"We are pleased to see that as the data from clinical trials accumulate, AE37 continues to show that it is not only on track to achieve a positive endpoint in the treatment of breast cancer, but also shows clear advantages over other peptide and cancer vaccine strategies," said Eric von Hofe, Ph.D., President of Antigen Express. "The clinical path forward for AE37 is straightforward, with the Phase III trial designed and ready to be implemented."
Per trial design in the ongoing Phase II study, patients are being followed for clinical recurrences; data regarding the efficacy of the AE37 vaccine will be reported after a median follow-up of 24 months. Antigen Express anticipates being able to hold an end of Phase II meeting with the FDA in the second half of 2012, followed by initiation of a pivotal Phase III trial. The company is currently seeking a partner for Phase III development and commercialization.
Antigen Express' novel Ii-Key Hybrid Preventive HER-2/neu Peptide Vaccine (AE37) is an "off-the-shelf" cancer immunotherapy product candidate that is easier and less costly to produce than comparable cell-based approaches. AE37 is derived from a fragment of the HER2 oncoprotein, which is expressed in a variety of tumors including 75-80% of breast cancers as well as a high percentage of prostate, ovarian and other cancers. AE37 is positioned initially as an adjuvant therapy for at least 50% of breast cancer patients; i.e., those with low-to-intermediate levels of HER-2 expression who are not eligible for treatment with trastuzumab (Herceptin®). Only 25% of breast ca
|SOURCE Generex Biotechnology Corporation|
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