Chemteach,
Elizabethtx is in the trial in San Antonio as well - and her site is not military.
HLA-A are a group of
human leukocyte antigens (HLA) that are
encoded by the HLA-A
locus on human chromosome 6p. The HLA genes constitute a large subset of the
Major histocompatibility complex (MHC) of humans, according to Wikipedia. It is another way of subdividing cancers, such as Her+ or ER-.
E75 is another name for Neuvax to prevent Her2+ breast cancer with HLA-A2 positive.
NeuVax, developed by
Galena Biopharma, Inc., is a peptide-based
vaccine aimed at preventing or delaying the recurrence of breast cancer in cancer survivors who achieve
remission after standard of care treatment (e.g., surgery,
radiation,
chemotherapy).
[1] It consists of the E75 synthetic peptide initially isolated from
HER2/neu proto-oncogene combined with the immune adjuvant, granulocyte macrophage colony stimulating factor (rhGM-CSF from yeast).
[2] NeuVax works by harnessing the patient’s own immune system to seek out and attack any residual cancer cells that express HER2/neu.
NeuVax has been tested as adjuvant treatment in nearly 200 breast cancer patients over a total of 5 years, and has shown to be safe and effective in Phase 2 trials.
[4] As a result, two additional NeuVax trials underway are: (1) a 700 patient Phase 3 trial for FDA approval
[5] and (2) a 300 patient Phase 2 trial studying the combination of NeuVax and Herceptin®. (Again Wiki)
On Yahoo Finance I found this info:
E75 is over 1/2 year ahead of AE, but appears to be harsher on patients in the initial clinical trials.
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The first of these vaccines to be explored in the adjuvant setting was E75 (OT 6/25/08). In the largest of the E75 trials, which Dr. Peoples reported on at the meeting, approximately 180 node-positive and high-risk, node-negative women maximally treated and disease-free entered the Phase II study. A total of 101 HLA-typed A2-positive patients were vaccinated and 79 A2-negative patients were followed prospectively as controls.
One of the drawbacks of using a peptide-based vaccine, Dr. Peoples explained, is that it is HLA-restricted and therefore only useful in HLA-A2 positive patients. That strategy, however, was chosen specifically because HLA-A2 positive patients make up about half of the HER-2/neu breast cancer population.
Locally, 82% of patients experienced Grade 1 toxicities and 18% had Grade 2 toxicities, while systemic toxicity was mild, at 15.5% for Grade 0; 69%, Grade 1; 13%, Grade 2; and 2%, Grade 3.
Local reactions can be fairly intense, Dr. Peoples noted. We split our injection into two sites. You will see a lot of erythema and some induration. These are the type of reactions you can get and they only make up a minority.
Two other peptides, GP2 and AE37, were also studied in Phase I trials modeled after the early studies of E75 and showed similar safety profiles.
GP2 is close in relationship to E75, being a short peptide that stimulates CD8 killer cells and a CPI epitope. However the peptide is found in another portion of the protein and there are different characteristics associated with GP2 in terms of its binding, potentially for the subsets of T cells it stimulates. AE37, on the other hand, is a longer peptide and stimulates CD4 helper cells.
Similarly, local toxicities for AE37 were 40% for Grade 1 and 60% for Grade 2. Systemic toxicities were 13%, Grade 0; 73%, Grade 1; and 13%, Grade 2
This information is a little old, more recent interim reports have been published on the trials.