Generex Biotechnology subsidiary Antigen Express has reported promising early results in a Phase II trial of its breast cancer treatment. The vaccine, called AE37, cut the recurrence of breast cancer in women who weren't eligible for treatment with Herceptin. Although the findings have yet to reach statistical significance, the developer expects to have further results in hand in 2012.
AE37 is based on Antigen's platform Ii-Key Hybrid technology platform, which uses modified antigen fragments to increase the reaction from CD4+ T helper cells. This boosts the immune system's ability to recognize and destroy cancerous cells.
Antigen's study included 250 patients. After 22 months, Antigen reported disease-free survival in the low HER2 expressing patients was 88.6% in the group that received AE37, compared with 71.9% in the control arm. Additionally, women who got the vaccine exhibited a statistically significant increase in positive immune reactions to a test dose of HER2 protein, the company said in a release.
"Women with breast cancers expressing low levels of HER2 do not benefit from targeted HER2 therapies that are currently available," explained breast cancer researcher George Peoples at the annual San Antonio Breast Cancer Symposium. "Our research is focused on reducing the recurrence of cancer using a woman's own immune system to fight her disease, including breast cancers that express low levels of HER2. The AE37 vaccine is based on over 5 years of research and continues to show promise in a well-designed and ongoing randomized Phase 2 clinical trial that if positive, will allow rapid transition to Phase 3." Antigen plans to move forward with a Phase III trial of the vaccine after an end of Phase II meeting with the FDA in the first half of 2012.
- here's the Antigen Express release