BISCAYNE PHARMACEUTICALS’ GHRH TECHNOLOGY FEATURED IN PRESENTATIONS AT INTERNATIONAL SOCIETY FOR HEART RESEARCH MEETING

—New Data Shows the Company’s Growth Hormone-Releasing Hormone (GHRH) Agonist Reduced Infarct Size and Activated Cardiac Regeneration Pathways in an Animal <b\>Model of Myocardial Infarction—</b\>

—Biscayne Scientific Advisor and Nobel Laureate Dr. Andrew V. Schally Is Presenting a Plenary Lecture Discussing His GHRH Technology Discoveries Applicable to Coronary Heart Disease, Cancer and Other Disorders, and Licensed to Biscayne—

Miami Beach and Miami, FL – May 14, 2014– Biscayne Pharmaceuticals, Inc. today announced that its growth hormone-releasing hormone (GHRH) technology will be featured in several presentations at the 35th International Society for Heart Research (ISHR) North American Section Meeting being held in Miami Beach, FL, May 12-15, 2014.

The opening plenary lecture features Dr. Andrew V. Schally, a world-renowned drug researcher and Nobel laureate who pioneered the field of hypothalamic peptide drugs. Dr. Schally is the Distinguished Leonard Miller Professor of Pathology and Professor, Division of Hematology/Oncology and Division of Endocrinology at the Miami Miller School of Medicine. He will be discussing the clinical applications of his recent discoveries regarding growth hormone-releasing hormone (GHRH).1 Rights to develop the GHRH technology have been licensed to Biscayne Pharmaceuticals by the University of Miami.

Dr. Schally notes, “Hypothalamic peptides have long been successfully translated from research into drugs that set standards of clinical care. Antagonists and agonists of GHRH have tremendous clinical potential, proven with elegant scientific studies in cancer, cardiology and other important diseases.”

Joshua M. Hare, MD, a scientific co-founder of Biscayne, who is the Louis Lemberg Professor of Medicine in the University of Miami Miller School of Medicine, is working with Dr. Schally to develop the GHRH technology for coronary heart disease.

Data from a study of Biscayne’s GHRH agonist MR-409, (BIS-5409), being presented at the ISHR meeting, shows that in a swine model of myocardial infarction, MR-409 significantly reduced infarct size and increased endothelial function compared to a placebo control group. The researchers also report that GHRH receptors were abundant in the border zone of the group treated with MR-409 compared to the placebo group, suggesting that local activation of the GHRH pathway may lead to a regenerative process in heart disease.2

Dr. Hare noted, “This encouraging study is the most recent to show that GHRH agonists may represent a unique and powerful approach to reduce and repair the cardiac damage that disables and kills millions of coronary heart disease patients each year. I look forward to working with the Dr. Schally and the Biscayne team to further develop this approach for clinical testing in patients.”

Biscayne’s lead GHRH agonists have demonstrated a unique capacity to repair the heart following ischemic injury, such as a heart attack, and are in preclinical development for the repair of damaged cardiac tissue. GHRH agonists directly activate GHRH receptors in the heart, stimulating tissue healing through a variety of mechanisms. GHRH agonists may represent a new class of therapy for cardiac conditions that presently afflict millions of patients worldwide.

Biscayne’s GHRH antagonists are in preclinical development for the treatment of cancer. The GHRH antagonists work through a novel pathway that inhibits the growth of tumors. In animal studies, these antagonists have shown promising anti-tumor activity and are synergistic with chemotherapy. The company believes that its GHRH antagonists may have therapeutic potential in many types of tumors.

  1. Dr. Andrew V. Schally, Plenary Talk: Hypothalamic Hormones: From Neuroendocrinology to Therapy of Cancer and Other Diseases, May 13, 8:00-8:45am.
  2. Dr. Luiza Lima Bagno, Reduction of Scar Tissue after GHRH--A Treatment in a Swine Model of Sub- acute Ischemic Cardiomyopathy, May 15, 4:30-6:00pm

For more information on the 35th International Society for Heart Research (ISHR), North American Section Meeting, visit here.

About Biscayne Pharmaceuticals

Biscayne Pharmaceuticals, Inc. is a privately held biopharmaceutical company discovering and developing novel therapies based on growth hormone-releasing hormone (GHRH) analogs. The company’s technology stems from the discoveries of Dr. Andrew V. Schally, a Nobel laureate and pioneering endocrine drug developer. Biscayne’s lead compounds include GHRH antagonists in development for the treatment of cancer, and GHRH agonists for the repair of cardiac damage in heart disease patients. GHRH analogs may also have utility in other conditions, such as Alzheimer’s disease. Biscayne’s technology is licensed from the University of Miami and the company is headquartered in Miami, FL. For more information, visit www.biscaynepharmaceuticals.com