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Sun BioPharma, Inc. Provides an Update on Ongoing Front-line Pancreatic Cancer Clinical Trial
Sun BioPharma, Inc. Provides an Update on Ongoing Front-line Pancreatic Cancer Clinical Trial.
About this update from Panbela Therapeutics, Inc.
[{"type":"text","content":"\nPreliminary Efficacy Signals Seen with SBP-101 Administered in Combination with Gemcitabine and Nab-paclitaxelDSMB Approves Enrollment of 3rd and Final Cohort MINNEAPOLIS, July 22, 2019 (GLOBE NEWSWIRE) -- Sun BioPharma, Inc. (OTCQB: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, today provides an update on the Company’s current clinical trial.\n Front-Line Combination Pancreatic Cancer Dose Escalation Study Following successful conclusion of the first SBP-101 dose escalation study in heavily pretreated pancreatic cancer patients that showed SBP-101 could be administered safely as monotherapy, a second Phase 1 safety study entitled, “SBP-101 Administered in Combination with Gemcitabine and Nab-paclitaxel in Newly Diagnosed Patients with Metastatic Pancreatic Ductal Adenocarcinoma” was undertaken to evaluate the addition of SBP-101 to front line gemcitabine and nab-paclitaxel treatment. Two of 3 planned cohorts receiving the combination have completed enrollment. Following review by the Data Safety Monitoring Board of cohort 2 data, approval was received to advance to the 3rd and final planned dose level of SBP-101.  To date, SBP-101, administered as a 3-drug combination, has shown no evidence of contributing to the bone marrow toxicity or peripheral neuropathy commonly seen in patients receiving gemcitabine and nab-paclitaxel treatment for pancreatic cancer. Encouraging signals of efficacy were also noted in the second cohort. Six of 6 subjects (100%) had significant decreases in CA19-9 levels during treatment, with changes from baseline ranging from 75% to 95%. The CA19-9 level changes were accompanied by RECIST tumor assessments of 4 partial responses and 2 subjects with stable disease. Dr. Suzanne Gagnon, Chief Medical Officer at Sun BioPharma, remarked, “Despite being an early phase study, we are excited about the response rate we are seeing in these subjects when given SBP-101 in addition to gemcitabine and nab-paclitaxel. Since prior reports in the literature have shown a positive correlation between CA19-9 decreases and overall survival, we have amended our study to follow the subjects for survival. As we continue to work with our excellent investigators in the USA and Australia on cohort 3, we are opening additi...