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Targeted Genetics, M.D. Anderson Cancer Center And University Of Pittsburgh,,Report Phase I Clinical Trial Results Of Gene Therapy Treatment For Cancer

HER-2/neu can be reversed by injecting the E1A gene into patients with breast and ovarian cancers, making E1A a viable option to study as treatment for a broad range of cancers."

The phase I dose-escalation study treated 12 patients with metastatic or recurrent breast and ovarian cancers with weekly injections of an E1A gene incorporated into a liposome, which improved the gene's ability to penetrate human cells. The first three patients who have been evaluated all showed E1A gene expression in both cancer and non-cancer cells. Additionally, these three patients all exhibited decreased levels of surrogate tumor markers. Planning for Phase II trials is currently underway.

A similar treatment using E1A is being tested by Targeted Genetics for head and neck cancer. Research led by Dr. George Yoo of Wayne State University in Detroit, Michigan also was presented in a poster session at AACR. Using a direct injection of the E1A gene into solid tumors, this Phase I study demonstrated safety with no associated systemic toxicities. In addition, in a majority of patients, treated tumors exhibited stable disease after E1A therapy. Targeted Genetics plans to initiate Phase II clinical trials for the treatment of head and neck cancer in the second half of 1998.

"This is extremely exciting for Targeted Genetics because the work presented at AACR validates our E1A approach to gene therapy," said H. Stewart Parker, President and CEO. "Our research shows that we can safely deliver the E1A gene and see its expression in the cells to which it was delivered. Moreover, in the three patients examined so far, we have shown a decrease in HER-2/neu expression. This observation encourages us to continue our work in E1A, and we are excited about its potential as a therapy for several different types of cancer."

According to the AACR, over 180,000 new cases of breast cancer were reported in 1997. Of those, approximately 44,000 will be fatal. Ovarian cancer, with near
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Contact: Amy Flood
a.flood@noonanrusso.com
212-696-4455, x. 211
Noonan/Russo Communications
30-Mar-1998


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