On May 14, 2015 Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) reported that updated data from the on-going Phase II clinical trial of the AE37 breast cancer vaccine under development at the Company’s wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com), will be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Generex, MAY 14, 2015, http://www.prnewswire.com/news-releases/generex-provides-data-update-from-ae37-phase-ii-breast-cancer-trial-one-year-post-completion-of-enrollment-300082832.html [SID:1234506564]). The current analysis was performed on data that was examined one year after the last patient was enrolled into the trial. The ASCO (Free ASCO Whitepaper) meeting will be held from May 29 to June 2, 2015 in Chicago, IL.
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The abstract, entitled ‘Final Pre-specified Analysis of the Phase II Trial of the AE37+GM-CSF Vaccine in High Risk Breast Cancer Patients to Prevent Recurrence", by Julia Greene, et al will be presented on May 30 during the Breast Cancer – HER2/ER session. The study reports on the anticipated five year disease free survival in patients enrolled in a controlled, randomized, and single-blinded Phase II trial that completed enrollment in January of 2014. A prior interim analysis conducted in 2011, as well as a primary efficacy analysis conducted in 2013, pointed to a benefit of the AE37 vaccine in patients not receiving Herceptin and, in particular, patients with triple negative breast cancer. This latter group represents a patient population of high unmet need. The present study continues to show a trend in this population, with a 35% reduction in the relative risk of recurrence in patients receiving the AE37 vaccine.
The AE37 cancer vaccine is distinguished among other cancer vaccines by its ability to specifically activate CD4+ T helper cells, which are critical in generating an effective immune response. The improved immunological potency, together with an excellent safety profile, offer particular advantages for combination with other targeted or immunological therapies. In addition to the Phase II study in breast cancer patients, AE37 also has been tested in a Phase I study in prostate cancer patients. In that study it was shown that, even three years after receiving the last dose of AE37, patients consistently displayed a vigorous reaction, demonstrating a long-lasting, specific, and robust response to AE37.