On May 31, 2019 CrystalGenomics, Inc. (www.cgxinc.com), a leading biopharmaceutical company developing novel small molecule therapeutics reported that it has received an approval from the Korea Food & Drug Administration (KFDA) to begin Phase I clinical study of CG200745, its novel molecular targeted cancer therapeutic (Press release, CrystalGenomics, MAY 31, 2010, View Source;id=836&page=8&num=51&nowpos=1017&type=&sermun=&qu=&tb_name=eng_news&rt_page=/en/news/news.php [SID1234539171]). This KFDA approval makes it CrystalGenomics’ second recent announcement of initiating clinical trials as it has only been 20 days since its previous announcement on plans to initiate the Phase I Multiple Ascending Dose Study for CG400549, its novel antibiotic candidate for MRSA.
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CG200745 is being developed to potentially overcome negative side effect profiles of traditional cancer therapies. One of the major flaws of traditional oncology agents is the severe toxicity issue as current agents tend to target and kill even the normal healthy cells that are around the cancerous cells. Because CG200745 has been designed to specifically target the cancerous cells, it is also referred to as a "Molecular Targeted Cancer Therapeutic" that will not harm the non-cancerous cells.
While being designed to test human safety as its primary objective, this Phase I study will also attempt to collect efficacy profiles of CG200745 on various types of cancers and also, its effects of combination therapy to see if CG200745’s co-administration will result in synergic effect of increasing effectiveness of existing cancer therapies. It is anticipated that CG200745 will be developed to treat cancer types of high incidences such as colon cancer, breast cancer, gastric cancer, and hematological cancers including lymphoma, leukemia and multiple myeloma.
Preclinical study results have confirmed CG200745’s safety profile done in Europe, and its efficacy was also demonstrated against various cancer cell lines. It was also observed that CG200745 had better efficacy profile than Merck’s recently approved Zolinza.
"We are excited to conduct our study at the Seoul Asan Medical Center, a premier hospital with one of the highest standards in Korea. We are highly optimistic moving forward and look forward to the opportunity to provide new hope and improved quality of life for many suffering cancer patients," commented Dr. Joong Myung Cho, President & CEO of CrystalGenomics.