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Sun BioPharma, Inc. Announces Completion of the Fifth Patient Cohort in the Dose Escalation Phase 1a Study of SBP-101 for Pancreatic Cancer
Sun BioPharma, Inc. Announces Completion of the Fifth Patient Cohort in the Dose Escalation Phase 1a Study of SBP-101 for Pancreatic Cancer.
About this update from Panbela Therapeutics, Inc.
[{"type":"text","content":"\nNext Cohort of Patients Initiates Pathway to Determining Maximum Tolerated Dose (MTD)Summary Data of First Five Cohorts Show Efficacy SignalsMINNEAPOLIS, June 07, 2017 (GLOBE NEWSWIRE) -- Sun BioPharma, Inc. (OTCQB:SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, today announced completion of the fifth patient cohort in the dose-escalation phase of the Company’s Phase 1 clinical study using SBP-101 to treat patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDA).\nPhase 1a Trial UpdateAfter review of the fifth cohort patients by the Data Safety Monitoring Board (DSMB) it has been determined to dose the next cohort at a lower dose level in order to approach the Maximum Tolerated Dose (MTD) of SBP-101. Based on Company analysis of the safety and efficacy data from 25 patients in Cohorts 1-5, direction from the DSMB and per the approved protocol for this Phase 1a study, the next cohort of patients will consist of three patients treated at the same dose level of Cohort 4. Patients are currently being recruited for this next cohort and one patient has completed the first cycle of dosing. It is expected that this cohort of patients will be completed by August 2017.“We are encouraged by the results we are seeing in this Phase 1a study as well as  our progress in determining the MTD at this stage,” said David B. Kaysen, President and CEO of Sun BioPharma. “Determining the MTD is the goal of any Phase 1a study which will allow us to proceed with the next phase of the clinical development of SBP-101.”Review of Top-Line Interim Data“We have done a preliminary review of the patients that have been enrolled in Cohorts 1-5 of the study and are encouraged by the results we are seeing in these heavily pre-treated patients,” commented Suzanne Gagnon, M.D., Sun BioPharma’s Chief Medical Officer. “We are observing a dose-response effect on target tumor burden.”Of the 25 patients enrolled through May 15, 2017, all but one patient had received at least two prior chemotherapy regimens. In addition to assessment of safety, 20 of the 25 patients were evaluable for preliminary signals of efficacy prior to or at the eight-week conclusion of their first cycle of treatment using the Res...