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Key patent obtained for Introgen's Phase 3 product.

Introgen Therapeutics, Inc. (Austin, TX; 512-708-9310) and The University of Texas M. D. Anderson Cancer Center (Austin, TX) announced that the United States Patent and Trademark Office has issued to The Board of Regents of The University of Texas System United States patent number 6,410,010. The patent broadly covers all adenoviral p53 compositions, therapeutic and otherwise, that express adequate p53 in amounts sufficient to suppress the growth of or kill cancer cells in patients including ADVEXIN, Introgen's p53 cancer therapeutic.

The patent also covers adenoviral p53 that incorporates a specific type of promoter that helps cells to express the p53 tumor suppressor gene, the key gene in the ADVEXIN therapeutic. Introgen

Therapeutics is the exclusive licensee of this patent and is currently enrolling head and neck cancer patients in two phase 3 trials evaluating ADVEXIN gene therapy.

David L. Parker, Ph.D., J.D., Introgen's vice president of intellectual property said, "We have previously received patents on the clinical use and the manufacture of the product candidate. Now we have patented the ADVEXIN gene therapeutic directly as a composition of matter. This is therefore a key patent in our ever-expanding portfolio of intellectual property, one that further demonstrates our leadership in the gene therapy arena."

ADVEXIN is covered by 8 issued United States patents in virtually all relevant areas including compositions, methods of administering the product in virtually any form alone and with the most widely used treatments, and process and production.

ADVEXIN, formerly designated by Introgen as INGN 201, is a patented cancer therapeutic incorporating the p53 tumor suppressor gene in an adenoviral delivery system. ADVEXIN is designed to use the p53 gene to kill cancer cells and to stop tumor growth, without harming normal cells, in cancer patients with both normal and damaged p53 genes. The p53 gene interferes with cancer cells because it is a tumor suppressor gene and carries instructions to make a protein that reacts with the damaged DNA of a cancer cell. Specifically, the p53 protein activates one of two pathways in these cells, to either stop growth by arresting cancer cell growth or inducing cancer cell death via a process of programmed cell death, called apoptosis. Both processes provide an important brake to the development of certain cancers.

Introgen controls a number of United States patents that relate to adenoviral p53 as well as p53 combination therapy. Three patents cover gene therapy of cancer using a p53 tumor suppressor gene in combination with one or more chemotherapeutic drugs, radiation therapies, or other agents that have a damaging effect on the DNA of cancer cells. Two of these patents cover the clinical use of the p53 gene before, during or after treatment with chemotherapy or radiotherapy, and the third covers therapy using the p53 gene in combination with a class of chemotherapy agents called DNA repair inhibitors. An additional patent covers the treatment of cancer with adenoviral p53 to kill tumor cells and promote tumor regression.

Introgen is a leader in the development and production of gene-based drugs 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. Through more than 20 clinical trials, the company has treated hundreds of patients with thousands of doses of its lead product candidate, ADVEXIN adenoviral p53 therapy. Introgen is conducting two controlled, randomized phase 3 clinical trials with ADVEXIN for the treatment of head and neck cancer, a phase 2 study in breast cancer, as well as phase 1 trials in prostate, ovarian, bladder, and brain cancers, and completed phase 2 studies in lung and head and neck cancers.
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Comment:Key patent obtained for Introgen's Phase 3 product.
Publication:BIOTECH Patent News
Article Type:Brief Article
Geographic Code:1USA
Date:Jul 1, 2002
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