GLG Pharma’s STAT3 Signaling Inhibitor Selected for NCI’s PREVENT Cancer Preclinical Drug Development Program

Jupiter, Florida July 16, 2013- GLG Pharma, LLC announces scientific and financial resources of the PREVENT Cancer program of the National Cancer Institute of the NIH have been approved to study the effects of its STAT3 signaling inhibitor, GLG-302 as a breast cancer chemopreventive. The PREVENT Program is a National Cancer Institute-supported pipeline to bring new and novel cancer preventing interventions and biomarkers through preclinical development towards clinical trials.

"The selected GLG Pharma study entitled “Evaluate GLG-302 in the Prevention of Mammary Cancers in the ER(+) Methylnitrosourea Rat Model and the ER(–) MMTV-NEU Mouse Model” using well established models of breast cancer will focus on the following areas:

1) Evaluate the MTD, effect on STAT3 in normal mammary tissue and oral efficacy of GLG-302 in mouse models of breast cancer.

2) Assess effects on tumor latency, incidence, multiplicity, and body weight.

This key study is an in-depth continuation of preliminary studies already conducted by GLG Pharma. In these studies GLG-302 was shown to suppress tumor growth in a number of animal models, to have a wide therapeutic index and was well tolerated.

In recommending approval of resources for the project, the PREVENT panel of external experts observed “This pathway is implicated in multiple cancer types. The value of the study goes beyond validating the pathway.”

According to the Centers for Disease Control and Prevention, aside from non-melanoma skin cancer, breast cancer is the most common cancer among women in the United States. It is also one of the leading causes of cancer death among women of all races. In the US in 2010, over 200,000 new cases and more than 40,000 deaths due to breast cancer occurred. The greatest achievement for this disease would be to treat high risk women who don’t have detectable breast cancer with an agent that is safe and well tolerated, and would prevent malignant conversion of normal breast cells to cancer.

Hector J. Gomez, MD, PhD, Chairman and CEO of GLG Pharma commented: “The NIH grant confirms the high level of scientific interest and the significant potential of our patented STAT3 signaling inhibitors in cancer prevention. This research program will provide important findings and form the basis for further evaluation and development of new therapeutic and chemopreventive agents in the prevention of breast and other cancers”.

About GLG Pharma

Founded in 2009 and located in Jupiter, Florida, GLG Pharma, LLC is a privately held, early stage, biotechnology company developing personalized therapies for patients with cancer and other proliferative diseases. GLG Pharma’s therapeutics are expected to aid in the treatment of a wide variety of cancers and address unmet needs in the multi-billion dollar anti-cancer market with potentially greater efficacy and fewer side effects than existing therapies. For more information on GLG Pharma visit: http://www.glgpharma.com

About NCI PREVENT

The PREVENT Cancer Drug Development Program is a National Cancer Institute-supported pipeline to bring new cancer preventing interventions and biomarkers through preclinical development towards clinical trials.

PREVENT is an active NCI partnership with successful applicants to enable the milestone-driven progression of novel cancer preventive chemical or biological agents (singly or in combination) and biomarkers from the lab bench towards proof-of principle clinical testing and registration or validation.

PREVENT is a flexible entry-point system that will optimize and test an agent depending on the stage of development, with the goal of filing an Investigational New Drug Application with the U.S. Food and Drug Administration and entering it into clinical testing. http://prevention.cancer.gov/programs-resources/programs/prevent

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