US firm Generex Biotechnology says that the first patient has received its immunotherapeutic AE37 vaccine as part of a new combination regimen approach for breast and ovarian cancer patients. This vaccine therapy is designed to activate immune cells that can detect and destroy cancer cells. AE37 is being developed by the company's wholly-owned immunotherapeutics subsidiary, Antigen Express.
The new Phase I clinical trial, being performed at the Mary Crowley Cancer Research Centers in Dallas and the Brooke Army Medical Center in San Antonio, will assess safety and immunological response in patients with either breast and/or ovarian cancer. Patients in the study will be clinically cancer free, having completed primary standard of care breast and/or ovarian therapies.
AE37 specifically increases the ability of CD4+ T helper cells to recognize HER-2/neu expressing cancer cells in immunized patients, which should prompt the immune system to mount a robust anti-cancer response. The cancers of all patients in these trials express some level of HER-2/neu. An advantage of using this type of active immunotherapy, as opposed to passive immunotherapy such as treatment with Herceptin (trastuzumab), is that activated immune cells can detect and destroy cancer cells expressing much lower levels of HER-2/neu than is needed for recognition by Herceptin.
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