FDA Authorizes Clinical Trial - Experimental Cancer Therapy

FDA Authorizes Clinical Trial To Test Experimental Cancer Therapy.

The Buffalo (NY) Business First (7/25, Bertola, Subscription Publication) “Morning Roundup” blog reported Kinex Pharmaceuticals Inc. announced Monday that the US Food and Drug Administration has accepted its investigational new drug application, authorizing the company to “begin US-based,” Phase I clinical trials on its cancer drug Oraxol (oral paclitaxel with HM30181A). The Buffalo-based biopharmaceutical firm said Oraxol “allows for oral delivery of paclitaxel when combined with an absorption enhancer from Korea-based Hanmi Pharmaceutical Co. Ltd.” Kinex holds “global development and commercialization rights for Oraxol,” with the exception of India, Japan and Korea.