Introgen Therapeutics has announced that a patent with broad claims directed to combination therapy with the p53 gene and conventional chemotherapy or radiation was issued in China. Patent ZL95192776.0 entitled, "Compositions Comprising DNA Damaging Agents and p53," was issued to the Board of Regents of The University of Texas System and is exclusively licensed to Introgen.
David L. Parker, Ph.D., J.D., Introgen's senior vice president of intellectual property, said, "Strategically, this is an important patent that further compliments our existing international patent portfolio. This development augments our goal to address significant populations of cancer patients receiving radiation or chemotherapy treatments, who may also be candidates for p53 therapy."
In 1994, Introgen entered into a license agreement with The University of Texas System and M. D. Anderson Cancer Center, a component of The University of Texas System, and one of the largest academic cancer centers in the world. The licensed technologies include some of Introgen's most important product candidates, including its p53 technologies.
Parker continued, "We now have two issued Chinese patents covering adenoviral p53 products and their use in the clinic. We have a number of additional pending applications in China and other countries in Asia and around the world, and hope to report new patent issuances in the near future."
Introgen's strategic vision for its intellectual property portfolio is to emphasize a net of worldwide protection, complementing markets that Introgen ultimately envisions for its products. Thus, Introgen has endeavored to file its more important applications in many different national markets throughout Europe and in Asia. The Chinese patent that is reported here mirrors similar filings throughout these strategically important jurisdictions and is exemplary of Introgen's strategy.
Introgen has conducted and published the results of Phase 2 clinical trials of ADVEXIN therapy combined with chemotherapy and radiation for the treatment of breast cancer and lung cancer respectively. In the breast cancer study performed in women with very large tumors, the combination of ADVEXIN and chemotherapy resulted in objective clinical responses with greater than 50 percent tumor reduction in all patients and the ability to remove all of the tumors surgically. In non-small cell lung cancer patients, combined ADVEXIN and radiation treatment resulted in 63 percent biopsy-proven complete responses at three months. These combined ADVEXIN treatment data are better than the expected results with chemotherapy or radiation alone. Our data in lung cancer patients, presented in May 2005, indicate that another of Introgen's p53 based therapies, INGN 225, may sensitize tumors to the effects of platinum and taxane chemotherapies, that are among the most widely employed drugs in the treatment of cancer.
It is estimated by the American Cancer Society that in the United States almost 1.5 million patients are treated each year with radiation therapy and chemotherapy. Worldwide estimates for patients receiving these therapies exceed 5 million patients annually.