Emeryville, California, April 25th 2007 -- CrystalGenomics announced that the United States Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for the clinical development of its proprietary COX-2 & carbonic anhydrase inhibitor, CG100649, for the treatment of osteoarthritis, rheumatoid arthritis and acute pain.
CG100649’s unique and potent dual inhibition mechanism has been designed to achieve an optimal cardiovascular safety profile with selective and potent COX-2 inhibition specifically targeting areas of inflammation and pain.
This is CrystalGenomics’ first IND approval in United States. In Europe, CG100649 has already completed two Phase I studies in the UK, and a Phase II trial will start at multiple sites in Europe beginning 3rd Quarter this year. US Phase I study on CG100649 will initiate next month, with 48 healthy volunteers testing for safety and PK. The company plans to initiate an additional clinical safety study in North America for further safety testing with assessment of a key cardiovascular safety marker.
“The US IND approval of CG100649 is a major milestone for CrystalGenomics, and underscores the potential of CG100649 to provide an ideal efficacy and safety profile for treating osteoarthritis and painful inflammatory disorders. We are excited about launching the U.S. clinical trial of CG100649 in the coming weeks and hope to duplicate the success of the Phase I studies in the UK,” said Dr. Joong Myung Cho, Chief Executive Officer.
“We hope to follow this IND with other programs in our pipeline. Other programs are progressing well towards the clinic, and the company plans to seek partnership collaborations in the coming year,” said Paul Kim, Chief Business Officer of CG Pharmaceuticals (CrystalGenomics’ US subsidiary)
About CrystalGenomics
CrystalGenomics is a leading structure-based drug discovery company headquartered in Seoul, Korea with a US presence in Emerville, California. CrystalGenomics has assembled a diverse pipeline of novel drug discovery programs in the areas of cancer, inflammation and metabolic diseases. CrystalGenomics has, along with CG100649, two further product candidates including CG200745, an oral/IV HDAC inhibitor for cancer, and HIF(Hypoxia Inducible Factory) stabilizer compound, both of which are in pre-clinical development. The Company has established several drug discovery collaborations with Japanese Pharmas including Daiichi, Tanabe, and OncoTherapy. CrystalGenomics is publicly-held with a listing on the KOSDAQ exchange.
For further information on CrystalGenomics, please visit the Company’s website at www.cgxinc.com and www.cgpharma.com
Forward-Looking Statements This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular statements related to the research and development of CG100649 and other compounds. Such statements reflect the current views of CrystalGenomics management and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors. There can be no assurance that such development efforts will succeed, that the products will receive required regulatory clearance or, even if such regulatory clearance is received, that the subsequent products will ultimately achieve commercial success. Further, any forward-looking statements contained in this announcement speak only as of the date hereof, and CrystalGenomics expressly disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
