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Sun BioPharma, Inc. Summarizes SBP-101 Phase 1 Clinical Data Presented at ASCO 2020 Annual Gastrointestinal Cancers Symposium
Sun BioPharma, Inc. Summarizes SBP-101 Phase 1 Clinical Data Presented at ASCO 2020 Annual Gastrointestinal Cancers Symposium.
About this update from Panbela Therapeutics, Inc.
[{"type":"text","content":"\n SBP-101 was well tolerated in combination with gemcitabine and nab-paclitaxelObjective Response Rate (ORR) was 62% by RECIST criteriaStudy expansion in patients with pancreatic cancer planned to begin in Q2 SAN FRANCISCO, Jan. 24, 2020 (GLOBE NEWSWIRE) -- Sun BioPharma, Inc. (OTCQB: SNBP), a clinical-stage biopharmaceutical company developing disruptive therapeutics for the treatment of people with pancreatic cancer, today summarized initial Phase 1  clinical data for SBP-101, which was presented in a poster session at the American Society for Clinical Oncology (ASCO) 2020 Gastrointestinal Cancers Symposium. SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI), a metabolic pathway of critical importance in cell function in multiple tumor types. Based upon the study data presented today, the adverse event profile of SBP-101 at the optimal dose level was manageable and an expansion study in patients with pancreatic ductal adenocarcinoma (PDA) is planned to begin during the second quarter of 2020. “We are excited about the early results from this Phase 1 trial, which suggest improved activity of SBP-101 in combination with gemcitabine and nab-paclitaxel, along with a  tolerable adverse event profile,” said Dr. Dusan Kotasek, Director, Clinical Research at Adelaide Cancer Centre and a key Principal Investigator in both the monotherapy and combination therapy studies of SBP-101. “Pancreatic ductal adenocarcinoma is an area of incredibly high unmet medical need, and by evaluating SBP-101 with the current standard of care, we hope to be able to offer patients an improved therapeutic option.” Preliminary Results Demonstrate Tolerability and Clinical Activity in Metastatic Treatment-Naïve Patients As of the data cut off date of January 4, 2020, the addition of SBP-101 to the combination of gemcitabine plus nab-paclitaxel did not increase the frequency of grade 3/4 hematologic adverse events, peripheral neuropathy, nausea or diarrhea when compared to historical control data for patients who were treated with gemcitabine plus nab-paclitaxel. The most common adverse events (all grades) attributed to treatment with SBP-101 were fatigue, elevated LFTs, and injection site pain. The most common grade 3/4 adverse event was elevation in liver function tests, ...