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Sun BioPharma Achieves Significant Milestone with Successful Completion of Patient Enrollment in Phase 1a Dose Escalation Safety Study of SBP-101 for Patients with Pancreatic Cancer
Sun BioPharma Achieves Significant Milestone with Successful Completion of Patient Enrollment in Phase 1a Dose Escalation Safety Study of SBP-101 for Patients with Pancreatic Cancer.
About this update from Panbela Therapeutics, Inc.
[{"type":"text","content":"\n\n Updated Preliminary Top-Line Data Continue to Show Signals of Efficacy                    MINNEAPOLIS, Oct. 04, 2017 (GLOBE NEWSWIRE) -- Sun BioPharma, Inc. (OTCQB:SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, today announced the successful completion of patient enrollment in the Company’s Phase 1a dose escalation safety study using SBP-101 for patients with previously treated locally advanced or metastatic pancreatic ductal adenocarcinoma (PDA).\n Phase 1a Trial Completion of Patient Enrollment After reviewing data from the sixth and final cohort of patients, as well as data from all 29 patients enrolled in the study, the Data Safety Monitoring Board (DSMB) has recommended a safe and well-tolerated dose level of SBP-101 to be used for further clinical development.  “We were pleased to see a relatively benign safety profile at the recommended dose level,” said James Abbruzzese, MD, the study’s DSMB Chair. “With no evidence of bone marrow toxicity at the doses tested, we are comfortable supporting the testing of SBP-101 in treatment combinations.” According to Suzanne Gagnon, MD, Sun BioPharma’s Chief Medical Officer, “We are now finalizing the design of a new study to assess SBP-101 in combination with gemcitabine and nab-paclitaxel in previously untreated patients with metastatic PDA.  Enrollment is expected to begin in early 2018.” Update of Preliminary Top-Line Data Of the 29 patients enrolled in the study, all but five patients had received two or more prior chemotherapy regimens.  In addition to being evaluated for safety, 24 of the patients were evaluable for preliminary signals of efficacy prior to or at the eight-week conclusion of their first cycle of treatment.  Based upon Response Evaluation Criteria in Solid Tumors (RECIST), the current standard for evaluating changes in the size of tumors, 8 of the 24 patients (33%) had Stable Disease (SD) and 16 of 24 had Progressive Disease (PD).  Of the 28 patients who had follow-up blood tests measuring the tumor marker CA 19-9 associated with PDA, 11 (39%) had reductions in CA 19-9 levels, as measured at least once after the baseline assessment. To date, the bes...