WORCESTER, Mass. and TORONTO, Jan. 30, 2013 /PRNewswire/ -- Generex Biotechnology Corporation ( www.generex.com) (OTCBB: GNBT) today provided an overview on the early breast cancer competitive status of the lead cancer immunotherapy product, AE37, under development at its wholly-owned subsidiary, Antigen Express, Inc. ( www.antigenexpress.com). A detailed update on development plans will be provided during the previously announced conference call scheduled for Thursday, January 31, 2013. Antigen Express is in late Phase IIb clinical development for early stage breast cancer that has provided very encouraging interim results and Phase I testing in prostate cancer has been completed.
The specific advantage of the cancer immunotherapy product AE37 is in early breast cancer by potentially stimulating the immune system to target HER2 (the target for Herceptin's effect) on breast cancer cells at low levels independent of immune type of the person. This follows in the footsteps of one of the most successful therapeutics ever developed for breast cancer (Herceptin), though AE37 potentially addresses an early breast cancer patient population of unmet need several times more common than those treated with Herceptin. In particular, while Herceptin is approved for use in roughly 25% of early stage breast cancer patients with high expression of HER2, it is not approved for the larger group of women (50% of women with early breast cancer) who have lower levels of expression of the target for Herceptin (HER2). Rather than attacking HER2 cancer cells directly as does Herceptin, AE37 works by stimulating the immune system to recognize HER2. The greater sensitivity of the immune system can thereby be brought to bear to recognize and kill cancer cells in this larger low HER2 expressing early breast cancer population. An additional potential advantage is that the immunological memory induced by AE37 means the immune system may continue to scan for and kill HER2 cancer cells long after AE37 treatment has been completed.