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Sun BioPharma to Initiate Fifth Patient Cohort in its Dose Escalation Phase 1 Study of SBP-101 for Pancreatic Cancer
Sun BioPharma to Initiate Fifth Patient Cohort in its Dose Escalation Phase 1 Study of SBP-101 for Pancreatic Cancer.
About this update from Panbela Therapeutics, Inc.
[{"type":"text","content":"\n\n Data Safety Monitoring Board (DSMB) for the Study Unconditionally Approves Moving into Fifth CohortThrough Four Cohorts 15 Patients Have Received Escalating Doses of SBP-101 MINNEAPOLIS, Dec. 07, 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 Company’s clinical study, has completed its safety review of the data from cycle 1 dosing of the fourth cohort of patients. As a result of this review by the DSMB, Sun Biopharma has begun recruiting patients for the fifth patient cohort in the dose escalation phase of the study. The Company currently expects to begin dosing patients in the fifth cohort as early as December 12, 2016, which is approximately 60 days after the fourth 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 fourth group and no drug-related serious adverse events occurred. Patients are tolerating SBP-101 very well! We continued to see no evidence of bone marrow toxicity. Based on the unconditional approval by the DSMB we will immediately commence with the recruitment of the fifth cohort of patients using a higher dose of SBP-101.” “We are encouraged by the enthusiasm for our Phase 1 trial at the study sites as we continued the rapid pace of enrollment with our fourth cohort allowing us to move quickly into the fifth cohort. Through our first four cohorts, we have dosed and captured data from 15 patients, some of whom have completed multiple dosing cycles. This represents a significant base of safety data for SBP-101,” commented David B. Kaysen, President and CEO of Sun BioPharma. “We are extremely grateful for the dedication of the clinical teams at our study sites and for the patients who have volunteered to be part of our study.” Two of the Company’s study sites are in the United States: Mayo Clinic Scottsdale and HonorHealth, both in Scottsdale, AZ and three study sites are in Australia: The Ashford Cancer Centre in Adel...