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Biscayne Pharmaceuticals has closed a $1.5 million financing deal.  The new company is developing novel growth hormone-releasing hormone (GHRH) drugs based on recent discoveries by the company’s scientific advisor, Dr. Andrew V. Schally, a world-renowned drug researcher and Nobel laureate who pioneered the field of hypothalamic peptide drugs.  Biscayne also announced that it has exclusively licensed intellectual property from the University of Miami that includes worldwide rights to the Schally GHRH technology, including GHRH antagonists with potential in the treatment of cancer and GHRH agonists with potential as an innovative approach to treating heart disease.

Dr. Schally, the Distinguished Leonard M. Miller Professor of Pathology & Professor of Hematology and Oncology at the University of Miami Miller School of Medicine, was awarded the Nobel Prize in Medicine for his breakthrough work on peptide hormones and the brain.  He has had a prolific career as the inventor of many important new drugs, having discovered a number of agents based on luteinizing hormone-releasing hormone (LHRH).  Products stemming from his discoveries continue as mainstays of therapy in oncology and gynecology and generate billions of dollars in sales each year.

Dr. Schally commented, “New GHRH analogs are the latest in a line of synthetic hypothalamic hormones with potential as novel therapeutics for multiple diseases.  A number of our GHRH antagonists have demonstrated promising preclinical activity against many types of cancer, including hard-to-treat prostate cancer, and our GHRH agonists may represent a wholly new regenerative approach to treating heart disease.  GHRH analogs may also have utility in other conditions, such as Alzheimer’s disease.  I look forward to working with the accomplished team at Biscayne to advance our rich pipeline of drug candidates.”

Biscayne’s lead GHRH antagonist is in preclinical development initially for the treatment of castrate-resistant prostate cancer (CRPC), a particularly lethal form of prostate cancer affecting 30,000 new patients each year in the US.  The GHRH antagonists work through a novel pathway that reduces the levels of hormones fueling the growth of tumors.  In animal studies, these antagonists have shown promising anti-tumor activity and were synergistic with chemotherapy.  The company believes that GHRH antagonists may have therapeutic potential in many other types of tumors, including breast, brain, lung, colon and skin.

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.

In preclinical studies, GHRH agonists improved both cardiac structure and function and reduced myocardial infarct size and scarring, thereby reducing the chance of future heart failure.  Joshua M. Hare, MD, a scientific co-founder of Biscayne, who is the Louis Lemberg Professor of Medicine in the University of Miami Health System, is working with Dr. Schally to develop the GHRH technology for coronary heart disease.

Dr. Hare noted, “Despite the many advances in cardiovascular therapy, millions of patients are disabled and ultimately killed each year from cardiac damage due to coronary heart disease.  Our GHRH agonists represent a unique and powerful approach aimed at developing drugs to reduce and repair this damage.  I look forward to working with the Biscayne team to rapidly develop this approach for testing in patients.”

The Reich Group, an investment firm based in Miami Beach, Florida, led the financing.  Samuel Reich, Managing Partner of The Reich Group and formerly a founder and Executive Vice President of Acuity Pharmaceuticals and OPKO Health, is joining Biscayne Pharmaceuticals as Chief Executive Officer and Chairman of the Board of Directors.

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