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Targeted Genetics expands patent portfolio for program.

Targeted Genetics Corporation (Seattle, WA; 206-521-7823) announced the issuance of an additional patent related to its E1A gene therapy program for the treatment of cancer. The patent , United States Patent 6,395,712, "Sensitization of HER-2/Neu Overexpressing Cancer Cells to Chemotherapy," issued to the University of Texas M. D. Anderson Cancer Center and is exclusively licensed to Targeted Genetics. The patent covers the use of the E1A gene in the treatment of HER-2/neu positive cancers. HER-2/neu has been associated with increased rates of metastasis, resistance to chemotherapy and poor prognosis.

"Our growing body of clinical and preclinical studies suggests that E1A is able to decrease expression of HER-2/neu," said Pervin Anklesaria, Ph.D., Vice President, Research at Targeted Genetics. "HER-2/neu is associated with very aggressive cancers, which frequently are resistant to chemotherapy or radiation therapy, and we believe that reducing its expression may play a significant role in achieving positive outcomes in the treatment of these cancers. We already have demonstrated in clinical trials that E1A can reduce HER-2/neu expression in patients with HER-2/neu positive breast and ovarian cancers."

The E1A gene has been shown to inhibit tumor formation and growth in a variety of clinical and preclinical studies. Data from these studies show that E1A can regulate the expression of a number of other genes, which allows for multiple mechanisms of action. In addition to decreasing the expression of certain oncogenes such as HER-2/neu, E1A also has been shown to increase the expression of genes that lead to cell death. Oncogenes are genes that when expressed at abnormally high levels contribute to converting a normal cell into a cancer cell. E1A also sensitizes cells to the effects of chemotherapy or radiation therapy and induces programmed cell death (apoptosis). Targeted Genetics' patent portfolio also includes a number of patents and patent applications covering the use of the E1A gene or fragments of the gene in all cancers, as a single agent or in conjunction with chemotherapy.

Targeted Genetics has completed a series of single-agent studies utilizing the DCC, or DC cholesterol based gene delivery formulation, one of the company's synthetic gene delivery systems. These studies of tgDCC-E1A in several cancer indications suggest that the DCC-E1A product is well tolerated and has a good safety profile and data have yielded encouraging results in patients with very advanced disease. The clinical development strategy for tgDCC-E1A is focused on the use of the product candidate in combination with chemotherapy or radiation therapy. Interim data from a Phase I study of tgDCC-E1A in combination with intraperitoneal chemotherapy support the good safety profile of the combined regimen and demonstrate a reduction in levels of CA-125, a marker for ovarian cancer, in six of seven patients who entered the study with CA-125 levels above 20 U/Ml. A Phase I study of tgDCC-E1A in combination with intravenous chemotherapy in ovarian cancer patients is expected to start in mid-2002, and a Phase II study in combination with radiation therapy for the treatment of head and neck cancer is ongoing. An interim analysis of the head and neck study is anticipated in mid-2002. Targeted Genetics develops gene therapy products for the treatment of acquired and inherited diseases. The company has lead clinical product development programs targeting cystic fibrosis and cancer, and a promising pipeline of product candidates focused on hemophilia, arthritis, cancer and AIDS prophylaxis. The company has a broad platform of gene delivery technologies and, through its majority-owned subsidiary, CellExSys, a promising body of technology for cellular therapy.
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Title Annotation:Targeted Genetics Corp.U.S. Patent 6,395,712 issued to the University of Texas M. D. Anderson Cancer Center
Publication:BIOTECH Patent News
Article Type:Brief Article
Geographic Code:1USA
Date:Jun 1, 2002
Words:589
Previous Article:Introgen's mda-7 gene therapeutic receives patent.
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