Dendreon Corporation (Nasdaq
NDN) today announced that updated results from a Phase 1 clinical trial of APC8024 the company's investigational immunotherapy for HER-2/neu-positive cancers indicate that APC8024 continues to demonstrate clinical benefit and statistically significant T-cell immune responses in patients with advanced metastatic HER-2/neu positive breast cancer. The findings were presented Sunday March 28 at the 95th Annual Meeting of the American Association for Cancer Research in Orlando Florida.
Results from 18 patients with advanced metastatic HER-2/neu-positive breast cancer (2+ or 3+ by immunohistochemistry or positive by FISH) were presented. All but one of the patients had failed Herceptin therapy and most patients had also failed chemotherapy treatment including 32 percent of whom had received more than three chemotherapy regimens. Clinical benefit was demonstrated in 22 percent of patients treated with APC8024 including three patients with prolonged stabilization of disease. Further long-term follow up on these patients indicates that they experienced stabilization of their disease for 15 20 and 22 months following treatment with APC8024 respectively without requiring additional chemotherapy. Treatment with APC8024 was well tolerated with no significant side effects reported and no evidence of cardiotoxicity. Treatment with APC8024 also induced a robust cellular immune response specific to HER-2/neu antigens and this immune response was statistically significant.
"It is encouraging that we are seeing both strong immunologic effects and prolonged stabilization of disease in selected patients which now includes very extended durations post-treatment. Such results are notable among patients with advanced metastatic disease who have failed other treatment modalities " said John W. Park M.D. assistant professor of medicine and director of Novel Therapeutics in Breast Oncology at the University of California San Francisco Comprehensive Cancer Center and principal investigator of the study. "Based on these results we certainly believe that further studies are warranted."
The APC8024 vaccine targets tumors that express the HER-2/neu marker. In humans HER-2/neu is overexpressed in a variety of solid tumors. APC8024 uses Dendreon's proprietary Antigen Delivery Cassette(TM) technology to genetically engineer antigens such as HER-2/neu to bind to antigen presenting cells and stimulate T-cell immunity. Treatment consists of three vaccinations with APC8024 over the course of a one-month period. The APC8024 approach is similar to the approach used in the development of Provenge Dendreon's therapeutic prostate cancer vaccine which has produced promising results in a Phase 3 clinical trial.
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