Phase II Pancreatic Study

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At ASCO 2017, we presented a retrospective review of 11 late-stage pancreatic cancer patients who were treated in our First Human Study or as Compassionate Use Patients, each of whom had failed or refused other available therapies. Clinical Benefit was documented for all subjects. Overall reduction in tumor size was seen in 27.3% (3/11) of patients, including one complete response (“CR”) with progression-free survival (or PFS) of at least six months duration, and two partial responses with one known PFS of 15 weeks. 72.7% (8/11) of patients had stable disease ranging from 6-61 weeks. Two subjects who were listed as stable disease had an overall survival of 43 and 23 months, with no further treatment. All 11 subjects had quality-of-life benefits, including 1-3 points improvement in Eastern Cooperative Oncology Group Performance Status (“ECOG PS”); 1-5 point mean improvement on EORTC questionnaire (scale 1-7); weight gain (1-5 lbs.); and reduction in pain levels (1-9 points/10 scale) with cessation of all analgesics by the end of cycle 1 (six weeks) in 36% of subjects (4/11).

We intend to initiate a Phase II pancreatic cancer trial by the first quarter of calendar 2018. The trial is expected to be focused on refractory subjects who have failed or refused possible available treatment options.