., May 2 /PRNewswire/ -- Avigen, Inc. (Nasdaq: AVGN) today announced another addition to its growing adeno-associated virus (AAV) patent portfolio with the issuance of United States Patent No. 6,218,180 covering AAV vectors containing broad classes of genes known as cytokines, tumor suppressors, and suicide genes. As composition of matter claims, the patent is not limited to the treatment of any disease, route of administration, or manufacturing process. This patent expires in 2018.
Several genes protected by the patent within the context of an AAV vector are currently on the market or being tested in clinical trials by other biotechnology and pharmaceutical companies using other delivery methods. Recombinant beta-interferon protein, sold under the trade name AVONEX(R) and manufactured by Biogen, Inc., is used to treat multiple sclerosis. Other genes, including beta-interferon, p53 and granulocyte-macrophage colony stimulating factor (GM-CSF) are currently being tested in clinical trials for the treatment of cancer using other vector systems.
Avigen now holds or has licensed 21 issued patents that cover the manufacture and use of AAV vectors to treat a variety of diseases. An additional 36 AAV patent applications are pending in the United States and over 300 AAV patent applications are pending in international markets.
"Since our founding, Avigen has been committed to being the first company focused exclusively on developing AAV gene therapy technology for treating hemophilia and other genetic disorders," said John Monahan, Ph.D., President and CEO of Avigen. "Our research and clinical trial results to date continue to demonstrate that Avigen's AAV vector technology is a safe and promising gene therapy delivery system. This new patent enhances our leading position in AAV vector technology and, combined with promising pre-clinical results, paves the way for Avigen's expected future clinical trials."
In conjunction with collaborative research conducted in the laboratories of Drs. Jun Yoshida and Masaaki Mizuno from Nagoya University in Japan, Avigen was issued the new patent after its pioneering research demonstrated the feasibility of an AAV-based gene therapy approach to treating cancer with several genes within the class of protected genes. Corresponding patents are pending in major international markets.
"With our collaborators at leading medical centers around the world, we're working to transform our core science into gene therapy products to treat diseases," said Kenneth Chahine, Ph.D., J.D., Vice President of Business Development and Intellectual Property. "Our extensive patent portfolio protects the inventions borne of these collaborations and the capital investments necessary to commercialize these potentially valuable gene therapy products."
Advantages of AAV Vectors
Avigen's gene therapy products are based on gene delivery systems called vectors. AAV vectors are derived from AAV, a common non-pathogenic human virus, and take advantage of the natural efficiency with which viruses deliver genes to cells. To produce an AAV vector, Avigen modifies the virus by removing the viral genes and replacing them with genes for therapeutic proteins. Avigen's proprietary technology uses AAV vectors to combine desirable properties of viral and non-viral vectors and may offer several potential advantages over other gene therapy vectors. These advantages include efficient delivery of genes to both dividing and non-dividing target cells, absence of viral genes that may be responsible for causing an undesirable immune response, in vivo administration to patients, higher levels of gene expression and improved stability allowing AAV vectors to be manufactured, stored and handled like more traditional pharmaceutical products. Avigen believes that its proprietary manufacturing process will simplify manufacturing and purification and achieve increased yield of high purity AAV vectors.
Avigen's Coagulin-B(TM) Now In Clinical Testing
In 1999, a Phase I clinical trial of Coagulin-B(TM), Avigen's gene therapy treatment for hemophilia B, was initiated at The Childrens Hospital of Philadelphia and Stanford University Medical Center. In this trial, Avigen's proprietary AAV vectors carrying the missing gene for Factor IX protein production are injected into the patients' muscle tissue. The early results have demonstrated the therapy to be safe and well tolerated in all patients treated as well as an effective approach to delivering the missing gene. Additionally, fifty percent of the low and medium dose patients in the trial have demonstrated a significant reduction in the usage of recombinant Factor IX protein injections. Avigen hopes to soon begin the second part of its two-prong hemophilia B delivery strategy by a initiating a second clinical trial in which AAV vectors will be delivered into patients' livers by means of an arterial injection. Factor IX deficiency affects roughly 15,000 patients in the U.S., Europe, Canada and Japan with an annual cost of treatment with recombinant or plasma-derived factor IX approaching $400 million.
Based in the San Francisco Bay area, Avigen, Inc., is a biotechnology company involved in the development of gene therapy products derived from AAV for the treatment of inherited and acquired diseases. Avigen's proposed gene therapy products are designed for in vivo administration to achieve the production of therapeutic proteins within the body. Additional information on Avigen's proprietary gene therapies can be found at www.avigen.com.
Note: This news release
contains forward-looking statements relating to the effect of patents issued
and licensed, as well as Avigen's current and planned clinical trials.
These forward-looking statements involve risks and uncertainties. In particular,
the foregoing discussion of the effect of patents issued and licensed involves
the risks that third parties may be successful in challenging the patents,
that granted claims may be held invalid or interpreted differently by a
court of law, that other patents will issue that will block Avigen from
commercializing the technology, and that new technologies will be developed
that are superior in treating the diseases targeted by Avigen. The foregoing
discussion regarding Avigen's current and planned clinical trials is subject
to risks and uncertainties, including: the risk that Avigen will experience
delays in concluding the current hemophilia B clinical trial, or hemophilia
B liver administration clinical trial, due to difficulties in completing
required regulatory requirements, including requisite proof of adequate
efficacy and/or safety; and the risk that because only a small number of
patients have been treated in the hemophilia B trial, the results of this
trial are not necessarily indicative of results that can be obtained in
a larger population. Other risks are detailed from time to time in documents
filed by Avigen with the SEC, including Avigen's report on Form 10-K for
the year ended June 30, 2000.
Source: Avigen, Inc.
Contact: investors, Thomas J. Paulson, Chief Financial Officer, of Avigen, Inc., 510-748-7150, or firstname.lastname@example.org; or press, Kelly Finley of Halsted Communications, Inc., 800-600-7111, ext. 233, or email@example.com, for Avigen, Inc.