Vaccine generates strong immune response in women with advanced disease.

2003 JAN 8 - (NewsRx.com & NewsRx.net) -- Dendreon Corp. (DNDN) has announced that results of a phase I study indicate that APC8024, the company's investigational therapeutic vaccine for breast, ovarian and colon cancer appears to be safe and stimulates immunity, and is showing signs of clinical benefit in patients with advanced, metastatic, Her-2-positive breast cancer.

The data were presented at the 25th Annual San Antonio Breast Cancer Symposium by John Park, MD, University of California San Francisco Comprehensive Cancer Center.

In this study, 16 women received treatment with the vaccine APC8024 and were evaluated for safety, immune response and exploratory signs of clinical benefit. At 3 months' follow-up of 11 evaluable patients, 6 patients (54%) had stable disease, and 1 patient had a partial response with a more than 50% reduction in tumor volume. An immune response to APC8024 was detected in 100% of evaluable patients. Side effects were minor, consisting primarily of fever and chills following vaccine infusion.

One patient showed a partial clinical response demonstrated by a 50% or greater decrease in tumor size.

"It is encouraging to see strong immunologic effects, as well as antitumor effects in an initial trial, which consisted of patients with advanced breast cancer who had largely failed other treatments, including Herceptin," said Park. "These results confirm preclinical studies that have ...