Pancreatic cancer has a dismal prognosis and few therapeutic alternatives. The American Cancer Society estimates that approximately 43,000 Americans are diagnosed with pancreatic cancer each year with 37,000 deaths from the disease. Current therapies include chemoradiation and surgery.  Currently, surgery is the only potentially curative option.  However, less than 15% of patients are diagnosed with resectable disease and most still develop metastases with five-year survival less than 20%. Few drugs have been approved for pancreatic cancer in the last two decades, yielding extremely modest improvements in patient outcomes.  Aggressive treatments such as FOLFIRINOX or gemcitabine/nab-paclitaxel yield median survival of less than one year and significant toxicity. Pancreatic cancer represents a dire, unmet medical need.  


GMCI is being evaluated for pancreatic cancer in combination with surgery and chemoradiation.  A Phase 1 study was recently completed demonstrating safety and potential efficacy of GMCI as adjuvant to surgery for resectable disease (Arm A) or to 5-FU chemoradiation for locally advanced disease (Arm B). Each patient received two cycles of GMCI.  Twenty-four patients completed therapy, 12 per arm, with no dose-limiting toxicities. CD8(+) T cell infiltration increased an average of 22-fold (range six fold to 75-fold) compared with baseline (p = 0.0021). PD-L1 expression increased in 5/7 samples analyzed. Overall survival data was promising, with one node-positive resected patient alive >66 months without recurrence (and has remained cancer free to date). Patient-reported quality of life showed no evidence of deterioration.  Mark Bloomston, M.D., previously Associate Professor, Surgical Oncology Fellowship Director, and Director of the GI Cancer Service Line, Ohio State University, was the principal investigator of the study.  The results of the study were published in Cancer Immunology and Immunotherapy in June 2015  (link).


Based on the foregoing, we have commenced  a follow on clinical study with the current more aggressive standard of care chemotherapy and radiation for patients with borderline resectable and locally advanced pancreatic cancer.



Principal Investigator

Carl Schmidt, MD,

Surgical Oncology,

Ohio State University.





 

For more information on  PaTK01  study , Click

Clinicaltrials.gov

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Pancreatic Cancer