Sun BioPharma, Inc. Announces Dosing of First Patient in Phase 1 Clinical Study of SBP-101 for...
Wednesday, January 6, 2016
January 6, 2016
Sun BioPharma, Inc. Announces Dosing of First Patient in Phase 1 Clinical Study of SBP-101 for Pancreatic Cancer
-Developing a disruptive therapeutics platform targeting large unmet medical needs;
-First-in-class proprietary polyamine compound designed specifically for pancreatic disease;
-Anticipates Entering the Clinic in US during the 1H 2016
MINNEAPOLIS and MELBOURNE, Australia, Jan. 06, 2016 (GLOBE NEWSWIRE) -- Sun BioPharma, Inc. (OTCPink:SNBP), a biopharmaceutical company currently focused on developing therapies for pancreatic diseases, today announced the dosing of the first patient in a Phase 1 study evaluating the safety of SBP-101 in patients previously treated for pancreatic cancer. The Phase 1 study is a dose escalation study to determine safety and explore efficacy endpoints in patients with pancreatic ductal adenocarcinoma (PDA) who have failed prior treatment. The study is intended to enroll a maximum of 54 patients from three centers in Australia and three centers in the United States. Sun BioPharma Australia Pty Ltd, a wholly owned subsidiary of Sun BioPharma, Inc., is the sponsor of the study.
"This is a significant development for our lead drug candidate, SBP-101," commented David Kaysen, President and Chief Executive Officer of Sun BioPharma. "We anticipate enrolling patients at two other centers in Australia and expect to enter the clinic in the US during the first half of this year. We recently presented compelling preclinical data on SBP-101 at the 2015 American Pancreatic Association (APA) Annual Meeting and this data gives us confidence that our novel and disruptive approach could potentially provide relief for patients suffering from one of the deadliest forms of cancer."
The first study patient is being treated at the Adelaide Cancer Centre in Adelaide, Australia, under the direction of Associate Professor Dusan Kotasek, the Principal Investigator (PI) for the Phase 1 study. A Co-Founder of the Adelaide Cancer Centre, Dr. Kotasek has published over 60 scientific papers in oncology and he is one of Australia's leading cancer clinical research experts. "Pancreatic cancer is a most challenging disease with few significant options available that have a meaningful impact on patient survival," commented Dr. Kotasek. "We are very excited to participate in this clinical study and to evaluate the safety and potential efficacy of SBP-101 in our patients with pancreatic cancer."
"Pancreatic cancer is the third most common cause of cancer deaths in the United States and represents a significant unmet medical need, with patients having a poor prognosis and limited life expectancy," commented Suzanne Gagnon, MD, Chief Medical Officer of Sun BioPharma. "Our pre-clinical studies demonstrated compelling efficacy of SBP-101 in multiple animal models of human pancreatic cancer and we look forward to its progress in the clinic."
SBP-101 is a first-in-class proprietary polyamine compound designed to exert therapeutic effects in a mechanism specific to the pancreas. The molecule has been shown to be highly effective in human pancreatic cancer models, demonstrating superior activity to existing chemotherapy agents. Excellent potential for combination therapy for pancreatic cancer has also been demonstrated. SBP-101 is expected to hold an edge over current pancreatic cancer therapies, since it specifically targets the exocrine pancreas, sparing the insulin producing islet cells and has shown efficacy against primary and metastatic disease in animal models of human pancreatic cancer. Sun BioPharma licensed SBP-101 from the University of Florida in 2011.
About Sun BioPharma
Sun BioPharma Inc. is a next-generation biopharmaceutical company developing disruptive therapeutics for serious unmet medical needs. The company's initial programs are aimed at diseases of the pancreas, including pancreatic cancer and pancreatitis. Sun BioPharma has scientific collaborations with pancreatic disease experts at The Ohio State University, the Fred Hutchinson Cancer Center in Seattle, Translational Genomics (TGen) and the Mayo Clinic in Scottsdale, AZ, Cedars Sinai Medical Center in Los Angeles, the University of Minnesota, the Austin Health Cancer Trials Centre and the Box Hill Hospital in Melbourne, Australia, and the Adelaide Cancer Centre in Adelaide, Australia. Further information can be found at: www.sunbiopharma.com. Sun BioPharma's common stock is currently quoted on the OTCPink marketplace under the symbol: SNBP.
Forward-Looking Statements Safe Harbor
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Sun BioPharma or SBP-101, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute "forward-looking statements" For purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1955. Any statements that are not historical fact (including, but not limited to statements that contain words such as "anticipate," "believe," "expect," "intend," "potential" and "plan,") should also be considered to be forward-looking statements. Forward-looking statements involve numerous risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, the need and ability to obtain capital and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect Sun BioPharma and its business, particularly those disclosed from time to time in Sun BioPharma's filings with the Securities and Exchange Commission. Shareholders and other readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they are made. Sun BioPharma disclaims any intent or obligation to update these forward-looking statements.