WORCESTER, Mass. and TORONTO, Nov. 13, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB:GNBT) today provided the following update on company initiatives.
Antigen Express, Inc. ( www.antigenexpress.com), a wholly-owned subsidiary of Generex, is in late Phase II clinical development of a novel immunotherapeutic for breast cancer (AE37) that demonstrates promising trends in preventing relapse. The interim results of the large, controlled, randomized, and single blinded trial were the subject of an end of Phase II study report written for submission to the FDA with input from the Antigen Express AE37 Breast Cancer Vaccine Scientific Advisory Board (SAB) of Internationally-recognized experts in the field of breast cancer.
Based on this report, in response to the written request for the end of Phase II meeting with the FDA, the Company was given the option of proceeding expeditiously with the submission of a protocol for the Phase III study. As the Phase III trial design has been established with the advice of the SAB, the Company is proceeding with the development of a full Phase III protocol, electing to do this under the auspices of a special protocol assessment (SPA). The SPA process was developed by the FDA as a means to ensure that the trial design and endpoints are acceptable to the agency and thereby expedite the approval process once the endpoints are met.
In particular, the specific population planned for the Phase III trial are those patients with low levels of expression of the HER2 oncoprotein who are not eligible for treatment with the drug Herceptin. Representing a significant, unmet need in the management of breast cancer, this low-HER2 population is twice the size of the high-HER2 population (who are candidates for treatment with Herceptin). Subject to the availability of funding, Antigen Express expects to initiate this Phase III trial in 2013.