A Quick Backgrounder on Generex’s Ii-key Hybrid Vaccine AE37 for Breast Cancer

January 6th, 2010 by admin Leave a reply »

So how is the drug Performing?

So far so good, would be my reaction. In Phase I clinical trials AE37 was shown to have superior immunogenicity to other peptide vaccines investigated to date. And in the Phase II clinical trials it appears the drug is performing as expected. In an interview given with Dr. Eric von Hofe, he stated that so far in the Phase II clinical trials that at an interim analysis in breast cancer patients that, “Of the patients that received the vaccine, there were zero out of 49 who relapsed. In the control group, five out of 71 relapsed. The risk of relapse in the population we’re studying is roughly 20 percent after two years. The goal of our trial is to cut that relapse rate by at least by a half (interview link here courtesy of Worcester Business Journal).” Those are some pretty strong initial statistics for a drug just entering Phase II trials.

Keep in mind that Breast Cancer isn’t the only indication AE37 is going for, the vaccine technology (AE37) is also being applied to Prostate Cancer and Melanoma. Results from the Phase I clinical trial in prostate cancer patients showed that the vaccine was safe and produced the desired immunological responses. Will a Phase II trial in Prostate Cancer be on the horizon? My money would be on that it is, given the fact that cancer vaccines could possibly unlock a potentially potent cancer fighting agent. On a side note, a remarkable cancer immunotherapy that works similarly to this one is Dendreon’s Provenge which is largely expected to get approval this year.

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