Dr. Elizabeth Mittendorf's AE37 vaccine study

[pilgrim37]

Hi all:
You've probably seen in today's news very promising results in Dr. Elizabeth Mittendorf's study re AE37 vaccine treatment of breast cancer. In 2009 I was diagnosed with stage III her2+ and had 3 months taxol/herceptin, bilateral mastectomy, 3 months A/C, and 5 weeks radiation, plus balance of year on herceptin.

I'm very interested in this trial -- anyone have a link to the actual trial?

Thank you!

['lizbeth]

Here is a link to the company that makes AE37:
http://www.antigenexpress.com/default.asp

Here is a clinical trial with an AE37 arm, there should be more . . .
I'm currently in the GPII arm of this trial with my final booster shots being completed next month

http://clinicaltrials.gov/ct2/show/N...cr=Open&rank=6

['lizbeth]

Generex Biotechnology Corporation (OTCBB: GNBT) today provided an update to the clinical development & regulatory strategy for its cancer vaccine, AE37. Positive interim Phase 2b clinical data from the study in HER-2 expressing breast cancer subjects (presented last month at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas) has lead to an earlier-than-expected advancement in the overall development of AE37 for both breast and prostate cancer indications.AE37 is a novel Ii-Key Hybrid-based HER-2/neu Peptide Vaccine designed to train the immune system, independent of HLA-type, to track down cancer cells throughout the body and destroy them. The positive interim Phase 2b results, building upon completed pre-clinical and Phase I breast cancer studies, enables Antigen Express to move up the timing of key development and regulatory plans. In particular, the company will organize an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) by the end of Q1 2012. With the FDA's guidance, the Company will move into a pivotal Phase 3 clinical development program in women with loco-regional breast cancer that express low to moderate levels of HER2. Parallel steps will be taken with the European Medicines Agency using the same Phase 2b results. The Phase 2b is currently planned to enroll a total of 300 women and will continue as planned to provide additional valuable information on efficacy and safety of AE37 as the Company pursues its Phase 3 trial plans.
Dr. Eric von Hofe, Ph.D., President of Antigen Express, said: "While the number of patients with recurrent breast cancer is still too low to confirm statistical significance in this ongoing study, the approximate 46% reduction in breast cancer recurrence in low HER2 expressing tumors together with excellent safety enables us to move forward in requesting an End-of-Phase II meeting with the FDA."
Importantly, the majority of women with loco-regional breast cancer have low to moderate expressing HER2 tumors and currently are treated with chemotherapy and radiotherapy only. There is no approved targeted HER2 therapy for these women.

Google article for more info on 2nd page . . .

[pilgrim37]

thanks 'lizbeth! Congratulations to getting into the study. Turns out I'm too far out from treatment -- I think you have to get in within 6 months of the end of treatment. I believe this is the future -- very exciting!

['lizbeth]

Yes, I enrolled before I was 6 months out, very lucky to be in the trial and I have had amazing care from the wonderful nurses at Brooke Army Med Ctr. I have my last boost in just a few weeks, amazing how the time goes by fast when I live NED.

[mimi1952]

Yes, I tried to get enrolled too and I am too far out from treatment as well. Thanks to all who keep posting about our possibilities.