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Sun BioPharma Receives DSMB Approval to Start Fourth Patient Cohort in the Dose Escalation Phase 1 Study of SBP-101 for Pancreatic Cancer
Sun BioPharma Receives DSMB Approval to Start Fourth Patient Cohort in the Dose Escalation Phase 1 Study of SBP-101 for Pancreatic Cancer.
About this update from Panbela Therapeutics, Inc.
[{"type":"text","content":"\n\n MINNEAPOLIS, Oct. 06, 2016 (GLOBE NEWSWIRE) -- Sun BioPharma, Inc. (OTCQB:SNBP), a biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic diseases, today announced that the Data Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the clinical trial, has completed its safety review of the data from the dosing of the third cohort of patients. As a result of this positive review by the DSMB, Sun BioPharma has initiated the fourth patient cohort in the dose escalation phase of the study. The Company currently expects to begin dosing patients in the fourth cohort as early as October 10, 2016, which is approximately 60 days after the third patient cohort commenced dosing.\n “Our safety data from this Phase 1 Study continue to be encouraging,” said Suzanne Gagnon, M.D., Sun BioPharma’s Chief Medical Officer. “Once again there were no dose-limiting toxicities in the third group and no drug-related serious adverse events occurred.  In addition, we have not observed any evidence of bone marrow toxicity. Based on the review by the DSMB we will commence with the enrollment of the next cohort of patients using a higher dose of SBP-101.” The Data Safety Monitoring Board is chaired by James Abbruzzese, MD, Professor of Medicine, member of Duke Cancer Institute and Chief, Division of Medical Oncology at Duke University School of Medicine, who is one of the foremost leaders in the clinical study and treatment of pancreatic cancer and co-chaired by Dr. David Goldstein, Conjoint Professor and a Senior Staff Specialist in the Department of Medical Oncology at Prince of Wales Hospital in Sydney, Australia who has extensively studied the influence of host cells on tumor progression in pancreatic cancer. “We are encouraged by the enthusiasm for the Phase 1 trial at our study sites as evidenced by the rapid enrollment in the third cohort and the identification and screening of potential patients for the fourth cohort,” commented David B. Kaysen, President and CEO of Sun BioPharma. “The combination of this rapid enrollment with the acceleration of the DSMB review is accelerating the pace of the study which may now complete by Q2 2017, which is significantly earlier than we had anticipated when the trial sta...