Seoul, South Korea, August 15, 2014 --(PR.com
)-- CrystalGenomics, Inc., a clinical stage biopharmaceutical company headquartered in Korea, has reported a positive outcome from an investigational preclinical research conducted, in part, at the University of Texas MD Anderson Cancer Center by Dr. Raymond N. DuBois’ laboratory where the purpose of the research was to explore the potential anti-tumor effects of polmacoxib (formerly CG100649), CrystalGenomics’ novel Non-Steroidal Anti-Inflammatory Drug (NSAID) candidate with its NDA pending for an approval by the MFDS of South Korea for the relief of signs and symptoms of osteoarthritis. On December 1, 2012 Dr. DuBois Laboratory on Inflammation and Cancer relocated to the Biodesign Institute at Arizona State University in Tempe, Arizona.
The preclinical research was designed to examine the possible use of polmacoxib for both prevention and treatment of colorectal cancer (CRC). For the first part of the research, a premalignant mouse model was used to determine efficacy of polmacoxib in polyp reduction and it was observed that polmacoxib was effective in reducing the polyp number and size in both the small and large intestines in the prevention study. In the treatment study, polmacoxib demonstrated significant growth suppression of established polyps in the small intestine and also, reduction of the polyp growth in the colon. These results suggested that polmacoxib would be effective in prevention and treatment of polyps.
The second part of the study examined polmacoxib’s ability to suppress growth of human colorectal carcinoma in the subcutaneous and orthotopic xenograft mouse models. With the subcutaneous model, it was observed that treatment with polmacoxib lead to significant reduction of subcutaneous tumor growth. Similarly, it was observed that treatment with polmacoxib inhibited CRC growth in an orthotopic xenograft mouse model. Overall results from both mouse models lead to a conclusion that polmacoxib could be effective in not only prevention of CRC through reduction of premalignant polyp number and size but also, treatment of CRC by suppressing growth of malignant colonic lesions in humans. More detailed results of this preclinical research have been published in the August edition of the Investigational New Drugs Journal.
The preclinical research was conducted at the laboratory of Dr. Raymond DuBois, an internationally renowned investigator and researcher in the field of cancer, especially in the link between colorectal cancer, arthritis drugs and the cyclooxygenase-2 (COX-2) enzyme. His group was the first to demonstrate elevation of COX-2 expression in colorectal adenomas and carcinomas. Dr. DuBois had previously served as the president of the American Association for Cancer Research, provost and executive vice president of MD Anderson and currently is the Executive Director of the Biodesign Institute at Arizona State University (http://www.biodesign.asu.edu/).
Chairman & CEO of CrystalGenomics, Dr. Joong Myung Cho said, “We are extremely pleased with the outcome of this preclinical study as it provides tremendous potential for polmacoxib to become a widely prescribed drug for not only pain & inflammation associated conditions but also for oncology. It was quite exciting to work with a world renowned cancer center and to have the research led by a premier investigator. Although further clinical studies will be required for the oncology applications should we choose to pursue that path, we believe that polmacoxib is capable of making a significant contribution in the improvement of human health as there still are great unmet medical needs in the both areas of osteoarthritis and colorectal cancer.”
Polmacoxib is a first-in-class NSAID drug candidate that is a dual inhibitor of COX-2 and carbonic anhydrase (CA). Polmacoxib’s interaction with CA in red blood cells provides it with a novel "tissue-specific" transport mechanism that is designed to deliver sustained levels of drug to inflamed tissues, while maintaining low systemic exposure. After successful completion of 9 clinical studies in different parts of the globe, an NDA has been filed with the MFDS of South Korea where an approval is anticipated within this year.
CrystalGenomics Inc. is a clinical stage biopharmaceutical company focused in the discovery and development of novel drugs in therapeutic areas of unmet medical needs including inflammation, oncology and infectious disease. For more information on CrystalGenomics, please visit: www.cgxinc.com.