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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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Wednesday, May 30, 2012

Breast Cancer Vaccine Reduces Recurrence

The following is an article published by the American Association for Cancer Research for the May edition of Cancer Discovery

Women with a history of HER2-positive breast cancer show lower rates of relapse after inoculation.

A novel hybrid vaccine reduced recurrence rates in patients with HER2-positive breast cancer by 43% after 22 months in early results of a phase IIb randomized clinical trial. Of 201 patients rendered disease free by standard treatment, those who received the vaccination had a recurrence rate of about 10.3% compared to 18% in the control group.

“We need to continue to follow these patients, but there is enough of a trend that a phase III trial is warranted,” says Elizabeth Mittendorf, MD, a surgical oncologist at MD Anderson Cancer Center in Houston and the trial's national principal investigator. The results will be presented June 4 at the 2012 Annual Meeting of the American Society of Clinical Oncology.

Antigen Express of Worcester, MA, the company producing the vaccine and a partial funder of the trial, plans to follow up with a phase III study.

The vaccine teaches CD4+ T-helper cells, immune cells that are critical in mounting a response against foreign invaders, to recognize the HER2 protein, which is expressed at some level in 75% to 80% of breast cancer tumors. The vaccine's hybrid design combines a fragment of HER2 with a novel peptide based on the immune-regulatory li protein that, in laboratory tests, was found to enhance the potency of the vaccine 250-fold.

Because the vaccine is effective in tumors with any level of HER2 expression, it may aid patients who are not eligible for targeted therapy with Herceptin (trastuzumab; Genentech) because their tumor HER2 levels are too low.

If it is eventually approved, the vaccine could be delivered in any physician's office. The ongoing trial included monthly injections for 6 months followed by boosters every 6 months for 3 years. To heighten immune response, the vaccine was paired with an immune stimulant known as granulocyte macrophage colony-stimulating factor, which was also given to patients in the control arm of the trial.

The trial targets women who are disease free after standard-of-care treatment rather than those with metastatic disease, because the vaccine was not likely to overcome aggressive and invasive tumors. “It's a paradigm shift in trial design for cancer vaccines,” says Mittendorf, who is now developing a trial giving the vaccine with chemotherapy prior to surgery to test whether inoculation during immune system reconstitution improves outcomes.

©2012 American Association for Cancer Research.

Source HERE.