Biscayne Pharmaceuticals Presents Data At 2014 San Antonio Breast Cancer Symposium Further Confirming The Relevance Of Its GHRH Target In Cancer

—Expanded Data Set Confirms a Majority of Primary and Metastatic Breast Tumors Have Receptors for Growth Hormone-Releasing Hormone (GHRH)—

—Biscayne is Developing GHRH Antagonists as Novel Drugs for Breast and Other Cancers—


San Antonio, TX and Miami, FL– December 9, 2014 – Biscayne Pharmaceuticals, Inc., today announced that data further supporting the anti-cancer potential of its technology that blocks the cancer promoting effects of growth hormone-releasing hormone (GHRH) will be featured in a presentation at the 2014 San Antonio Breast Cancer Symposium.

In healthy individuals, GHRH is made in the brain and directs the pituitary to release the growth hormone needed to manage normal growth and tissue repair. Dr. Andrew V. Schally, a world-renowned drug researcher and Nobel laureate, discovered that the growth of cancer cells is also affected by GHRH. Studies in cancer models show that numerous types of cancer cells, including breast cancer, have receptors for GHRH and can also produce GHRH on their own, thereby fueling their own growth. Biscayne Pharmaceuticals has licensed rights to Dr. Schally’s GHRH discoveries and is developing GHRH antagonists that inhibit tumor growth by binding to and blocking the activity of the GHRH receptors on cancer cells.

The data will be presented by Biscayne’s Medical Director, Norman Block, MD, who is also Clinical Director of the Endocrine, Polypeptide and Cancer Institute at the Veterans Affairs Medical Center in Miami and the L. Austin Weeks Family Professor of Urologic Research at the University of Miami Miller School of Medicine. In the presentation1, Dr. Block and his colleagues report data using specimens from an expanded sample of breast cancer patients. They conclude that the majority of breast cancers in this sample were GHRH-receptor positive, including about two-thirds of all primary tumors, 86% of those primary tumors that had matched metastases and more than three-quarters of the metastatic tumors. Nearby non-cancerous tissue in these patients did not test positive for GHRH receptors, thereby confirming the validity of GHRH as a potential selective target for new breast cancer drugs.

Dr. Block, who conducts research in collaboration with Dr. Schally, commented, “This expanded study, which doubled the number of patient samples presented earlier this year, further confirms our positive findings in breast cancer patients. The results provide added clinical confidence in the relevance of the extensive body of preclinical data showing that GHRH, acting independently as a growth factor, is an important driver of breast tumor growth, and support the concept that GHRH antagonists may have potential as therapeutics for human cancers, including breast cancer. These encouraging findings further support our plans to advance our lead GHRH antagonist into human clinical trials as soon as feasible.”

Biscayne’s GHRH antagonists are in preclinical development for the treatment of cancer. In animal studies, these antagonists have shown promising anti-tumor activity with minimal side effects. The company believes that its GHRH antagonists may have therapeutic potential in many types of tumors, including breast cancer.

1. Expression of GHRH-R in Mammary Carcinoma: A Potentially Targetable Predictor

M Nadji, N Block, A V Schally, J Lara, R Michaelson, Suhail M Ali, K Leitzel and A Lipton, 2014 SABCS, Halls A-B, Poster Session 4, P4-07, 7:30-9:00 am CT, December 12, 2014.

The 2014 San Antonio Breast Cancer Symposium is presented by the Cancer Therapy & Research Center at UT Health Science Center San Antonio, the American Association for Cancer Research (AACR), and Baylor College of Medicine and will take place December 9-13, 2014. For more information visit http://www.sabcs.org/

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 biscaynepharmaceuticals.com

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