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Hollinshead Phase I Colorectal Cancer Vaccine Study Demonstrated Positive Results

Product History: Anti-Cancer Vaccines. Dr. Ariel Hollinshead was a pioneer of active specific cancer immunotherapy in the 1970's and 80'sHollinshead's cancer vaccines were shown to be safe and effective in Phase I-II-III clinical testing in the USALab analysis indicated a correlation between responding patients and an IgG1 antibody responsePatients that did not generate or sustain an antibody response resulted in recurrence of the malignancyPassive immunotherapy with antigen-specific 9459

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Hollinshead Phase I Colorectal Cancer Vaccine Study Demonstrated Positive Results

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    1. Neogenix Oncology Inc A Cancer Therapeutics & Diagnostics Company PRE-CLINICAL DEVELOPMENT OF A NOVEL THERAPEUTIC ANTIBODY TO TREAT PANCREAS AND COLORECTAL CANCERS

    3. Vaccine Preparation and Screening Procedure

    4. Hollinshead Phase I Colorectal Cancer Vaccine Study Demonstrated Positive Results

    5. Hollinshead Phase II and Phase III Lung Cancer Vaccine Trials Demonstrated Positive Results In 1976, Stewart, Hollinshead, et al. reported the results of a controlled Phase II study using lung cancer TAA to demonstrate improved survival of post-operative stage I lung cancer patients (Annals of NY Acad. Sci. 277: 436-466, 1976) A follow-up randomized Phase III trial was performed with 85 pts with resectable stage I and II squamous cell lung cancer. The 5-year survival data are shown (J Surg Oncol. 46(1):9-14, 1991):

    6. Product Overview

    7. Production of a Cancer-Specific Antibody

    8. Selection and Development of NPC-1 mAb

    9. Tumor Cell Binding by NPC-1 Chimeric mAb

    10. Killing Activity of NPC-1 Chimeric mAb

    11. Strategy to Identify Tumor-Specific Antigens (TSAs)

    12. Detection of NPC-1 Antigen by Western Blotting

    13. NPC-1C Therapeutic Drug Development Parts of an IND (investigational new drug) application: Pre-clinical package In vitro, in vivo research results including efficacy Toxicology testing results Pharmacokinetic testing results Biodistribution results Antibody responses Cytokine responses Tissue staining results Target description Chemistry, Manufacturing, and Controls (CMC) Information from Goodwin Biotech, Inc., contract manufacturer Purity, identity, strength, formulation, stability, virus reduction, release testing, etc… Clinical protocol Patient information, consent forms, IRB approval Drug dosing information Monitoring and adverse events reporting

    16. Pre-Clinical Pharmacokinetic Study Results

    17. Mouse Anti-NPC-1C Antibody Results

    18. NPC-1C Toxicity/Safety Study

    19. NPC-1C Pre-clinical Toxicity Study Results

    20. NPC-1C Pre-clinical Toxicity Study Results

    21. NPC-1C Manufacturing

    22. “A Phase 1/2A Therapeutic, Open Label, Multi-Center Clinical Trial of NPC-1C, a Chimeric Monoclonal Antibody, in Adults with Recurrent, Locally Advanced Unresectable or Metastatic Pancreatic and Colorectal Cancer After Standard Therapy”

    23. Acknowledgements

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