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To: Bucky Katt who wrote (9561)	11/18/2002 4:09:31 PM
From: BW	Read Replies (1) \| Respond to of 48461

how's TGEN looking? think .60 might hold from this news? Targeted Genetics' Non-Viral Systemic Gene Delivery Shows Reduction in Tumor Growth in Preclinical Studies Monday November 18, 9:00 am ET Publication in Cancer Research Supports Further Study of LPD-E1A as Novel Treatment Approach SEATTLE, Nov. 18 /PRNewswire-FirstCall/ -- Targeted Genetics Corporation (Nasdaq: TGEN - News) and collaborators at the University of Texas M. D. Anderson Cancer Center today announced data demonstrating that E1A, the Company's proprietary tumor suppressor gene, when given with its proprietary systemic gene delivery system, results in a reduction in tumor growth, and in some cases, complete elimination of tumors in animal models of cancer. In the study, LPD-E1A was intravenously (IV) administered and proved effective in multiple tumor models. Results suggest evidence of systemic delivery of the E1A gene, and demonstrated a reduction in tumor growth, increased levels of apoptosis (programmed cell death) and altered regulation of certain genes associated with cancer. The data were published in the current issue of Cancer Research and is titled "Systemic Gene Therapy in Human Xenograft Tumor Models by Liposomal Delivery of the E1A Gene." Previous preclinical and clinical studies have demonstrated anti-tumor responses in subjects treated with the E1A gene. Research conducted in this study utilized the LPD (Liposome Polycation DNA) formulation to deliver the E1A gene. The LPD-E1A complex was delivered via IV injection to mice bearing human breast or head and neck tumor xenografts. Enhanced suppression of tumor growth and an increase in survival was most significant after treatment with a combination of paclitaxel (chemotherapy treatment) and E1A when compared to paclitaxel alone. Further results demonstrate expression of E1A protein in the tumors that correlated with down-regulation of HER-2/neu (an oncogene associated with certain cancers), enhanced apoptosis and reduced tumor volume. "Targeted Genetics' study of systemic gene delivery using LPD is a novel approach to gene therapy," said Ralph Paul, Ph.D., Director of Technology Discovery, Targeted Genetics Corporation and an author of the paper. "Current synthetic gene delivery systems are not amenable to systemic delivery and have been used primarily for local administration. However, previous studies have shown that the LPD formulation has improved stability, enhanced gene transfer properties and allows for systemic delivery in contrast to earlier generations of lipid based gene delivery systems. We believe these results validate the potential of LPD as a systemic gene delivery system, and further support the use of E1A gene therapy for the treatment of cancer. We are in the process of building on the LPD formulation to develop targeted gene delivery systems that could be used as novel therapeutic agents for primary and metastatic cancer treatments, given either alone or in combination with chemotherapeutic agents." Data highlights: -- After 48 hours of treatment, mice treated with LPD-E1A demonstrated expression of E1A protein within the peritumoral areas; no E1A expression was observed in the control-treated mice. -- After 11 weekly injections, 8 out of 10 mice treated with LPD-E1A were tumor-free, whereas only 1 out of 10 mice in the control group remained tumor-free. -- After 36 hours of treatment, data revealed the most significant increase in apoptosis in the tumors treated with both LPD-E1A and paclitaxel (mean 26.3 percent) compared with tumors treated with either LPD-E1A (mean 8.7 percent) or paclitaxel (6.3 percent) alone. To date, many synthetic vectors have not been amenable to systemic administration due to their rapid elimination from the bloodstream and their accumulation in undesired sites. Local administration, directly into tumors, has been the standard for synthetic gene delivery. Targeted Genetics is developing synthetic vectors based on LPD, in which DNA is condensed prior to encapsulation in lipid, which produces particles of small and defined size. This significantly contributes to the stability of the complex and enables vector particles delivered via intravenous administration to travel throughout the body with greatly reduced rates of degradation, thus improving gene transfer efficiency. The ability to deliver genes via systemic administration may have a great impact on the treatment of both primary tumors and those which have spread throughout the body. "We are encouraged by results of studies evaluating systemic delivery of LPD-E1A and look forward to future studies," said Naoto T. Ueno, M.D., Ph.D., Assistant Professor of the Department of Blood and Marrow Transplantation at the M. D. Anderson Cancer Center. "Specific responses, including reduction in tumor size and apoptosis, demonstrate the positive impact of LPD systemic delivery of the E1A gene on cancer mouse models, and validates further study to better understand its potential in the treatment of a variety of cancers." E1A Background 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 cancer, as a single agent or in conjunction with chemotherapy.