[Janelle]

Here is the email that I just received from Dr. Mittendorf:

Ms -

It was nice chatting with you today regarding our program using HER2/neu-derived peptide vaccines. As we discussed, it will likely be late summer or early fall before Apthera launches the phase III trial for NeuVax (E75). The trial we are close to launching at MD Anderson is the AE37/GP2 efficacy (phase II) trial. I have attached a powerpoint presentation that I just gave to a group and the trial schema is slide #25. Much of the data in this powerpoint talk is published in our Clinical Cancer Research paper which I have also attached for your review. There is some unpublished data in the talk so I would ask that you not distribute copies of this presentation. If you would like to review it with your treating oncologist that would be fine and I would be happy to answer any questions either of you may have. Also, I am unable at this time to provide copies of the manuscript detailing the AE37 phase I trial but it is in press for publication in the Journal of Clinical Oncology. The manuscript detailing the GP2 phase I trial is in preparation.

WIth respect to inclusion and exclusion criteria for the trial, I have listed those below.

You asked that I provide contact information and that is included at the bottom of this email. The most reliable way to get in touch with me is via email.

I will be in touch as more details regarding our trial start date become sorted out.

Beth



G.3.1 Inclusion Criteria

1. NP or high-risk NN breast cancer patients. The latter is defined as any one of the following: T2, grade 3, lymphovascular invasion, ER/PR negative, or N0 (i+).
2. HER2/neu-expressing tumor (IHC 1-3+ and/or positive FISH >1.2)
3. Completion of primary standard of care breast cancer therapies (i.e., surgery, chemotherapy, immunotherapy and radiation therapy as appropriate per standard of care for patients' specific cancer)
4. Clinically cancer-free (no evidence of disease)
5. Patients may be enrolled between 1-6 months from completion of standard primary breast cancer therapies.
6. Immunologically intact by recall anergy testing (defined below)
7. Good performance status (defined below)
8. Capable of informed consent

G.3.2 Exclusion Criteria

1. HER2/neu- breast cancers (IHC 0)
2. Clinical and/or radiographic evidence of residual or persistent breast cancer
3. Anergic by the Mantoux panel of recall antigens
4. Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
5. In poor health (Karnofsky <60%, ECOG >2)
6. Tbili >1.8, creatinine>2, hemoglobin<10, platelets<50,000, WBC<2,000
7. Active pulmonary disease requiring medication to include multiple inhalers
8. Pregnancy (urine HCG)
9. Breast feeding
10. History of autoimmune disease

Elizabeth A. Mittendorf, M.D.
Department of Surgical Oncology
U. T. M.D. Anderson Cancer Center
1515 Holcombe Blvd. Unit 444
Houston, TX 77030
Phone: (713)792-7216
Fax: (713)745-5235
Pager: (713)404-2202
email: eamitten@mdanderson.org