Phase II data and summary of Phase I studies presented at ASCO
New Orleans, LA-May 22, 2000-Targeted Genetics Corporation (Nasdaq: TGEN) yesterday presented data from its clinical studies of tgDCC-E1A, the Company's lead cancer therapy, at the 36th American Society of Clinical Oncology Annual Meeting in New Orleans, Louisiana. Dr. Thomas C. Reynolds, Vice President, Clinical Affairs at Targeted Genetics, presented data from clinical trials of tgDCC-E1A in patients with head and neck cancer or ovarian cancer at a poster discussion session on the topic of Biologic Therapy for cancer. Preclinical data from studies of a systemic delivery formulation of E1A also were presented in the same poster.
Data from a recently completed Phase II study of tgDCC-E1A in recurrent head and neck squamous cell carcinoma (HNSCC) were presented in an abstract titled "Activity of E1A in Human Clinical Trials." The Phase II study evaluated tgDCC-E1A as single-agent therapy in 24 patients with recurrent HNSCC. Patients received 30ug DNA/cm3 of tumor via intratumoral injection daily for three days and then weekly for seven weeks. The most common side effect was pain at the injection site, and no serious adverse events related to tgDCC-E1A were reported. Of 20 evaluable patients, 45% showed objective responses or stabilization of their disease as assessed by CT analysis. A 5% complete response rate also was observed by the same criteria. Tumor response was determined as a function of tumor growth measured by physical exam and by two-dimensional and three-dimensional CT analysis.
"These data suggest that tgDCC-E1A is safe and will be useful in the treatment of head and neck cancer," said Dr. Reynolds. "Although patients in this study had very advanced disease, we were able to generate a 45% response rate using tgDCC-E1A as a single agent. Preclinical studies show that E1A can sensitize tumors to radiation and chemotherapy and we believe that comb
Contact: Page Sargisson
415-677-4455 x 229