Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) today announced that it has reached a pre-specified point in the ongoing Phase II trial of its AE37 breast cancer vaccine to initiate its primary efficacy analysis. The drug is a novel immunotherapeutic cancer vaccine being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). A previously released positive interim analysis showed a strong trend toward reduced relapse in breast cancer patients receiving the AE37 vaccine.
The immunotherapeutic vaccine AE37 is designed to stimulate a robust immune response against the HER2 protein, which is expressed in a large percentage of patients with breast and other cancer types. While the highly successful drug Herceptin is approved for use only in patients whose tumors express the highest levels of HER2 (roughly 25% of patients), AE37 is targeted to patients whose cancers express even low levels of the HER2 protein. Not surprisingly, the interim analysis showed that AE37 appeared to perform best in those patients who did not receive Herceptin. It is particularly this patient population of low HER2 expressing cancer patients that represents one of the largest areas of unmet need among breast cancer patients.
The Phase II trial involves the use of 15 sites in the US and Europe and is being conducted under a company-sponsored Investigational New Drug Application (IND). The planned analysis will compare disease free survival in AE37-treated versus control patients. The trial is a single-blinded, controlled, and 1:1 randomized study in patients who have been recently diagnosed with node-positive or high-risk node-negative breast cancer and received standard-of-care therapy. As the largest cancer vaccine trial conducted to date in breast cancer patients, the results are expected to help foster a partnership for the Company's upcoming Phase III trial.
The Company is presently preparing for a lock of the data, after which it will be analyzed in accordance with the study's statistical analysis plan. This primary efficacy analysis will be the second formal analysis of data from the trial. A third analysis is set to occur 12 months after enrollment of the final patient in the study.
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