USA-based Apthera presented positive clinical data on its HER2/neu vaccine based on the E75 immunogenic peptide developed for the immunotherapy of breast cancer and other HER2/neu-expressing cancers.
The findings, which were reported at the 2006 San Antonio Breast Cancer Symposium, Texas, USA, show that all vaccinated patients have demonstrated in vivo immunologic responses as well as in vivo delayed-type hypersensitivity responses post-vaccination though variable. At this point, clinical recurrence rates at 24 months are 5.6% (5/90) for vaccinated patients versus 14.8% (12/81) for the observation group (p=0.04).
A total of 90 patients have so far received the vaccine, while 81 are in the observation arm of the study. Toxicity has been minimal with local reactions being 86% Grade I and 14% Grade II. Systemic toxicity has been only 16% Grade 0, 70% Grade I, 13% Grade II, and 1% Grade III and mainly attributable to the granulocyte macrophage colony-stimulating factor.
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