Generex Biotechnology Corp. (fka GNBTQ)

[WeeZuhl]

AE37 ASCO DATA 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

Generex Provides Data Update from AE37 Phase II Breast Cancer Trial One Year Post Completion of Enrollment
9:30 AM ET, 05/14/2015 - PR Newswire

WORCESTER, Mass. and TORONTO, May 14, 2015 /PRNewswire/ -- Generex


....updated data from the on-going Phase II clinical trial of the AE37 breast cancer vaccine .....


....The current analysis was performed on data that was examined one year after the last patient was enrolled into the trial. The ASCO meeting will be held from May 29 to June 2, 2015 in Chicago, IL.


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.

Congratulations to the Antigen team. This shows there is great promise for AE37, especially for this tough to manage population with triple-negative breast cancer. Nothing else has shown anything near this effective for this group. No way this can be let alone. I think we can expect to hear more soon. I suspect the next step will be a combination trial with at least one other peptide. I suspect it will be with Dr. Mittendorf as primary investigator.

Question: Will the new peptide(s) be hybrid vaccine with Ii-key moeity? I would think so.