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CuraGen To Start Drug Study
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Business New Haven
3/17/2003
By: BNH
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NEW HAVEN - CuraGen Corp.'s investigational new drug application has been approved by the U.S. Food & Drug Administration (FDA), allowing the company to begin clinical trials for CG53135, a potential protein therapeutic to treat oral mucositis, a side effect of chemotherapy and radiotherapy. The company said it will start a multi-center Phase I clinical trial to evaluate safety and pharmacokinetics in patients with cancer who are at risk for mucositis following chemotherapy.
Oral mucositis results in the degradation of mucosal tissue which can range from redness and irritation to severe ulcerations of the mouth and throat. In preclinical studies, the potential protein therapeutic reduced tissue inflammation and degeneration and minimized the severity and extent of mucosal tissue damage, the company said.
"CuraGen has become one of the first genomics companies to successfully transition from a target discovery company into a genomics-based pharmaceutical company," said CuraGen CEO Jonathan M. Rothberg. "This molecule represents the first of many promising candidates that we believe will emerge from our portfolio of discovery and preclinical stage projects."
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