Introgen Therapeutics Inc announced that it has been awarded U.S. Patent No. 6,726,907, entitled "Purified Adenovirus Compositions." This patent broadly covers purified adenoviral compositions or preparations without limitation to the type of adenovirus, the use or application of the adenovirus and without limitation as to how the adenovirus is produced. This patent complements and broadens a previously issued patent in Introgen's intellectual property portfolio directed to processes for purifying adenoviruses.
"This patent adds considerably to Introgen's extensive adenovirus intellectual property portfolio. It covers adenovirus of commercial scale purity, regardless of whether the adenovirus is used as a delivery system for therapeutic genes, used directly as a therapeutic agent in and of itself, used as a vaccine or vaccine component or simply used for research and development purposes. This patent complements, and expands the coverage of Introgen's previously announced patent that covers the commercial production of adenoviruses in general, again, without regard to the gene they carry or the use to which they are put," said David Parker, Introgen's vice president for intellectual property.
Dr. Parker continued, "Since they are not limited to any particular adenovirus, these two patents should be of substantial commercial relevance in that adenoviruses are important elements in a number of therapeutic and vaccine product candidates currently being developed by a number of companies. Further, a significant number of related applications are pending in the U.S. and internationally. As previously announced, we will be assessing our adenovirus intellectual property for potential out-licensing opportunities, as well as using our patents to strategically position our own product candidates."
"This key enabling technology validates Introgen's leadership in adenovirus production and purification technology," said Dr. Peter Clarke, Introgen's vice president of Production and Technical Processes. "This patent arises out of our extensive process development efforts at Introgen. The underlying technologies have been validated by our ability to supply high quality adenoviral vectors for our clinical development programs and by the selection of Introgen, under a process guided by the FDA, to manufacture the worldwide adenoviral reference material to be used by companies and academic institutions developing adenovirus-based products."
In the past five years adenovirus has been the most common vector for direct administration to patients. The field has now matured so that, in addition to Introgen's Advexin, INGN241 and INGN007 product candidates, there are a number of purified adenoviral products being developed worldwide. Introgen has an established history in the manufacture of adenoviral vectors for human clinical trials, and has produced numerous lots of adenoviral product using this patented method. Introgen's various adenovirus-based products have been used to treat patients in clinical studies in North America and Europe. The purified compositions covered by this patent have been implemented in a controlled Good Manufacturing Practices (GMP) environment and have been applied to the production of materials used in Introgen's worldwide clinical development program, including the ongoing Phase 3 pivotal studies in head and neck cancer.
Introgen is a leading developer of biopharmaceutical products designed to induce therapeutic protein expression using non-integrating gene agents for the treatment of cancer and other diseases. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates a commercial-scale, CGMP manufacturing facility.