Introgen Therapeutics Inc announced that the United States Patent and Trademark Office issued United States patent number 6,262,032 B1 to Aventis Pharmaceuticals. The patent, "Method of Destroying Hyperproliferative Cells by Combining p53 and Taxoid Treatment" relates to the combination of the p53 gene and the use of taxanes, which is the class of chemotherapeutic agents that includes Taxotere and Taxol. This type of combination therapy is used in Introgen's ongoing phase 2 breast cancer study. This is one of several patents, pending or issued, that Introgen has licensed exclusively from Aventis Pharmaceuticals.

"A strong component of Introgen's patent portfolio is its various patents directed to the use of p53 in combination with DNA damaging agents such as radiation or cisplatin," said David L. Parker, vice president of intellectual property for Introgen. "The issuance of this patent expands this approach, and our portfolio, to include combinations of p53 with taxanes, a class of agents proven to be clinically important in treating a variety of cancers. This gives Introgen about ten U.S. patents that cover p53 therapy in general and therapy with our Advexin product in particular."

Virtually all cancer patients receive DNA damaging agents such as chemotherapy or radiotherapy as part of standard cancer treatment. By treating cancer cells with chemotherapy and/or radiotherapy prior to receiving gene therapy, the effects of the gene therapy treatment, and that of the chemotherapeutic, are enhanced.

Introgen is currently conducting a phase 2 clinical study to investigate the efficacy and safety of Advexin as a treatment for patients with advanced breast cancer in combination with two chemotherapeutic drugs, docetaxel (Taxotere) and doxorubicin (Adriamycin). Aventis partially funds this study. Advexin is already the subject of two randomized and controlled phase 3 clinical trials for treating patients with advanced head and neck cancer.