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[[File:NeuVax_Logo.jpg|thumb|right|]]
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'''NeuVax''', developed by [[Galena Biopharma]], Inc., is a peptide-based [[Cancer vaccine|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]]).<ref>[http://www.ncbi.nlm.nih.gov/pubmed/20845479 Holmes, JP et al. (2011) Use of booster inoculations to sustain the clinical effect of an adjuvant breast cancer vaccine: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02], ''Cancer'', 117(3), 463-71. doi: 10.1002/cncr.25586.</ref> 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).<ref>[http://www.ncbi.nlm.nih.gov/pubmed/18392824 Amin, A. et al.(2008) 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] ''Cancer Immunol Immunother'', 57(12), 1817-25.</ref> 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 [[Breast cancer|breast]], [[Ovarian cancer|ovarian]], [[Pancreatic cancer|pancreatic]], [[Colon cancer|colon]], [[Bladder cancer|bladder]] and [[Prostate cancer|prostate]] cancers.<ref>[http://www.expert-reviews.com/doi/abs/10.1586/erv.10.167?journalCode=erv Benavides L, Sears A, & Gates J.(2011) Comparison of Different HER2/neu Vaccines in Adjuvant Breast Cancer Trials: Implications for Dosing of Peptide Vaccines], Expert Reviews Vaccines, 10(2), 201-210. doi:10.1586/erv.10.167.</ref>
'''NeuVax''', developed by [[Galena Biopharma]], Inc., is a peptide-based [[Cancer vaccine|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]]).<ref>{{cite journal |doi=10.1002/cncr.25586}}</ref> 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).<ref>{{cite journal |pmid=18392824}}</ref> 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 [[Breast cancer|breast]], [[Ovarian cancer|ovarian]], [[Pancreatic cancer|pancreatic]], [[Colon cancer|colon]], [[Bladder cancer|bladder]] and [[Prostate cancer|prostate]] cancers.<ref>{{cite journal |doi=10.1586/erv.10.167}}</ref>


==Clinical trials==
==Clinical trials==
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.<ref>{{cite doi|10.1002/cncr.26574}}</ref> As a result, two additional NeuVax trials underway are: (1) a 700 patient Phase 3 trial for FDA approval<ref>[http://clinicaltrials.gov/ct2/show/NCT01479244 Phase 3 PRESENT Trial]</ref> and (2) a 300 patient Phase 2 trial studying the combination of NeuVax and Herceptin® (trastuzumab).<ref name=forbes>{{cite journal|last=Marcial|first=Gene|title=Roche Accelerates Defense Strategy to Protect Breast-Cancer Drug Herceptin's Turf|journal=Forbes|date=March 15, 2012|url=http://www.forbes.com/sites/genemarcial/2012/03/15/roche-accelerates-defense-strategy-to-protect-breast-cancer-drug-herceptins-turf/|accessdate=22 April 2012}}</ref>
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.<ref>{{cite journal |doi=10.1002/cncr.26574}}</ref> As a result, two additional NeuVax trials underway are: (1) a 700 patient Phase 3 trial for FDA approval<ref>{{ClinicalTrialsGov|NCT01479244|Efficacy and Safety Study of NeuVax(TM) Vaccine to Prevent Breast Cancer Recurrence (PRESENT)}}</ref> and (2) a 300 patient Phase 2 trial studying the combination of NeuVax and Herceptin® (trastuzumab).<ref name=forbes>{{cite news |last=Marcial |first=Gene |title=Roche Accelerates Defense Strategy to Protect Breast-Cancer Drug Herceptin's Turf |work=Forbes |date=March 15, 2012 |url=http://www.forbes.com/sites/genemarcial/2012/03/15/roche-accelerates-defense-strategy-to-protect-breast-cancer-drug-herceptins-turf/ |accessdate=22 April 2012}}</ref>


==References==
==References==

Revision as of 02:21, 2 September 2012

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, a protein associated with tumors in breast, ovarian, pancreatic, colon, bladder and prostate cancers.[3]

Clinical trials

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® (trastuzumab).[6]

References

  1. ^ . doi:10.1002/cncr.25586. {{cite journal}}: Cite journal requires |journal= (help); Missing or empty |title= (help)
  2. ^ . PMID 18392824. {{cite journal}}: Cite journal requires |journal= (help); Missing or empty |title= (help)
  3. ^ . doi:10.1586/erv.10.167. {{cite journal}}: Cite journal requires |journal= (help); Missing or empty |title= (help)
  4. ^ . doi:10.1002/cncr.26574. {{cite journal}}: Cite journal requires |journal= (help); Missing or empty |title= (help)
  5. ^ Clinical trial number NCT01479244 for "Efficacy and Safety Study of NeuVax(TM) Vaccine to Prevent Breast Cancer Recurrence (PRESENT)" at ClinicalTrials.gov
  6. ^ Marcial, Gene (March 15, 2012). "Roche Accelerates Defense Strategy to Protect Breast-Cancer Drug Herceptin's Turf". Forbes. Retrieved 22 April 2012.