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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. As a result, two additional NeuVax trials registered or underway are: (1) a 700 patient Phase 3 trial for FDA approval - not yet
233:"Assessment of immunologic response and recurrence patterns among patients with clinical recurrence after vaccination with a preventive HER2/neu peptide vaccine: From US Military Cancer Institute Clinical Trials Group Study I-01 and I-02"
161:
Holmes, Jarrod P.; Clifton, Guy T.; Patil, Ritesh; Benavides, Linda C.; Gates, Jeremy D.; Stojadinovic, Alexander; Mittendorf, Elizabeth A.; Ponniah, Sathibalan; Peoples, George E. (2011).
231:
Amin, Asna; Benavides, Linda C.; Holmes, Jarrod P.; Gates, Jeremy D.; Carmichael, Mark G.; Hueman, Matthew T.; Mittendorf, Elizabeth A.; Storrer, Catherine E.; et al. (2008).
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with low-to-intermediate HER-2 expression, where the five-year recurrence rate dropped from 26% to 6%. The vaccine is now in a Phase III study called PRESENT, short for (
363:
Mittendorf, Elizabeth A.; Clifton, Guy T.; Holmes, Jarrod P.; Clive, Kevin S.; Patil, Ritesh; Benavides, Linda C.; Gates, Jeremy D.; Sears, Alan K.; et al. (2012).
413:
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Benavides, Linda C; Sears, Alan K; Gates, Jeremy D; Clifton, Guy T; Clive, Kevin S; Carmichael, Mark G; Holmes, Jarrod P; Mittendorf, Elizabeth A; et al. (2011).
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NeuVax works by harnessing the patient's own immune system to seek out and attack any residual cancer cells that express HER2/neu, a protein associated with tumors in
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reatment (ClinicalTrials.gov identifier NCT01479244). This study is taking place under an FDA Special
Protocol Assessment.
318:"Comparison of different HER2/neuvaccines in adjuvant breast cancer trials: Implications for dosing of peptide vaccines"
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365:"Clinical trial results of the HER-2/neu (E75) vaccine to prevent breast cancer recurrence in high-risk patients"
291:"Efficacy and Safety Study of NeuVax(Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence (PRESENT)"
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for "Efficacy and Safety Study of NeuVax(TM) Vaccine to
Prevent Breast Cancer Recurrence (PRESENT)" at
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163:"Use of booster inoculations to sustain the clinical effect of an adjuvant breast cancer vaccine"
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aimed at preventing or delaying the recurrence of breast cancer in cancer survivors who achieve
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recruiting and (2) a 300 patient Phase 2 trial studying the combination of NeuVax and
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414:"Roche Accelerates Defense Strategy to Protect Breast-Cancer Drug Herceptin's Turf"
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ode-Positive Breast Cancer with Low to
Intermediate HER2 Expression with NeuVax
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NeuVax in Phase II showed effectiveness in early-stage, node-positive
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NeuVax is the E75 synthetic peptide initially isolated from
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proto-oncogene (being HER2/neu p366-379) combined with the
37:after standard of care treatment (e.g., surgery,
71:granulocyte macrophage colony stimulating factor
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8:
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45:). The product's developer is the US
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297:. U.S. National Institutes of Health
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412:Marcial, Gene (March 15, 2012).
237:Cancer Immunology, Immunotherapy
1:
466:
322:Expert Review of Vaccines
250:10.1007/s00262-008-0509-2
73:(rhGM-CSF from yeast).
212:Clinical trial number
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381:10.1002/cncr.26574
334:10.1586/erv.10.167
295:Clinicaltrials.gov
220:ClinicalTrials.gov
180:10.1002/cncr.25586
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450:Cancer treatments
144:® (trastuzumab).
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445:Peptide vaccines
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375:(10): 2594–602.
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243:(12): 1817–25.
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135:Clinical trials
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67:immune adjuvant
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328:(2): 201–10.
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173:(3): 463–71.
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88:ecurrence in
84:revention of
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78:breast cancer
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47:biotechnology
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29:is a peptide
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421:. Retrieved
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299:. Retrieved
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43:chemotherapy
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215:NCT01479244
57:The product
439:Categories
148:References
117:pancreatic
301:1 January
142:Herceptin
131:cancers.
39:radiation
35:remission
423:22 April
399:21989902
350:19213303
342:21332269
277:24008297
269:18392824
260:11031077
197:31298280
189:20845479
129:prostate
63:HER2/neu
49:company
390:3428069
125:bladder
113:ovarian
31:vaccine
16:Vaccine
418:Forbes
397:
387:
369:Cancer
348:
340:
275:
267:
257:
195:
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167:Cancer
109:breast
27:NeuVax
346:S2CID
273:S2CID
193:S2CID
121:colon
96:tage
92:arly-
425:2012
395:PMID
338:PMID
303:2016
265:PMID
185:PMID
127:and
385:PMC
377:doi
373:118
330:doi
255:PMC
245:doi
175:doi
171:117
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102:T
98:N
94:S
90:E
86:R
82:P
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