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Generex Biotechnology, and their wholly owned subsidiary Antigen Express, are developing promising new drugs to treat diabetes, as well as synthetic peptide vaccines targeting HER2/neu cancer and pandemic flu. The flagship product for Generex is Oral-lyn buccal insulin. Antigen Express' leading vaccine is the AE37 HER2/neu synthetic peptide vaccine to prevent breast cancer recurrence. I am not qualified to offer investment or medical advice, and make no claims that I am an expert in these areas. I am a layman and a shareholder in this company. The left side of Pipeline Review holds blogs regarding Generex and Antigen Express, while the right side offers items of due diligence mixed with my analysis which may be of interest to others seeking to learn about Generex's pipeline. If the left side only shows the latest blog, click on the word home to view them all.

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Tuesday, April 13, 2010

Antigen Express AE37 Data to be Presented at ASCO 2010

The American Society of Clinical Oncology (ASCO) is the world’s leading professional organization representing physicians who care for people with cancer. With more than 28,000 members, ASCO is committed to improving cancer care through scientific meetings, educational programs and peer-reviewed journals. Generex's wholly owned vaccine subsidiary, Antigen Express, is currently evaluating its novel II-key hybrid HER2/neu peptide AE37 in a multi-center Phase II trial vaccine for patients in breast cancer under a research agreement with the United States Military Cancer Institute. New data for the AE37 vaccine will be presented at the 2010 American Society of Clinical Oncology ASCO Annual Meeting that will be held in Chicago from JUNE 4-8, 2010.

The title of the abstract is "Effect of a novel II-key hybrid HER2/neu peptide AE37 vaccine with GM-CSF as compared to GM-CSF alone on levels of regulatory T-cell (Treg) populations". The author/speaker is Dr. Guy T Clifton, who has worked extensively on peptide based therapuetic vaccines at the USMCI with Antigen Express collaborator Col. George Peoples. The full abstract will be available at the ASCO Annual Meeting website in mid-May.

This update follows the impressive interim results for the HER2/neu AE37 vaccine in its Phase II trial which were unvield at the San Antonio Breast Cancer Symposium in December 2009. Two hundred disease-free, high risk breast cancer patients who have completed standard adjuvant therapy are being enrolled and randomized to receive six monthly inoculations of either the AE37 peptide vaccine or the adjuvant GM-CSF alone to compare their ability to prevent recurrence. This interim analysis followed the first 49 patients in the AE37 group and the first 71 for the control group. At a median follow up of 13 months, there were been no (0.0%) recurrences in the AE37 group of patients (0/49), compared to 7.0% (5/71) in the control group. You can view the SABCS poster here.