New Study Published In PNAS Shows Biscayne's GHRH Agonists Could Increase The Feasiblity Of Beta Cell Transplants To Treat Type 1 Diabetes

MIAMI, Oct. 20, 2015 /PRNewswire/ -- Biscayne Pharmaceuticals, Inc., today reported that a new study published in the current online edition of the Proceedings of the National Academy of Sciences (PNAS) shows that Biscayne's growth hormone-releasing hormone (GHRH) agonists increase the viability and functionality of pancreatic beta islet cells in multiple models of Type 1 diabetes.¹ The studies were conducted in the laboratory of Dr. Andrew V. Schally, a scientific adviser to Biscayne and Nobel laureate who is a renowned endocrine researcher and drug developer.

Dr. Stephen Collins, President and CEO of Biscayne Pharmaceuticals, noted, "Biscayne's GHRH agonists have demonstrated encouraging preclinical potential in a number of diseases, including cardiovascular disease and diabetes. This new study from Dr. Schally's lab reinforces his earlier research that suggests our GHRH agonists could contribute significantly to the feasibility of new approaches to treating diabetes by transplanting or otherwise enhancing the function of pancreatic beta islet cells."

A number of researchers are working to develop improved therapeutic strategies for the transplantation of pancreatic islet cells as a potential long-term treatment for Type 1 diabetes. In previous research, Dr. Schally and his colleagues showed that GHRH agonists could positively influence the growth, function and engraftment of islet cells in preclinical models.

In this study, the research team demonstrated that its improved GHRH agonists were able to achieve even greater therapeutic effects. In vitro treatment of pancreatic beta islet cells with the improved GHRH agonists increased cell proliferation, islet size, the expression of insulin and insulin-like growth factor-1 (IGF-1), and also stimulated insulin secretion in response to a glucose challenge. In a well-validated mouse model of Type 1 diabetes, Biscayne's GHRH agonists dramatically reduced the severity of induced diabetes in animals receiving beta cell transplants, including increasing serum insulin and IGF-1 levels and the animals' ability to achieve normal blood glucose levels and to respond to a high glucose challenge. The authors note that these findings may also have application to Type 2 diabetes.

In addition to the work being conducted by Dr. Schally in diabetes, Biscayne is developing GHRH agonists as a potential treatment for cardiac damage resulting from heart attacks and other cardiovascular disorders. Biscayne is also developing GHRH antagonists that inhibit tumor growth by blocking the activity of GHRH receptors on cancer cells. In xenograft studies, these antagonists have shown excellent safety and promising anti-tumor activity in a range of cancers, and the company believes they may have therapeutic potential in multiple types of difficult-to-treat tumors.

Biscayne has licensed rights to the GHRH discoveries of Dr. Schally's laboratory from the University of Miami.

¹ Beneficial effects of growth hormone-releasing hormone agonists on rat INS-1 cells and on streptozotocin-induced NOD/SCID mice, Xianyang Zhang, Tengjiao Cui, Jinlin He, Haibo Wang, Renzhi Cai Petra Popovics, Irving Vidaurre, Wei Sha, Janine Schmid, Barbara Ludwig, Norman L. Block, Stefan R. Bornstein and Andrew V. Schally, Early Edition: doi: 10.1073/pnas.1518540112   

About Biscayne Pharmaceuticals
Biscayne Pharmaceuticals is a clinical-stage biotechnology company developing drugs for difficult-to-treat conditions in two major disease areas: CNS disorders such as refractory epilepsy and drug-resistant cancer. Both programs are based on novel approaches with demonstrated potential for superior efficacy and safety. Lead CNS compound BIS-001 has shown striking efficacy in highly predictive models of difficult-to-treat epileptic conditions such as Complex Partial Seizures and Dravet syndrome. A Phase 1b/2a study is planned for 2016. Biscayne is also developing new cancer therapies that block growth hormone-releasing hormone (GHRH) receptors, a novel target that is present on many cancer cells. Biscayne plans to initiate IND-enabling studies for lead cancer agent BIS-1062 in the coming months. Biscayne's technology is licensed from Harvard University, the University of Miami, Yale University and the University of South Florida. Biscayne is headquartered in Miami, FL. For more information, visit biscaynepharmaceuticals.com

SOURCE Biscayne Pharmaceuticals, Inc.

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